chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Rash began on 01/05/2005 c/o itching and rash spreading. Child was exposed to varicella about 2 weeks ago.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Rash pruritic
Clinical narrative: Left arm red, swollen, hot and with cluster patch. Pt states it itches.
Age: 10.0
Sex: F
Vaccine: TTOX
Symptoms: Abscess, Injection site erythema, Injection site oedema, Skin nodule, Tenderness
Clinical narrative: Possible febrile abscess-red, tender, swollen (small apple) at injection site, improved with symptoms therapy. Afebrile. Resolved over 5 days, now small nodule (01/06/05).
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Erythema, Irritability, Pyrexia, Rash maculo-papular, Rhinorrhoea
Clinical narrative: Pt contracted measles (rubeola) after receiving MMR
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Viral infection
Clinical narrative: Pt contracted measles (rubeola) after receiving MMR
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis
Clinical narrative: Cellulitis, treated with Keflex x 10 days
Age: 26.0
Sex: F
Vaccine: IPV, TD, TYP, UNK
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt reports onset of pruritus 12/20/04 and urticaria 12/21/04. Evaluated in ED, treated with Prednisone 60mg qd, Vanitidin 150 bid, Benadryl prn
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Parotid gland enlargement
Clinical narrative: Bilateral parotid swelling 15 days after MMR and HBC 3
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Left arm redness and swollen- antibiotic given Keflex
Age: 1.83
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Vaccines administered 11/03/2004 did well that night. Next day about 1:00PM (11/4/04). Started running high Temp about 103. Had seizure, mom took to ER.
Age: 1.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Rash maculo-papular, Rash vesicular
Clinical narrative: Received at 1 year old check up, DTP, MMR, Varivax, PPD test. Noted maculopapular and vesicular rash on back of right leg. 1 week after immunization treatment. Benadryl PO
Age: 1.1
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Injection site pain, Injection site rash, Viral infection
Clinical narrative: Painful rash right thigh
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Left upper arm red and swollen and warm. Pt's mother was instructed to give Motrin and apply ice packs. Also was given cephalexin.
Age: 1.02
Sex: F
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Skin nodule
Clinical narrative: Rt varicella vaccine given 12/16/04 reaction came out red with a bump x3wks.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: 2nd Hep B vaccination on 12/17/04, left deltoid arm, shoulder pain
Age: 84.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Anaphylactic reaction, Apnoea, Cardiac arrest, Coma, Hyperglycaemia
Clinical narrative: Cardiac arrest with CPR/cardioversion and ICU care for 5 days. Discharge Summary received on 1/12/2005 states pt experienced ventricular fibrillation and was unresponsive.
Age: 84.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Hypokalaemia, Leukocytosis, Liver function test abnormal, Myocardial infarction, Oedema peripheral
Clinical narrative: Cardiac arrest with CPR/cardioversion and ICU care for 5 days. Discharge Summary received on 1/12/2005 states pt experienced ventricular fibrillation and was unresponsive.
Age: 84.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Pneumonia, Stupor, Tongue oedema, Ventricular fibrillation
Clinical narrative: Cardiac arrest with CPR/cardioversion and ICU care for 5 days. Discharge Summary received on 1/12/2005 states pt experienced ventricular fibrillation and was unresponsive.
Age: 84.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Dyspnoea, Loss of consciousness, Malaise, Pulse absent
Clinical narrative: Cardiac arrest with CPR/cardioversion and ICU care for 5 days. Discharge Summary received on 1/12/2005 states pt experienced ventricular fibrillation and was unresponsive.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Circulatory collapse, Dehydration, Drug ineffective, Lung infiltration, Pneumonia
Clinical narrative: Information was reported in a letter to the editor concerning a 24 year old resident of developmental center with panhyopituitarism, who had been previously vaccinated against all childhood diseases and had serosusceptibility to varicella who was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. Concomitant therapy included 22.5mg/d of hydrocortisone. After 18 days the pt had a fever of 38 to 39 degrees C and a maculopapular rash on her trunk. On day 19, the papules changed to monolocular collapsing vesicles. On day 20, a similar rash appeared on her extremities and face. Successive crops of rash resulted in the presence of several stages of vesicle maturation. The total number of lesions was estimated to be 150 to 200 and it was reported that she had chickenpox. On day 21, she developed more skin lesions and her temp rose to 39degrees C with mild dehydration. A chest radiograph revealed a right basilar pulmonary infiltrate. It was reported that the pt had pneumonia. From day 21 to day 29 the pt was hospitalized in an isolation room with negative pressure to prevent airborne viral transmission and received 1260 mg/d of acyclovir intravenously. It was reported that the pt eventually recovered. The reporter felt that the most likely cause of this illness was the vaccination because of its temporal consistency with the incubation period of varicella (14 to 21 days) and the lack of any contemporary cases of wild type varicella among staff or other residents. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash maculo-papular, Viral infection
Clinical narrative: Information was reported in a letter to the editor concerning a 24 year old resident of developmental center with panhyopituitarism, who had been previously vaccinated against all childhood diseases and had serosusceptibility to varicella who was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. Concomitant therapy included 22.5mg/d of hydrocortisone. After 18 days the pt had a fever of 38 to 39 degrees C and a maculopapular rash on her trunk. On day 19, the papules changed to monolocular collapsing vesicles. On day 20, a similar rash appeared on her extremities and face. Successive crops of rash resulted in the presence of several stages of vesicle maturation. The total number of lesions was estimated to be 150 to 200 and it was reported that she had chickenpox. On day 21, she developed more skin lesions and her temp rose to 39degrees C with mild dehydration. A chest radiograph revealed a right basilar pulmonary infiltrate. It was reported that the pt had pneumonia. From day 21 to day 29 the pt was hospitalized in an isolation room with negative pressure to prevent airborne viral transmission and received 1260 mg/d of acyclovir intravenously. It was reported that the pt eventually recovered. The reporter felt that the most likely cause of this illness was the vaccination because of its temporal consistency with the incubation period of varicella (14 to 21 days) and the lack of any contemporary cases of wild type varicella among staff or other residents. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Oedema
