chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dry eye, Facial palsy, Headache, Hypoaesthesia, Muscle twitching
Clinical narrative: 11/17/03 started with dry right eye and twitching of eye. Shortly after intermittent numbness of right side of face and external ear. On 12/3/03 facial and eye drooping and difficulty closing eye. Right sided neck pain. Headaches. 12/8/03 saw nurse, diagnosed with Bell's Palsy and started on Medrol dose pack 401G. Still in treatment
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain
Clinical narrative: 11/17/03 started with dry right eye and twitching of eye. Shortly after intermittent numbness of right side of face and external ear. On 12/3/03 facial and eye drooping and difficulty closing eye. Right sided neck pain. Headaches. 12/8/03 saw nurse, diagnosed with Bell's Palsy and started on Medrol dose pack 401G. Still in treatment
Age: 6.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Oedema, Pain, Pyrexia
Clinical narrative: Fever 103-104. Swollen, painful arm.
Age: 6.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Injection site erythema, Pain, Pyrexia
Clinical narrative: Fever 103-104. Swollen, painful arm.
Age: 38.0
Sex: F
Vaccine: ANTH
Symptoms: Chills, Dizziness, Erythema, Headache, Urticaria
Clinical narrative: Red hives to chest and neck. C/o headache, chills, lightheadedness.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Fatigue, Injection site oedema, Injection site pain
Clinical narrative: Body aches, fever up to 102.  Extreme fatigue, upper respiratory symptoms.  Cough, congestion, sore throat still ongoing.  Two days of total laryngitis.  Difficulty breathing.  Swollen glands.  Also, local reaction on arm-pain, swelling and itching.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Laryngitis, Lymphadenopathy, Nasal congestion, Pain, Pharyngolaryngeal pain
Clinical narrative: Body aches, fever up to 102.  Extreme fatigue, upper respiratory symptoms.  Cough, congestion, sore throat still ongoing.  Two days of total laryngitis.  Difficulty breathing.  Swollen glands.  Also, local reaction on arm-pain, swelling and itching.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Pyrexia, Upper respiratory tract infection
Clinical narrative: Body aches, fever up to 102.  Extreme fatigue, upper respiratory symptoms.  Cough, congestion, sore throat still ongoing.  Two days of total laryngitis.  Difficulty breathing.  Swollen glands.  Also, local reaction on arm-pain, swelling and itching.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: Numbness and weakness at left arm.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Right deltoid-injection site with redness, warmth, circular area.  Local cellulitis-antibiotic given.
Age: 1.8
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Urticaria developed about 4 hours after vaccine.
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Patient had a mild reaction dollar size redness.
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site oedema, Pruritus, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Swollen/red/itchy/slight fever.  Same reaction as last year.  Went away a week ago.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pyrexia
Clinical narrative: After injection about 8-12 hours, noted increased injection site soreness and fever.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Hives above waistline.  Light amount, approximately 20 spots.  Completely cleared up by 11/19/2003.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Rash macular, Throat tightness
Clinical narrative: 12/03/2003 @ 11:53, presented to ER with throat swelling, neck pain for several hours; mild difficulty swelling, no dyspnea.  Rash-macular over cheeks, no hives.  Given per mouth Benadryl/Ibuprofen.  ? Reactions as 2 days later, but thought should be reported.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Swollen, red, indurated arm-told to use Tylenol per mouth and cold packs.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Oedema peripheral, Pain, Pruritus
Clinical narrative: Large, red, inflamed area on arm for 2 weeks, painful, itchy. Used Benadryl cream for itching.
Age: 44.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Site red, hot to touch.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchiness all over body and hives. Awaken with severe symptoms as above at 12:05 AM 12/3/03. Took Benadryl 50mg, went to sleep. Woke in morning with mild symptoms until mid morning and started itching again. ER - Solumedrol IV, Benadryl 25mg, Tagament IV.
Age: 47.0
Sex: M
Vaccine: FLUX, HEP, HEPA, IPV, MMR, TD
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Pain, Skin irritation
Clinical narrative: TB tine reaction, 15-20mm induration, red, irritated, warm to touch, and tender.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: The child's right thigh is swollen and red and warm to touch. The area is the size of a lemon.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Musculoskeletal discomfort, Myalgia
Clinical narrative: Numbness and severe "throbbing" muscle pain from left shoulder to left fingertips. No redness, warmth or edema noted. Discomfort interfered with activities of daily living. Treated with rest, alternating Tylenol 650mg and Motrin 400mg. Pain started 9 AM 10/14/03 and continued until 10/16/03 9 AM. No residual effects noted.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Hypoaesthesia, Pain, Vasodilatation
Clinical narrative: Reported 2-3 hours after injection. Pt c/o numbness to fingers, pain up to the forearm. Left leg feels funny. Veins in arm bulging. On 10/30/03 veins still bulging. Arm is numb.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal distension, Abdominal pain
Clinical narrative: Pt noted abdominal cramps 10/30/03 about 8 PM. All day 10/31/03 and 11/01/03 she experienced frequent abdominal cramping and a bloating feeling but denied symptoms of vomiting or diarrhea. Symptoms gone by 11/01/03 and pt did not seek any medical attention or treatment. Pt reported to State Health Center on 11/3/03.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pain
Clinical narrative: Left shoulder swollen, red, hot, tender to touch.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Acne, Feeling hot, Injection site erythema, Injection site mass, Oedema peripheral
Clinical narrative: Left arm red and swollen from shoulder to elbow. Warm and sensitive to touch. Lump at site of injection. White pimples on rest of arm area. Nurse discussed reaction with parent and referred to PCP. Child is being seen 12/4/03 by PCP.
