chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Death, Haemophilus infection, Meningitis, Vaccination failure
Clinical narrative: It was reported in a published article, title as stated above that 1 child experienced true vaccination failure and developed invasive Hib disease, also referred to as meningitis, despite vaccination with doses of PedvaxHib. (manufacturer unknown). It was reported that the patient experience death, cause unspecified. No further information was available at the time of this report. No outcome information was reported. Upon internal review, invasive Hib disease was determined to be an other important medical event. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Haemophilus infection, Meningitis
Clinical narrative: It was reported in a published article, title as stated above that 11 children developed invasive Hib disease, also referred to as meningitis, after being partially immunized with a median of 1 dose of PedvaxHib (OMPC) (manufacturer unknown) (range 1-2 doses). No further information was available at the time of this report. No outcome information was reported. Upon internal review, invasive Hib disease/meningitis was determined to be an other important medical event. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Death, Haemophilus infection, Vaccination failure
Clinical narrative: It was reported in a published article, that 2 children developed invasive Hib disease, after being partially immunized with a median of 1 dose of PedvaxHib (OMPC) (manufacturer unknown) (range 1-2 doses). It was reported that 2 infants died because of nontypeable H influenzae invasive disease. No further information was available at the time of this report. Upon internal review, invasive Hib disease was determined to be an other important medical event. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Hypersensitivity, Oedema peripheral, Skin warm
Clinical narrative: Mother stated pt received immunizations on 2/06/07 and the next day, pts arms started swelling, had redness and warm to touch.  This occurred in both arms.  Mother took pt to urgent care on Friday and was told by doctor at urgent care that pt had allergic reaction to both alternate warm and cold packs.
Age: 18.0
Sex: F
Vaccine: HEP, MNQ, TDAP
Symptoms: Dyskinesia, Eye rolling, Feeling abnormal, Musculoskeletal stiffness, Unresponsive to stimuli
Clinical narrative: After receiving last vaccine, she stated "I feel funny" (immediately after the injection). Eyes rolled back, head pulled to the right, body stiffened, legs jerking, unresponsive.  Lasted less than 1 minute.
Age: 15.0
Sex: M
Vaccine: HEP, IPV, MMRV, TD
Symptoms: Wrong drug administered
Clinical narrative: -none- accidental MMRV combo vaccine in incorrect age group.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Irritability, Wrong drug administered
Clinical narrative: Fluvirin was administered instead of Fluzone-"off label" use of vaccine by accident.  Clinic contacted manufacturer and Imm. program consultant, who talked with NIP.  Dose will count as 1st dose.  Fluzone to be given in 4 wks.  Talked with mother 1/24/07 and explained about vaccine. She stated that child is doing fine-just a little fussy; no fever.  Will return to clinic 02/20/07 for Fluzone.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Noticed left arm swollen, slight pain at site on 1-18-07 late pm. Seen at health dept 1-19-07-LA swollen-no reddness, no warmth to touch-has MD appt 1-22-07.  Will eval if needed at that time.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Rash generalised, Wheezing
Clinical narrative: Rash (bright red) over most of body, bil. wheezing, no edema. Pulse ok 130-145, O2 Sat. 97%. 10:20 am 1 tsp (12.5mg) Childrens Benadryl-no swelling to lips, tongue or throat.  Taken to ER by school
Sex: M
Vaccine: FLUX, IPV
Symptoms: Erythema
Clinical narrative: Pt has red area 15cm x 9cm
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting 4:30 am 2-11-07 to 5:00 pm
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vomiting
Clinical narrative: Nausea and vomiting 4:30 am 2-11-07 to 5:00 pm
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hyperaesthesia, Pruritus, Urticaria
Clinical narrative: Generalized itching started the evening of vaccine. Increased in sensitivity, esp in scalp over next 3 days. Broke out in hives 3 days after vaccine-both arms and face.  Given po Benadryl with improvement.  Hives gone after 2 doses of Benadryl.  Rx for Zyrtec started.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity, Pruritus, Urticaria
Clinical narrative: Generalized itching started the evening of vaccine. Increased in sensitivity, esp in scalp over next 3 days. Broke out in hives 3 days after vaccine-both arms and face.  Given po Benadryl with improvement.  Hives gone after 2 doses of Benadryl.  Rx for Zyrtec started.
Age: 59.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Pruritus
Clinical narrative: Pt received a Tdap immunization in the R deltoid on 2/5/07. She had no reaction until 2/11/07. At that time she started itching and noticed two 3x3 inch area of erythema with a 1/2 inch area that connected them. Seen by Dr. No apparent infection. Spoke with pt today and it is itching and is fading. Not itching 2/13/07 and decreased erythema.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Hyperreflexia, Hypokinesia, Mobility decreased, Musculoskeletal discomfort
Clinical narrative: 3 days after administration of Adacel pt was unable to move R shoulder, or rise from laying or sitting position w/o assistance. Discomfort in hips with weight bearing. Blurred vision, transient nausea, gait is stiff with marked discomfort somewhat relieved with Naprosyn. On exam decreased ROM to R UE decreased strength in R neck. Hyperreflexia to R UE and R LE.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Nuclear magnetic resonance imaging normal, Parkinsonian gait, Red blood cell sedimentation rate increased, Vision blurred
Clinical narrative: 3 days after administration of Adacel pt was unable to move R shoulder, or rise from laying or sitting position w/o assistance. Discomfort in hips with weight bearing. Blurred vision, transient nausea, gait is stiff with marked discomfort somewhat relieved with Naprosyn. On exam decreased ROM to R UE decreased strength in R neck. Hyperreflexia to R UE and R LE.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Aspiration, Chest X-ray, Cough, Cyanosis, Oxygen saturation decreased
Clinical narrative: Given Rotateq immediately coughed, gagged. Pt briefly cyanotic. Continued to gag/cough, O2 Sat 88-97%. Transported by EMT to ED to R/O aspiration. CX ray negative.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Retching
Clinical narrative: Given Rotateq immediately coughed, gagged. Pt briefly cyanotic. Continued to gag/cough, O2 Sat 88-97%. Transported by EMT to ED to R/O aspiration. CX ray negative.