Clinical narrative: Pt had flu shot in morning, has had flu shots before with no problems, not allergic to eggs. Had no symptoms until evening while eating supper blisters formed at back and top of mouth and started swelling. Called her sister because concerned about breathing. Sister came immediately. Blister broke and bled about 1/2 cup blood, no other symptoms or swelling. Pt went to ER, ER did not know what caused blister. Pt saw an oral surgeon the next day and he said it might have been flu shot. Pt would not give name of the doctor. Called pt to make sure she was ok she said yes, the blister is healing. She said who the oral surgeon was. He gave her amoxicillin, prednisone, and nystatin mouth wash.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Malaise, Pyrexia, Tenderness
Clinical narrative: With 24 hours of Pneumovax developed severe redness on arm and tenderness (at injection site), plus fever/ malaise above 101F, was reported in case this lot for some reason was affected somehow, since usually reactions I've seen are not this bad.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Contusion, Injection site pain, Muscle twitching
Clinical narrative: 12/21/04 phone call from pt stating right upper arm is hurting, muscle is twitching with red, blue and purple bruising approx 1" wide and 23" long starting at injection site, denies memory of injury, states is working with use. Reviewed VIS, referred to family Dr.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Dry skin, Injection site erythema, Pruritus, Rash
Clinical narrative: About 4 hours after receiving Hep B vaccine, he developed a red, sandpaper texture rash on his face and he complained that it itched.
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: 2x2 inch circular red, warm to touch on right upper thigh. Tx: Benadryl, cold compress
Age: 16.0
Sex: F
Vaccine: HEP, IPV, MMR, TD
Symptoms: Facial palsy, Hypoaesthesia
Clinical narrative: Child from out of country, no shot records avail. Must have Imms to attend school. 9/10/04 received MMR, HepB1,IPV1,Td1 9/15/04 Patient had + PPD @ 20mm 9/23/04 Cxr/LFTs OK. Daily INH prophylaxis start. 10/12/04 received MMR2, HepB2, IPV2,TD2 10/16/04 LFTs WNL 10/20/04 exam WNL Continues INH daily 12/23/04 presented with right facial droop & Numbness.  Stopped INH, started eye lubrication & protection. Diagnosed Bell's Palsy. No history of tick bite. 12/24 labs WNL 1/3/05 about 50% resolution of symptoms. 1/10/05 about 90% resolution, able to close eye now, though weaker than other. Will continue followup and repeat lymes x1 at 4-6 weeks.
Age: 63.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Flushing, Headache
Clinical narrative: About 15 minutes after receiving the vaccine, while driving, developed a severe case of dizziness and felt flush.  Only lasted about 2 minutes.  Later that day, developed a headache
Age: 0.91
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Hypersensitivity, Nausea, Rash, Vomiting
Clinical narrative: Two days after receiving influenza vaccine the child developed a rash around his mouth.  Mother reports that he also became nauseated and began vomiting. Reports that he also developed diarrhea at this time. Reports that she took him to his physician two days later and was diagnosed with egg allergy by "blood testing."  No medication was provided by physician or any further treatment. Family has now moved and may be reached at the above cell phone number.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Abnormal behaviour, Lethargy
Clinical narrative: Mother reported that soon after his vaccine he was "lethargic".  She states that we did not respond as usual for several hours.  He did eat normally.  He has acted normally since that time.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: "Pain, swelling, and redness at the site of the pneumonia shot and going down arm. He received pneumovax 1/11/05 ,developed the above has been going down but still there,he denies fever and chills. Hx pneumovax in the past with no side effects,denies itching at the site."  Previous is copied from physician note. Arm appeared swollen about half way from elbow to wrist, with erythema.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR, PPV
Symptoms: Face oedema, Oedema
Clinical narrative: Pt had immediate swelling in deltoid shot was given.  Pt also had swelling in his lips. 2nd MMR was given sq in same arm as 1st pneumococcal polysaccharide IM.  Both in right arm.  Left arm 4th IPV was given sq and 5th Dtap was given IM.  Due to reaction Benedryl 12.5mg was given IM in right thigh.  No further reactions have occurred.  Benedryl brought down all swelling.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection given 1/10/05 - swelling and redness about 2.5 inches on 1/11/05 - additional swelling, redness and warmth to touch late 1/12/05 and 1/13/05 to double in size. On 1/13/05 patient was sent to be seen in the ER for tmt of symptoms
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Condition aggravated, Eczema, Erythema
Clinical narrative: Pt reports a history of eczema since childhood. He states that every winter he has eczema on his arms, legs, and trunk and controls it with a humidifier in his home and the use of Eucerin cream and lotions. He states that his eczema clears in the spring when he no longer has to heat his home. Rash had cleared for this year.    04 Apr 04 he received anthrax # 1: approx 8 days later he noticed red marks in the folds of his arms and neck. Area on his neck was from his chin to his chest and was 3-4 inches across the front of his neck. He used lotion, which helped. He stated he noticed a lot of itching on his neck. Pt reported that he never had eczema on his neck before and was not sure if this redness on his neck was even eczema as it was unlike his previous eczema flares. States the area was almost cleared when he got his second anthrax.  28 Apr 04 he received anthrax #2: one week later he reported eczema on every finger from his knuckle to the tip of his finger and on his rt arm extensor surface near his elbow. He has never had lesions in these areas before.  By 12 May all lesions have cleared completely.  Follow up call on 13 Jan 05 post deployment: No further outbreaks other than his usual winter outbreaks.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Immune system disorder, Laboratory test abnormal, Malaise
Clinical narrative: Fainted at first vaccine, felt progressively sicker through series.  Ended up with many issues including fatigue and auto-immune issues.
