chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Convulsion, Erythema, Fear, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: Benston had the exact same stiffening, seizure like episodes as he had after his 2 month vaccinations.  It was a Saturday morning and he had his first one.  His whole body tightened, his face got red and it lasted about 5 seconds.  It looked involuntary and his eyes got big like he was scared but he didn't cry afterward.  He had two more that same day 3/13 in the afternoon.  Then he had another one on 3/15 in the late afternoon.  That was the last one.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Reaction to previous exposure to any vaccine
Clinical narrative: Benston had the exact same stiffening, seizure like episodes as he had after his 2 month vaccinations.  It was a Saturday morning and he had his first one.  His whole body tightened, his face got red and it lasted about 5 seconds.  It looked involuntary and his eyes got big like he was scared but he didn't cry afterward.  He had two more that same day 3/13 in the afternoon.  Then he had another one on 3/15 in the late afternoon.  That was the last one.
Age: 48.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Arthralgia, Blood test, Condition aggravated, Injection site discolouration, Injection site erythema
Clinical narrative: The area around the injection site turned white, and the area around the white turned red.  It became swollen, started burning/itching and there was heat in the red area.  The swelling and redness progressed to the elbow.  There was pain in the elbow joint once the swelling and redness hit there.  I was treated at an urgent care facility, was given a shot of antibiotics and then a prescription for a sulfa antibiotic.  On the 31st I went to emergency room because the swelling and redness was not abating.  I was given Augmentin.  Both emergency room and the urgent care facility said it was MRSA.  But there were no open wounds.  No blood work was done and no one reported the reaction.
Age: 48.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: The area around the injection site turned white, and the area around the white turned red.  It became swollen, started burning/itching and there was heat in the red area.  The swelling and redness progressed to the elbow.  There was pain in the elbow joint once the swelling and redness hit there.  I was treated at an urgent care facility, was given a shot of antibiotics and then a prescription for a sulfa antibiotic.  On the 31st I went to emergency room because the swelling and redness was not abating.  I was given Augmentin.  Both emergency room and the urgent care facility said it was MRSA.  But there were no open wounds.  No blood work was done and no one reported the reaction.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Rash, Urticaria
Clinical narrative: Site Swelling and redness 3 days prior to onset of rash/hives on Torso, Neck, Face, Arms, Diaper area.  Treatment as prescribed by physician is 1/2 tsp of Children's Zyrtec two times daily for 5-7 days.
Age: 27.0
Sex: F
Vaccine: DTP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Pain in extremity
Clinical narrative: I did not feel any pain, or see any redness the day that the shot was administered. While at work the following day, I noticed that my upper arm felt sore. I also noticed that there was a raised red bump where the shot was administered. The bump felt hard to the touch.
Age: 44.0
Sex: F
Vaccine: SMALL
Symptoms: Pruritus generalised, Rash vesicular
Clinical narrative: Intense itching all over body. Noticed vesicular rash to upper arms, flank,thighs, posterior knees.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration
Clinical narrative: Left shoulder local reaction 5cm induration. Treatment KEFLEX 500mg one PO 3x daily for 10 days.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: No adverse event
Clinical narrative: - DTAP #5 was given (R) leg 4-12-10, pt was seen 4-13-10 without redness & without cellulitis in area of injection site.
Age: 1.66
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Mom noticed 4/13/10 at breakfast time vaccine given approx. 1:30 pm 4/12/10. Left thigh red area 11 cm x 6 cm warm to touch.
Age: 1.03
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 3 days after Hep A given RAT mom noticed RAT red and swollen. No fever. PE on 4/12 fever about 3cm area of warmth erythema present lateral thigh.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: Patient called would not come in nor did she want to go to doctor. She described rash like blotches on arms and legs.
Age: 64.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: From telephone note on 3/24: Recieved call reporting veteran had suddenly developed nausea, vomiting, and a fever to 102.8 yesterday afternoon. Wife concerned this could be related to the H1N1 Flu vaccine veteran recieved on Tuesday. Says she gave veteran Tylenol and sponged him with luke warm water. Temp is down to 99. Veteran still has some nausea but has been able to keep water and other  fluids down. Urine output is adequate.
Age: 0.17
Sex: F
Vaccine: DTPHEP, PNC, RV
Symptoms: Blood test, Exaggerated startle response, Infantile spasms, Nuclear magnetic resonance imaging
Clinical narrative: exaggerated startle reflex, each lasting approximately 1 second, sets of 5-15, 5-15 sets/day (diagnosed with infantile spasms)
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Headache, Loss of consciousness, Pallor
Clinical narrative: Client recieved her first HPV vaccine at the clinic and blacked out about 5-10 seconds after receipt of the vaccine.  She complained of headache and was pale.  We lay her on the ground, took her blood pressure (100/60) and gave her a snack since she had not eaten since breakfast.  She recovered after about 10 minutes on the floor and I had her sit in a chair for 10 minutes before leaving with both parents.