Sex: F
Vaccine: PPV, TDAP
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Fever, nausea, vomiting, diarrhea, headache, x 4 days, L deltoid red x 4 days, R deltoid red, swollen, tissue hard at site x 10 days, Treatment of symptoms until resolved.
Sex: F
Vaccine: PPV, TDAP
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, nausea, vomiting, diarrhea, headache, x 4 days, L deltoid red x 4 days, R deltoid red, swollen, tissue hard at site x 10 days, Treatment of symptoms until resolved.
Age: 50.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Cellulitis, Full blood count normal, HIV test negative, Lymphadenopathy
Clinical narrative: Cellulitis, with lymphangitis and tender large L axillary lymph node (3cm), vesicular and draining and pus. Started on levaPak
Age: 50.0
Sex: M
Vaccine: SMALL
Symptoms: Lymphangitis, Rash vesicular, Tenderness
Clinical narrative: Cellulitis, with lymphangitis and tender large L axillary lymph node (3cm), vesicular and draining and pus. Started on levaPak
Age: 42.0
Sex: F
Vaccine: FLU3, HEP, HEPA, IPV, MMR, TDAP
Symptoms: Rash, Sensitivity of teeth
Clinical narrative: Our client received vaccines January 16, 2007. On January 22 she noticed a rash on her stomach, which moved on her back and up into her armpits. It was still moving when she called on January 25th. She had no hives, no fever, no chills. I spoke with the PA-C, who said it sounded like a histamine reaction and we advised her to try an antihistamine or see a doctor or go to the emergency room, if it concerned her. Also, she and another person, who received vaccines at our clinic the same day, both had a tooth that had become sensitive. We advised her to see a dentist.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Pallor, Vomiting
Clinical narrative: 1:40 PM client received 3 vaccines 1st Dtap and polio in LA, MMR #2 placed in RA. 3 to 5 minutes after receiving shots client became pale, started vomiting and had local reaction redness to RA (MMR injection site). Client laid on bed, legs elevated, cold compress placed on forehead. Client took several swallows of coke cola. No difficulty breathing or swallowing noted. BP checked at 2:15 pm 90/58, color returned to face client walking around.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Received Pneumovax shot believes it's his 2nd dose 1st given about 7 years ago or so. That night he developed soreness, mild erythema and swelling which extended down/distal his upper ext to wrist. Some improvement now, 3 days later, but not completely resolved.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Received Pneumovax shot believes it's his 2nd dose 1st given about 7 years ago or so. That night he developed soreness, mild erythema and swelling which extended down/distal his upper ext to wrist. Some improvement now, 3 days later, but not completely resolved.
Age: 1.49
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Dyspnoea, Urticaria
Clinical narrative: AT 9:30 am, patient was given 2 vaccines, Dtap, Hib. Returned to office around 11:45 am with hives all over. Mom reports that he had gasped for breath at two different times. No wheezing noted by physician. Patient was currently without respiratory distress. Benadryl 3/4 tsp given by mouth and 0.1 mg of Epinephrine was given IM.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 2/8 L arm red and swollen in injection site. Pt took IBU.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC, VARCEL
Symptoms: Cellulitis, Urticaria
Clinical narrative: On 2/2/07 noticed "welts" on left thigh came to office 2/5/07 and diagnosed with left cellulitis.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Left deltoid area - red with edema and hear 10 cm. Ice and OTC Benadryl cream.
Age: 9.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Inappropriate schedule of drug administration, Injection site pruritus, Medication error, Swelling
Clinical narrative: Localized swelling, pruritic at site.
Age: 0.13
Sex: M
Vaccine: HEP
Symptoms: Full blood count normal, Pyrexia, Urine analysis normal
Clinical narrative: Seen in ER of 1 month WCC for 103.5 temperature had normal CBC and UA - attributed to HBV.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 1.43
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Within 10 minutes of injection, he had red whelps on both arms and hands. Redness at injection site. We gave him Benadryl 12.5 mg IM and put ice packs to both injection sites.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Dyskinesia, Skin nodule
Clinical narrative: Seen in office on 2/7/07 Per dad and nurse patient jerked left leg during vaccination - knot noted on 2/6. Eval: slight pucker to skin left thigh with 1 cm round, firm nodule, nontender, no erythema. No treatment - reassurance.