Age: 1.34
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: PATIENT DEVELOPED GIANT HIVES BILATERALLY ON LEGS AND TORSO, SIX HOURS POST INJECTION OF DOSE NUMBER TWO OF INFLUENZA VACCINE.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, CSF test abnormal, Chest discomfort, Dyspnoea, Faecal incontinence
Clinical narrative: Monday, December 20, 2004 patient received his flu shot.  On Wednesday, December 22, 2004 he began having symptoms of tingling and numbness in hands and feet, severe sensitivity to cold (tap water felt icy), tightness in leg muscles, tightness in chest, shortness of breath, unable to stand at times, unable to walk at times, headache, severe upper back pain.  He was admitted to hospital on December 25, 2004 through the ER.  He received MRIs, EMG, numerous blood tests.  On Tuesday, December 28, 2004 the back pain was tolerable and walking with assistance.  The doctors said it was a "clinical diagnosis" and discharged him to home without any medications.  The evening of December 28, 2004 the pain returned.  He was admitted to another hospital through the ER on Wednesday, December 29, 2004.  The severe pain persisted.  MRIs, flat plate of abdomen, spinal tap, blood tests were done.  Spinal tap showed high protein levels in the spinal fluid and a definite diagnosis of Guillain-Barre Syndrome was determined. Pain finally became managable and pt was discharged to home on Wednesday, January 12, 2005 with pain medication, Prednisone, Nexium and Duragesic patch and Physical Therapy.   2/7/05 Medical Records of 12/29/2004-1/11/2005 received.   FINAL DX: Guillain Barre syndrome Records state pt experienced HA & tingling in toes on 12/22/04 that progressed to back pain, stumbling and spincter control diminished.  Admitted to outlying hospital 12/27-12/27, Neuro & cardio consults done, MRI of brain & spine WNL, EMG mildly abnormal, but pt improved & d/c to home.  Then back pain acutely worsened, paresthesias of LEs continued & readmitted to higher level of care.  Neuro consult & LP done.  Reflexes decreased.  Improved & d/c to inpatient rehab.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Gait disturbance, Guillain-Barre syndrome, Headache, Hypersensitivity, Hypoaesthesia
Clinical narrative: Monday, December 20, 2004 patient received his flu shot.  On Wednesday, December 22, 2004 he began having symptoms of tingling and numbness in hands and feet, severe sensitivity to cold (tap water felt icy), tightness in leg muscles, tightness in chest, shortness of breath, unable to stand at times, unable to walk at times, headache, severe upper back pain.  He was admitted to hospital on December 25, 2004 through the ER.  He received MRIs, EMG, numerous blood tests.  On Tuesday, December 28, 2004 the back pain was tolerable and walking with assistance.  The doctors said it was a "clinical diagnosis" and discharged him to home without any medications.  The evening of December 28, 2004 the pain returned.  He was admitted to another hospital through the ER on Wednesday, December 29, 2004.  The severe pain persisted.  MRIs, flat plate of abdomen, spinal tap, blood tests were done.  Spinal tap showed high protein levels in the spinal fluid and a definite diagnosis of Guillain-Barre Syndrome was determined. Pain finally became managable and pt was discharged to home on Wednesday, January 12, 2005 with pain medication, Prednisone, Nexium and Duragesic patch and Physical Therapy.   2/7/05 Medical Records of 12/29/2004-1/11/2005 received.   FINAL DX: Guillain Barre syndrome Records state pt experienced HA & tingling in toes on 12/22/04 that progressed to back pain, stumbling and spincter control diminished.  Admitted to outlying hospital 12/27-12/27, Neuro & cardio consults done, MRI of brain & spine WNL, EMG mildly abnormal, but pt improved & d/c to home.  Then back pain acutely worsened, paresthesias of LEs continued & readmitted to higher level of care.  Neuro consult & LP done.  Reflexes decreased.  Improved & d/c to inpatient rehab.
