chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Joint stiffness, Joint swelling, Oedema peripheral, Pain
Clinical narrative: Developed swelling in L knee on 10-16-07. Felt tight, no pain. Developed swelling in both knees 11-17-07. On 11-18-07 swelling went to hands, ankles, wrists. Also developed pain on 11-18-07 in all joints. Has appointment with doctor in afternoon of 11-19-07. Has taken Advil sporatically when developed pain.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Pyrexia, Skin nodule
Clinical narrative: Unable to get a hold of patient until 11/05/07.  Patient received flu vaccine 11/01/07, reports during that night she felt like she might of ran a fever (some sweating, never took temp)  When she awoke the next morning, she noticed a large walnut size lump under left jaw and small one under right jaw, not sore to the touch, or sore throat or any other adverse effects.  11/05/07 reports lumps almost gone.  Instructed to see HCP.
Age: 71.0
Sex: F
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: none at this time
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV
Symptoms: Erythema, Rash macular
Clinical narrative: Very red face and splotched face/chest.  No reactin to injection sites.  Report given to patient at ER 2:35 p.m.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site cellulitis
Clinical narrative: On 10/30, DTaP4 and HepA1 administered IM L thigh. Pt left clinic in good condition. On 11/1, parent/child RTC with L thigh cellulitis. Pt treated by same provider with course of Keflex.
Age: 77.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt. had redness, swelling and itching at injection site.
Age: 6.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 11/07/07 Mother called stating child has large red swollen area to left deltoid at site of hep A #2 vaccination he received on 11/01/07.  She had been out of town since last friday so she did not know when reaction started.  Child was with father.  Instructed to apply warm moist packs on 20 minutes off.  She might give Benadryl for age, instructed to contact her family doctor.  11/14/07 Mother called states child saw family Dr.  Topical ointment applied and ordered Benedryl and Ibuprophen.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Haematochezia, Inappropriate schedule of drug administration, Mucous stools
Clinical narrative: mucous and small amount of blood in stool
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Bronchopneumonia, Death, Electrolyte imbalance, Gastroenteritis, Histology
Clinical narrative: Child started with high fever, 48 C, post vaccination and died on 11/12/2007.  12/11/2007 Reviewed autopsy report which states COD as acute bronchopneumonia complicated by acute gastroenteritis.  Blood c/s neg.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Pyrexia
Clinical narrative: Child started with high fever, 48 C, post vaccination and died on 11/12/2007.  12/11/2007 Reviewed autopsy report which states COD as acute bronchopneumonia complicated by acute gastroenteritis.  Blood c/s neg.
Age: 44.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Blood pressure, Head injury, Heart rate normal, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Immedicately after receiving a Hepatitis A vaccine, the patient passed out and was unresponsive for aprox 1 minute.  Patient hit the right side of her head on the tile floor.  Ice bag to lump on head.  911 was called and paramedics checked her out.  BP 118/90 and Pulse 60.
Age: 44.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Immedicately after receiving a Hepatitis A vaccine, the patient passed out and was unresponsive for aprox 1 minute.  Patient hit the right side of her head on the tile floor.  Ice bag to lump on head.  911 was called and paramedics checked her out.  BP 118/90 and Pulse 60.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Blister, Cellulitis, Erythema, Hyperaesthesia, Induration
Clinical narrative: On 10/9/07, the patient received 4 vaccinations: polio, DTaP, MMR, and Varicella. That night, he developed pain at the site of injection without any visual signs. The next morning, about 20 hours after the injections, he was erythematous from the elbow to the shoulder. He took 2 doses of diphenhydramine with no improvement in symptoms. Two days after the injections, the erythema had increased and spread to involve the forearm and his right hand became edematous. He started to experience pain and had decreased range of motion of his entire arm, including the fingers. When he presented to the ED 3 days after the injections, the right arm was swollen from the shoulder to the hand. It is indurated, erythematous, blanching, and warm to touch, with hyperesthesia. There was an area of localized vesicles close to the antecubital site and about 4 cm from the presumed site of injection. The patient was admitted to the hospital and treated with clindamycin, diphenhydramine, ibuprofen, and acetaminophen. No follow-up information is available. Evaluation. Generalized varicella-like rash (4-5%), cellulitis, secondary skin infections are commonly reported after Varicella Virus Vaccine injections (Lexi-Comp). Summary. Local varicella rash and cellulitis with possible superinfection.  12/1/2007 MR received for DOS 10/12-13/2007 with DX: Acute Febrile Illness.  Upper extremity Cellulitis. Pt presented to ER with c/o injection site pain, erythema, and edema of the R hand. ROM decreased in arm.  Pt initially txd with Benadryl with no improvement. On PE swelling noted on R arm from shoulder to hand. (+) Induration, balnching, warmth, hyperesthesia.  Localized vesicles noted in AC area.  Txd with IV abx and d/c'd.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Oedema peripheral, Pain in extremity