Age: 0.69
Sex: F
Vaccine: DTAPHEPBIP, FLU(H1N1), HIBV, PNC
Symptoms: Body temperature increased, Vomiting, White blood cell count decreased
Clinical narrative: temp. 102R emesis X 3 Treated with alternating Tylenol and Motrin and oral fluids.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Lymphadenopathy, Neck pain, Pruritus, Rash erythematous, Rash generalised
Clinical narrative: Red rashes developed after 8-10 days smallpox placement rashes - both arms, chest & back, states his rash worsened after wearing a new T-shirt he never washed. Pleased see attached providers notes.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Skin lesion
Clinical narrative: Red rashes developed after 8-10 days smallpox placement rashes - both arms, chest & back, states his rash worsened after wearing a new T-shirt he never washed. Pleased see attached providers notes.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Lymphadenopathy, Neck pain, Pruritus, Rash, Rash erythematous
Clinical narrative: Red rashes developed after 8-10 days smallpox placement rashes - both arms, chest & back, states his rash worsened after wearing a new T-shirt he never washed. Pleased see attached providers notes.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Rash, Skin lesion
Clinical narrative: Presented to the clinic with rashes / lesions to the trunk which started about 4/9/10. See attached notes.
Age: 32.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Unevaluable event
Clinical narrative: See attached clinical notes.
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Unevaluable event
Clinical narrative: See attached clinic notes.
Age: 15.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Full blood count normal, Injection site pruritus, Injection site swelling
Clinical narrative: Left arm swelling and itching around injection site.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: Maculopapular, pruritic rash over neck, shoulders and trunk. Started: 24 hr after vaccine given. For itch (used x 2 days prn) BENADRYL. Mostly resolved and no itch 9 days after vaccine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash at site of administration of vaccine
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Computerised tomogram normal, Convulsion, Depression, Electroencephalogram, Headache
Clinical narrative: Headaches passing out and now 2 years laters seizures started occurring 01/01/2010, leg shaking, personality changes, depression, restless sleep
Age: 13.0
Sex: F
Vaccine: HPVX
Symptoms: Loss of consciousness, Nuclear magnetic resonance imaging normal, Personality change, Restlessness, Tremor
Clinical narrative: Headaches passing out and now 2 years laters seizures started occurring 01/01/2010, leg shaking, personality changes, depression, restless sleep
Age: 25.0
Sex: F
Vaccine: MMR, TD
Symptoms: Diarrhoea, Dizziness, Dysgeusia, Feeling hot, Flatulence
Clinical narrative: Metallic taste in mouth, Diarrhea, Gas, Vomiting, Dizziness, Felt warm but no fever, head ache
Age: 25.0
Sex: F
Vaccine: MMR, TD
Symptoms: Headache, Vomiting
Clinical narrative: Metallic taste in mouth, Diarrhea, Gas, Vomiting, Dizziness, Felt warm but no fever, head ache
Age: 34.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Drug exposure during pregnancy, Intra-uterine death
Clinical narrative: My wife was pregnant 23 weeks. The baby died and the time of death was around the 15th of Dec. The doctor said that there is no way that the vaccine could have caused it. I am reporting this on my wife's behalf as I thought we should report it either way. Just in case some statistics are collected and help some one in the future.
Age: 39.0
Sex: M
Vaccine: ANTH, FLUX(H1N1), HEP
Symptoms: Chills, Dizziness, Influenza like illness, Pain, Pyrexia
Clinical narrative: FLU LIKE SYMPTOMS, FEVER, ACHES, CHILLS, DIZZINESS, LIGHTHEADEDNESS, AND THEN ON 4/14/2010 AM A RED RASH ANTERIOR AND DISTAL TO THE SITE OF THE ANTHRAX VACCINATION, UPPER ANT ARM
Age: 39.0
Sex: M
Vaccine: ANTH, FLUX(H1N1), HEP
Symptoms: Rash erythematous
Clinical narrative: FLU LIKE SYMPTOMS, FEVER, ACHES, CHILLS, DIZZINESS, LIGHTHEADEDNESS, AND THEN ON 4/14/2010 AM A RED RASH ANTERIOR AND DISTAL TO THE SITE OF THE ANTHRAX VACCINATION, UPPER ANT ARM
Age: 69.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Areflexia, Lumbar puncture, Muscular weakness, Pain in extremity
Clinical narrative: 12 days after receiving H.1.N.1 flu shot, both legs started aching and lost all reflexes. Extreme muscle weakness in both legs.
Age: 54.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Received live ?attenuated H1N1 vaccine at age 54. Vaccine licensed for age 2 - 49.