Age: 37.0
Sex: F
Vaccine: RAB
Symptoms: Face oedema, Urticaria
Clinical narrative: Hives started Fri 11/21 after vaccination, lips swelling. Took her own Prednisone. Came to ED. IV initiated. Benadryl, Solumedrol and Pepcid IV given, Vistaril PO. Discharged stable condition.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Infection, Rash papular
Clinical narrative: 12/2/03: diagnosed with chicken pox disease. Parents noticed rash on back 11/30/03. Spread rapidly, red papules on torso, legs, etc.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site oedema, Injection site warmth
Clinical narrative: Child received vaccine on 11/14/03 Fri., to ER 11/15/03 with the following symptoms: left thigh red, hot, swollen area. Received Decadron 4mg IM. F/U visit in office 11/18/03: site had improved, no redness, no temp.
Age: 45.0
Sex: F
Vaccine: RAB
Symptoms: Pruritus, Urticaria
Clinical narrative: Developed itching, welts on Sun 11/23. Called FMD, took her own Prednisone 40mg PO, tapered to 20mg Mon 11/24 and Tues 11/25. (Not treated in ED).
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Infection, Pyrexia, Skin ulcer
Clinical narrative: Various post vaccine symptoms of C-pox isolation, Sx: fever, headache. Lesions, 2 with crusty scabs.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site warmth, Oedema peripheral, Urticaria
Clinical narrative: Within a day his whole upper arm swelled significantly; was red and hot, took an antihistamine, swelling went down. 10 days following shot broke out in hives around site, very itchy, swelled again.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Oedema peripheral, Pain
Clinical narrative: Left arm swollen, tender erythematous area 12 x 26cm, 1.5cm larger circumference than right.
Age: 15.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain upper, Aggression, Anorexia, Arthralgia, Headache
Clinical narrative: 09/26: Sore inject site; 09/29: Increased muscle and joint soreness; 10/05: Combative, argumentive, headache, T99-100, begged to stop tx to MD, who encouraged completion of Rx.  10/17: Stomach burning, no appetitie.  10/30: Continued gi sx joint pain. 11/16: States she feels she is returning to normal.
Age: 15.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pain, Myalgia, Pyrexia
Clinical narrative: 09/26: Sore inject site; 09/29: Increased muscle and joint soreness; 10/05: Combative, argumentive, headache, T99-100, begged to stop tx to MD, who encouraged completion of Rx.  10/17: Stomach burning, no appetitie.  10/30: Continued gi sx joint pain. 11/16: States she feels she is returning to normal.
Age: 1.08
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Convulsion, Pyrexia, Swelling
Clinical narrative: Immediate swelling of jaw. Focal seizure of hand. Temp to 105.7, 9 days of fever up and down.
Age: 1.33
Sex: M
Vaccine: HBHEPB, MMR
Symptoms: Cough, Pruritus, Pyrexia, Rash erythematous, Rhinorrhoea
Clinical narrative: 11/19/03: T 101.7 degrees F; 11/20/03: T 102.7 F; 11/21/03: T 99.0 F; 11/22: T 103.5 F with raised red spots on cheeks, back, hands and knees. C/o cough, runny nose, itchiness. MD notified. Rx: Cefzil. 11/24: Temp down, condition improved.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema
Clinical narrative: 7x8 cm ring of erythema surrounding injection site not pruritic.  No induration left shoulder (deltoid muscle).
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blood pH decreased, Laboratory test abnormal
Clinical narrative: Mom remembers onset pediatrician 07/08/2003 constant increased and decreased in # till his next well baby exam (09/22/03).  When patient referred per diagnosis and treatment of his ITP.  PH=3000 on 09/22/03.  Received Winkho increased to 8,000 stable to 1/2 late 10/03. 2nd WinRho given 10/31/2003.  Follow up MD.
Age: 1.2
Sex: M
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Anorexia, Asthma, Cough, Otitis media, Pyrexia
Clinical narrative: Patient developed generalized macular-papular rash on and off, high fever.  10 days after MMR, Varicella, Comvax and PCV no achiness.  Hospitalized at clinic. The discharge summary received on 4/5/04 states decreased appetite, cough, wheeze and otitis media.