Clinical narrative: On 10/9/07, the patient received 4 vaccinations: polio, DTaP, MMR, and Varicella. That night, he developed pain at the site of injection without any visual signs. The next morning, about 20 hours after the injections, he was erythematous from the elbow to the shoulder. He took 2 doses of diphenhydramine with no improvement in symptoms. Two days after the injections, the erythema had increased and spread to involve the forearm and his right hand became edematous. He started to experience pain and had decreased range of motion of his entire arm, including the fingers. When he presented to the ED 3 days after the injections, the right arm was swollen from the shoulder to the hand. It is indurated, erythematous, blanching, and warm to touch, with hyperesthesia. There was an area of localized vesicles close to the antecubital site and about 4 cm from the presumed site of injection. The patient was admitted to the hospital and treated with clindamycin, diphenhydramine, ibuprofen, and acetaminophen. No follow-up information is available. Evaluation. Generalized varicella-like rash (4-5%), cellulitis, secondary skin infections are commonly reported after Varicella Virus Vaccine injections (Lexi-Comp). Summary. Local varicella rash and cellulitis with possible superinfection.  12/1/2007 MR received for DOS 10/12-13/2007 with DX: Acute Febrile Illness.  Upper extremity Cellulitis. Pt presented to ER with c/o injection site pain, erythema, and edema of the R hand. ROM decreased in arm.  Pt initially txd with Benadryl with no improvement. On PE swelling noted on R arm from shoulder to hand. (+) Induration, balnching, warmth, hyperesthesia.  Localized vesicles noted in AC area.  Txd with IV abx and d/c'd.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pallor, Rash vesicular, Skin warm, Superinfection, Varicella post vaccine
Clinical narrative: On 10/9/07, the patient received 4 vaccinations: polio, DTaP, MMR, and Varicella. That night, he developed pain at the site of injection without any visual signs. The next morning, about 20 hours after the injections, he was erythematous from the elbow to the shoulder. He took 2 doses of diphenhydramine with no improvement in symptoms. Two days after the injections, the erythema had increased and spread to involve the forearm and his right hand became edematous. He started to experience pain and had decreased range of motion of his entire arm, including the fingers. When he presented to the ED 3 days after the injections, the right arm was swollen from the shoulder to the hand. It is indurated, erythematous, blanching, and warm to touch, with hyperesthesia. There was an area of localized vesicles close to the antecubital site and about 4 cm from the presumed site of injection. The patient was admitted to the hospital and treated with clindamycin, diphenhydramine, ibuprofen, and acetaminophen. No follow-up information is available. Evaluation. Generalized varicella-like rash (4-5%), cellulitis, secondary skin infections are commonly reported after Varicella Virus Vaccine injections (Lexi-Comp). Summary. Local varicella rash and cellulitis with possible superinfection.  12/1/2007 MR received for DOS 10/12-13/2007 with DX: Acute Febrile Illness.  Upper extremity Cellulitis. Pt presented to ER with c/o injection site pain, erythema, and edema of the R hand. ROM decreased in arm.  Pt initially txd with Benadryl with no improvement. On PE swelling noted on R arm from shoulder to hand. (+) Induration, balnching, warmth, hyperesthesia.  Localized vesicles noted in AC area.  Txd with IV abx and d/c'd.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Lethargy, Malaise, Pain
Clinical narrative: 10-16-07: Received vaccination.  10-18-2007:  Woke up and felt aches in legs, arms, and back.  Experienced general malaise and lethargy.  Symptoms were more pronounced upon awakening.  No fever or chills.  Took intermittent ibuprofen 400 mg once to twice daily.  10-27-07:  Symptoms resolved.
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Received shot on 11/13/2007. By noon on 11-14, she experienced redness, swelling, hot to touch at site of injection, fever to 101 x3 days, and joint pain in hips, knees, back pain for several days. Her primary MD told her to take 800mg Ibuprofen Q6, as needed, Claritin, and Keflex (in case). She feels better today, 11-19.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: SYNCOPE ON TWO OCCASIONS  11/11/2007 4pm and11/17/2007 6pm patient recover fully
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV, RV5
Symptoms: Constipation, Diarrhoea, Mucous stools
Clinical narrative: temporary change in stool pattern (mucousy stool, then diarrhea, then no stool for more than two days)   was temporarily switched to soy formula, then was recommended a glycerin suppository if constipation persisted
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: ON 10/29, HPV, VARICELLA, AND FLU ADMINISTERED; 11/01 PARENT/PT RTC WITH CELLULITIS AT IMMUNIZATION SITE.  PT TREATED EMPIRICALLY BY SAME PROVIDER WITH COURSE OF KEFLEX. PT MEDICALLY EXCUSED FROM SCHOOL X 2DAYS.
Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Blood pressure decreased, Dizziness, Heart rate increased, Immediate post-injection reaction, Malaise
Clinical narrative: Patient had a syncopal episode 5 minutes after shot was administered.  Patient stated severe nausea, dizziness, and "not feeling right".  Bp dropped from 104/58 to 80/6o, Pulse increased to 100.  patient was places supine with q5minute VS until VSS 40 minutes post-injection. Patient discharged from clinic with instructions to present to ER/call 911 any recurrence of s/s.
Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Syncope
Clinical narrative: Patient had a syncopal episode 5 minutes after shot was administered.  Patient stated severe nausea, dizziness, and "not feeling right".  Bp dropped from 104/58 to 80/6o, Pulse increased to 100.  patient was places supine with q5minute VS until VSS 40 minutes post-injection. Patient discharged from clinic with instructions to present to ER/call 911 any recurrence of s/s.
