chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.24
Sex: F
Vaccine: HIBV, VARCEL, HIBV, VARCEL, HIBV, VARCEL, HIBV, VARCEL
Symptoms: Bacterial infection, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning an 8 yr old white female with no known allergies and a history of acute dermatitis who on 12Mar99 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (lot627336/1056H). Concomitant vaccination included a fourth dose of Hib conj vaccine (tet toxoid) (ActHib) (lot0998390) IM in the left thigh. On 15Jul06 she had strep throat which was treated with amoxicillin (500 bid) for 10 days. On 24Jul06 the pt developed full blown chicken pox with over 500 lesions. The pt also developed a secondary infection which was treated with cephalexin (Keflex). The physician reported this to be vaccine failure. On 03Aug06 the pt recovered. The lesions were gone. There was no product quality complaint involved. Additional information received indicated that the pt's father died of pneumonia secondary to varicella which he developed on 25Jul2006. The pt's sibling received varicella virus vaccine live on 30Jan01 and did not develop varicella. The secondary infection was considered to be an important medical event (OMIC). Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a physician and a medical assistant concerning an 18 yr old female with no pertinent medical history or allergies, who on 17Aug06 was vaccinated IM with HPV rL1 6 11 16 18 VLP vaccine (yeast) (0.5ml) (lot 653650/0702F). There was no concomitant therapy. Subsequently, on 18Aug06 the pt developed a rash and hives. It was reported that this was not an injection site rash. The pt presented to her physician's office on 18Aug06 with hives all over her body. She was treated with oral diphenhydramine hydrochloride (Benadryl). It was also reported that the pt went to the ER twice on 19Aug06 and 20Aug06 and was treated with intravenous methylprednisolone sodium succinate (Solu Medrol) for the hives and welts all over her body and was released (it was also reported that the pt was given IV saline). The pt was scheduled to have a follow up visit with her physician within a week. At the time of this report, the pt had not recovered. The rash and generalized urticaria were felt to be other important medical events. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chest pain, Malaise, Nasal congestion, Rash
Clinical narrative: Information has been received from a health professional concerning a 71 yr old female with penicillin and morphine allergies and a history of shingles who on 19Jul06 was vaccinated IM with a 0.65 ml dose of varicella zoster virus vaccine live (lot 65295/0621F). There was no concomitant medication. On 26Jul06 the pt experienced a rash with little tiny blisters. She also had a congested chest and chest pain associated with the rash. The rash would come and go and was worse in the afternoon. The pt was treated with triamcinolone cream and diphenhydramine hydrochloride (Benadryl). The pt reported that she was very sick, but was feeling better. The pt reported that she was seen by another physician who noted that she had a rash inside her esophagus, chest and lung. The week of 14Aug06 the pt was fine, but on 23Aug06 she broke out in blisters. The pt had been taking diphenhydramine hydrochloride (Benadryl) 25mg TID. On 24Aug06 the pt was going to take two 25mg tablets of diphenhydramine hydrochloride (Benadryl) since her rash is always worse in the afternoon. The nurse reported that the pt had a history of cancer and had a tumor in her head a year ago, in 2005. The pt was in remission and was in between her chemotherapy treatments, with the last treatment in May 2006. At the time of the report, the pt had not yet recovered. There was no product quality complaint involved. The pt's chest pain was considered to be an other important medical event (OMIC). Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Alopecia, Amnesia, Anorexia, Anxiety, Back pain
Clinical narrative: Depression, mood anxiety, memory loss, sleep insomnia, suicide attempt, headaches, loss appetite, low back pain, gastroenteritis, hair loss, pain right foot.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Depression, Gastroenteritis, Headache, Insomnia, Mood altered
Clinical narrative: Depression, mood anxiety, memory loss, sleep insomnia, suicide attempt, headaches, loss appetite, low back pain, gastroenteritis, hair loss, pain right foot.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Pain in extremity, Suicide attempt
Clinical narrative: Depression, mood anxiety, memory loss, sleep insomnia, suicide attempt, headaches, loss appetite, low back pain, gastroenteritis, hair loss, pain right foot.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Skin nodule
Clinical narrative: Small bump in the head
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Neuropathy, Neuropathy peripheral, Sensory disturbance
Clinical narrative: Progressive poly peripheral neuropathy (sensory only) persistent current SX at 12 weeks. Initial severe local reaction left arm injection site.
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP, HEPA, TDAP
Symptoms: Headache, Injection site reaction
Clinical narrative: Local reaction to left upper arm, HA +
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP, HEPA, TDAP
Symptoms: Cellulitis, Injection site oedema, Injection site pain
Clinical narrative: Local reaction to left upper arm, HA +
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP, HEPA, TDAP
Symptoms: Headache, Injection site reaction
Clinical narrative: Edema at inj site, pain at inj site, poss. cellulitis. Tx: Benadryl, compresses to arm, Augmentin.