Age: 1.2
Sex: M
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Rash macular, Rash papular
Clinical narrative: Patient developed generalized macular-papular rash on and off, high fever.  10 days after MMR, Varicella, Comvax and PCV no achiness.  Hospitalized at clinic. The discharge summary received on 4/5/04 states decreased appetite, cough, wheeze and otitis media.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Throat tightness, Wheezing
Clinical narrative: A report was received from a health care professional on 14 November 2003 concerning a 27 year old female vacinee who experienced closure of the throat, whcih was considered to be medically significant, 12 hours after receiving Fluvirin vaccine on 22 October 2003. On 22 October 2003, the vaccinee's "throat closed" 12 hours after receiving Fluvirin. The vaccinee wsa seen in an emergency room. The acute "throat closure" resolved, however, the vaccinee stated that she was still experiencing night time symptoms of "throat closure" which included wheezing and shortness of breath. At the time of vaccination, information regarding neomycin and polymycin allergies was not obtained. The vaccinee had not recovered at the time of the report. THere was insufficient information to determine the reporter's causality assessment. Update on 05 December 2003: follow-up information was received from the sponsor indicating that an error was made in the reporting assessment of this case during the QC by company pharmacovigilance. This case is to be reported. Follow-up pending.
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Pneumonia, Pyrexia
Clinical narrative: This case was considered medically important (OMIC). Information regarding FluMist nasal solution was received from a pediatrician regarding a 13 year old male who developed pneumonia. Relevant medical history was not provided. Indication for FluMist was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. The pediatrician reported that the child had a fever on the same day as the FluMist administration. One hour post-immunization, his fever was 104 degrees F. Two days post-immunization, he was diagnosed with pneumonia. No additional information was available at the time of this report. Follow UP: The reporter considered this event medically important. Follow-up information received from the physician on 16-Dec-2003 provided patient identifiers, immunization date, onset date, test results and outcome. Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a pediatrician regarding a 13 year old male who develooped penumonia. At 13 years of age, the child received the first dose on 11-Nov-20003. The pediatrician reported that the child developed a fever 4 hours post -immunization. The fever ranged from 102 deg. F. to 104 deg F and persisted for 2 days. On 13-Nov-2003, the child was seen by the pediatrician and diagnosed with pneumonia. The child recovered. The pediatrician noted that she did not consider this event related to vaccine administratiion.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Folliculitis, Laboratory test abnormal
Clinical narrative: Folliculitis/Cellulitis developed 16 days after smallpox vaccination.  Admitted to hospital.  Pustules grew out MRSA.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood pressure increased, Hypersensitivity, Injection site warmth, Oedema peripheral, Tenderness
Clinical narrative: Left arm swelled from shoulder to elbow-very large, hot and tender. B/P increased to 207/104 and normal B/P around 125/76. Took 3 days for arm to return to normal. To ER on 10/11/03. Given Benadryl and prescribed Prednisone 20mg po QD  x6days and Keflex 500mg 1 tab po q 6h x 10days. Dx: Acute Allergic Reaction.
Age: 27.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Sore arm started within hours of vaccination.  Pain continued at the injection site and towards back of deltoid muscle rotating around upper arm, stopping approx 1 inch from underarm crease.    Pain is achy in nature and worse with motion that has now persisted for 3 weeks.  Pain is 2/5 on scale of 0/5.
Age: 39.0
Sex: M
Vaccine: FLUX
Symptoms: Pruritus, Rash
Clinical narrative: On Friday 12/5 small rash broke out on entire body after shower. Very ichy! saturday and sunday rash spread became larger and became more ichy. finally on sunday night after tring cortizon cream I became so ichy I went to clinic. Dr gave me IM shot of some type of steroid and another IM shot of some form of antihistamine. symptoms were gone by the time I got home. I was presribed Methylprednisolone 4MGUD and hydroxyzineHCL 25MG 1 every eigt hours for iching. the meds work but every morning after shower rash comes back and tkes most of the morning to subside.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Swelling, Urticaria
Clinical narrative: 11/25/03 recieved vaccine, 11/26/03 called office and stated that child had big huge welt on right leg. "looks like hit with a ball", size of 50 cent piece, mom to start ibuprophen.  later in the day mom reported swelling looked like it was going down some.  mom was to continue with ibuprophen and return to clinic if it got worse.  11/27/03 Right leg is worse and swelling as gone around the whole leg.  Called on-call Provider, they felt child should be seen and mom took her to the ER.  The swelling was all the way around the leg.  ER was not sure why it happened and called it cellulitis and gave child antibiotics.  12/02/03  mom reports that child is doing much better.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Flu vaccine given on 12/08/03 lt deltoid muscle, employee noticed redness, soreness, swelling at injection site on 12/09/03. Symptoms increased by am of 12/10/03, reported to employee health office today.Sent employee to convenient care office, MD instructed her to continue to watch area and report any increase in symptoms.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Pain