Age: 35.0
Sex: F
Vaccine: TD, TYP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia, Urticaria
Clinical narrative: Localized swelling, redness, tenderness, mild fever, swelling and hives on face.
Age: 0.27
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Anorexia, Conversion disorder, Crying, Hyperhidrosis
Clinical narrative: Infant received first set of immunizations on 11-22-06 with the exception of having received his first Hepatitis B at birth. His appointment for his second set of immunizations was scheduled for 01/31/07 and it was at that time that the mother reported that the infant had cried for 4 hours straight after receiving his immunizations on 11-22-06. Mother reported that the child "felt a little warm but not feverish" but denied checking his temperature with a thermometer. She stated the infant "turned a bright plum color and was sweaty" from crying so much. Mother also reported that infant was kicking and hysterical during the 4 hour crying period. She stated that the crying started immediately after he received his immunizations. Denied any whelps, hives, or seizures. The infant refused to breast-feed or take a bottle that day. On day 2 the child was fussy but his appetite was better. Day 3 showed more improvement with his appetite and fussiness and by Day 4 he was back to normal. Instructed mother to consult with MD and get permission to receive immunization and bring record from MD with permission to administer immunizations.
Age: 0.27
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Skin warm
Clinical narrative: Infant received first set of immunizations on 11-22-06 with the exception of having received his first Hepatitis B at birth. His appointment for his second set of immunizations was scheduled for 01/31/07 and it was at that time that the mother reported that the infant had cried for 4 hours straight after receiving his immunizations on 11-22-06. Mother reported that the child "felt a little warm but not feverish" but denied checking his temperature with a thermometer. She stated the infant "turned a bright plum color and was sweaty" from crying so much. Mother also reported that infant was kicking and hysterical during the 4 hour crying period. She stated that the crying started immediately after he received his immunizations. Denied any whelps, hives, or seizures. The infant refused to breast-feed or take a bottle that day. On day 2 the child was fussy but his appetite was better. Day 3 showed more improvement with his appetite and fussiness and by Day 4 he was back to normal. Instructed mother to consult with MD and get permission to receive immunization and bring record from MD with permission to administer immunizations.
Age: 0.22
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Cold compress therapy, Crying, Skin nodule
Clinical narrative: Grandma reported that patient started crying shortly after patient had received vaccinations. Patient was crying uncontrollably and was taken into emergency room reported by grandma. Patient went to ER were they applied cold packs to right thigh. Grandma report that knot started reducing in size. and through night to go down.
Age: 1.02
Sex: M
Vaccine: MMR
Symptoms: Febrile convulsion
Clinical narrative: MMR - Wednesday 2/7/07 febrile seizure. Friday 2/9/07 seen in office 2/12/07 - no sequelae.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site cellulitis
Clinical narrative: Got cellulitis on R thigh at site of injection. Had to go to ER got 3 days of IV antibiotics follow by oral antibiotics.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Bradycardia, Computerised tomogram normal, Loss of consciousness, Road traffic accident
Clinical narrative: Blacked out while driving. (loss of consciousness) no injuries, car was totaled.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Decreased appetite, Pyrexia, Rash
Clinical narrative: He had fever on and off x 4 of 104, rash on shoulder 3x days. Decreased appetite.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Anxiety, Dyspnoea, Hyperhidrosis, Hypersensitivity, Mental status changes
Clinical narrative: Administered Varicella approx 4:15pm 1-2 min later pt c/o sore throat, hands and throat mom reported yes when asked is having difficulty breathing, began to faint, color pale, diaphoretic, layer flat, not responding, aroused by ammonia inhalant but mental status altered, remained diaphoretic and pale. Administered 03 ml Epi SQ followed by 6ml Benadryl IM. 4:20 pm B/P 80/60 P 70 4:25pm, B/P P 72 pt responded to meds, mom called 911 at beginning of event. Paramedics arrived around 4:30pm transported via ambulance appeared stable. TC mom child back in school today, at ER till 10pm, DX allergic reaction VX anxiety/syncope, kept till 10pm Tue Epi wore off. Discharged to home with 2 day prescription for Prednisone, prescribed Epi Pen and mom told to observe 2 wks, saw PCP Dr 2/18 who prescribed Epi Pen for school too, advised no more varicella vaccine.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Pallor, Pharyngolaryngeal pain, Syncope, Unresponsive to stimuli
Clinical narrative: Administered Varicella approx 4:15pm 1-2 min later pt c/o sore throat, hands and throat mom reported yes when asked is having difficulty breathing, began to faint, color pale, diaphoretic, layer flat, not responding, aroused by ammonia inhalant but mental status altered, remained diaphoretic and pale. Administered 03 ml Epi SQ followed by 6ml Benadryl IM. 4:20 pm B/P 80/60 P 70 4:25pm, B/P P 72 pt responded to meds, mom called 911 at beginning of event. Paramedics arrived around 4:30pm transported via ambulance appeared stable. TC mom child back in school today, at ER till 10pm, DX allergic reaction VX anxiety/syncope, kept till 10pm Tue Epi wore off. Discharged to home with 2 day prescription for Prednisone, prescribed Epi Pen and mom told to observe 2 wks, saw PCP Dr 2/18 who prescribed Epi Pen for school too, advised no more varicella vaccine.