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Hypokinesia, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: Monday, December 20, 2004 patient received his flu shot.  On Wednesday, December 22, 2004 he began having symptoms of tingling and numbness in hands and feet, severe sensitivity to cold (tap water felt icy), tightness in leg muscles, tightness in chest, shortness of breath, unable to stand at times, unable to walk at times, headache, severe upper back pain.  He was admitted to hospital on December 25, 2004 through the ER.  He received MRIs, EMG, numerous blood tests.  On Tuesday, December 28, 2004 the back pain was tolerable and walking with assistance.  The doctors said it was a "clinical diagnosis" and discharged him to home without any medications.  The evening of December 28, 2004 the pain returned.  He was admitted to another hospital through the ER on Wednesday, December 29, 2004.  The severe pain persisted.  MRIs, flat plate of abdomen, spinal tap, blood tests were done.  Spinal tap showed high protein levels in the spinal fluid and a definite diagnosis of Guillain-Barre Syndrome was determined. Pain finally became managable and pt was discharged to home on Wednesday, January 12, 2005 with pain medication, Prednisone, Nexium and Duragesic patch and Physical Therapy.   2/7/05 Medical Records of 12/29/2004-1/11/2005 received.   FINAL DX: Guillain Barre syndrome Records state pt experienced HA & tingling in toes on 12/22/04 that progressed to back pain, stumbling and spincter control diminished.  Admitted to outlying hospital 12/27-12/27, Neuro & cardio consults done, MRI of brain & spine WNL, EMG mildly abnormal, but pt improved & d/c to home.  Then back pain acutely worsened, paresthesias of LEs continued & readmitted to higher level of care.  Neuro consult & LP done.  Reflexes decreased.  Improved & d/c to inpatient rehab.
Age: 16.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Infection transmission via personal contact, Pruritus, Rash, Viral infection
Clinical narrative: PATIENT'S SISTER (AGE 20) CAME DOWN WITH A CASE OF CHICKEN POX (SHE HAD ITCHING BUMPS ALL OVER HER THAT BECAME SCABS) AND THEN HER BOYFRIEND GOT IT FROM HER BY REPORT OF THE MOTHER.
Age: 40.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Dizziness, Dyspnoea, Heart rate increased, Pallor
Clinical narrative: Dizziness, difficulty breathing, wheezing, paleness, weak, fast heart beat. This occurred about an hour after being administered the flumist vaccine. I was told by nurse that even if I have asthma I could still have vaccine as long as I'm taking medication for asthma.
Age: 40.0
Sex: F
Vaccine: FLUN3
Symptoms: Wheezing
Clinical narrative: Dizziness, difficulty breathing, wheezing, paleness, weak, fast heart beat. This occurred about an hour after being administered the flumist vaccine. I was told by nurse that even if I have asthma I could still have vaccine as long as I'm taking medication for asthma.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Atelectasis, Convulsion, Cough, Drug ineffective, Dyspnoea
Clinical narrative: Patient experienced fever, cough and seizure. Discharge Summary received on 2/7/2005 states SOB and myalgia. Medical Records received on 2/7/2005 states atelectasis.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperglycaemia, Influenza, Myalgia, Pyrexia
Clinical narrative: Patient experienced fever, cough and seizure. Discharge Summary received on 2/7/2005 states SOB and myalgia. Medical Records received on 2/7/2005 states atelectasis.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Eye swelling, Pruritus, Urticaria
Clinical narrative: Started with itching of stomach, progressed to swelling of left eye (swollen shut) and hives all over body with itching. Entire event occurred within 30 minutes. 911 was called, patient was given a dose of Benadryl and Albuterol nebulizer treatment.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Fever of 102 degrees, macular papular rash over face, trunk, arms and legs. Symptoms lasted 4 days, treated with Palgic 4mg qd, Cortane B lotion and Tylenol. Full recovery noted.
Age: 38.0
Sex: U
Vaccine: VARCEL
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: Miserable with fever on Sunday. Skin lesions started on Tuesday, which are mostly red a few are papular.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Injection site erythema
Clinical narrative: A 4 year old was given DTaP in the left arm IM and Prevnar in the right are IM on 01/11/05 She was seen on 01/13/05 with localized red rash on the left arm (7x6cm) and right arm (5x4cm). Left arm rash started evening of 01/12/05 and right arm rash the morning of 01/13/05.
Age: 0.56
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, IPV
Symptoms: Flushing, Injection site erythema, Injection site swelling
Clinical narrative: Immediately after child received immunizations, there was generalized flushing of face and body. The IPV injection site had a red appearance with swelling measuring approximately 20-23cm. No respiratory distress present. Ice pack applied to site for 10 minutes. Mother and child waited in the health department, redness and swelling subsided without further swelling.  HR 120 R/S, RSP 26 even
Age: 0.56
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, IPV
Symptoms: Injection site oedema
Clinical narrative: Immediately after child received immunizations, there was generalized flushing of face and body. The IPV injection site had a red appearance with swelling measuring approximately 20-23cm. No respiratory distress present. Ice pack applied to site for 10 minutes. Mother and child waited in the health department, redness and swelling subsided without further swelling.  HR 120 R/S, RSP 26 even
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: DTaP immunization administered to left deltoid IM, with ETOH prep to site before each immunization was administered. The patient was restrained properly by his mother to prevent patient from moving and getting possibly scratched by the needle. No incident occurred during administration of immunizations. Mom brought patient in 01/12/05 with redness and swelling to left deltoid, warm to touch. No fever measured at time of visit.  Doctor examined patient and indicates doing well on 01/13/05.