Clinical narrative: Patient received a flu shot, Fluzone 0.5 ml I.M. in the rt. deltoid at approximately 9:20 a.m. Friday, December 5, 2003. She denied any allergies, but had "never had a flu shot before." "After going to bed that night, she awakened approximately 1 a.m. Saturday morning because of pain in her arm." She noticed a small bruise at the injection site, but states there was no redness or swelling. She applied a cool compress and took an O.T.C. pain medication. She called the Health Dept. on Tuesday 12/9/2003 and was advised to call her physician. When I spoke with her today Wednesday 12/10/03 she stated she is still having difficulty and her physician stated there was little he could do for her. She would have to wait for it to resolve. She stated she was told to continue with her O.T.C. Meds and to apply warm moist compresses. She is following that advice.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Pain, Shoulder pain, Tenderness
Clinical narrative: HAD LG LUMP IN BACK OF UPPER ARM,IT WENT AWAY AFTER 2 DAYS, PUT I WAS LEFT WITH SHOULDER JOINT PAIN AND A TENDER AREA TO THE TOUCH ON THE BACK UPPER AREA OF LEFT SHOULDER. IF I SLEEP WITH MY ARM UP WHEN I WAKE AND PUT MY ARM DOWN IT IS PAINFULL
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Eye movement disorder, Feeling hot, Hyperhidrosis, Listless, Loss of consciousness
Clinical narrative: The 14 yo male patient came into the immunization clinic for his first HBV.  Up to this time the patient has had no problems with his routine childhood immunizations. After the HBV was given, the patient sat down stating he was feeling funny.  His eyes rolled back and he then became listless. At this time he was supported and moved to the floor.  His coat was removed. His airway was protected. He then had a loss of conscousness and began making snorting noises from his throat. At the same time his arms stiffened and curled toward his chest, appearing decordicate.  This stiffening lasted approximately 3 minutes.  The LOC lasted approximately 4-5 minutes. An ammonia ampule was used to try and wake him. Upon wakening, he was very pale, warm and diaphoretic.  He remained supine on the floor for approximately another 10-15 minutes.  During this time a sucker was given and then later some water.  The patient came into immunization clinic during the lunch hour and had not eaten.  The RN advised the mother to call the family physician and update him to the events of the day regarding the immunization and request quidelines for additional HBV.  The RN advised the mother that it would be inappropriate for the health department to proceed with #2 and #3 HBV.  It would be more appropriate for the child to get the vaccine from his PCP. He was then assisted into the car by his mother.
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Malaise, Musculoskeletal stiffness, Pallor
Clinical narrative: The 14 yo male patient came into the immunization clinic for his first HBV.  Up to this time the patient has had no problems with his routine childhood immunizations. After the HBV was given, the patient sat down stating he was feeling funny.  His eyes rolled back and he then became listless. At this time he was supported and moved to the floor.  His coat was removed. His airway was protected. He then had a loss of conscousness and began making snorting noises from his throat. At the same time his arms stiffened and curled toward his chest, appearing decordicate.  This stiffening lasted approximately 3 minutes.  The LOC lasted approximately 4-5 minutes. An ammonia ampule was used to try and wake him. Upon wakening, he was very pale, warm and diaphoretic.  He remained supine on the floor for approximately another 10-15 minutes.  During this time a sucker was given and then later some water.  The patient came into immunization clinic during the lunch hour and had not eaten.  The RN advised the mother to call the family physician and update him to the events of the day regarding the immunization and request quidelines for additional HBV.  The RN advised the mother that it would be inappropriate for the health department to proceed with #2 and #3 HBV.  It would be more appropriate for the child to get the vaccine from his PCP. He was then assisted into the car by his mother.
Age: 74.0
Sex: U
Vaccine: FLU3
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Listless, Vomiting
Clinical narrative: I received the vaccine at 1:30 PM on 12-08-03. That evening approx. 9:30 PM I started to vomit profusely with diarhea also. That continued thru the nite. This is Wed. the 10th & I can't take food yet. Stomach, Ribs are very sore. I have no fever but am listless & tired out. Dr. told me to drink fluids so I won't dehydrate & tylenol.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Agitation, Irritability, Pyrexia
Clinical narrative: 12 hours after vaccination pt began woke from a fitful sleep.  Pt was unconsolable.  Child was running a fever of 101 rectally.  Next day child was running fever of 103 and was very destraught.  I called the Dr's office, hours later did not get a call back.  Called again at 5 pm and explained that child was running high fever and was unusualy cranky.  Was adviced to go to after hours clinic.  Child was seen my Dr at after hour clinic.  Dr stated ear, and throat were clear.  There was some clear nasal discharge.  Pt had 101.1 fever at that time, axillary.  Advised to monitor child closely and get a CBC done the next day.  Took child for blood draw and called the doctor later in the day to see if a cbc had been done on the date of the vaccinations.  Doctor called back and spoke to my husband.  He was not sure if she said that a cbc was taken at the office or not.  Doctor advised she would try to get the results of the cbc done today.  She did not call back.  At 5 pm I called the office, they had just closed.  At 5:01 I paged the Dr.  The doctor called back.  I advised her that pt was still out of sorts and running a fever of 101 despite tylenol and motrin given alternatively every 6 hours.  She said office was closed and I would have to call back tomorrow, Thursday to get the results of the blood work.  Vaccines were given to the child at 3:30 on Monday 12-8.