Age: 1.04
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC, VARCEL
Symptoms: Erythema, Injection site induration
Clinical narrative: Induration of L thigh in area of injections.  Much worse than the normal reaction, with associated erythema and duskiness.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Blood culture negative, Culture stool negative, Culture urine negative, Diarrhoea, Lethargy
Clinical narrative: on 12/05/2006, the patient vomited 3 or 4 times and also had 3 episodes of diarrhea. 1 hour later, while in the office, he became lethargic, gray and needed stimulation and blow-by oxygen. He was transported by EMS to the emergency department.  03/27/2007 MR received for a 2 night hospital stay for c/o vomiting and diarrhea x4 as well as a parental report of turning blue.  Infant has has runny nose, congestion, and coughing x 2 weeks. PE: low grade fever, cough, runny nose, TMs dull and erythematous bilaterally, coarse breath sounds with good air movement, small rectal fissure. Txd with IVF and antibiotics.  Vomiting resolved, still had diarrhea upon D/C. Primary DX:  AGE. Secondary DX: leukocytosis.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Oxygen supplementation, Pallor, Vomiting, White blood cell count increased
Clinical narrative: on 12/05/2006, the patient vomited 3 or 4 times and also had 3 episodes of diarrhea. 1 hour later, while in the office, he became lethargic, gray and needed stimulation and blow-by oxygen. He was transported by EMS to the emergency department.  03/27/2007 MR received for a 2 night hospital stay for c/o vomiting and diarrhea x4 as well as a parental report of turning blue.  Infant has has runny nose, congestion, and coughing x 2 weeks. PE: low grade fever, cough, runny nose, TMs dull and erythematous bilaterally, coarse breath sounds with good air movement, small rectal fissure. Txd with IVF and antibiotics.  Vomiting resolved, still had diarrhea upon D/C. Primary DX:  AGE. Secondary DX: leukocytosis.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Joint swelling, X-ray
Clinical narrative: Joint pain, soreness, and swelling after Anthrax Vaccination.  Currently taking Motrin.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: @/14/07:   Given IM injection on 12/6/06 in right deltoid.  States injection site still very sore and complaint of pain in right shoulder and upper arm when doing exercises or at rest.  Has not taken any OTC meds or used moist heat to arm - may have taken Advil immediately after vaccination.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Dyspnoea, Throat irritation
Clinical narrative: Patient calls on tuesday am as our office was closed on monday.  She states she was in the emergency room over the weekend.  After receiving the flu shot on friday she had "roughness in her throat", difficulty breathing, dizziness and was sick to her stomach.  She was told in the er that she should not receivet the flu shot again.  She was prescribed generic benadryl, famotine 20mg, and prednisone 20 mg.  She did not have any symptoms in the area the injection was given which was the Right Deltoid.  Client does not recall when I spoke with her after the event if she had ever had the flu shot in the past, she thinks that she had not ever had one.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Culture throat negative, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: AFEBRILE ERYTHEMATOUS FINE PAPULAR PRURITIC RASH ON CHEST, LEGS, BACK AND ABDOMEN BEGINNING 2 DAYS POST VACCINATION.  PRURITITS AND ERYTHEMA RESPONDED TO ORAL BENADRYL.
Age: 24.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Grand mal convulsion
Clinical narrative: Had Tonic Clonic seizure witnessed by nurse and doctor immediately after vaccine administration (Td). Seizure lasted less than 1 minute. Patient with no PMH, no meds. No prior history of seizure as per patient.
Age: 27.0
Sex: F
Vaccine: DTAP
Symptoms: Discomfort, Erythema, Induration, Injection site discomfort, Injection site warmth
Clinical narrative: 2-16-07: vaccine administered  2-17-07: developed redness/swelling/local heat & discomfort 2-18-07:all same except local discomfort increasing  2-19-07: pain now radiating down arm and present with movement; induration measured - 60mm x 50mm (employee works at a hospital; employee health nurse there meaured the induration).  Applied ice x2, 2 ES Tylenol and benadryl taken.  2-20-07:  Notified me of reaction.  Per employee health nurse at the job location now, induration slightly larger.  I advised her to seek medical care from her doctor. This vaccine was given as part of an employee benefit .  She does not have the insurance that provides the benefit.     Manufacturer of vaccine is: Sanofi Pasteur Limited (Adacel)
Age: 27.0
Sex: F
Vaccine: DTAP
Symptoms: Pain, Skin warm, Swelling
Clinical narrative: 2-16-07: vaccine administered  2-17-07: developed redness/swelling/local heat & discomfort 2-18-07:all same except local discomfort increasing  2-19-07: pain now radiating down arm and present with movement; induration measured - 60mm x 50mm (employee works at a hospital; employee health nurse there meaured the induration).  Applied ice x2, 2 ES Tylenol and benadryl taken.  2-20-07:  Notified me of reaction.  Per employee health nurse at the job location now, induration slightly larger.  I advised her to seek medical care from her doctor. This vaccine was given as part of an employee benefit .  She does not have the insurance that provides the benefit.     Manufacturer of vaccine is: Sanofi Pasteur Limited (Adacel)
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: CV recieved an IM Hepatitis B Vaccination in the shoulder. 1.5 hours later, patient developed pain in her arm. It began to swell up and become hard. She was unable to move her arm. She recieved Bactrim and Vicodin as treatment. The reaction dissapated over 1 week
Age: 0.66
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect, Oxygen saturation
Clinical narrative: A FOURTH DOSE OF ROTATEQ WAS GIVEN ON 2/8/07 @ 12:55. FIRST DOSE OF ROTATEQ WAS NOT NOTED OF HIS IZ CARD IN CHART. WHEN THIS WAS DISCOVERED, I CALLED THE CDC TO ASK FOR POSSIBLE SIDE EFFECTS. DR CALLED FAMILY TO NOTIFY. NO KNOWN SIDE EFFECTS REPORTED BY FAMILY. AT TIME OF APPT. T:99.5;CHILD HAD SLIGHT COUGH O2SAT:98%
Age: 1.3
Sex: F
Vaccine: HIBV, MMRV
Symptoms: Insomnia, Irritability, Malaise, Pyrexia, Rash
Clinical narrative: Patient ran fever, extremely fussy, not sleeping, general malaise, and developed a rash after 10 days.