Age: 1.19
Sex: F
Vaccine: HIBV, PNC
Symptoms: Electroencephalogram, Pyrexia, Tonic convulsion
Clinical narrative: Pt. developed fever 103.1 after receiving 2 vaccines on 3/8/10. Developed tonicoclonic convulsion next morning lasting 1 minute. First in life convulsion.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling, Nausea
Clinical narrative: 4-6 10 Pm: hives on R&L forearms nausea Injection site itchy 4-7-10: Injection site painful, raised ~ 3" red 4-8-10: Injection site hard, raised ~ 3"; painful. Increased pruritis.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: 4-6 10 Pm: hives on R&L forearms nausea Injection site itchy 4-7-10: Injection site painful, raised ~ 3" red 4-8-10: Injection site hard, raised ~ 3"; painful. Increased pruritis.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Erythema, Skin oedema, Skin warm
Clinical narrative: Red, warm, 3 cm area of warmth/edema. Use warm compress and TYLENOL.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Ear pain, Hypoaesthesia facial, Oropharyngeal pain, Pharyngeal hypoaesthesia, Throat irritation
Clinical narrative: Within one hr. of vaccine, patient complained of throat pain going towards ears. This quickly resolved. patient then said her throat "felt funny". By this she meant her throat and cheeks felt numbs. She was in no distress and had no trouble breathing. We recommended she go to ER. While at ER, all symptoms resolved without treatment.
Age: 20.0
Sex: M
Vaccine: UNK
Symptoms: Injection site reaction
Clinical narrative: Pt. had secondary reaction appear above initial vaccination site.
Age: 70.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Guillain-Barre syndrome, Pain in extremity
Clinical narrative: Lower extremity pain and generalized weakness.  Eventually diagnosed with Guillain-Barre Syndrome. Discharged to a rehabilitation facility 3/12/2010.
Age: 44.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain, Periarthritis, Surgery
Clinical narrative: Received TDAP shot on 9/14/09. Notified physician on 10/21/09 of continued limited range of motion/pain at the injection site and in my shoulder, excruciating pain when I raise arm higher than my shoulder or reach behind my back. Saw physician on 1/8/10 because of worsening condition. Performed x-rays, prescribed meloxicam and physical therapy. Went to physical therapy on 1/11, 1/13, and 1/18, but had to discontinue because the exercises were aggravating a urogynecological condition. (Underwent surgery on 3/4 and 3/31 for the urogynecological condition. Currently on 12-week limited activity restrictions). Saw orthopedic doctor on 4/13/10 who diagnosed frozen shoulder and prescribed Flexeril, Vicodin, and Relafen, as well as aqua-therapy. Going to neurologist on 4/15/10 for 2nd opinion because (after researching), I believe I am suffering from brachial neuritis.
Age: 44.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: X-ray
Clinical narrative: Received TDAP shot on 9/14/09. Notified physician on 10/21/09 of continued limited range of motion/pain at the injection site and in my shoulder, excruciating pain when I raise arm higher than my shoulder or reach behind my back. Saw physician on 1/8/10 because of worsening condition. Performed x-rays, prescribed meloxicam and physical therapy. Went to physical therapy on 1/11, 1/13, and 1/18, but had to discontinue because the exercises were aggravating a urogynecological condition. (Underwent surgery on 3/4 and 3/31 for the urogynecological condition. Currently on 12-week limited activity restrictions). Saw orthopedic doctor on 4/13/10 who diagnosed frozen shoulder and prescribed Flexeril, Vicodin, and Relafen, as well as aqua-therapy. Going to neurologist on 4/15/10 for 2nd opinion because (after researching), I believe I am suffering from brachial neuritis.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Rash maculo-papular, Varicella
Clinical narrative: Patient started with maculapapular rash in varying stages, starting 10 days after vaccine administration, clinically has chickenpox. There is no fever on day 3 of rash. Still with spots, case seemed mild so far.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left shoulder swelling, pain, redness- see chart note.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Antibody test negative, Arthralgia, Blood thyroid stimulating hormone normal, Bone pain, Condition aggravated
Clinical narrative: 45 y/o AD. SM is preparing to retire from the military as of 01APR10 and contacts to "tie up any loose ends" and make sure there is documentation and a VAERS filed about the tender, 1/4 inch nodule he developed in his right supper arm at his AVA injection site, in addition to the joint stiffness and chronic discomfort he experienced in his right shoulder, hip and knee for 6 months after receipt of AVA #5 on 29MAR04, upon return from deployment. He experienced similar tender nodules at the injection site (LUE) w/ AVA #4 (03/11/2004); AVA #3 (03/14/2003); AVA #1 (02/11/2003), but did not developed joint pain and stiffness until mid April 2004, 2-3 weeks after receipt of AVA #5 on 03/29/04 and his sx continued x 6 months from APR-SEP 2004. He denies any personal hx of RA, SLE or joint trauma. His family hx is unknown as he is adopted. He never saw a Rheumatologist, as his sx basically resolved after 6 months, but now he c/o's residual dx of OA a/w stiffness and pain in his lumbar spine and knees (R>L). NKDA, no environmental allergies, no food allergies. PMH neg for DM or CA. Personal Hx: 45 y/o AD x 27 years. Married, 2 children. Tobacco: 18-yr pack hx smoking- quit in 2000. ETOH: social only, no binging, DUI'S or blackout's. No illicit drug use.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Discomfort, HLA marker study, Injection site nodule, Injection site pain, Joint stiffness