Age: 13.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: ON 10/29, FLU, VARICELLA ADMINISTERED, PT LEFT IN GOOD CONDITION; ON 11/01, PT RTC WITH CELLULITIS AT IMMUNIZATION SITE. PT TREATED EMPIRICALLY WITH COURSE OF KEFLEX. PT MEDICALLY EXCUSED FROM SCHOOL FOR 2 DAYS.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Complement factor C3, Complement factor C4, Erythema multiforme, Full blood count normal
Clinical narrative: Developed serum sickness 1-2 days after vaccination.  Pt had received the influenza vaccine once prior last year.  He developed urticaria, hives, erythema multiforme type lesions, no mucosal lesions, diffuse swelling and tenderness of all joints
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Joint swelling, Proteinuria, Red blood cell sedimentation rate increased, Serum sickness, Urine analysis abnormal
Clinical narrative: Developed serum sickness 1-2 days after vaccination.  Pt had received the influenza vaccine once prior last year.  He developed urticaria, hives, erythema multiforme type lesions, no mucosal lesions, diffuse swelling and tenderness of all joints
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Developed serum sickness 1-2 days after vaccination.  Pt had received the influenza vaccine once prior last year.  He developed urticaria, hives, erythema multiforme type lesions, no mucosal lesions, diffuse swelling and tenderness of all joints
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error, Wrong drug administered
Clinical narrative: Seen in clinic for flu vaccination and was given adult flu vaccine (flulaval) 0.5ml
Age: 8.0
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: ON 10/29, FLU AND VARICELLA ADMINISTERED, PT LEFT IN GOOD CONDITION; 0N 11/2, PT RTC WITH CELLULITIS AT VARICELLA IMMUNIZATION SITE. PT TREATED EMPIRICALLY WITH COURSE OF KEFLEX, AND MEDICALLY EXCUSED FROM SCHOOL FOR 2 DAYS.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Red Rash from top of deltoid muscle(injection site) down under arm and into arm pit also hot to the touch
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Hypokinesia, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: 16 hours after injection moderate pain in entire arm.  Pain made sleeping difficult.  Difficulty lifting arm above heart due to pain.  Treated with OTC ibprofen 200 mg.  28 h low fever and lower back pain.  Treated with OTC tylenol.  40 after injection sever pain in arm.  Pain radiating down to fingertips.  Too painful to sleep.  Difficulty using arm due to pain.  Treated with double OTC ibprofen dosage every 4 to 6 hours.  Low fever persisted.  At 58 hours fever is gone and pain is mild, still using OTC ibprofen at recomended dosage.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: 16 hours after injection moderate pain in entire arm.  Pain made sleeping difficult.  Difficulty lifting arm above heart due to pain.  Treated with OTC ibprofen 200 mg.  28 h low fever and lower back pain.  Treated with OTC tylenol.  40 after injection sever pain in arm.  Pain radiating down to fingertips.  Too painful to sleep.  Difficulty using arm due to pain.  Treated with double OTC ibprofen dosage every 4 to 6 hours.  Low fever persisted.  At 58 hours fever is gone and pain is mild, still using OTC ibprofen at recomended dosage.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error, Wrong drug administered
Clinical narrative: seen in cliinic for flu vaccination and was given adult flu vaccine (flulaval) 0.5ml
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Allergy to animal, Cough, Dyspnoea, Wheezing
Clinical narrative: aprx 2 1/2 hrs later, slight cough turned into, weezing and breathing difficulty. It lasted about 6hrs. I thought I was getting sick, so went to bed early. When I woke following am, I felt better and realized it was an allergy attack.  That kind of attack only happens to me when I visit a friend who has a cat.
Age: 41.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: Flu Mist vaccine given 10 days after smallpox vaccine given.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error, Wrong drug administered
Clinical narrative: seen in clinic for flu vaccination and was given adult flu vaccine (flulaval) 0.5ml
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Headache, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: 11-2-07:  Received pneumovax and influenza vaccinations in the morning.  In the evening patient's arm was swollen and warm.  11-3-07:  Developed localized hives (about 15-20) in right arm near injection site.  Also had a headache upon awakening and arm pain.  Pt took 800 mg of ibuprofen for headache and pain.  Pt's pain decreased however headache remained so pt took Axert.  11-4-07:  Hives stopped but pt still had redness and swelling down arm.  11-5-07:  Pt still had headache and upper arm showed some warmth and swelling but did improve.  Pt went to see PCP on this day and PCP advised to apply heat or cold pack and to take benadryl and ibuprofen for symptom control.  11-6-07:  Pt felt better on this day.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Urticaria
Clinical narrative: 11-2-07:  Received pneumovax and influenza vaccinations in the morning.  In the evening patient's arm was swollen and warm.  11-3-07:  Developed localized hives (about 15-20) in right arm near injection site.  Also had a headache upon awakening and arm pain.  Pt took 800 mg of ibuprofen for headache and pain.  Pt's pain decreased however headache remained so pt took Axert.  11-4-07:  Hives stopped but pt still had redness and swelling down arm.  11-5-07:  Pt still had headache and upper arm showed some warmth and swelling but did improve.  Pt went to see PCP on this day and PCP advised to apply heat or cold pack and to take benadryl and ibuprofen for symptom control.  11-6-07:  Pt felt better on this day.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error, Wrong drug administered
Clinical narrative: seen in clinic for flu vaccination and was given adult flu vaccine (flulaval) 0.5ml
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error, Wrong drug administered
Clinical narrative: seen in clinic for flu vaccination and was given adult flu vaccine (flulaval) 0.5ml
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: seen in clinic for flu vaccination and was given adult flu vaccine (flulaval) 0.5ml
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: Flu mist given 13 days after smallpox vaccine administered.