Age: 51.0
Sex: U
Vaccine: FLU3
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: usual flu vaccine on 2/12/07, the night of injection got severe pain, swelling in arm, but no fever, SOB, hives or other reaction
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza, Influenza serology negative, Nausea, Pyrexia, Vomiting
Clinical narrative: FLU SYMPTOMS-N/V,DIARRHEA, FEVER-101F. STATED ALREADY HAD GI BUG BACK IN NOV. 2006. WAS NOT VACCINATED FOR FLU THIS YEAR. SENT TO EMERGENCY DEPT TO R/O FLU. INFLUENZA WAS RULED OUT.
Age: 34.0
Sex: F
Vaccine: DTAP
Symptoms: Medication error, Wrong drug administered
Clinical narrative: Patient was sent to this office to receive diptheria, tetanus, pertussis immunization following recommendation of pediatrician after delivery.  Medication was ordered from hospital pharmacy and administered.  It was then noted that the medication received was "Infanrix" which is not approved for adults.  CDC notifed, transferred to public health advisor who reports that patient should not experience any serious adverse effects from immunization.  May have slight increase in local reaction if anything.  Indicates that appropriate immunization would be Boostrix or Adacel.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Developed varicilla rash 14 days after recieving vaccine
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Left artm with area of hardness + redness extending from injection site - total size of rxm approx greater than the size of 4 quarters.  Patient's mom reports patient has been scratching site.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Musculoskeletal stiffness
Clinical narrative: PATIENT REPORTED MUSCLE STIFFNESS AND WEAKNESS STARTING 2-3 DAYS AFTER IMMUNIZATION. NOT SURE IF PATIENT WAS GOING TO SEE DOCTOR.  SHE BELIEVED THAT WAS SUBSIDING AFTER 2-3 WEEKS.
Sex: M
Vaccine: FLU3, HEPA, HIBV, MMRV
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Right thigh swollen and firm mass to palpation.
Age: 0.22
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Crying, Dyskinesia, Screaming
Clinical narrative: Crying for 3 hours, screaming for 3 hours, 2/12 hours of jerking.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Tremor
Clinical narrative: Head and body shaking observed by parents, Distressed cry.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Asthenia, Dehydration, Gait disturbance, Guillain-Barre syndrome, Hyperkinesia
Clinical narrative: Initial report received on 22/Sep/2006. An "approximately" 16 year old female patient, with a history of attention deficit disorder, had received an intramuscular, first dose injection of Menactra, lot number U2069AA, and in intramuscular, first dose injection of Gardasil, Lot number 0637F, on 07/Jul/2006. She ha d no illness at the time of vaccination. Concomitant medications included Adderall 50 mg. Thirteen days post vaccination, the patient experienced weakness "times several months."Although the report is difficult to read, it appears the reporter had written,  "this was not objectively noticed then, but mostly after the vaccine." The event required hospitalization for one day. The patient was examined by a  neurologist and treated with IVIG. The event was reported as Guillain Barre syndrome. The patient recovered from the event. This case has not yet been confirmed by CISA (Clinical immunization safety assessment network) as being Guillain Barre syndrome following Menactra vaccination. The onset of symptoms may have been prior to vaccination. Follow-up information received on 27/Sep/2006. Per the reporter, "there is doubt regarding the date of onset. The symptoms may have started in June of 2006 prior to vaccination. The neurologist's history of weakness goes back to late June before immunization. The primary care physician's report on the VAERS form was based on a physician assistant's screening history prior to vaccine administration that was not specific for neurologic symptoms. Comments regarding GBS confirmation status, "unless we get other information from the patient/family to the contrary, the neurologist's consult should stand, and this would not be a post vaccine Guillain Barre case. Follow up information received on 12 February 2007 from a manufacturer, whose reference number is WAES0702USA00828. This manufacturer received the original report. This manufacturer reported the lot number for Gardasil as being 653937/0637F. The lot number in the case was amended from 0637F to 653937/0637F per this new information. New information concerning this case included that on 20 July 2006, the patient experienced asthenia, dehydration, gait abnormality, hyperkinesia, and paresthesia and was noted to have an unspecified abnormal lab test and was diagnosed with Guillain Barre syndrome. The patient was subsequently hospitalized for one day. The patient recovered from the events after a duration of 13 days. Reportedly, the patient had been well on the day of vaccination, however, shortly after vaccination, she became weak, but several months later, her symptoms were not objectively noticed. The events of asthenia, dehydration, gait abnormality, hyperkinesia, and paresthesia were added to the case.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Paraesthesia