Age: 25.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Lymphangitis, Pyrexia
Clinical narrative: Redness, warmth, and fever 2 days after vaccine.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Immune system disorder, Influenza like illness, Malaise, Myalgia, Nausea
Clinical narrative: A report was received from a foreign regulatory authority on 4/3/01 concerning a 70 year old female patient who experienced influenza-like symptoms and an SLE reaction, which resulted in hospitalization on 10/7/00 after receiving the Fluvirin vaccine. The patient had a history of essential thrombocytosis and hypertension. The patient had experienced symptoms of malaise, myalgia, fever, and nausea in conjunction with the influenza vaccination for several years. The patient was received felodipine, propranolol, aspirin, bendrofumethiazide and hydroxycarbamide concomitantly. On 10/2/00, the patient received the Fluvirin vaccine. On 10/7/00, the patient experienced influenza like symptoms and a SLE reaction. She developed the same symptoms as with previus vaccinations but her complaints increased. She had peaks of fever, symptoms from the lungs and hepatic influence. Investigation showed symptoms similar to SLE. She improved quickly after treatment with unspecified corticosteroids. The patient recovered without sequelae from the influenza like symptoms but the SLE reaction is persisting. The reporter assessed the relationship of the Fluvirin vaccine to the Influenza like symptoms as probable due to connection in time and similar cases and to the SLE reaction as possible due to similar cases.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: A report was received from a foreign regulatory authority on 4/3/01 concerning a 70 year old female patient who experienced influenza-like symptoms and an SLE reaction, which resulted in hospitalization on 10/7/00 after receiving the Fluvirin vaccine. The patient had a history of essential thrombocytosis and hypertension. The patient had experienced symptoms of malaise, myalgia, fever, and nausea in conjunction with the influenza vaccination for several years. The patient was received felodipine, propranolol, aspirin, bendrofumethiazide and hydroxycarbamide concomitantly. On 10/2/00, the patient received the Fluvirin vaccine. On 10/7/00, the patient experienced influenza like symptoms and a SLE reaction. She developed the same symptoms as with previus vaccinations but her complaints increased. She had peaks of fever, symptoms from the lungs and hepatic influence. Investigation showed symptoms similar to SLE. She improved quickly after treatment with unspecified corticosteroids. The patient recovered without sequelae from the influenza like symptoms but the SLE reaction is persisting. The reporter assessed the relationship of the Fluvirin vaccine to the Influenza like symptoms as probable due to connection in time and similar cases and to the SLE reaction as possible due to similar cases.
Age: 7.0
Sex: M
Vaccine: FLU3, PNC
Symptoms: Influenza like illness, Lethargy, Nausea, Vomiting
Clinical narrative: A report was received from a health professional on 4/9/01 concerning a 7 year old male patient who experienced flu-like symptoms, severe nausea, vomiting, and lethargy 1 day after receiving the Fluvirin vaccine, IM, on 3/1/01 (batch # E73100LA) which lead to hospitalization. The patient has a relevant medical history of sickle cell disease. The patient received a dose of Prevnar concomitantly. On 3/2/01 the patient experienced a syndrome of events including flu-like symptoms, severe nausea/vomiting, and lethargy for the duration of one week. The patient was not fully ambulatory and required inpatient hospitalization. The reporter was unsure of the duration of hospitalization. The patient was eventually discharged without further complications. After this adverse experience the physician noticed that his current stock of Fluvirin vaccines had partially crystalized. The reporter noted that the storage temperature was 33 degrees F, below the recommended 36-46 degrees F for this product. It was recommended that the remainder of the physician's stock be discarded. There was insufficient information to determine the causality assessment of the reporter.
Age: 43.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Injection site reaction, Injection site swelling, Pyrexia, Tachycardia
Clinical narrative: A report was received from a health professional on 05/01/2001, concerning a 43 year old male patient who experienced tachycardia, fever and injection site reaction a day after receiving the Fluvirin vaccine and PNU-Imme-23 vaccination on 12/05/2000. On 12/06/2000, the patient experienced a tachycardia, and a fever of 99.8 degrees.  He also developed an injection site reaction characterized by swelling and warmth.  His blood pressure was 112/74 mmHg.  The patient recovered. There was insufficient information to determine the reporter's causality assessment.