Clinical narrative: 45 y/o AD. SM is preparing to retire from the military as of 01APR10 and contacts to "tie up any loose ends" and make sure there is documentation and a VAERS filed about the tender, 1/4 inch nodule he developed in his right supper arm at his AVA injection site, in addition to the joint stiffness and chronic discomfort he experienced in his right shoulder, hip and knee for 6 months after receipt of AVA #5 on 29MAR04, upon return from deployment. He experienced similar tender nodules at the injection site (LUE) w/ AVA #4 (03/11/2004); AVA #3 (03/14/2003); AVA #1 (02/11/2003), but did not developed joint pain and stiffness until mid April 2004, 2-3 weeks after receipt of AVA #5 on 03/29/04 and his sx continued x 6 months from APR-SEP 2004. He denies any personal hx of RA, SLE or joint trauma. His family hx is unknown as he is adopted. He never saw a Rheumatologist, as his sx basically resolved after 6 months, but now he c/o's residual dx of OA a/w stiffness and pain in his lumbar spine and knees (R>L). NKDA, no environmental allergies, no food allergies. PMH neg for DM or CA. Personal Hx: 45 y/o AD x 27 years. Married, 2 children. Tobacco: 18-yr pack hx smoking- quit in 2000. ETOH: social only, no binging, DUI'S or blackout's. No illicit drug use.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Metabolic function test normal, Osteoarthritis, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: 45 y/o AD. SM is preparing to retire from the military as of 01APR10 and contacts to "tie up any loose ends" and make sure there is documentation and a VAERS filed about the tender, 1/4 inch nodule he developed in his right supper arm at his AVA injection site, in addition to the joint stiffness and chronic discomfort he experienced in his right shoulder, hip and knee for 6 months after receipt of AVA #5 on 29MAR04, upon return from deployment. He experienced similar tender nodules at the injection site (LUE) w/ AVA #4 (03/11/2004); AVA #3 (03/14/2003); AVA #1 (02/11/2003), but did not developed joint pain and stiffness until mid April 2004, 2-3 weeks after receipt of AVA #5 on 03/29/04 and his sx continued x 6 months from APR-SEP 2004. He denies any personal hx of RA, SLE or joint trauma. His family hx is unknown as he is adopted. He never saw a Rheumatologist, as his sx basically resolved after 6 months, but now he c/o's residual dx of OA a/w stiffness and pain in his lumbar spine and knees (R>L). NKDA, no environmental allergies, no food allergies. PMH neg for DM or CA. Personal Hx: 45 y/o AD x 27 years. Married, 2 children. Tobacco: 18-yr pack hx smoking- quit in 2000. ETOH: social only, no binging, DUI'S or blackout's. No illicit drug use.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Pain, Rash
Clinical narrative: (1) Excessive body aching - (2) Constant head pain - (3) Spots in the body that come and go.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Pt. received VARICELLA, MMR, DTAP in Rt arm and in Lft arm. (L) deltoid warm and swollen today.
Age: 50.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Rash generalised
Clinical narrative: Unable to move arm/shoulder. Body rash from neck to hips. Reaction 4 hrs. after vaccination.
Age: 2.0
Sex: M
Vaccine: FLU(H1N1), HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Child mistakenly given adult dose (1 ml) of Hep A vaccine.
Age: 1.1
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC, VARCEL
Symptoms: Injection site rash
Clinical narrative: 7/23/09 father called H.D. stating "poisoning type" rash noted on child's thigh in approximate area where a vaccine was given - right thigh. Suspect VARIVAX. 7/26/09 rash resolved without any treatment.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Malaise, Pain, Pyrexia
Clinical narrative: 7/27/09 Pt. called to c/o continued swelling of (L) deltoid area - onset day after ADACEL injection at same site. Also had malaise and fever which subsided. Status deltoid area feels warm and looks blotchy" - no raised rash. Had significant pain last week - subsiding. Follow-up - resolved without treatment by 7/30/09.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Rash macular
Clinical narrative: 7/27/09 Pt. called to c/o continued swelling of (L) deltoid area - onset day after ADACEL injection at same site. Also had malaise and fever which subsided. Status deltoid area feels warm and looks blotchy" - no raised rash. Had significant pain last week - subsiding. Follow-up - resolved without treatment by 7/30/09.
Age: 28.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Eye pruritus, Eye swelling, Rash papular, Rash pruritic
Clinical narrative: Red raised pimply rash on stomach and his right eye puffy / itchy. He took Benadryl with minimal relief from the itching. Today he has the rash on upper extremities and torso which continues to be very itchy. He denies any difficulty breathing, dizziness, headache or any other symptoms.
Age: 34.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Computerised tomogram, Headache, Nuclear magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: 12Feb 10 - Onset of almost daily headaches, sometimes associated with shooting pains in hands and feet. No muscle weakness. History or chronic headaches since 1994.