Age: 48.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Blood pressure increased, Fatigue
Clinical narrative: 10 minutes after receiving vaccination, patient complained of feeling very tired and weak.  Blood pressure elevated at 165/95.  Patient referred to primary care doctor for blood pressure management
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Contusion, Full blood count, Henoch-Schonlein purpura, Joint swelling, Urine analysis
Clinical narrative: On October 28th my husband returned home where my daughters were being cared for by their grandparents.  We noticed small bruises on her legs and swelling in her ankles we took her to the ER where they said it was an injury.  I took her to her pediatrician the following day and found out she had Henoch-Schonlein Purpura (HSP).  This occurred approximately a week after she received her flu mist.  Her flu mist was administered on October 19, 2007.  It is difficult to know if the symptoms occurred earlier because my husband and I were out of town for the weekend and she was in the care of her grandparents.  She has received the flu shot before know as Flu Zone.  She had the flu shot in 2003,2004,2005, and 2006.  This was the first year she received the flu mist. 12/10/07-records received for DOS 10/28/07-DX: ankle contusion. See in ED bruising on ankles. 12/26/07-office note 11/14/07-well visit.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error, Wrong drug administered
Clinical narrative: seen in clinic for flu vaccination and was given adult flu vaccine (flulaval) 0.5ml
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error, Wrong drug administered
Clinical narrative: seen in clinic for flu vaccination and was given adult flu vaccine (flulaval) 0.5ml
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error, Wrong drug administered
Clinical narrative: seen in clinic for flu vaccination and was given adult flu vaccine (flulaval) 0.5ml
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error, Wrong drug administered
Clinical narrative: seen in clinic for flu vaccination and was given adult flu vaccine (flulaval) 0.5ml
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased activity, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: 11-6-07:  Vaccine administered and pt felt fine on this day.  11-7-07:  Pt had headache all day, aches all over body, felt very fatigued, was nauseated, couldn't move, and felt like passing out due to dizziness.  No fever or chills.  Pt took tylenol every evening unti felt better.  11-14-07:  Pt started to feel better.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: 11-6-07:  Vaccine administered and pt felt fine on this day.  11-7-07:  Pt had headache all day, aches all over body, felt very fatigued, was nauseated, couldn't move, and felt like passing out due to dizziness.  No fever or chills.  Pt took tylenol every evening unti felt better.  11-14-07:  Pt started to feel better.
Age: 23.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: Two live vaccines given 14 days apart.  No adverse reaction or treatment sought
Age: 40.0
Sex: U
Vaccine: FLU3
Symptoms: Blood pressure increased, Headache, Immediate post-injection reaction, Injection site pruritus, Injection site rash
Clinical narrative: Immediate itching at site of injection, generalized pruritis, Headache, nauseated, shakey, sensation, rash surrounding site of injection, erythematous, very fine papules.  BP elevated--142/96, heart pounding.
Age: 40.0
Sex: U
Vaccine: FLU3
Symptoms: Nausea, Palpitations, Pruritus generalised, Rash erythematous, Rash papular
Clinical narrative: Immediate itching at site of injection, generalized pruritis, Headache, nauseated, shakey, sensation, rash surrounding site of injection, erythematous, very fine papules.  BP elevated--142/96, heart pounding.
Age: 40.0
Sex: U
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Immediate itching at site of injection, generalized pruritis, Headache, nauseated, shakey, sensation, rash surrounding site of injection, erythematous, very fine papules.  BP elevated--142/96, heart pounding.
Age: 19.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: Received smallpox on 11/3/07 and received flumist on 11/18/07
Age: 43.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: Smallpox given on 11/3/07, Flumist given on 11/15/07
Age: 41.0
Sex: M
Vaccine: FLUN3
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: Two live vaccines given two weeks apart. No adverse reaction or treatment given.
Age: 15.0
Sex: F
Vaccine: FLU3, MNQ, VARCEL
Symptoms: Muscle tightness, Pain in extremity, Tremor
Clinical narrative: "Shaking" of left arm with pain- ER evaluation was muscle tightening treat with heat and ibuprofen.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient states within 45 mintues of Pneumococcal 23 vaccine her (l) arm begin to turn red, swelling and causing pain. Pt. had this vaccine on 11-13-07 and was her 1st vaccine. Pt. called 11-15-07 and reported. I ref. her to PMD. MD adv. use Benadryl. Pt. improved.
Age: 35.0
Sex: F
Vaccine: MMR, TD, VARCEL
Symptoms: Cold compress therapy, Immunisation reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PATIENT RECIEVED A VARICELLA VACCINE ON 11/16/2007, STATED RED & PAINFUL ON 11/17/2007. EXAMED BY DR. NOTED RED, SLIGHTLY RAISED, WARM TO TOUCH AREA LEFT ARM AT SITE VARICELLA VACCINE WAS GIVEN. ADVISED PROBABLE MEDICATION REACTION, NOT ABSESSED OR INFECTED. ADVISED TO APPLY SOLD COMPRESS FOR COMFORT.