Sex: M
Vaccine: FLUX
Symptoms: Arteritis, Asthenia, Conjunctival oedema, Exophthalmos, Eyelid ptosis
Clinical narrative: A literature report was received on 13Jun01, concerning a 70 year old male pt who experienced giant cell arteritis which led to hospitalization immediately after receiving influenza vaccine on an unk date. On an unk date, the pt developed a common cold with headache which he was able to relieve with aspirin. Despite this infection he was vaccinated against influenza 5 days after the onset of symptoms. Immediately after vaccination he developed a newly located severe headache, fever, facial oedema and high blood pressure. Ten days after vaccination, his headache became so severe that he had to be hospitalized. Initially, only chemosis and facial oedema were found. The C-reactive protein level was 29.5 mg/dL (reference value, less than 1 mg/dL). His headache was relieved with opiates, but antibiotics were ineffective. On the third day of hospitalization, he also developed blurred vision, proptosis, pain on eye movements, and weakness of the right upper limb. Magnetic sodium (1000 IU/d) was begun. On the fifth day of hospitalization, the pt developed proptosis and chemosis of the right eye, bilateral ptosis, spontaneous nystagmus, weakness of the right abducens muscle, ad peripheral facial palsy on the right side, and his visual acuity further deteriorated. The C-reactive protein level further increased, and levels of thrombocytes and immunoglobulins were elevated in samples of serum and cerebrospinal fluid. The blood sedimentation rate was 94/92 mm/h. Cerebral angiography on the eleventh day of hospitalization revealed recanalized carvernous sinus thrombosis and tortuous temporal arteries, which, along with the clinical and laboratory findings, led the physician to the suspicion of arteritis temporalis. Giant cell arteritis was confirmed by the temporal artery biopsy findings. Overall 4 of the 5 criteria were fulfilled. Treatment with antibiotics and heparin was discontinued. Corticosteroid therapy was initiated and relieved all the described abnormalities during the following days. The pt's recovery was almost complete. All previous serological abnormalities had normalized. Only slight weakness of the right upper extremity persisted.  The reporter had assessed the relationship of the influenza vaccine to the event as likely. That the common preceding vaccination contributed to the GCA was also stated to be quite likely. The physician stated that it can not be definitely excluded that the influenza-like symptoms at the onset were already the initial manifestation of GCA. The physician stated that the GCA was responsible for most of the abnormal findings although it could not be definitely excluded that facial nerve palsy and plexopathy were due to the initial vial infection before the vaccination. Impaired visual acuity, bilateral ptosis, abducens paresis, proptosis and facial oedema were assumed to have been caused by the carvernous sinus thrombosis.
Sex: M
Vaccine: FLUX
Symptoms: Face oedema, Headache, Hypertension, Laboratory test abnormal, Nystagmus
Clinical narrative: A literature report was received on 13Jun01, concerning a 70 year old male pt who experienced giant cell arteritis which led to hospitalization immediately after receiving influenza vaccine on an unk date. On an unk date, the pt developed a common cold with headache which he was able to relieve with aspirin. Despite this infection he was vaccinated against influenza 5 days after the onset of symptoms. Immediately after vaccination he developed a newly located severe headache, fever, facial oedema and high blood pressure. Ten days after vaccination, his headache became so severe that he had to be hospitalized. Initially, only chemosis and facial oedema were found. The C-reactive protein level was 29.5 mg/dL (reference value, less than 1 mg/dL). His headache was relieved with opiates, but antibiotics were ineffective. On the third day of hospitalization, he also developed blurred vision, proptosis, pain on eye movements, and weakness of the right upper limb. Magnetic sodium (1000 IU/d) was begun. On the fifth day of hospitalization, the pt developed proptosis and chemosis of the right eye, bilateral ptosis, spontaneous nystagmus, weakness of the right abducens muscle, ad peripheral facial palsy on the right side, and his visual acuity further deteriorated. The C-reactive protein level further increased, and levels of thrombocytes and immunoglobulins were elevated in samples of serum and cerebrospinal fluid. The blood sedimentation rate was 94/92 mm/h. Cerebral angiography on the eleventh day of hospitalization revealed recanalized carvernous sinus thrombosis and tortuous temporal arteries, which, along with the clinical and laboratory findings, led the physician to the suspicion of arteritis temporalis. Giant cell arteritis was confirmed by the temporal artery biopsy findings. Overall 4 of the 5 criteria were fulfilled. Treatment with antibiotics and heparin was discontinued. Corticosteroid therapy was initiated and relieved all the described abnormalities during the following days. The pt's recovery was almost complete. All previous serological abnormalities had normalized. Only slight weakness of the right upper extremity persisted.  The reporter had assessed the relationship of the influenza vaccine to the event as likely. That the common preceding vaccination contributed to the GCA was also stated to be quite likely. The physician stated that it can not be definitely excluded that the influenza-like symptoms at the onset were already the initial manifestation of GCA. The physician stated that the GCA was responsible for most of the abnormal findings although it could not be definitely excluded that facial nerve palsy and plexopathy were due to the initial vial infection before the vaccination. Impaired visual acuity, bilateral ptosis, abducens paresis, proptosis and facial oedema were assumed to have been caused by the carvernous sinus thrombosis.