Age: 7.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dysphonia, Pyrexia
Clinical narrative: Fever, Chills Horseness
Age: 61.0
Sex: F
Vaccine: SMALL, ANTH, SMALL
Symptoms: Cardiac failure congestive, Chest discomfort, Chills, Decreased appetite, Dyspnoea
Clinical narrative: Pt received 4th dose Anthrax and 1st dose Smallpox vaccines on 2/7/03. Pt described local itching at the smallpox site, but denied other symptoms or complaints. She received a 2nd dose Smallpox on 2/20/03 after the earlier dose didn't "take." On 2/21/03 the pt complained of fever, chills, headache, poor appetite, muscle aches, and swollen glands in her neck, which lasted 4-6 hrs. On 2/26/03 she noted palpitations lasting about a minute. She denies specific cardiac-related complaints until the last week in April, when she noted swelling of her feet. On 5/1/03, she began experiencing continuous heart palpitations accompanied by mild dyspnea, weakness, and chest discomfort. She was admitted to the hospital for 6 days, diagnosis of atrial fibrillation and congestive heart failure. Information received 12/8/03: Pt returned to the hospital for 3 days in mid-November for heart rate of 40 and arm pain. Stress test performed and adjustments made to medications. Pt continues to follow-up with a cardiologist.
Age: 61.0
Sex: F
Vaccine: SMALL, ANTH, SMALL
Symptoms: Headache, Hypertension, Laboratory test abnormal, Lymphadenopathy, Myalgia
Clinical narrative: Pt received 4th dose Anthrax and 1st dose Smallpox vaccines on 2/7/03. Pt described local itching at the smallpox site, but denied other symptoms or complaints. She received a 2nd dose Smallpox on 2/20/03 after the earlier dose didn't "take." On 2/21/03 the pt complained of fever, chills, headache, poor appetite, muscle aches, and swollen glands in her neck, which lasted 4-6 hrs. On 2/26/03 she noted palpitations lasting about a minute. She denies specific cardiac-related complaints until the last week in April, when she noted swelling of her feet. On 5/1/03, she began experiencing continuous heart palpitations accompanied by mild dyspnea, weakness, and chest discomfort. She was admitted to the hospital for 6 days, diagnosis of atrial fibrillation and congestive heart failure. Information received 12/8/03: Pt returned to the hospital for 3 days in mid-November for heart rate of 40 and arm pain. Stress test performed and adjustments made to medications. Pt continues to follow-up with a cardiologist.
Age: 61.0
Sex: F
Vaccine: SMALL, ANTH, SMALL
Symptoms: Oedema, Oedema peripheral, Pain, Palpitations, Pyrexia
Clinical narrative: Pt received 4th dose Anthrax and 1st dose Smallpox vaccines on 2/7/03. Pt described local itching at the smallpox site, but denied other symptoms or complaints. She received a 2nd dose Smallpox on 2/20/03 after the earlier dose didn't "take." On 2/21/03 the pt complained of fever, chills, headache, poor appetite, muscle aches, and swollen glands in her neck, which lasted 4-6 hrs. On 2/26/03 she noted palpitations lasting about a minute. She denies specific cardiac-related complaints until the last week in April, when she noted swelling of her feet. On 5/1/03, she began experiencing continuous heart palpitations accompanied by mild dyspnea, weakness, and chest discomfort. She was admitted to the hospital for 6 days, diagnosis of atrial fibrillation and congestive heart failure. Information received 12/8/03: Pt returned to the hospital for 3 days in mid-November for heart rate of 40 and arm pain. Stress test performed and adjustments made to medications. Pt continues to follow-up with a cardiologist.
Age: 61.0
Sex: F
Vaccine: SMALL, ANTH, SMALL
Symptoms: Asthenia, Atrial fibrillation, Bradycardia, Cardiac failure congestive, Chest discomfort
Clinical narrative: Pt received 4th dose Anthrax and 1st dose Smallpox vaccines on 2/7/03. Pt described local itching at the smallpox site, but denied other symptoms or complaints. She received a 2nd dose Smallpox on 2/20/03 after the earlier dose didn't "take." On 2/21/03 the pt complained of fever, chills, headache, poor appetite, muscle aches, and swollen glands in her neck, which lasted 4-6 hrs. On 2/26/03 she noted palpitations lasting about a minute. She denies specific cardiac-related complaints until the last week in April, when she noted swelling of her feet. On 5/1/03, she began experiencing continuous heart palpitations accompanied by mild dyspnea, weakness, and chest discomfort. She was admitted to the hospital for 6 days, diagnosis of atrial fibrillation and congestive heart failure. Information received 12/8/03: Pt returned to the hospital for 3 days in mid-November for heart rate of 40 and arm pain. Stress test performed and adjustments made to medications. Pt continues to follow-up with a cardiologist.