Age: 35.0
Sex: F
Vaccine: MMR, TD, VARCEL
Symptoms: Injection site warmth
Clinical narrative: PATIENT RECIEVED A VARICELLA VACCINE ON 11/16/2007, STATED RED & PAINFUL ON 11/17/2007. EXAMED BY DR. NOTED RED, SLIGHTLY RAISED, WARM TO TOUCH AREA LEFT ARM AT SITE VARICELLA VACCINE WAS GIVEN. ADVISED PROBABLE MEDICATION REACTION, NOT ABSESSED OR INFECTED. ADVISED TO APPLY SOLD COMPRESS FOR COMFORT.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal distension, Arthralgia, Back pain, Full blood count normal, Muscular weakness
Clinical narrative: 10-30-07:  Vaccine given.  11-05-07:  Had severe lower back pain radiating to the hips.  Also had bloating in the abdomen.  11-06-07:  Went to ER and had CBC and kidney function tests taken.  All tests were normal.  Received vicodin and norflex in the ER but only took one dose due to nausea.  11-7-07:  Went to PCP.  Pt has been taking ibuprofen to help combat symptoms all this time.  11-8-07:  MRI was obtained and revealed L2 edema of unknown reason.  Also on this day the pt's legs felt weak and still had back pain.  11-14-07:  Ultrasound of the abdomen was taken and was unremarkable.  11-15-07:  Pt started to feel better.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Nuclear magnetic resonance imaging abnormal, Renal function test normal, Ultrasound abdomen normal
Clinical narrative: 10-30-07:  Vaccine given.  11-05-07:  Had severe lower back pain radiating to the hips.  Also had bloating in the abdomen.  11-06-07:  Went to ER and had CBC and kidney function tests taken.  All tests were normal.  Received vicodin and norflex in the ER but only took one dose due to nausea.  11-7-07:  Went to PCP.  Pt has been taking ibuprofen to help combat symptoms all this time.  11-8-07:  MRI was obtained and revealed L2 edema of unknown reason.  Also on this day the pt's legs felt weak and still had back pain.  11-14-07:  Ultrasound of the abdomen was taken and was unremarkable.  11-15-07:  Pt started to feel better.
Age: 0.75
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None at time of injection
Age: 55.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Chills, Drug hypersensitivity, Hyperventilation, Pain
Clinical narrative: Onset 12 hours after vaccination of severe body and joint aches, fever, chills, hyperventilaion.
Age: 55.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Onset 12 hours after vaccination of severe body and joint aches, fever, chills, hyperventilaion.
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Angioedema, Lip swelling, Swollen tongue
Clinical narrative: angioedema (swollen lips and tongue) vaccine 10/20 1130 am Symptoms began 10/22 5pm no labs done . sent home with benadryl
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder
Clinical narrative: Information has been received, via the Merck pregnancy registry, from a physician, concerning an 18 year old female patient with asthma, who was pregnant, (approximately 10-14 weeks pregnant), and on 15-MAY-2007 was vaccinated with the first dose, 0.5ml, of Gardasil (Lot #655620/0171U). The physician confirmed that no adverse effect was involved. No further details were reported. Follow up information from a nurse practitioner/certified nurse midwife, indicated the patient's LMP date was 17-MAR-2007 and the estimated date of conception as 31-MAR-2007. The estimated date of delivery was 22-DEC-2007. Additional follow up information indicated that on 03-NOV-2007, the pregnancy resulted in a "premature birth and a low birth weight baby" (gestational week not specified). The infant's (gender not specified) birth weight was less than 5 pounds. The infant continued in the hospital after 1 week, due to feeding difficulties. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Encephalitis herpes, Incorrect dose administered
Clinical narrative: Information has been received from a pharmacist concerning a male who on approximately 09-OCT-2007 (reported as "about a month ago") was vaccinated with a 0.5 ML dose of Zostavax (Oka/Merck). The pharmacist reported that the patient was hospitalized with herpetic encephalitis. The patient's herpetic encephalitis persisted. The herpetic encephalitis was considered to be immediately life-threatening. There was no product quality complaint. In follow-up information received 09-NOV-2007, the pharmacist reported that she had limited information. She stated that a nurse came to the pharmacy and mentioned that they had a patient who was very sick and they were trying to figure out what was wrong with him. The nurse mentioned to the pharmacist that she reviewed the patient's history and the patient had been vaccinated with Zostavax (Oka/Merck) about a month ago. The pharmacist did not have any additional information since she did not review the chart and did not know who the treating physician was. In follow-up information received on 13-NOV-2007, the pharmacist reported that the pharmacy department had no further information. Herpetic encephalitis was considered to be an other important medical event. No further information is available.
Age: 0.4
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Abdominal rigidity, Abnormal faeces, Bowel movement irregularity, Haematochezia, Screaming
Clinical narrative: Information has been received from a health professional concerning a 16 week old male who on 29-AUG-2007 received a first oral dose, and on 29-OCT-2007 he received a second oral dose of Rotateq (lot# 656379/0505U. Concomitant vaccination on 29-AUG-2007 included Prevnar, (manufacturer unspecified) DTaP and poliovirus vaccine. It was reported that on 16-OCT-2007 he was taken to the emergency room after he had developed screaming for five hours, had bowel movements two to three times a week, and when there were bowel movements it was several times a day with odor and blood in the stool. On 08-NOV-2007 he developed a hard abdomen,was screaming rhythmly, vomited six times, and was hospitalized. Treatment, diagnostics, and current patient status was not reported. A product quality complaint was not reported. Further information was not available. Upon internal review, it was determined that bowel movements several times a day with blood in the stool was an other medical event. Additional information has been requested. 1/9/08-records received for DOS 11/8-11/9/07-DC DX: Intermittent insussusception, resolved. Reflux.  Had a gasping episode on 11/7/07 at 5:00 a.m., appeared to shake his legs and arms and let out a giant gasp proceeded to a shrill cry. Later vomited 10-11 times over 2 hours. Continued over course of next day to have intermitten high-pitched screams.