Sex: M
Vaccine: FLUX
Symptoms: Paralysis, Pharyngitis, Pyrexia, Rhinitis, Thrombosis
Clinical narrative: A literature report was received on 13Jun01, concerning a 70 year old male pt who experienced giant cell arteritis which led to hospitalization immediately after receiving influenza vaccine on an unk date. On an unk date, the pt developed a common cold with headache which he was able to relieve with aspirin. Despite this infection he was vaccinated against influenza 5 days after the onset of symptoms. Immediately after vaccination he developed a newly located severe headache, fever, facial oedema and high blood pressure. Ten days after vaccination, his headache became so severe that he had to be hospitalized. Initially, only chemosis and facial oedema were found. The C-reactive protein level was 29.5 mg/dL (reference value, less than 1 mg/dL). His headache was relieved with opiates, but antibiotics were ineffective. On the third day of hospitalization, he also developed blurred vision, proptosis, pain on eye movements, and weakness of the right upper limb. Magnetic sodium (1000 IU/d) was begun. On the fifth day of hospitalization, the pt developed proptosis and chemosis of the right eye, bilateral ptosis, spontaneous nystagmus, weakness of the right abducens muscle, ad peripheral facial palsy on the right side, and his visual acuity further deteriorated. The C-reactive protein level further increased, and levels of thrombocytes and immunoglobulins were elevated in samples of serum and cerebrospinal fluid. The blood sedimentation rate was 94/92 mm/h. Cerebral angiography on the eleventh day of hospitalization revealed recanalized carvernous sinus thrombosis and tortuous temporal arteries, which, along with the clinical and laboratory findings, led the physician to the suspicion of arteritis temporalis. Giant cell arteritis was confirmed by the temporal artery biopsy findings. Overall 4 of the 5 criteria were fulfilled. Treatment with antibiotics and heparin was discontinued. Corticosteroid therapy was initiated and relieved all the described abnormalities during the following days. The pt's recovery was almost complete. All previous serological abnormalities had normalized. Only slight weakness of the right upper extremity persisted.  The reporter had assessed the relationship of the influenza vaccine to the event as likely. That the common preceding vaccination contributed to the GCA was also stated to be quite likely. The physician stated that it can not be definitely excluded that the influenza-like symptoms at the onset were already the initial manifestation of GCA. The physician stated that the GCA was responsible for most of the abnormal findings although it could not be definitely excluded that facial nerve palsy and plexopathy were due to the initial vial infection before the vaccination. Impaired visual acuity, bilateral ptosis, abducens paresis, proptosis and facial oedema were assumed to have been caused by the carvernous sinus thrombosis.
Sex: M
Vaccine: FLUX
Symptoms: Viral infection, Vision blurred, Visual disturbance
Clinical narrative: A literature report was received on 13Jun01, concerning a 70 year old male pt who experienced giant cell arteritis which led to hospitalization immediately after receiving influenza vaccine on an unk date. On an unk date, the pt developed a common cold with headache which he was able to relieve with aspirin. Despite this infection he was vaccinated against influenza 5 days after the onset of symptoms. Immediately after vaccination he developed a newly located severe headache, fever, facial oedema and high blood pressure. Ten days after vaccination, his headache became so severe that he had to be hospitalized. Initially, only chemosis and facial oedema were found. The C-reactive protein level was 29.5 mg/dL (reference value, less than 1 mg/dL). His headache was relieved with opiates, but antibiotics were ineffective. On the third day of hospitalization, he also developed blurred vision, proptosis, pain on eye movements, and weakness of the right upper limb. Magnetic sodium (1000 IU/d) was begun. On the fifth day of hospitalization, the pt developed proptosis and chemosis of the right eye, bilateral ptosis, spontaneous nystagmus, weakness of the right abducens muscle, ad peripheral facial palsy on the right side, and his visual acuity further deteriorated. The C-reactive protein level further increased, and levels of thrombocytes and immunoglobulins were elevated in samples of serum and cerebrospinal fluid. The blood sedimentation rate was 94/92 mm/h. Cerebral angiography on the eleventh day of hospitalization revealed recanalized carvernous sinus thrombosis and tortuous temporal arteries, which, along with the clinical and laboratory findings, led the physician to the suspicion of arteritis temporalis. Giant cell arteritis was confirmed by the temporal artery biopsy findings. Overall 4 of the 5 criteria were fulfilled. Treatment with antibiotics and heparin was discontinued. Corticosteroid therapy was initiated and relieved all the described abnormalities during the following days. The pt's recovery was almost complete. All previous serological abnormalities had normalized. Only slight weakness of the right upper extremity persisted.  The reporter had assessed the relationship of the influenza vaccine to the event as likely. That the common preceding vaccination contributed to the GCA was also stated to be quite likely. The physician stated that it can not be definitely excluded that the influenza-like symptoms at the onset were already the initial manifestation of GCA. The physician stated that the GCA was responsible for most of the abnormal findings although it could not be definitely excluded that facial nerve palsy and plexopathy were due to the initial vial infection before the vaccination. Impaired visual acuity, bilateral ptosis, abducens paresis, proptosis and facial oedema were assumed to have been caused by the carvernous sinus thrombosis.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Coordination abnormal, Hemiparesis, Pain, Radiculitis brachial