Clinical narrative: Initial report received on 22/Sep/2006. An "approximately" 16 year old female patient, with a history of attention deficit disorder, had received an intramuscular, first dose injection of Menactra, lot number U2069AA, and in intramuscular, first dose injection of Gardasil, Lot number 0637F, on 07/Jul/2006. She ha d no illness at the time of vaccination. Concomitant medications included Adderall 50 mg. Thirteen days post vaccination, the patient experienced weakness "times several months."Although the report is difficult to read, it appears the reporter had written,  "this was not objectively noticed then, but mostly after the vaccine." The event required hospitalization for one day. The patient was examined by a  neurologist and treated with IVIG. The event was reported as Guillain Barre syndrome. The patient recovered from the event. This case has not yet been confirmed by CISA (Clinical immunization safety assessment network) as being Guillain Barre syndrome following Menactra vaccination. The onset of symptoms may have been prior to vaccination. Follow-up information received on 27/Sep/2006. Per the reporter, "there is doubt regarding the date of onset. The symptoms may have started in June of 2006 prior to vaccination. The neurologist's history of weakness goes back to late June before immunization. The primary care physician's report on the VAERS form was based on a physician assistant's screening history prior to vaccine administration that was not specific for neurologic symptoms. Comments regarding GBS confirmation status, "unless we get other information from the patient/family to the contrary, the neurologist's consult should stand, and this would not be a post vaccine Guillain Barre case. Follow up information received on 12 February 2007 from a manufacturer, whose reference number is WAES0702USA00828. This manufacturer received the original report. This manufacturer reported the lot number for Gardasil as being 653937/0637F. The lot number in the case was amended from 0637F to 653937/0637F per this new information. New information concerning this case included that on 20 July 2006, the patient experienced asthenia, dehydration, gait abnormality, hyperkinesia, and paresthesia and was noted to have an unspecified abnormal lab test and was diagnosed with Guillain Barre syndrome. The patient was subsequently hospitalized for one day. The patient recovered from the events after a duration of 13 days. Reportedly, the patient had been well on the day of vaccination, however, shortly after vaccination, she became weak, but several months later, her symptoms were not objectively noticed. The events of asthenia, dehydration, gait abnormality, hyperkinesia, and paresthesia were added to the case.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Asthenia, Blood creatine phosphokinase normal, Dehydration, Electromyogram abnormal, Gait disturbance
Clinical narrative: Initial report received on 22/Sep/2006. An "approximately" 16 year old female patient, with a history of attention deficit disorder, had received an intramuscular, first dose injection of Menactra, lot number U2069AA, and in intramuscular, first dose injection of Gardasil, Lot number 0637F, on 07/Jul/2006. She ha d no illness at the time of vaccination. Concomitant medications included Adderall 50 mg. Thirteen days post vaccination, the patient experienced weakness "times several months."Although the report is difficult to read, it appears the reporter had written,  "this was not objectively noticed then, but mostly after the vaccine." The event required hospitalization for one day. The patient was examined by a  neurologist and treated with IVIG. The event was reported as Guillain Barre syndrome. The patient recovered from the event. This case has not yet been confirmed by CISA (Clinical immunization safety assessment network) as being Guillain Barre syndrome following Menactra vaccination. The onset of symptoms may have been prior to vaccination. Follow-up information received on 27/Sep/2006. Per the reporter, "there is doubt regarding the date of onset. The symptoms may have started in June of 2006 prior to vaccination. The neurologist's history of weakness goes back to late June before immunization. The primary care physician's report on the VAERS form was based on a physician assistant's screening history prior to vaccine administration that was not specific for neurologic symptoms. Comments regarding GBS confirmation status, "unless we get other information from the patient/family to the contrary, the neurologist's consult should stand, and this would not be a post vaccine Guillain Barre case. Follow up information received on 12 February 2007 from a manufacturer, whose reference number is WAES0702USA00828. This manufacturer received the original report. This manufacturer reported the lot number for Gardasil as being 653937/0637F. The lot number in the case was amended from 0637F to 653937/0637F per this new information. New information concerning this case included that on 20 July 2006, the patient experienced asthenia, dehydration, gait abnormality, hyperkinesia, and paresthesia and was noted to have an unspecified abnormal lab test and was diagnosed with Guillain Barre syndrome. The patient was subsequently hospitalized for one day. The patient recovered from the events after a duration of 13 days. Reportedly, the patient had been well on the day of vaccination, however, shortly after vaccination, she became weak, but several months later, her symptoms were not objectively noticed. The events of asthenia, dehydration, gait abnormality, hyperkinesia, and paresthesia were added to the case.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Guillain-Barre syndrome, Hyperkinesia, Immunoglobulins, Laboratory test abnormal, Neutrophil count increased