Age: 34.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Ultrasound scan
Clinical narrative: 12Feb 10 - Onset of almost daily headaches, sometimes associated with shooting pains in hands and feet. No muscle weakness. History or chronic headaches since 1994.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Husband reported that both he & his wife developed sore throat within 2 hours of receiving seasonal flu vaccine - also developed fever & aching & chills. Treated by PCP with Z pack & resolved after about 10 days.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Pt reported that within 2 hours of receiving seasonal flu vaccine both he and wife developed sore throat, then fever and aching with headache and chills. Treated by PCP with Z PACK and resolved after about 10 days.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Disorientation, Electroencephalogram, Encephalitis herpes, Laboratory test, Mental impairment
Clinical narrative: Patient received flu vaccine. 2 days later, patient very sleepy and falling asleep in the middle of activity. Oct 2. Pt wake up disoriented and went to her doctor and then she was admitted in Medical Ctr. MRI was done. Pt. was diagnosed with herpetic encephalitis. She received acyclovir IV, via pic line. She spent 2 weeks in hospital and 1 week in rehab. She received physical therapy. She has decreased mental capacity.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Somnolence
Clinical narrative: Patient received flu vaccine. 2 days later, patient very sleepy and falling asleep in the middle of activity. Oct 2. Pt wake up disoriented and went to her doctor and then she was admitted in Medical Ctr. MRI was done. Pt. was diagnosed with herpetic encephalitis. She received acyclovir IV, via pic line. She spent 2 weeks in hospital and 1 week in rehab. She received physical therapy. She has decreased mental capacity.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Rash pruritic, Urticaria
Clinical narrative: 1-1 1/2 hours after receiving HPV #2 developed an itchy rash. Presented the following morning at health dept with extensive hive-like reaction, Rx'd BENADRYL 50 mg every 4-6 hours.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: 4/6/09 Called to report pain in (L) deltoid area - started same night after ADACEL "felt like in the shoulder joint". No relief with TYLENOL. Worse next morning - some relief with VICODIN. Denies redness or swelling. No fever. Pain gradually resolved over 3 weeks. No further problems.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Henoch-Schonlein purpura, Immunology test, Immunology test abnormal
Clinical narrative: Presented to ED 3/8/10, seen @ dermatology clinic 3/9/10 started on prednisone taper, triamcinolone cream, hydroxyzine, referral to nephrologist, cardiologist and dietician diagnosis of Henoch - Schonlein purpura.
Age: 23.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Contraindication to vaccination, Eyes sunken, HIV test positive, Pallor
Clinical narrative: Pt presented to Rm 174 from lobby pale/eyes sunken.  When asked what's wrong, pt. replied "I got sick from the H1N1 nasal.  Pt assisted for stretcher to rest.  After 20 minutes color returned. That same afternoon pt seen at STD clinic and was told he was HIV positive. The pt was screened for the inactivated H1N1 Influenza vaccine and was given the live-attenuated H1N1 vaccine. Contact was finally on 03/05/2010 and ask the patient how he was doing after the episode he had with the H1N1 nasal H1N1 vaccine.  Did not acknowledge he had felt. Asked how was he doing - He said he was fine, no problems.  Instructed to see a physician if he felt bad or any probleems.  On 03/19/2010 he was contacted and he stated he was fine and not having any problems.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Pain of skin
Clinical narrative: Two weeks prior to seasonal flu vaccine pt stung by swarm of sweat bees. Stings covered upper body to breast line. When received seasonal flu vaccine, patient felt stinging sensation all over her upper body where bee stings had been. Denies sores, hives. No MD visit made.
Age: 1.51
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Full blood count normal, Influenza serology negative, Injection site swelling, Pyrexia
Clinical narrative: Localized swelling of thigh, fever 104.6 Rectally.