Age: 0.4
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a health professional concerning a 16 week old male who on 29-AUG-2007 received a first oral dose, and on 29-OCT-2007 he received a second oral dose of Rotateq (lot# 656379/0505U. Concomitant vaccination on 29-AUG-2007 included Prevnar, (manufacturer unspecified) DTaP and poliovirus vaccine. It was reported that on 16-OCT-2007 he was taken to the emergency room after he had developed screaming for five hours, had bowel movements two to three times a week, and when there were bowel movements it was several times a day with odor and blood in the stool. On 08-NOV-2007 he developed a hard abdomen,was screaming rhythmly, vomited six times, and was hospitalized. Treatment, diagnostics, and current patient status was not reported. A product quality complaint was not reported. Further information was not available. Upon internal review, it was determined that bowel movements several times a day with blood in the stool was an other medical event. Additional information has been requested. 1/9/08-records received for DOS 11/8-11/9/07-DC DX: Intermittent insussusception, resolved. Reflux.  Had a gasping episode on 11/7/07 at 5:00 a.m., appeared to shake his legs and arms and let out a giant gasp proceeded to a shrill cry. Later vomited 10-11 times over 2 hours. Continued over course of next day to have intermitten high-pitched screams.
Sex: M
Vaccine: PNC
Symptoms: Abasia, Arthritis infective, Purulent discharge
Clinical narrative: Information regarding Prevnar was received from a consumer regarding a 12-month-old male patient who experienced an infection in his knee which drained milky yellow pus; the patient could not walk for one week. The patient received a dose in Sep-2007. On an unspecified date in 2007, ten days after receiving Prevnar in his left thigh, the patient developed an infection in his knee which drained milky yellow pus; he could not walk for one week. The patient was hospitalized for 3 days and treated with an antibiotic; the patient recovered. No additional information was available at the time of this report.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Cellulitis, Erythema, Feeling hot, Pain
Clinical narrative: Initial report received on 05 November 2007 from a health care provider. An eight-year-old male patient, with no illness at the time of vaccination, had received a right arm, intramuscular injection of Fluzone SV 2007-2008, lot number U2499AA, on 03 November 2007. Within 24 hours post-vaccination, the patient experienced erythema, pain, blisters, and a feeling of "hot." The affected area was from the top of the arm to below the elbow. The specific arm affected was not reported. The patient was subsequently diagnosed with cellulitis and admitted to the hospital for 24 hours. Treatment included vancomycin and steroids. Per the reporter, the events had almost resolved.
Sex: U
Vaccine: FLU3
Symptoms: Attention deficit/hyperactivity disorder, Hearing impaired, Tic
Clinical narrative: Initial report received on 05 November 2007. An unidentified patient (age not reported; gender unknown) developed Attention Deficit Disorder (ADD), nervous tics and hearing disturbances (onset dates unknown) after receiving a Fluzone vaccination in December 2006 (lot number and route/site of administration unknown). Patient outcome was not reported. No additional information was provided at the time of this report. The reporter, who identified herself only by first name, refused to provided contact information concerning the facility that administered the vaccine. Follow-up information, therefore, cannot be requested at this time. The reporter indicated that she would call back.
Age: 41.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Cough, Dyspnoea, Injection site erythema, Pruritus, Urticaria
Clinical narrative: Itching, coughing, hives, SOB, redness over influenza injection site, Benadryl IV, Solumedrol IV, Epinephrine, Pepcid IV, MS IV. Toprol.  12/04/2007 MR received for DOS 11/14-16/2007 with D/C Dx: Anaphylactic reaction to Influenza A immunization. Chest pain, etiology uncertain, possibly related to the reaction.  Post-menopausal.   Pt presented to ER with a reaction to the flu shot which consisted of  throat irritation, cough, urticaria, swelling, itching and respiratory compromise. Treated with epi, Benadryl, steroids and O2 with gradual improvement.  However, pt developed L-side chest pressure and pain which was not responsive to morphine.  Admitted to ICU for observation and eval. Pt had several recurrances during hospital stay. Improvement noted with Labetalol and po beta-blockers.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Immediate post-injection reaction, Tachycardia
Clinical narrative: Coughing, chest tightness, tachycardia within 3-5 min. of injection. Rec'd 25 mg Benadryl + 125mg solu Medrol with resolution of symptoms
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC, VARCEL
Symptoms: Convulsion
Clinical narrative: 40 minute afebrile seizure about 11 hrs after receiving vaccines.  11/30/2007 MR received ER visit 11/10/2007 with DX:  Likely Febrile Seizure.  Infant developed fever on the pm of vax.  Pt was witnessed to fall, become unresponsive, foam at the mouth, and vomit.  Pt had L sided shaking of L arm and leg lasting ~40 minutes.   PE (+) for coarse lung sounds with bilateral rhonchi, otherwise WNL. Pt d/cd home to F/U as outpatient.