Clinical narrative: Initial report received on 22/Sep/2006. An "approximately" 16 year old female patient, with a history of attention deficit disorder, had received an intramuscular, first dose injection of Menactra, lot number U2069AA, and in intramuscular, first dose injection of Gardasil, Lot number 0637F, on 07/Jul/2006. She ha d no illness at the time of vaccination. Concomitant medications included Adderall 50 mg. Thirteen days post vaccination, the patient experienced weakness "times several months."Although the report is difficult to read, it appears the reporter had written,  "this was not objectively noticed then, but mostly after the vaccine." The event required hospitalization for one day. The patient was examined by a  neurologist and treated with IVIG. The event was reported as Guillain Barre syndrome. The patient recovered from the event. This case has not yet been confirmed by CISA (Clinical immunization safety assessment network) as being Guillain Barre syndrome following Menactra vaccination. The onset of symptoms may have been prior to vaccination. Follow-up information received on 27/Sep/2006. Per the reporter, "there is doubt regarding the date of onset. The symptoms may have started in June of 2006 prior to vaccination. The neurologist's history of weakness goes back to late June before immunization. The primary care physician's report on the VAERS form was based on a physician assistant's screening history prior to vaccine administration that was not specific for neurologic symptoms. Comments regarding GBS confirmation status, "unless we get other information from the patient/family to the contrary, the neurologist's consult should stand, and this would not be a post vaccine Guillain Barre case. Follow up information received on 12 February 2007 from a manufacturer, whose reference number is WAES0702USA00828. This manufacturer received the original report. This manufacturer reported the lot number for Gardasil as being 653937/0637F. The lot number in the case was amended from 0637F to 653937/0637F per this new information. New information concerning this case included that on 20 July 2006, the patient experienced asthenia, dehydration, gait abnormality, hyperkinesia, and paresthesia and was noted to have an unspecified abnormal lab test and was diagnosed with Guillain Barre syndrome. The patient was subsequently hospitalized for one day. The patient recovered from the events after a duration of 13 days. Reportedly, the patient had been well on the day of vaccination, however, shortly after vaccination, she became weak, but several months later, her symptoms were not objectively noticed. The events of asthenia, dehydration, gait abnormality, hyperkinesia, and paresthesia were added to the case.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Paraesthesia, Psychomotor hyperactivity
Clinical narrative: Initial report received on 22/Sep/2006. An "approximately" 16 year old female patient, with a history of attention deficit disorder, had received an intramuscular, first dose injection of Menactra, lot number U2069AA, and in intramuscular, first dose injection of Gardasil, Lot number 0637F, on 07/Jul/2006. She ha d no illness at the time of vaccination. Concomitant medications included Adderall 50 mg. Thirteen days post vaccination, the patient experienced weakness "times several months."Although the report is difficult to read, it appears the reporter had written,  "this was not objectively noticed then, but mostly after the vaccine." The event required hospitalization for one day. The patient was examined by a  neurologist and treated with IVIG. The event was reported as Guillain Barre syndrome. The patient recovered from the event. This case has not yet been confirmed by CISA (Clinical immunization safety assessment network) as being Guillain Barre syndrome following Menactra vaccination. The onset of symptoms may have been prior to vaccination. Follow-up information received on 27/Sep/2006. Per the reporter, "there is doubt regarding the date of onset. The symptoms may have started in June of 2006 prior to vaccination. The neurologist's history of weakness goes back to late June before immunization. The primary care physician's report on the VAERS form was based on a physician assistant's screening history prior to vaccine administration that was not specific for neurologic symptoms. Comments regarding GBS confirmation status, "unless we get other information from the patient/family to the contrary, the neurologist's consult should stand, and this would not be a post vaccine Guillain Barre case. Follow up information received on 12 February 2007 from a manufacturer, whose reference number is WAES0702USA00828. This manufacturer received the original report. This manufacturer reported the lot number for Gardasil as being 653937/0637F. The lot number in the case was amended from 0637F to 653937/0637F per this new information. New information concerning this case included that on 20 July 2006, the patient experienced asthenia, dehydration, gait abnormality, hyperkinesia, and paresthesia and was noted to have an unspecified abnormal lab test and was diagnosed with Guillain Barre syndrome. The patient was subsequently hospitalized for one day. The patient recovered from the events after a duration of 13 days. Reportedly, the patient had been well on the day of vaccination, however, shortly after vaccination, she became weak, but several months later, her symptoms were not objectively noticed. The events of asthenia, dehydration, gait abnormality, hyperkinesia, and paresthesia were added to the case.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: 5 minutes after Pt received vaccines, fainted LOC lasted about 5 seconds then pt dizzy and lightheaded for about 5-10 min and relieved by 10 min resting supine then 5 min sitting and drinking gatorade/eating cheese crackers.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Dizziness, Headache, Pain
Clinical narrative: Mother called 2/20/07 stating pt felt body pain esp bilat arms, dizziness with movement and HA, Temp 99.7.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug screen negative, Dysstasia, Feeling drunk, Incoherent, Lethargy