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP, HEPA, TDAP
Symptoms: Cellulitis, Injection site oedema, Injection site pain
Clinical narrative: Edema at inj site, pain at inj site, poss. cellulitis. Tx: Benadryl, compresses to arm, Augmentin.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Pt got chickenpox after being vaccinated.
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Injection site induration, Tenderness
Clinical narrative: Seen in office 1 week after I given with cellulitis left thigh. Upper injection 2cm erythematous, firm, tender. Lower injection erythema, warmth, tender diffuse 5.5x 3 cm. TX'd with Amoxicillin 250 mg BID x 10D. Zyrtec 2.5 mg PHS.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Rash macular
Clinical narrative: Dtap given IM in right thigh 8/21/06, Seen in office 8/22/06 with moderate swelling of right thigh and knee. Blotchy erythema, not indurated, hot or tender, no treatment.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HEP, HIBV, IPV
Symptoms: Pyrexia
Clinical narrative: Fever for two days following vaccine.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Medication error
Clinical narrative: Soreness at injection site and mild redness.
Age: 38.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Medication error
Clinical narrative: Soreness at injection site and mild redness.
Age: 54.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Medication error
Clinical narrative: Soreness at injection site and mild redness.
Age: 15.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Medication error
Clinical narrative: Soreness at injection site, and mild redness.
Age: 17.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Medication error
Clinical narrative: Pain at injection site and mild redness.
Age: 18.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Soreness at injection site and mild redness.
Age: 47.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Soreness at injection site and mild redness
Age: 22.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Soreness at injection site and mild redness.
Age: 28.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Soreness at injection site and mild redness.
Age: 47.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Soreness at injection site and mild redness.
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Soreness at injection site and mild redness.
Age: 51.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Soreness at injection site and mild redness.
Age: 28.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Soreness at injection site and mild redness.
Age: 16.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Soreness at injection site and mild redness.
Age: 41.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Soreness at injection site and mild redness.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Varicella vaccine breakthrough. Diagnosed with varicella 8/26/06. Had 6 lesions no fever.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Temp, nausea, headache
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Anterior L thigh red and swollen 3x4 cm after getting shots on 8/25/2006
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rash erythematous, Rash macular, Urticaria, Wheezing
Clinical narrative: Fine erythematous macules on eye lids, frontal scalp with salivation, described at ER as urticarial (sent there for monitoring). Change in breathing patter with occ wheeze at office.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: Pt received Pneumovax 8/24/06 per pt report: developed pain and swelling, redness below the injection site, then developed hives on trunk of her body.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Lt arm swelling, redness, increased pain 2-3 days after vaccine given. Rx started 8/24/06.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Blister, Cellulitis, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Redness and swelling at site which progressed to blisters. Low grade fever at home. On exam, T=100F, 7cm x 9cm area of erythema, tenderness, induration right lateral thigh (inj site) with 5cm x 5cm central area of blisters, largest 3mm. Treated as cellulitis with cephalexin.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Tenderness
Clinical narrative: Redness and swelling at site which progressed to blisters. Low grade fever at home. On exam, T=100F, 7cm x 9cm area of erythema, tenderness, induration right lateral thigh (inj site) with 5cm x 5cm central area of blisters, largest 3mm. Treated as cellulitis with cephalexin.
Age: 64.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Cough, Rhinorrhoea
Clinical narrative: Wakened in noc with severe cough and runny nose, was ok by morning. This cough felt like I would choke and was prolonged over 2 hr period with episodes lasting 30-60secs or so. The runny nose was excessive down the back of my throat. Not clear if this could have been a reaction or not. I was fine the next day with the drainage continuing for 2-3 days without cough.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Local reaction at injection site at left upper 5.5cm erythematous, indurated reaction at injection site, no pain, temp 99.0, BP 82/51, pulse 112, RR 23, P ox 99%.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Erythema, Fall, Headache, Injury
Clinical narrative: Child was in for 12 yo PE, given TDaP at approx 4:20pm without incident. Proceeded to walk into office hallway with mother to check out desk. Appeared to have syncope episode without warning, fell face down onto linoleum floor. Regained consciousness in about 20 secs responding to name, opening eyes. HR 96 RR 20 BP 106/60. O2 100%. C/O slight nausea, lightheadedness, when attempted to sit up x 2. Erythematous area mild forehead, SL ecchymosis lip, nose periorbital area.  Persistent HA, nausea, pallor when upright transferred to ED by ambulance.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of consciousness, Nausea, Pallor, Sinus arrhythmia, Syncope
Clinical narrative: Child was in for 12 yo PE, given TDaP at approx 4:20pm without incident. Proceeded to walk into office hallway with mother to check out desk. Appeared to have syncope episode without warning, fell face down onto linoleum floor. Regained consciousness in about 20 secs responding to name, opening eyes. HR 96 RR 20 BP 106/60. O2 100%. C/O slight nausea, lightheadedness, when attempted to sit up x 2. Erythematous area mild forehead, SL ecchymosis lip, nose periorbital area.  Persistent HA, nausea, pallor when upright transferred to ED by ambulance.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Arthralgia, Erythema multiforme, Pain in extremity, Skin ulcer, Urticaria
Clinical narrative: Erythema multiforme, generalized hives, target lesions painful feet and ankle.