Age: 61.0
Sex: F
Vaccine: SMALL, ANTH, SMALL
Symptoms: Chills, Decreased appetite, Dyspnoea, Headache, Lymphadenopathy
Clinical narrative: Pt received 4th dose Anthrax and 1st dose Smallpox vaccines on 2/7/03. Pt described local itching at the smallpox site, but denied other symptoms or complaints. She received a 2nd dose Smallpox on 2/20/03 after the earlier dose didn't "take." On 2/21/03 the pt complained of fever, chills, headache, poor appetite, muscle aches, and swollen glands in her neck, which lasted 4-6 hrs. On 2/26/03 she noted palpitations lasting about a minute. She denies specific cardiac-related complaints until the last week in April, when she noted swelling of her feet. On 5/1/03, she began experiencing continuous heart palpitations accompanied by mild dyspnea, weakness, and chest discomfort. She was admitted to the hospital for 6 days, diagnosis of atrial fibrillation and congestive heart failure. Information received 12/8/03: Pt returned to the hospital for 3 days in mid-November for heart rate of 40 and arm pain. Stress test performed and adjustments made to medications. Pt continues to follow-up with a cardiologist.
Age: 61.0
Sex: F
Vaccine: SMALL, ANTH, SMALL
Symptoms: Myalgia, Oedema peripheral, Pain, Palpitations, Pyrexia
Clinical narrative: Pt received 4th dose Anthrax and 1st dose Smallpox vaccines on 2/7/03. Pt described local itching at the smallpox site, but denied other symptoms or complaints. She received a 2nd dose Smallpox on 2/20/03 after the earlier dose didn't "take." On 2/21/03 the pt complained of fever, chills, headache, poor appetite, muscle aches, and swollen glands in her neck, which lasted 4-6 hrs. On 2/26/03 she noted palpitations lasting about a minute. She denies specific cardiac-related complaints until the last week in April, when she noted swelling of her feet. On 5/1/03, she began experiencing continuous heart palpitations accompanied by mild dyspnea, weakness, and chest discomfort. She was admitted to the hospital for 6 days, diagnosis of atrial fibrillation and congestive heart failure. Information received 12/8/03: Pt returned to the hospital for 3 days in mid-November for heart rate of 40 and arm pain. Stress test performed and adjustments made to medications. Pt continues to follow-up with a cardiologist.
Age: 43.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Anaphylactic reaction, Apnoea, Chest discomfort, Convulsion, Dyspnoea
Clinical narrative: Received flu vaccine at work on October 31, 2003 at approximately 1:00pm.  Developed anaphylactic reaction, respiratory arrest, seizures, and overall body rash.  Was placed on ventalator 50 minutes after receiving vaccine.  Hospitalized October31 through November 12, 2003.  Developed left sided weakness for which I am in physical therapy, and continue with occasional body rash and gastritis.
Age: 43.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Flushing, Gastritis, Loss of consciousness, Pruritus
Clinical narrative: Received flu vaccine at work on October 31, 2003 at approximately 1:00pm.  Developed anaphylactic reaction, respiratory arrest, seizures, and overall body rash.  Was placed on ventalator 50 minutes after receiving vaccine.  Hospitalized October31 through November 12, 2003.  Developed left sided weakness for which I am in physical therapy, and continue with occasional body rash and gastritis.
Age: 43.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Anaphylactic reaction, Convulsion, Gastritis, Hemiparesis, Rash
Clinical narrative: Received flu vaccine at work on October 31, 2003 at approximately 1:00pm.  Developed anaphylactic reaction, respiratory arrest, seizures, and overall body rash.  Was placed on ventalator 50 minutes after receiving vaccine.  Hospitalized October31 through November 12, 2003.  Developed left sided weakness for which I am in physical therapy, and continue with occasional body rash and gastritis.
Age: 43.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Respiratory arrest
Clinical narrative: Received flu vaccine at work on October 31, 2003 at approximately 1:00pm.  Developed anaphylactic reaction, respiratory arrest, seizures, and overall body rash.  Was placed on ventalator 50 minutes after receiving vaccine.  Hospitalized October31 through November 12, 2003.  Developed left sided weakness for which I am in physical therapy, and continue with occasional body rash and gastritis.
Age: 1.0
Sex: M
Vaccine: IPV, PNC, VARCEL, IPV, PNC, VARCEL
Symptoms: Abdominal pain, Intussusception
Clinical narrative: Information has been received from a physician concerning a 12 month old male in good health with no conditions or allergies who on 11/11/03 was vaccinated with a standard dose of varicella virus vaccine live (lot # 644795-0335N), SC. Concomitant therapy that day included poliovirus vaccine inactivated and pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine (PREVNAR). There were reported to be no chronic medications. On 11/21/03 the patient developed abdominal distention and was taken to the emergency room. While in the emergency room, the child was diagnosed with intussusception and received an air enema under the supervision of a surgeon. The patient was admitted, observed for 24 hours, and discharged on 11/21/03. The patient had recovered completely since he was reported to be perfectly fine now, per physician. The physician also reported that it was not clear that the event was related to the varicella virus vaccine live, but thought that this should be reported. Additional information has been requested.  Follow up on 12/16/03: "Information has been received from a physician concerning a 12 month old male in "good health" with no conditions or allergies (food or medications) who on 11/11/03 was vaccinated with a "standard dose" of varicella virus vaccine live (oka/merck)(site unknown)(lot # 644795/0335N), SC.  Concomitant therapy that day included IPV and Pneumococcal 4 6B 9V 14 18C 23F conj vaccine.  There were reported to be "no chronic" medications.  On 11/21/03 the pt developed abdominal distention and was taken to the ER.  Blood work was performed and was negative.  While in the ER, after an ultrasound, the child was diagnosed with intussusception and received an air enema under the supervision of a surgeon.  The child had a BE done to reduce it and was admitted, observed for 24 hours after the reduction, and was discharged on 11/22/03 and was "now fine".  The reporter "did not know if there is a link between the varicella virus vaccine live and the intussusception" but because of the timing of it after the vaccination she thought that she should report the event.  It was noted that the child had received all previous childhood immunizations with no problems.  No further information is expected."