Clinical narrative: Information has been received from a licensed practical nurse concerning an 18 year old female with a penicillin allergy and allergy to BENADRYL who on 11-FEB-2007 was vaccinated at another practice with a first dose of Gardasil. There was no concomitant medication. On 11-FEB-2007, 30 minutes after the vaccination, the patient "felt lethargic and could not stand on her own". "She looked like she was drunk and she did not make any sense when she spoke". The patient went to an emergency department and was released. She was reported to have no rash or breathing problems. It was also reported that a urinalysis was clear and drug test was normal. She was reported to have recovered 12 hours after the vaccination./ The reporter felt that the patient's symptoms were disabling. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Urine analysis normal
Clinical narrative: Information has been received from a licensed practical nurse concerning an 18 year old female with a penicillin allergy and allergy to BENADRYL who on 11-FEB-2007 was vaccinated at another practice with a first dose of Gardasil. There was no concomitant medication. On 11-FEB-2007, 30 minutes after the vaccination, the patient "felt lethargic and could not stand on her own". "She looked like she was drunk and she did not make any sense when she spoke". The patient went to an emergency department and was released. She was reported to have no rash or breathing problems. It was also reported that a urinalysis was clear and drug test was normal. She was reported to have recovered 12 hours after the vaccination./ The reporter felt that the patient's symptoms were disabling. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Amniocentesis, Drug exposure during pregnancy, Foetal disorder, Pregnancy, Ultrasound scan
Clinical narrative: Information has been received from a medical assistant concerning her 18 year old daughter with family history free from abnormalities who in August 2006, was vaccinated with Gardasil (lot # not reported) injection, IM. Concomitant therapy included varicella virus vaccine live (lot # not reported) given in September 2006). The patient sought medical attention. At the time of reporting, the patient was 4 months pregnant (estimated last menstrual period 03-NOV-2006 and estimated date of delivery 10-AUG-2007). Her unborn child has fetal abnormalities which were detected shortly after vaccination with Gardasil and varicella virus vaccine live. On an unspecified date, the patient had ultrasounds and amniocentesis  performed. Additional information was received from the patient's mother via telephone call who reported that her daughter is currently under the care of perinatologist. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Hepatic enzyme increased, Lethargy
Clinical narrative: This case was reported by a physician and described the occurrence of increased liver enzymes in a 4-year-old male subject who was vaccinated with Havrix for prophylaxis. Concurrent vaccination included influenza virus vaccine given on 27 January 2007. Concurrent medications included Amoxicillin trihydrate and Dimetapp-DM. On 27 January 2007 the subject received 1st dose of Havrix at 720 elisa units. At an unspecified time after vaccination with Havrix, the subject experienced increased liver enzymes and lethargy. This case was assessed as medically serious. At the time of reporting the outcome of the events were was unspecified. The physician considered the events were possibility related to vaccination with Havrix.
Age: 15.0
Sex: M
Vaccine: TDAP
Clinical narrative: Tdap IM left deltoid at 1045. 02/22/2007 Call to reporter re: ? AE.  Box 7- "possible reaction to Tdap" and  redness around the waist.  02/26/2007 MR received from treating hospital for c/o swelling and tingling in the left arm and hand where he had received DTap vax. earlier in the day.   PE shows mild redness and swelling in the left hand.  No abnormality at the injection site.  Treated with Benadryl and D/C'd. Assessment:  Possible reaction to DTap.
Age: 66.0
Sex: F
Vaccine: MNQ, PPV, TD
Symptoms: Erythema, Oedema peripheral, Similar reaction on previous exposure to drug
Clinical narrative: Pt traveling to Africa and received vaccines 1/10/07 and 1/17/07.  On 1/17/07 pt received TD. Menommune and Pneumococcus vaccines.  1/19/07 pt called clinic and reported red and swollen arm down to elbow, was instructed to go to MD's office. Received antibiotics on 1/24/07 pt stated she was doing much better.  MD told pt it was likely due to Pneumococcus vaccine. Patient stated she had problems w/Pneumo vaccine the other time she received it (she forgot about receiving pneumo vaccine prior to vaccination 1/17/07)
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Intussusception, X-ray with contrast lower gastrointestinal tract
Clinical narrative: Had an intussusception reduced by barium enema on 2/16/07-Ileocal intussusception pain began on 2/15/07.  3/1/07 Received medical records from hospital which reveal patient experienced uncontrollable crying & diarrhea for 2 days along with apparent abdominal pain intermittently for several hours prior to ER.  Exam revealed abdomen distended & tender.  Patient d/c home same day as successful IS reduction to be f/u by PCP.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Intussusception, Pain, X-ray
Clinical narrative: Had an intussusception reduced by barium enema on 2/16/07-Ileocal intussusception pain began on 2/15/07.  3/1/07 Received medical records from hospital which reveal patient experienced uncontrollable crying & diarrhea for 2 days along with apparent abdominal pain intermittently for several hours prior to ER.  Exam revealed abdomen distended & tender.  Patient d/c home same day as successful IS reduction to be f/u by PCP.
Age: 1.42
Sex: F
Vaccine: DTAPH, HEPA, MMR, PNC
Symptoms: Anorexia, Pyrexia, Rash macular, Rhinorrhoea
Clinical narrative: blotchy red rash with spots on neck, abdomen and back areas.  Slight fever on 2/8/07 of 102f. Had loss of appetite and a runny nose. Rash does not seem to itch or bother pt.  Mom gave Motrin for fever which helped her.  One site had "bright redness and bumpy"