Age: 0.37
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever Tylenol given
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Headache, Platelet disorder, Prothrombin time prolonged, Pruritus, Purpura
Clinical narrative: Information has been received from a RN concerning a 5 yr old male with no known allergies and a history of dermatitis who on 21Aug06 at 14:00 was vaccinated SC with a 0.5ml first dose of MMR (lot 652679/1137R). Concomitant vaccination included a fourth dose of poliovirus vaccine inactivated (IPOL) (lot Y2050) given SC and a fifth dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (INFANRIX) (lot AC14B036AA) given IM. On 21Aug06 at 15:30 the pt developed a rash in two spots which had spread to five spots, penny sized behind the right ear, dime size on the left ear, and smaller than a dime size but getting larger on the side of the face near the ear, on the hairline and down the jaw line, the size of these erythematous spots were also reported to be 4-10mm. The pt also developed a headache and a little itching. The rash was reported to be non blanching with an irregular border and no center elevation, and reddish and purplish in color. Other faint sites were developing. The pt was being watched at the doctor's office and the pt was treated with diphenhydramine hydrochloride (Benadryl). It was reported that it was presumed that the pt valsalved and extravesated blood purpura. Labs were drawn, white blood cell count 8900, platelet count 313000, PT 11.5, and PTT 29. Subsequently, the pt recovered. There was no product quality complaint involved. The pt's events were considered to be other important medical events (OMIC). Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Rash, White blood cell disorder
Clinical narrative: Information has been received from a RN concerning a 5 yr old male with no known allergies and a history of dermatitis who on 21Aug06 at 14:00 was vaccinated SC with a 0.5ml first dose of MMR (lot 652679/1137R). Concomitant vaccination included a fourth dose of poliovirus vaccine inactivated (IPOL) (lot Y2050) given SC and a fifth dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (INFANRIX) (lot AC14B036AA) given IM. On 21Aug06 at 15:30 the pt developed a rash in two spots which had spread to five spots, penny sized behind the right ear, dime size on the left ear, and smaller than a dime size but getting larger on the side of the face near the ear, on the hairline and down the jaw line, the size of these erythematous spots were also reported to be 4-10mm. The pt also developed a headache and a little itching. The rash was reported to be non blanching with an irregular border and no center elevation, and reddish and purplish in color. Other faint sites were developing. The pt was being watched at the doctor's office and the pt was treated with diphenhydramine hydrochloride (Benadryl). It was reported that it was presumed that the pt valsalved and extravesated blood purpura. Labs were drawn, white blood cell count 8900, platelet count 313000, PT 11.5, and PTT 29. Subsequently, the pt recovered. There was no product quality complaint involved. The pt's events were considered to be other important medical events (OMIC). Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Headache, Pruritus, Purpura, Rash erythematous, Skin discolouration
Clinical narrative: Information has been received from a RN concerning a 5 yr old male with no known allergies and a history of dermatitis who on 21Aug06 at 14:00 was vaccinated SC with a 0.5ml first dose of MMR (lot 652679/1137R). Concomitant vaccination included a fourth dose of poliovirus vaccine inactivated (IPOL) (lot Y2050) given SC and a fifth dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (INFANRIX) (lot AC14B036AA) given IM. On 21Aug06 at 15:30 the pt developed a rash in two spots which had spread to five spots, penny sized behind the right ear, dime size on the left ear, and smaller than a dime size but getting larger on the side of the face near the ear, on the hairline and down the jaw line, the size of these erythematous spots were also reported to be 4-10mm. The pt also developed a headache and a little itching. The rash was reported to be non blanching with an irregular border and no center elevation, and reddish and purplish in color. Other faint sites were developing. The pt was being watched at the doctor's office and the pt was treated with diphenhydramine hydrochloride (Benadryl). It was reported that it was presumed that the pt valsalved and extravesated blood purpura. Labs were drawn, white blood cell count 8900, platelet count 313000, PT 11.5, and PTT 29. Subsequently, the pt recovered. There was no product quality complaint involved. The pt's events were considered to be other important medical events (OMIC). Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Cough, Dyspnoea, Wheezing
Clinical narrative: Initial information received on 21Aug06 from a health care professional. It was reported that a 79 yr old female pt received an initial dose of Adacel, lot C2457AA, admin IM in the left deltoid on 28Jun06 at 2:30PM. 30 mins post vaccination, the pt left the physician's office wheezing and feeling short of breath. She was treated with albuterol and prednisone on 03Jul06. On 08Jul06, the pt developed a non productive cough, wheezing, and chest tightness. A chest x ray showed no significant abnormalities. The pt was treated with Augmentin, Mucinex and prednisone. On 11Jul06, the pt was feeling better after the prednisone and continued taking Augmentin. Her shortness of breath and cough continued and she was started on Flovent. On 24Jul06, the pt's cough was worse and she was started on Bactrim. On 05Aug06, the pt began coughing again and was again treated with prednisone and albuterol, as well as Advair. On 14Aug06, her cough was worse again. The pt has not recovered from the events. The pt has a past medical history of seizure disorder, mild asthma, renal disorder and osteomalacia. She has no known drug allergies. She has no history of adverse event following prior vaccination and had no illnesses at the time of vaccination on 28Jun06.