Age: 1.0
Sex: M
Vaccine: IPV, PNC, VARCEL, IPV, PNC, VARCEL
Symptoms: Abdominal distension, Intussusception, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a 12 month old male in good health with no conditions or allergies who on 11/11/03 was vaccinated with a standard dose of varicella virus vaccine live (lot # 644795-0335N), SC. Concomitant therapy that day included poliovirus vaccine inactivated and pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine (PREVNAR). There were reported to be no chronic medications. On 11/21/03 the patient developed abdominal distention and was taken to the emergency room. While in the emergency room, the child was diagnosed with intussusception and received an air enema under the supervision of a surgeon. The patient was admitted, observed for 24 hours, and discharged on 11/21/03. The patient had recovered completely since he was reported to be perfectly fine now, per physician. The physician also reported that it was not clear that the event was related to the varicella virus vaccine live, but thought that this should be reported. Additional information has been requested.  Follow up on 12/16/03: "Information has been received from a physician concerning a 12 month old male in "good health" with no conditions or allergies (food or medications) who on 11/11/03 was vaccinated with a "standard dose" of varicella virus vaccine live (oka/merck)(site unknown)(lot # 644795/0335N), SC.  Concomitant therapy that day included IPV and Pneumococcal 4 6B 9V 14 18C 23F conj vaccine.  There were reported to be "no chronic" medications.  On 11/21/03 the pt developed abdominal distention and was taken to the ER.  Blood work was performed and was negative.  While in the ER, after an ultrasound, the child was diagnosed with intussusception and received an air enema under the supervision of a surgeon.  The child had a BE done to reduce it and was admitted, observed for 24 hours after the reduction, and was discharged on 11/22/03 and was "now fine".  The reporter "did not know if there is a link between the varicella virus vaccine live and the intussusception" but because of the timing of it after the vaccination she thought that she should report the event.  It was noted that the child had received all previous childhood immunizations with no problems.  No further information is expected."
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Bacterial infection, Brain oedema, Bronchitis, Pneumonia
Clinical narrative: Child died suddenly at day care on or about 6/5/03. No other specifics known. Autopsy report report received on 12/16/2003 states COD was bacterial pneumonia, bronchitis, and cerebral edema.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning her cousin's daughter with no relevant medical history reported who in approximately 2002 was vaccinated with a dose of MMR at 15 months of age (lot number not available). It was reported that the patient developed symptoms of autism right after she was vaccinated with MMR vaccine live. The reporter was unable to describe the symptoms. Unspecified medical attention was sought. The patient was recently diagnosed with Autism. The physician's had her on a strict diet because carbohydrates trigger the Autism. At the time of this report, the patient was 2 years old. Upon internal review, the patient's autism was considered an other important medical event (OMIC). Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a pharmacist concerning his child who was vaccinated with MMR (lot number not provided). Subsequently, the child developed autism. The child did seek unspecified medical attention. At the time of this report, the child's autism persisted. Upon internal review, autism was considered to be an other important medical event (OMIC). Additional information has been requested.  Follow up on 12/16/2003: "Additional information has been received from the pharmacist who reported that the child in this case had received MMR vaccination along with other vaccines that contain mercury in them and has since been diagnosed with Autism.  At the time of this report the pt's autism persisted.  The reporter felt that autism was related to therapy with MMR and the mercury in the vaccines.  Upon internal review autism was considered to be an other important medical event (OMIC). No further information is expected."
Age: 47.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Dyspnoea, Injection site erythema, Lethargy, Leukocytosis
Clinical narrative: Information has been received from a physician concerning a 47 year old male who was vaccinated with a dose of pneumococcal 23v polysacchride vaccine. On the same day the pt was also vaccinated at a different site with a dose of influenza virus vaccine. Fourteen hours later the pt developed a fever of 103 to 104 deg, was lethargic, had breathing problems, chills, swelling of his arms and a 4cm area of erythema at the pneumococcal 23v polysaccharide vaccine injection site. He was admitted to the ER, and subsequently, was hospitalized and started on steroids and ceftriaxone. His white blood cell count was 16,000 and later rose to 22,000. The physician expressed concern about the particular lot of vaccine and inquired if there was "a way to have the vaccine sent in to be looked at." Additional info has been requested. It was also reported that a male pt was vaccinated with a dose of pneumococcal 23v polyssaccharide vaccine and developed a swollen arm and redness from his shoulder to his wrist (WAES0312USA00217).  Follow up on 12/16/03: "Information has been received from a physician concerning a 47 year old male who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 646159-0287N).  On the same day the pt was also vaccinated at a different site with a dose of influenza virus vaccine (manufacturer unknown).  Fourteen hours later the pt developed a fever of 103 to 104 degrees, was lethargic, had breathing problems, chills, swelling of his arms and a 4cm area of erythema at the pneumococcal 23v polysaccharide vaccine injection site.  He was admitted to the ER, and subsequently, was hospitalized and started on steroids and ceftriaxone.  His white blood cell count was 16,000 and later rose to 22,000.  The physician expressed concern about the particular lot of vaccine and inquired if there was "a way to have the vaccine sent in to be looked at".  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additonal information has been requested.  It was also reported that a male pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 646159-0287N) and developed a swollen arm and redness from his shoulder to his wrist (WAES 0312USA00217).