Age: 1.1
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site rash, Varicella
Clinical narrative: - Red, bumpy rash at site of immunizations on L thigh. Localized to area around inj. site X 5 days. - Dx probable varicella, - Plan-watch for spread or signs of infection.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Local reaction, Skin warm, Swelling, Tenderness
Clinical narrative: Right arm local reaction 3 1/2" x 3 1/2" redness, tenderness, swelling, warm to touch. To take TYLENOL or Ibuprofen.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a physician and a medical secretary, concerning a 15 year old female patient, with acne and allergy to AUGMENTIN and a history of anemia after a fractured femur in 2007, who on 30-MAR-2010 (also reported as "sometime last week"), was vaccinated with the first 0.5 mL dose of GARDASIL (route not provided) (lot number 662304/1013Y). Other vaccines administered the same day included VARIVAX (Merck) (dose and route not reported) (lot number 665576/1206Y). Other concomitant therapy included FINACEA and ZYRTEC. On 30-MAR-2010, (also reported as "sometime last week"), the patient experienced syncope with seizures (also reported as seizures-like activity) for less than 30 seconds. On 30-MAR-2010, the patient recovered. The patient sought unspecified medical attention. No referrals made. Upon internal review, seizure was considered to be an other important medical event. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Congenital choroid plexus cyst, Drug exposure during pregnancy, Ultrasound scan abnormal
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 23 year old female who was vaccinated with the first dose of GARDASIL on 02-MAR-2009 and vaccinated with the second dose on 07-MAY-2009. There was no medical history. The reporter stated that the patient was now pregnant, and pregnancy was normal to date. The patient's last menstrual period was on 12-APR-2009 and estimated date of delivery was 17-JAN-2010. Her estimated date of conception was 20-APR-2009. A urine pregnancy test was performed. The patient had sought medical attention at the office. Follow up information has been received from the registered nurse concerning the patient with 2 previous pregnancies (1 full term delivery at 40 weeks and 1 elective termination), no birth defects in previous pregnancies, no infant complications in previous pregnancies and prenatal care (vitamins 1 tablet daily started on 06-MAY-2009) during pregnancy who delivered a male infant on 15-JAN-2010 (at 39 weeks). The infant was reported as normal with weight of 8 pounds 1 ounce and there were no complications or abnormalities. There were no infections or illnesses during pregnancy. On an unspecified date the patient had a positive sonogram of bilateral choroid plexus cyst and echogenic focus on the bowel. Follow up for genetic counseling "ie: Amino ml 46xx-AFP>ml." The mothers experience has been reported in 0906USA02107. Additional information is not expected.
Age: 1.06
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Nodule, Oedema peripheral, Pain, Rash
Clinical narrative: Sat pm 2/20/10-redness noted back of left hand, swollen with rash, pain, increased swelling; redness, pain with "knot" @ upper left forearm-taken to ER @ 11 p 2/20-redness, rash noted on face. Treated with ice, BENADRYL, MOTRIN. Afebrile pt had generalized rash which was partially cleared up 2/21 using BENADRYL cream and completely gone by 2/22/10.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR
Symptoms: Irritability, Pyrexia, Urine analysis normal
Clinical narrative: Fever to 104.5 and irritability normal physical exam, no rash.
Age: 1.05
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Ataxia, CSF test normal, Full blood count normal, Oxygen saturation, Pyrexia
Clinical narrative: Abrupt onset of ataxia evening of 4/8/10 --> fever occurred 2 hrs after onset of ataxia - office visit 4/9/10 -> ataxia and fever noted -> W/u at ER negative, CSF negative, lab normal.
Age: 1.05
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Urine analysis normal
Clinical narrative: Abrupt onset of ataxia evening of 4/8/10 --> fever occurred 2 hrs after onset of ataxia - office visit 4/9/10 -> ataxia and fever noted -> W/u at ER negative, CSF negative, lab normal.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Pain, Pain in extremity, Rash papular, Rash pruritic
Clinical narrative: Received SPV left arm 3/15/10 (previous SPV 1990). On 3/31/10 noted red, itchy papular rash in his right wrist and forearm (pt is right handed). The rash progressed to his left wrist/forearm on 4/1/10 and on 4/2/10 to the dorsal aspect of his right foot. On 4/3/10 the pt noted the rash on his abdomen and chest. Rash worsened after a warm shower. Denied fever, chills, N, V, diarrhea, abdominal pain or sore throat. Pt had been in a hotel since 3/28/10 and was using a number of new products (soap, shampoo, detergent). On 4/5/10 the pt began taking a non sedating antihistamine. On 4/9/10 the rash was almost resolved with a small patch remaining on the right wrist and the abdomen. Additionally on 4/1/10 the pt noted right am pain (4/10, dull, constant, increase with movement); denied numbness, tingling, axillary pain or lymphadenopathy. Pt started MOTRIN 800mg bid on 4/5/10 and increased to tid with food on 4/6/10 with resolution of pain on 4/8/10 (pt has had no further NSAIDS since 4/8/10).
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: 2"x2" red swollen area - 3/4/10 23:00, 102 F fever oral - 3/4/10 23:00.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: 1 single hive like at site of where injection was given. Noticed on pm of 4/13/10. Mom used BENADRYL cream and CLARITIN. No problems with SOB, tongue swelling etc. Just hive on arm. No other problems.