Age: 0.01
Sex: F
Vaccine: HEP
Symptoms: Abnormal sleep-related event, Premature baby, Sudden infant death syndrome
Clinical narrative: Family lost a baby about 1 year ago D/T accidental asphyxiation (wedging against parent and couch cushion. Undetermined category II SIDS. 9/19/06 Received Autopsy Report which reveals COD as SIDS with hx of cosleeping in adult bed with parent & twin sibling.  Patient was preemie due to c-section delivery of twin gestation & PDA./ss
Age: 0.66
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Lethargy, Somnolence, Vomiting
Clinical narrative: Vomiting, sleeping alot, lethargic.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Erythema, Eye swelling, Ocular hyperaemia, Pyrexia, Rash
Clinical narrative: Low grade temp facial puffiness and redness on the 28th, on the 29th rash over body, puffy red eyes, fever OTC Benadryl.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Swelling face
Clinical narrative: Low grade temp facial puffiness and redness on the 28th, on the 29th rash over body, puffy red eyes, fever OTC Benadryl.
Age: 0.53
Sex: U
Vaccine: DTAPHEPBIP, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Red, warm, indurated area on left thigh about 2 inches diameter.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Injection site induration
Clinical narrative: 10 cm induration of site of injection, severe lightheadedness.
Age: 1.25
Sex: F
Vaccine: DTAPH, MMR, PNC
Symptoms: Erythema, Rash pruritic
Clinical narrative: Red itchy, spotted rash all over body.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Gait disturbance, Hypotonia, Pyrexia
Clinical narrative: Foster mother give child Tylenol for 24 hrs. No Tylenol starting 8/20/06 in AM. On 08/20/2006 at 3PM child awakes from nap. He is limp on left side, head flops, has no balance and cannot get to sitting position. Episode lasted 30 minutes. Once arrived to ER child had improved. Temp was 100F. Tylenol given at 4PM and again at 8:30PM on 8/20/06. On 8/21/06 at 7:30AM child awoke with same symptoms and low grade fever. Foster mother gave his Tylenol and symptoms and fever resolved. No further symptoms reported.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: R arm swollen, red and hot from elbow to shoulder. Pt c/o itching. Tx'd with augmentin xr.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Tenderness
Clinical narrative: R arm swelling with swelling up into the shoulder and collar bone area very tender. No redness noted. No fever. Mild to moderate pain. Symptoms lasted one week and then was gone.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pt ran temp of 104 with vomiting.
Age: 0.48
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Hypokinesia, Hypotonia, Insomnia, Screaming
Clinical narrative: Mother stated that after the immunization baby was limp for 1 -1 1/2 days and not moving, extremities with frog leg position, cried alot and did not sleep. Went away the following day. Incident and vaccinations occurred on 4/24/06 but the report was completed on 8/10/06. On 8/10/06 infant received DT and had no problems, per discussion with clinic.
Age: 25.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Rash
Clinical narrative: Rash on neck, trunk and arms. Due to time between vaccination and reaction, not sure if related, but decided to send forth anyway.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Red, hot and swollen R deltoid.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site mass, Injection site pain, Injection site swelling, Oedema
Clinical narrative: Soreness at site initially, progressed soreness into left upper arm and Headache. After 24 hrs: left upper swollen, and left axilla, and L base of neck were sore. After 48 hrs: whole left arm swollen, lg goose egg size lumps were in my left axilla, left base of neck, both also had hard lymph nodes w/soreness. Start Medrol Dose pack 8/13/06, soreness gone by 8/17/06, but moderate edema noted still in base of neck 8/20/06.