Age: 47.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Oedema peripheral, Pyrexia, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a 47 year old male who was vaccinated with a dose of pneumococcal 23v polysacchride vaccine. On the same day the pt was also vaccinated at a different site with a dose of influenza virus vaccine. Fourteen hours later the pt developed a fever of 103 to 104 deg, was lethargic, had breathing problems, chills, swelling of his arms and a 4cm area of erythema at the pneumococcal 23v polysaccharide vaccine injection site. He was admitted to the ER, and subsequently, was hospitalized and started on steroids and ceftriaxone. His white blood cell count was 16,000 and later rose to 22,000. The physician expressed concern about the particular lot of vaccine and inquired if there was "a way to have the vaccine sent in to be looked at." Additional info has been requested. It was also reported that a male pt was vaccinated with a dose of pneumococcal 23v polyssaccharide vaccine and developed a swollen arm and redness from his shoulder to his wrist (WAES0312USA00217).  Follow up on 12/16/03: "Information has been received from a physician concerning a 47 year old male who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 646159-0287N).  On the same day the pt was also vaccinated at a different site with a dose of influenza virus vaccine (manufacturer unknown).  Fourteen hours later the pt developed a fever of 103 to 104 degrees, was lethargic, had breathing problems, chills, swelling of his arms and a 4cm area of erythema at the pneumococcal 23v polysaccharide vaccine injection site.  He was admitted to the ER, and subsequently, was hospitalized and started on steroids and ceftriaxone.  His white blood cell count was 16,000 and later rose to 22,000.  The physician expressed concern about the particular lot of vaccine and inquired if there was "a way to have the vaccine sent in to be looked at".  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additonal information has been requested.  It was also reported that a male pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 646159-0287N) and developed a swollen arm and redness from his shoulder to his wrist (WAES 0312USA00217).
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Coordination abnormal, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 12 month old female who on 10/06/03 was vaccinated with a 0.5ml dose of varicella virus vaccine live. On 10/13/03 the patient's mother called stating the child had a fever, rash, and is ataxic. It was reported that the child was being sent to the emergency room for evaluation. No other specific information is available at this time. Additional information was received the physician and a registered nurse which indicated that after speaking with the patient's parent, it was determined that the patient did not have an adverse event. It was noted that the patient only experienced a fever and was not ataxic. No further information is expected. This report no longer meets the criteria for expedited submission because follow up information indicated that the adverse experience of ataxia did not occur.
Age: 40.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Injection site pain, Injection site swelling, Lymphadenopathy, Oedema, Pain
Clinical narrative: Information has been received from a 40 year old female who on 11/17/03 was vaccinated IM in the left arm with a dose of pneumococcal 23v polysaccharide vaccine. On 11/19/03, the patient presented to the emegency room with excruciating pain in her arm and swelling at the injection site. The patient noted that within 3 days, the site had swelled to 5 inches in diameter. The patient also noted swelling at the site of the lymph node and swelling over her entire body. She also indicated that she cannot raise her arm at the present time. The patient was admitted to the hospital on 11/19/03, and received a shot of morphine for pain. It did not relieve her pain. She also received x-rays at the site of vaccination, and blood work was done. The results were not reported. The patient was discharged from the hospital on 11/20/03. On 11/23/03, she returned to the emergency room. At that time, she was given prednisone, which did not help. At the time of the report, the patient was still taking the prednisone. She was not admitted to the hospital on this occasion. On 11/25/03, the swelling at the site was reported as 3 inches in diameter, and the patient reported that she was still having excruciating pain at the site. The outcome was reported as not recovered. Follow up information received on 12/1/03 from the patient indicated that she went back into the hospital on 11/25/03. She reported that she was admitted for excruciating pain at the site of injection, and that the swelling is still 3 inches in diameter at the vaccination site. The reporter considered the swelling at the site of injection, the excruciating pain in the arm, the inability to raise her arm, the swelling of the lymph nodes, and the swelling over the entire body to be immediately life-threatening. Additional information has been requested. It has been determined that WAES #0311USA02852 is a duplicate of WAES #0312USA00048. Therefore, WAES #0311USA02852 is being deleted from our files and the reports consolidated into WAES #0312USA00048