Clinical narrative: Report received from a registered pharmacist regarding a possible adverse event associated with the use of Fluvirin. A 49 year old male patient received vaccination with Fluvirin, lot number E67930KA or E67940KA, on 10/10/00. On 12/2/00, this patient developed right parascapular pain and on 12/6/00 developed right hand weakness and dyscoordination. He has specific weakness of thumb and abduction of fingers with decreased pinch and grip strength. A C-Spine MRI was performed and did not explain symptoms. A MRI of his brain is pending. A tentative diagnosis has been made of brachial plexitis. The patient has a history of hypertension and takes lisinopril. No other information was provided. Attempts to obtain further information were attempted with reporter unable to provide any specific information. Follow up received from reporter on 6/27/01 via telephone. The reporter states that she received follow up information consisting of the following: The patient has not recovered and has regained 70% of his strength in his right arm and shoulder and still experiences pain in the right arm and prescapula requiring daily use of Motrin. The patient is seeing a neurologist who confers with Personage Turner Syndrome. No other information was available, further information requested from the reporter. (OMIC)
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Confusional state, Malaise, Memory impairment, Pyrexia
Clinical narrative: Spontaneous report received on 11/16/00 from a medical assistant in a dermatologist's office regarding an adverse event possibly related to administration of Fluvirin. On 10/6/00, this 83 year old female received a Fluvirin injection. Shortly after receiving the injection, she developed a temperature of 102 degrees F, chills, and general malaise. These symptoms lasted approximately four days. In mid-Octiber, she developed lesions on her hands and in her mouth. She was treated with an unspecified course of Prednisone, with symptom abatement. After completion of the Prednisone therapy, the symptoms reappeared. She was then treated with an injection of Kenalog and topical use of Orabase and Kenalog ointments; lesions remain at the time of this report. The diagnosis of Stevens-Johnson Syndrome has been made. The reporter stated that the dermatologist's office has treated this patient for over ten years. She indicates that patient is normally very mentally there, but that the patient hasn't been herself. She describes the patient as being easily confused and forgetful. Patient has a history of hypertension, pharyngitis, hypothyroidism, unidentified gastrointestinal problems, and increased weight loss. Additional information has been requested from the physician. Follow up information from PCP received on 10/11/01: The additional adverse events of sore throat and swollen lips were identified. Patient has resolution of symptoms by November 20, 2000. Dosages and therapy dates of concomitant medications were clarified.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Skin ulcer, Stevens-Johnson syndrome
Clinical narrative: Spontaneous report received on 11/16/00 from a medical assistant in a dermatologist's office regarding an adverse event possibly related to administration of Fluvirin. On 10/6/00, this 83 year old female received a Fluvirin injection. Shortly after receiving the injection, she developed a temperature of 102 degrees F, chills, and general malaise. These symptoms lasted approximately four days. In mid-Octiber, she developed lesions on her hands and in her mouth. She was treated with an unspecified course of Prednisone, with symptom abatement. After completion of the Prednisone therapy, the symptoms reappeared. She was then treated with an injection of Kenalog and topical use of Orabase and Kenalog ointments; lesions remain at the time of this report. The diagnosis of Stevens-Johnson Syndrome has been made. The reporter stated that the dermatologist's office has treated this patient for over ten years. She indicates that patient is normally very mentally there, but that the patient hasn't been herself. She describes the patient as being easily confused and forgetful. Patient has a history of hypertension, pharyngitis, hypothyroidism, unidentified gastrointestinal problems, and increased weight loss. Additional information has been requested from the physician. Follow up information from PCP received on 10/11/01: The additional adverse events of sore throat and swollen lips were identified. Patient has resolution of symptoms by November 20, 2000. Dosages and therapy dates of concomitant medications were clarified.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A report was received from a health care professional on 10/17/01 regarding a 4 year old male patient who experienced severe cellulitis on 10/16/01 after receiving Fluvirin vaccine (batch E05211KA) on 10/15/01. Concomitant medications included Ranitidine hydrochloride, Salbutamol and Cromoglicate sodium. The patient had 2 previous administrations of influenza vaccine in 2000 and 1999 without any adverse reaction. On 10/16//01, the patient's parent reported a severe cellulitis on their son's arm, located below the deltoid and above the elbow, at the site of the injection. The patient was seen by a physician on 10/17/01 when the cellulitis area was determined to be approximately 11.5cm by 12.5cm in size. The event was considered to be medically significant. The physician prescribed oral Cephalexin antibiotic to treat the cellulitis. The event was still ongoing at the time of reporting. The reporter has assessed the relationship of study medication to the event as probable. (OMIC)
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A report was received from a health professional on 11/1/01 concerning a 63 year old female patient who experienced cellulitis 2 days after receiving the Fluvirin vaccine on 10/30/01. Relevant medical history includes a hysterectomy, osteoarthritis, and hypertension on unknown dates. Co-medication taken by the patient included a topical Estrogen patch and Clindamycin. On 11/1/01, the patient experienced cellulitis of the entire right arm 2 days after receiving the Fluvirin vaccine. The Fluvirin administration was given in the right deltoid muscle. Therapeutic measures taken as a result of this event included Clindamycin and Diphenhydramine. The patient had not recovered at the time of report. The reporter assessed the relationship of the study medication to the event as possible. (OMIC)