Age: 1.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Coma, Crying, Dyskinesia, Screaming, Staring
Clinical narrative: 8/30/06 12:30PM jerking body movements, staring. 9/1/06 1:30AM-2:30AM, crying, staring, would not respond to mom.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Local swelling, redness, itchiness left deltoid.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Vomiting
Clinical narrative: One day after vaccinations experienced some vomiting. No treatment needed.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Pt developed fever 104-105 within 24 hrs of receiving vaccine Adacel.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Tenderness
Clinical narrative: Induration, erythema with tenderness to touch upper arm, shoulder to elbow, along lateral aspect.
Sex: U
Vaccine: HEPA
Symptoms: Cardiomyopathy, Laboratory test abnormal, Respiratory arrest
Clinical narrative: Cardiomyopathy, ?etiology, respiratory arrest 8/19/06. Hospitalized.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site swelling
Clinical narrative: Leg swelling onset evening of shot. 48 hrs later, upper and lower leg signif. swelling. Ultrasound negative for DVT. Treated with antibiotics for presumed cellulitis.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Local reaction to injection, 2 inch redness around injection site. Red, warm and swollen.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: 6cm erythema and induration at site of injection noted 12 days after injection.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Conjunctival discolouration, Injection site erythema, Pruritus
Clinical narrative: About 1/2 hr after 2nd varicella injection she developed bil conjunctival redness and itchiness. Responded to IM Benadryl. No skin, no cardio resp reactions.
Age: 1.05
Sex: F
Vaccine: HIBV, MMRV
Symptoms: Febrile convulsion, Pyrexia, Urticaria
Clinical narrative: Hive fever, febrile seizure
Age: 1.03
Sex: F
Vaccine: MMR
Symptoms: Rash, Viral infection
Clinical narrative: Patient seen with apparent chickenpox on 8/31/06.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: RIGHT ARM WITH SIGNIFICANT SWELLING, ERYTHEMA,WARMTH.  NON-TENDER TO PALPATION. NO STREAKING, KEFLEX 250/5 7.5 ML BID FOR 10 DAYS.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site warmth
Clinical narrative: 7 1/2 CM BY 5 3/4 CM AREA OF ERYTHEMA RT UPPER ARM. WARM TO TOUCH.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Screaming
Clinical narrative: Screamed unconsolably for 3 hours.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: This pt's left arm from top of should to bottom of elbow was very red and swollen.  No fever, exudate or other symptoms. Pt was moving arm well.
Age: 36.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 36 yo M was given routine Td vaccine IM in left deltoid on 8/31/06.  Post administration he developed significant redness, pain, and skin induration at injection site.  Presented back to office for evaluation of reaction on 09/01/2006.  No signs of infection.  Heat and NSAIDS suggested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Mother reports that approximately 4pm on 8-29-2006 she notice that her daughter was scratching her lt leg. States the next morning the area was about the size of a nickle. Also states that she wasn't feeling good so I kept her home. The morning of 8-31-2006 the area was much larger and warm to the touch. She sent her to Headstart and told the nurse about it. @4:45pm she brought her in to our office to check the area. It was red and measured 3 1/4 inches and was warm to the touch. Instr mother to put a cool compress on area or let her soak in tepid tub bath. Also instr to continue with the Tylenol and apply some benadryl cream to area.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, TDAP
Symptoms: Medication error
Clinical narrative: 4 MO WCC  PEDIARIX AND HIB GIVEN AND ADACEL GIVEN IN ERROR INSTEAD OF PREVNAR THAT WAS INTENDED THIRD IMMUNIZ.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This pt's left arm from top of should to bottom of elbow was very red and swollen.  No fever, exudate or other symptoms. Pt was moving arm well.
Age: 1.27
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: Mother reports that 2 wks after imm he broke out in fine red rash. "He has eczema and I wasn't sure if it was that." States that rash was it's worst on 7/27. MD refered him to Hosp on 8/2/06 because he couldn't get the rash to improve. He feels it is due to varicella. States that the doctor told mother he is to have no further live vac. On 8/7 mother reports that he had a fever of 101 and dark red rash on abd and forehead. She took him to dermatologist who feels it is combination on varicella and his eczema.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Joint stiffness, Musculoskeletal stiffness, Shoulder pain
Clinical narrative: Neck stiffness.  Shoulder pain. Joint stiffness.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Facial palsy
Clinical narrative: This case was reported by a physician to a sales representative and described the occurrence of Bells palsy in a 14 year old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, absorbed (Boostrix) for prophylaxis. Concurrent medical condition included mild asthma. On 5/15/06 the subject received 0.5 ml of Boostrix in her right arm. On 5/17/06, 2 days after vaccination with Boostrix, the subject experienced Bell's palsy. At the time of initial reporting. 5/17/06, the event was ongoing. The physician considered the event was possibly related to vaccination with Boostrix. Follow up received on 5/19/06 from another sales representative indicated that the vaccination was three weeks prior to this follow up. The event was unresolved at the time of reporting. Comment Bell's palsy was assessed as medically serious by manufacturer (OMIC).