Age: 0.5
Sex: M
Vaccine: FLUX, MMR
Symptoms: Autism, Feeling abnormal
Clinical narrative: Concerned about Mercury in flu shots caused "zombie"-like state in her child. MMR - has mercury in it. This causes autism later in life. Why is there mercury in MMR and Flu shots. Senator has been concerned.
Age: 77.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Asthenia, Atrial fibrillation, Computerised tomogram abnormal, Dyspnoea, Dyspnoea
Clinical narrative: Patient received influenza and Zostavax vaccines on 10/22. the next day she began to feel tired, weak, and generally not well. Over time she noticed shortness of breath with mild exertion. On admission she denied any fever, nausea, vomiting, diarrhea, abdominal pain, chest pain, headache, or neck stiffness. During hospitalization she did present with low grade fever along with previously described symptoms. A large pericardial effusion was detected upon further testing.12/06/07-records received for DOS 11/7-11/14/07-  Developed diarrhea and stool leukocyte positive.Weak, low grade fever, malaise, dyspnea, atrial fibrillation. Impression: probably autoimmune phenomenon possible related to recent immunizations, Pericarditis. Per 60 day follow up: Atrial fibrillation developed during hospitalization related to acute pericarditis. Pt was discharged home 11/14/2007. Patient is still alive, had lab work 1/21/2008.
Age: 77.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Echocardiogram abnormal, Fatigue, Malaise, Pericardial effusion, Pyrexia
Clinical narrative: Patient received influenza and Zostavax vaccines on 10/22. the next day she began to feel tired, weak, and generally not well. Over time she noticed shortness of breath with mild exertion. On admission she denied any fever, nausea, vomiting, diarrhea, abdominal pain, chest pain, headache, or neck stiffness. During hospitalization she did present with low grade fever along with previously described symptoms. A large pericardial effusion was detected upon further testing.12/06/07-records received for DOS 11/7-11/14/07-  Developed diarrhea and stool leukocyte positive.Weak, low grade fever, malaise, dyspnea, atrial fibrillation. Impression: probably autoimmune phenomenon possible related to recent immunizations, Pericarditis. Per 60 day follow up: Atrial fibrillation developed during hospitalization related to acute pericarditis. Pt was discharged home 11/14/2007. Patient is still alive, had lab work 1/21/2008.
Age: 11.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Band neutrophil count increased, Blood culture negative, Body temperature increased, Chest X-ray abnormal, Cough
Clinical narrative: 4 weeks prior to admission-patient-received varicella vaccine booster dose, developed mild respiratory symptoms about 2 weeks later, about one week patient developed small bumps on face, started zithromax 2 days patient, admitted 11/08/2007 with respiratory tract symptoms, high fever, decreased oral intake, sore mouth, dehydration and cough. Dermatology consultation; multiple discrete and some confluent erythematous targetoid macules, 1-1.5 cm in size, many with central bullae, most prominent on face and trunk, mucous membrane involvement of the eye, genitalia and mouth with prominent labial and intraoral erosions. Dx Steven Johnson syndrome, ID consultation Dx: Vaccine- associated varicella, erythema multiforme ophthalmology consultation: minimal ocular manifestation of questionable Steven-Johnson syndrome vs post varicellar booster. TX: pt rec'd Acyclovir, Rocephin, IVIG, hydration, steroids iv, steroid eye drops and artificial tears, pain medication, transferred to burn unit at hospital.  01/08/2008 MR received for DOS 11/8-12/2007 with Transfer DX:  Stevens-Johnson syndrome of unknown etiology.  Pt presented to ER with hx of cough (on and off) x 2 weeks, rash, vomiting and fever x 2 days. Pt initially dxd with bronchitis and given Zithromax. However pt continued to develop high fever, aches, sore throat and decreased appetite. Consults by ID, Ophthalmology, and Dermatology.  PE by ID (+) for fever with sinus tachycardia, glassy eyes, injected conjunctivae, parched lips, sloughing of oral mucosa, scattered vessicles in various stages on the body. Ophth for ocular involvement and photophobia.  Derm noted erythema multiforme like rash. TXd with abx, acyclovir, steroids, and then IVIg. Transferred to higher level of care. Lot # obtained from Tag-2 report and updated in database. 03/12/2008 D/C summary received from transfer facility for DOS 11/12-19/2007 with DX: Erythema multiforme major.  Stevens-Johnson syndrome. Per 60 day follow up: Status unknown, pt was transfered to hospital.