Age: 38.0
Sex: M
Vaccine: ANTH, MNQ
Symptoms: Malaise, Pruritus, Rash
Clinical narrative: Pt received shots Monday afternoon. States he felt sick all day Tuesday and took BENADRYL that afternoon. Wednesday morning, he states he noticed a rash on the front of his left shoulder near the armpit. No problems breathing. Itching on rash only. Was seen by a provider and was given instructions on further care.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Condition aggravated, Crying, Exaggerated startle response, Insomnia
Clinical narrative: Mom reports pt started crying uncontrollably 2 hours after receiving vaccines. Reports he cries all night and doesn't sleep. She states he startles or jumps like from an electric shock and then cries unconsolably.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Auricular swelling, Lip swelling, Swelling face, Urticaria, Vulvovaginal pruritus
Clinical narrative: Pt left office 15 min after called with complaints of vaginal itching, welts all over body. Rec. Benadryl, face lips and ears start swelling. Pt goes to ER. Given dexamethasone tablet, swelling going down.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral, Oropharyngeal pain, Urticaria
Clinical narrative: Sore throat, hives, swelling under arm where injection given starting 1 day after immunization.  Symptoms come and go X few weeks.  Pt tired BENADRYL with some relief.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Pain
Clinical narrative: Left deltoid inflammation with some redness. Pain with abduction. ADVIL PRN for pain.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, PNC13
Symptoms: Cough, Eye swelling, Swelling face, Wheezing
Clinical narrative: 20 min after receiving vaccines DTaP, PCV13, Hep A developed eye/face swelling w/ cough and wheezing, approximately equal to 1p 4/13. Dad gave BENADRYL, child napped, woke with no sx. Also drank some soy milk after shots but no other food or liquid. Allergic to dairy, egg.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid swelling, warm hard 9cm swelling, ice applied, nurse practitioner notified; sent to ER to rule out anaphylaxis at 2:20am on 11/10/06 came back same day with order for Medrol dose pack and Benadryl 25mg po qid x 3 days
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Dysgeusia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: States that she had a bad taste in mouth right after MMR; 3 days later, area of injection is red, hot to touch, tender & raised. The next day, she had complaints of more tenderness at injection site & that the left side of her throat felt "tight". The shot was given in the left arm.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Throat tightness, Ultrasound Doppler
Clinical narrative: States that she had a bad taste in mouth right after MMR; 3 days later, area of injection is red, hot to touch, tender & raised. The next day, she had complaints of more tenderness at injection site & that the left side of her throat felt "tight". The shot was given in the left arm.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Dizziness
Clinical narrative: Weakness, lightheadedness, arthralgias
Age: 33.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Swelling and redness of arm.  Fever-max 103.1
Age: 33.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Erythema, Injection site reaction, Myalgia, Oedema peripheral
Clinical narrative: Swelling and redness of arm.  Fever-max 103.1
Age: 33.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia, Tremor
Clinical narrative: Swelling and redness of arm.  Fever-max 103.1
Age: 17.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Rash, Swelling face
Clinical narrative: Patient returned to our office on 4/14/10 with complaints of swelling to her face and a rash on her neck that started after she got home the day she received the vaccine.
Age: 17.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Local swelling, Swelling face
Clinical narrative: Patient returned to our office on 4/14/10 with complaints of swelling to her face and a rash on her neck that started after she got home the day she received the vaccine.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Myalgia, Pyrexia, White blood cell count increased
Clinical narrative: PATIENT IN HOSPITAL WITH FEVER, CHILLS, MYALGIA AND ELEVATED WBC'S TWO DAYS AFTER PNEUMOVAX 23 VACCINE GIVEN DURING HIV CHECKUP.  NOTES FROM MEDICAL RECORD:  52 YO HIV POSITIVE PATIENT, WELL CONTROLLED.  MVA RESOLVING PAIN FROM INJURIES.  LYTIC LESION OF C SPINE.  NO EVIDENCE OF CANCER OR MULTIPLE MYELOMA.  ANEMIA, PERSISTS UNCLEAR DUE TO MVA.
Age: 15.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Asthenia, Cold sweat, Dizziness, Hypotonia, Hypoventilation
Clinical narrative: Dizzy, weak, pale and clammy skin and became limp.  Client blacked out and unresponsive to name x5 minutes.  Client responded to ammonia for a short time then blackout again, placed on floor, applied cold compresses and called EMS.  EMS arrived less than 5 minutes.  Client awake, responsive, maintained palpable pulse and respirations shallow On 03/10/2010 the health center called his aunt and she stated patient is doing fine.  She did not take him to the doctor as instructed beause he was doing fine.  No problems
Age: 15.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Loss of consciousness, Pallor, Unresponsive to stimuli
Clinical narrative: Dizzy, weak, pale and clammy skin and became limp.  Client blacked out and unresponsive to name x5 minutes.  Client responded to ammonia for a short time then blackout again, placed on floor, applied cold compresses and called EMS.  EMS arrived less than 5 minutes.  Client awake, responsive, maintained palpable pulse and respirations shallow On 03/10/2010 the health center called his aunt and she stated patient is doing fine.  She did not take him to the doctor as instructed beause he was doing fine.  No problems
Age: 20.0
Sex: M
Vaccine: RAB
Symptoms: Fatigue, Rash
Clinical narrative: Rash, feeling very tired. Pt did not seek medical assistance or inform provider until 4-14-10 @ 3:30 PM.