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Myalgia
Clinical narrative: This case was reported by a nurse and described the occurrence of an approximately 18-year-old male subject who was inadvertently given a repeat dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix) for prophylaxis.  Concurrent medications included Tuberculin (TB skin test) (PPD) and Triaz.  The subject received Boostrix on 22 February 2006.  On 05 June 2006 at 14:30, the subject inadvertently received a repeat dose of Boostrix (.5 ml, unknown).  At the time or reporting, the subject had no problems with the repeat dose of Boostrix, but his current status was unknown.  On follow-up, it was noted that the subject experienced soreness at the injection site with no redness or swelling.  The event resolved on 08 June 2006 and the nurse considered that the events were probably related to Boostrix.  Per the Boostrix prescribing information, Boostrix should be administered as a single injection.  There are no data to support repeat administration of Boostrix.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal discomfort, Pain
Clinical narrative: This case was reported by a nurse via a sales representative and described the occurrence of generalized pain in a 11-year-old male subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix) for prophylaxis.  On 25 July 2000, the subject had received his last diphtheria toxoid, tetanus toxoid, and acellular pertussis vaccine (DTaP vaccine).  On 24 July 2006, the subject received 1st dose of Boostrix (.lotAC52B009AA).  On 24 July 2006, "several hours" after vaccination with Boostrix, the subject experienced generalized aching, generalized pain, gastrointestinal upset, and at the time of initial reporting the outcome of the events were was unspecified.  The nurse was not sure that the subject's symptoms were caused by Boostrix; however, it was reported that the events were possibly related to vaccination with Boostrix.  Follow-up was received from the reporting nurse on 03 August 2006.  The nurse reported that at the time of immunization with Boostrix, the subject was "well" and that " there had been several cases of gastrointestinal virus with other patients in the office that day".  The subject had a history of asthma.  The events resolved on 25 July 2006.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Diarrhoea, Erythema, Pain
Clinical narrative: Had redness, swelling within 4 hrs. Severe pain, redness & swelling by next A.M.(lasted 3 days). 24 hrs later had chills, body aches, sore joints, Temp of 100.4. 36 hrs later had diarrhea. 5 days later symptoms had subsided.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Swelling
Clinical narrative: Had redness, swelling within 4 hrs. Severe pain, redness & swelling by next A.M.(lasted 3 days). 24 hrs later had chills, body aches, sore joints, Temp of 100.4. 36 hrs later had diarrhea. 5 days later symptoms had subsided.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Chills, Injection site swelling, Pyrexia, Tinnitus, Tremor
Clinical narrative: On Monday, August 21, the same day my daughter was vaccinated, she awoke in the night with a fever and chills. I didn't think much of it because she always gets a fever after vaccinations. She has also had swelling at injection site on some occasions. I gave her some children's ibuprofen, her fever subsided, and she went back to sleep. I noticed that she had a swelling around an injection on her right leg. Her fever did not return, but on Wednesday, August 23, we were eating lunch at 1:30 when she began complaining of seeing "flashes" of light. She was still seeing them that night when she laid down to go to bed. The next day she was still seeing them, so I called both her pediatrician and her allergist. The pediatrician said to call an opthamologist, and her allergist said it didn't sound like an allergic reaction and to call an opthamologist. We got an appointment with an opthamologist the next day. He dialated her eyes and found nothing wrong. Several days later on Sunday, August 27, she was laying in her bed to go to sleep when she told me that she felt like her legs were shaking. Her legs were not actually moving, but the felt like they were. The next night, Monday, August 28, she felt like her head was shaking, although it wasn't shaking. She also began to hear sounds like a buzzing sound. We got an appointment with her pediatrician the next morning, Tuesday August 29 at 8:45 a.m. On this morning she also stated that her "flashes" of light instead of just being white were now colored and grey, too. Her pediatrician said that her reaction was not a reaction to the shot, but a result of a fear of needles and referred her to a neuropsychologist. I disagree with the pediatrician because she has had many times that she has been stuck with needles (i.e. allergy testing, other vaccinations, blood drawn, even an i.v. once), and she has never reacted. In fact after this vaccination, she was playing and having fun at the park directly after the visit, and had forgotten all about the vaccinations. She and her sister play "giving shots" sometimes. I don't believe that it is logical to say that her reaction was due to a "fear of needles". It is logical that her reaction was due to either a bad vaccine or a reaction to the vaccine. She contines to see "flashes" of light, mainly colored, feel like she is shaking, and hear sounds. I believe the shots have caused central nervous system damage.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Vitreous floaters