Age: 11.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Culture throat negative, Dehydration, Erythema, Erythema multiforme, Haematocrit normal
Clinical narrative: 4 weeks prior to admission-patient-received varicella vaccine booster dose, developed mild respiratory symptoms about 2 weeks later, about one week patient developed small bumps on face, started zithromax 2 days patient, admitted 11/08/2007 with respiratory tract symptoms, high fever, decreased oral intake, sore mouth, dehydration and cough. Dermatology consultation; multiple discrete and some confluent erythematous targetoid macules, 1-1.5 cm in size, many with central bullae, most prominent on face and trunk, mucous membrane involvement of the eye, genitalia and mouth with prominent labial and intraoral erosions. Dx Steven Johnson syndrome, ID consultation Dx: Vaccine- associated varicella, erythema multiforme ophthalmology consultation: minimal ocular manifestation of questionable Steven-Johnson syndrome vs post varicellar booster. TX: pt rec'd Acyclovir, Rocephin, IVIG, hydration, steroids iv, steroid eye drops and artificial tears, pain medication, transferred to burn unit at hospital.  01/08/2008 MR received for DOS 11/8-12/2007 with Transfer DX:  Stevens-Johnson syndrome of unknown etiology.  Pt presented to ER with hx of cough (on and off) x 2 weeks, rash, vomiting and fever x 2 days. Pt initially dxd with bronchitis and given Zithromax. However pt continued to develop high fever, aches, sore throat and decreased appetite. Consults by ID, Ophthalmology, and Dermatology.  PE by ID (+) for fever with sinus tachycardia, glassy eyes, injected conjunctivae, parched lips, sloughing of oral mucosa, scattered vessicles in various stages on the body. Ophth for ocular involvement and photophobia.  Derm noted erythema multiforme like rash. TXd with abx, acyclovir, steroids, and then IVIg. Transferred to higher level of care. Lot # obtained from Tag-2 report and updated in database. 03/12/2008 D/C summary received from transfer facility for DOS 11/12-19/2007 with DX: Erythema multiforme major.  Stevens-Johnson syndrome. Per 60 day follow up: Status unknown, pt was transfered to hospital.
Age: 11.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Lymphocyte count decreased, Metabolic function test normal, Mycoplasma serology, Oral intake reduced, Oral pain
Clinical narrative: 4 weeks prior to admission-patient-received varicella vaccine booster dose, developed mild respiratory symptoms about 2 weeks later, about one week patient developed small bumps on face, started zithromax 2 days patient, admitted 11/08/2007 with respiratory tract symptoms, high fever, decreased oral intake, sore mouth, dehydration and cough. Dermatology consultation; multiple discrete and some confluent erythematous targetoid macules, 1-1.5 cm in size, many with central bullae, most prominent on face and trunk, mucous membrane involvement of the eye, genitalia and mouth with prominent labial and intraoral erosions. Dx Steven Johnson syndrome, ID consultation Dx: Vaccine- associated varicella, erythema multiforme ophthalmology consultation: minimal ocular manifestation of questionable Steven-Johnson syndrome vs post varicellar booster. TX: pt rec'd Acyclovir, Rocephin, IVIG, hydration, steroids iv, steroid eye drops and artificial tears, pain medication, transferred to burn unit at hospital.  01/08/2008 MR received for DOS 11/8-12/2007 with Transfer DX:  Stevens-Johnson syndrome of unknown etiology.  Pt presented to ER with hx of cough (on and off) x 2 weeks, rash, vomiting and fever x 2 days. Pt initially dxd with bronchitis and given Zithromax. However pt continued to develop high fever, aches, sore throat and decreased appetite. Consults by ID, Ophthalmology, and Dermatology.  PE by ID (+) for fever with sinus tachycardia, glassy eyes, injected conjunctivae, parched lips, sloughing of oral mucosa, scattered vessicles in various stages on the body. Ophth for ocular involvement and photophobia.  Derm noted erythema multiforme like rash. TXd with abx, acyclovir, steroids, and then IVIg. Transferred to higher level of care. Lot # obtained from Tag-2 report and updated in database. 03/12/2008 D/C summary received from transfer facility for DOS 11/12-19/2007 with DX: Erythema multiforme major.  Stevens-Johnson syndrome. Per 60 day follow up: Status unknown, pt was transfered to hospital.
Age: 11.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Platelet count normal, Pyrexia, Rash, Rash macular, Sinus tachycardia
Clinical narrative: 4 weeks prior to admission-patient-received varicella vaccine booster dose, developed mild respiratory symptoms about 2 weeks later, about one week patient developed small bumps on face, started zithromax 2 days patient, admitted 11/08/2007 with respiratory tract symptoms, high fever, decreased oral intake, sore mouth, dehydration and cough. Dermatology consultation; multiple discrete and some confluent erythematous targetoid macules, 1-1.5 cm in size, many with central bullae, most prominent on face and trunk, mucous membrane involvement of the eye, genitalia and mouth with prominent labial and intraoral erosions. Dx Steven Johnson syndrome, ID consultation Dx: Vaccine- associated varicella, erythema multiforme ophthalmology consultation: minimal ocular manifestation of questionable Steven-Johnson syndrome vs post varicellar booster. TX: pt rec'd Acyclovir, Rocephin, IVIG, hydration, steroids iv, steroid eye drops and artificial tears, pain medication, transferred to burn unit at hospital.  01/08/2008 MR received for DOS 11/8-12/2007 with Transfer DX:  Stevens-Johnson syndrome of unknown etiology.  Pt presented to ER with hx of cough (on and off) x 2 weeks, rash, vomiting and fever x 2 days. Pt initially dxd with bronchitis and given Zithromax. However pt continued to develop high fever, aches, sore throat and decreased appetite. Consults by ID, Ophthalmology, and Dermatology.  PE by ID (+) for fever with sinus tachycardia, glassy eyes, injected conjunctivae, parched lips, sloughing of oral mucosa, scattered vessicles in various stages on the body. Ophth for ocular involvement and photophobia.  Derm noted erythema multiforme like rash. TXd with abx, acyclovir, steroids, and then IVIg. Transferred to higher level of care. Lot # obtained from Tag-2 report and updated in database. 03/12/2008 D/C summary received from transfer facility for DOS 11/12-19/2007 with DX: Erythema multiforme major.  Stevens-Johnson syndrome. Per 60 day follow up: Status unknown, pt was transfered to hospital.