Age: 13.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Oedema peripheral, Pruritus, Skin warm
Clinical narrative: Right arm swollen 4"x3", warm to touch, itchy. Given Benadryl and recommended cool compresses.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Left arm red and swollen near injection site. Diagnosed with cellulitis and given Benadryl and Keflex 10 day course
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Asthenia, Dizziness, Dyspnoea, Erythema, Heart rate increased
Clinical narrative: pain at the injection site, fever over 102f, wheezing, difficulty of breathing, fast heart beat, high blood pressure, hives, weakness, dizziness, redness and swellen.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Hypertension, Injection site pain, Pyrexia, Swelling, Urticaria
Clinical narrative: pain at the injection site, fever over 102f, wheezing, difficulty of breathing, fast heart beat, high blood pressure, hives, weakness, dizziness, redness and swellen.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Wheezing
Clinical narrative: pain at the injection site, fever over 102f, wheezing, difficulty of breathing, fast heart beat, high blood pressure, hives, weakness, dizziness, redness and swellen.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Pruritus generalised, Rash
Clinical narrative: itching all over, moderate amount of redness and swelling at the injection site (13cm diameter), rash (eczema -like)
Age: 18.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Pruritus
Clinical narrative: Took a shower in the morning, it was itchy.
Age: 29.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Abortion spontaneous, Blood test, Drug exposure during pregnancy, Ultrasound scan
Clinical narrative: Pregnant and had a miscarriage right around the time of being vaccinated.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Fontanelle depressed, Immediate post-injection reaction, Irritability
Clinical narrative: Patient immediately developed markedly depressed anterior fontanelle which lasted 72 hours.  This was associated with irritability, but no fever.  Patient had no vomiting, no other neurological symptoms.
Age: 1.18
Sex: M
Vaccine: UNK
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Client had one Varicella vaccine age 1 yr and at 12 dx'd with chickenpox.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Client had one varicella vaccine at age 1 year and at age 12 dx'd with chickenpox.
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Client had one Varicella vaccine at age 1 yr and at age 12 dx'd with chicken pox.
Age: 1.04
Sex: M
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Client had one Varicella vaccine at 1 yr and at 12 dx'd with chickenpox.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Client had one Varicella vaccine @ age 1 yr & at age 12 dx'd with chickenpox.
Age: 1.38
Sex: F
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Client had one varicella vaccine at age 1 yr and at age 12 dx'd with chickenpox.
Age: 1.84
Sex: F
Vaccine: UNK
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Client had one Varicella vaccine at age 1 yr and at age 12 dx'd with chickenpox
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Combined initial and follow up report received on 01 Apr 2010. This patient was on treatment with Diovan Amlo Fix 320/5 mg, one tablet in the morning daily initiated on an unknown date for hypertension. On 09 Mar 2010, she received H1N1 vaccine and experienced urticaria and itch on the body including scalp and forearm and described it like something was poking her. She had never had this reaction before and thought that they occurred due to the vaccine, but she started the Diovan Amlo Fix coincidently. She was itching a lot, due which she hurt herself as the itch intense. As a measure, she stopped taking Diovan Amlo Fix on an unknown date. At the moment of contact she did not have any itching. The outcome was reported as recovered. The seriousness and causality were not reported. After an internal review on 14 Apr 2010 of the data received on 01 Apr 2010, H1N1 influenza virus vaccine (manufacturer and batch number unknown) was recorded and made as co-suspect.
Sex: U
Vaccine: FLUN3
Symptoms: Influenza like illness, Pyrexia, Rhinorrhoea
Clinical narrative: A spontaneous, non-serious events of fever, runny nose and general flu-like symptoms were reported by a physician involving children of unknown ages subsequent to FLUMIST administration. Medical history and concomitant medications were not reported. The patient's have received FLUMIST. The physician reported that "I've noticed that the kids I've given FLUMIST have had some side effects such as fever and runny nose or general flu-like symptoms". No further information was available. The outcome of the events, fever, runny nose and general flu-like symptoms, was unknown.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of "administration of expired product" was received from a health professional concerning a 30-month-old female subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. On 02-Mar-2010, expired FLUMIST was given. The product expired in 17-Feb-2010. There was no adverse event associated with this medication error as of 17-Mar-2010; therefore, treatment and reporter/sponsor causality assessment are not applicable, and the event is considered resolved. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product and administration of FLUMIST was received from a clinic administrator concerning a 24-month-old male subsequent to the administration of FLUMIST. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medications were not reported. On 22-Feb-2010, the patient was administered FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 13-May-2010 and incorporated into the narrative: information on late occurring adverse events.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product to a 44-month-old female was received from a clinic administrator concerning a 44-month-old female, subsequent to the administration of FLUMIST. The patient's medical history and concomitant medications were not reported. On 25-Feb-2010, the patient was administered FLUMIST. There was no adverse event associated with this administration; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from A non-serious spontaneous report of administration of expired product and administration of FLUMIST was received from a clinic administrator concerning a 24-month-old female subsequent to the administration of FLUMIST. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medications were not reported. On 23-Feb-2010, the patient was administered FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. 6/18/10 Additional information was received on 13-May-2010 and incorporated into the narrative: information on late occurring adverse events.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a clinic administrator concerning a 45 month-old female subsequent to the administration of FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medications were not reported. On 24-Feb-2010, the patient was administered FLUMIST. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.