Clinical narrative: On Monday, August 21, the same day my daughter was vaccinated, she awoke in the night with a fever and chills. I didn't think much of it because she always gets a fever after vaccinations. She has also had swelling at injection site on some occasions. I gave her some children's ibuprofen, her fever subsided, and she went back to sleep. I noticed that she had a swelling around an injection on her right leg. Her fever did not return, but on Wednesday, August 23, we were eating lunch at 1:30 when she began complaining of seeing "flashes" of light. She was still seeing them that night when she laid down to go to bed. The next day she was still seeing them, so I called both her pediatrician and her allergist. The pediatrician said to call an opthamologist, and her allergist said it didn't sound like an allergic reaction and to call an opthamologist. We got an appointment with an opthamologist the next day. He dialated her eyes and found nothing wrong. Several days later on Sunday, August 27, she was laying in her bed to go to sleep when she told me that she felt like her legs were shaking. Her legs were not actually moving, but the felt like they were. The next night, Monday, August 28, she felt like her head was shaking, although it wasn't shaking. She also began to hear sounds like a buzzing sound. We got an appointment with her pediatrician the next morning, Tuesday August 29 at 8:45 a.m. On this morning she also stated that her "flashes" of light instead of just being white were now colored and grey, too. Her pediatrician said that her reaction was not a reaction to the shot, but a result of a fear of needles and referred her to a neuropsychologist. I disagree with the pediatrician because she has had many times that she has been stuck with needles (i.e. allergy testing, other vaccinations, blood drawn, even an i.v. once), and she has never reacted. In fact after this vaccination, she was playing and having fun at the park directly after the visit, and had forgotten all about the vaccinations. She and her sister play "giving shots" sometimes. I don't believe that it is logical to say that her reaction was due to a "fear of needles". It is logical that her reaction was due to either a bad vaccine or a reaction to the vaccine. She contines to see "flashes" of light, mainly colored, feel like she is shaking, and hear sounds. I believe the shots have caused central nervous system damage.
Age: 80.0
Sex: M
Vaccine: UNK
Symptoms: Altered state of consciousness, Bedridden, Blood test, Chromaturia, Disability
Clinical narrative: Liver Failure, Swelling in Feet, Bed ridden, loss of awareness, total disability for several days. VA Neurology Clinic. Spoke with nurse she indicated that patient did not receive a vaccine but experienced an adverse event to an injection that was exacerbated by his oral medications. She will fax a copy of the office note for the DOS 08/03/2006 to validate medication administered. krk 09/13/06-office notes received from Biloxi VAMC for DOS 08/03/2006- office visit regarding prostate needle biopsy, results adenocarcinoma Gleason's score 6. Plan: RX Zoladex 10.8 mg given. Prescription for Flutamide 250 mg TID times 90 days, Zoladex. Later same day patient's wife contacted clinic stating patient began the Flutamide, he can hardly walk and his urine is real dark (no burning/discomfort). Wife state he is deteriorating and feels it's caused by the medication. Clinic instructed patient to discontinue Flutamide, increase fluid intake and if condition fails to improve within 24-48 hours or worsen to F/U with his PCP or ER. 01/1/2010 It has left him disabled, unable to walk real good, unable to have sex, unable to think. 02/09/10 Still in recovery, needs care almost died of liner failure, in hospital for four days.
Age: 80.0
Sex: M
Vaccine: UNK
Symptoms: Gait disturbance, Hepatic failure, Oedema peripheral, Sexual dysfunction, Urine analysis
Clinical narrative: Liver Failure, Swelling in Feet, Bed ridden, loss of awareness, total disability for several days. VA Neurology Clinic. Spoke with nurse she indicated that patient did not receive a vaccine but experienced an adverse event to an injection that was exacerbated by his oral medications. She will fax a copy of the office note for the DOS 08/03/2006 to validate medication administered. krk 09/13/06-office notes received from Biloxi VAMC for DOS 08/03/2006- office visit regarding prostate needle biopsy, results adenocarcinoma Gleason's score 6. Plan: RX Zoladex 10.8 mg given. Prescription for Flutamide 250 mg TID times 90 days, Zoladex. Later same day patient's wife contacted clinic stating patient began the Flutamide, he can hardly walk and his urine is real dark (no burning/discomfort). Wife state he is deteriorating and feels it's caused by the medication. Clinic instructed patient to discontinue Flutamide, increase fluid intake and if condition fails to improve within 24-48 hours or worsen to F/U with his PCP or ER. 01/1/2010 It has left him disabled, unable to walk real good, unable to have sex, unable to think. 02/09/10 Still in recovery, needs care almost died of liner failure, in hospital for four days.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash for 24 hours, arms, legs, back in " crops" with vesicles
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Angioneurotic oedema, Cold sweat, Coma, Dyspnoea, Eyelid oedema
Clinical narrative: Initial report received on 22Aug06 from another manf who originally received the report from a pharmacist who received the report from a physician. A 5 yr old male pt with no known allergies and a history of gastroesophageal reflux, and periodic breathing difficulty had received a fourth IM dose of Ipol, lot number Y0298, in the left thigh; a fifth IM dose of Infanrix, lot number AC14B008AA, in the left thigh; and a second SC dose of MMR II vaccine, in the right thigh, on 31May06 at 15:15PM. Approx ten minutes post immunization, the pt became uncomfortable, did not feel well, and began to have severe vomiting. This was followed by extreme itchiness of his feet, and whole body redness with hives on his left shoulder. The pt was fussy, disoriented, lethargic, and having trouble staying awake. He wanted to sleep. His blood pressure was 40mm systolic compared to 80mm systolic prior to the vaccinations. He was given oxygen, and an Epipen was administered. The pt was transported to the ER. On examination in the ER, the pt was somewhat unresponsive and needed a lot of stimulation to get him to wake up. He was erythematous all over but the hives had resolved. His vital signs were stable and he was treated with IV fluids, a second dose of epinephrine, Zantac, Zyrtec, and Solumedrol. By 17:00pm, the pt's erythema had resolved. His diagnosis was anaphylactic reaction likely secondary to the MMR II vaccine. The pt's recovery status was reported as being recovered on 01Jun06, the date of discharge from the hospital. The pt was discharged with a steroid for five days, a proton pump inhibitor, antihistamine for one month and an Epipen. Per the reporter, the pt had received a first dose of MMR vaccine, lot number 642645/0527M, on 29Aug02 with no problems. Per the other manf, the records of testing prior to release of Lot 649811/0491R in question have been rechecked and found to be satisfactory. The lot 649811/0491R met the requirements and was released by the regulatory agency. The event of anaphylactic reaction was considered by the other manf to be immediately life threatening, disabling and other important medical event (OMIC).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Nausea, Palpitations, Pruritus, Rash pruritic, Vomiting
Clinical narrative: Initial report received on 22Aug06 from another manf who originally received the report from a pharmacist who received the report from a physician. A 5 yr old male pt with no known allergies and a history of gastroesophageal reflux, and periodic breathing difficulty had received a fourth IM dose of Ipol, lot number Y0298, in the left thigh; a fifth IM dose of Infanrix, lot number AC14B008AA, in the left thigh; and a second SC dose of MMR II vaccine, in the right thigh, on 31May06 at 15:15PM. Approx ten minutes post immunization, the pt became uncomfortable, did not feel well, and began to have severe vomiting. This was followed by extreme itchiness of his feet, and whole body redness with hives on his left shoulder. The pt was fussy, disoriented, lethargic, and having trouble staying awake. He wanted to sleep. His blood pressure was 40mm systolic compared to 80mm systolic prior to the vaccinations. He was given oxygen, and an Epipen was administered. The pt was transported to the ER. On examination in the ER, the pt was somewhat unresponsive and needed a lot of stimulation to get him to wake up. He was erythematous all over but the hives had resolved. His vital signs were stable and he was treated with IV fluids, a second dose of epinephrine, Zantac, Zyrtec, and Solumedrol. By 17:00pm, the pt's erythema had resolved. His diagnosis was anaphylactic reaction likely secondary to the MMR II vaccine. The pt's recovery status was reported as being recovered on 01Jun06, the date of discharge from the hospital. The pt was discharged with a steroid for five days, a proton pump inhibitor, antihistamine for one month and an Epipen. Per the reporter, the pt had received a first dose of MMR vaccine, lot number 642645/0527M, on 29Aug02 with no problems. Per the other manf, the records of testing prior to release of Lot 649811/0491R in question have been rechecked and found to be satisfactory. The lot 649811/0491R met the requirements and was released by the regulatory agency. The event of anaphylactic reaction was considered by the other manf to be immediately life threatening, disabling and other important medical event (OMIC).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Anaphylactic reaction, Disorientation, Erythema, Hypotension, Hypoxia
Clinical narrative: Initial report received on 22Aug06 from another manf who originally received the report from a pharmacist who received the report from a physician. A 5 yr old male pt with no known allergies and a history of gastroesophageal reflux, and periodic breathing difficulty had received a fourth IM dose of Ipol, lot number Y0298, in the left thigh; a fifth IM dose of Infanrix, lot number AC14B008AA, in the left thigh; and a second SC dose of MMR II vaccine, in the right thigh, on 31May06 at 15:15PM. Approx ten minutes post immunization, the pt became uncomfortable, did not feel well, and began to have severe vomiting. This was followed by extreme itchiness of his feet, and whole body redness with hives on his left shoulder. The pt was fussy, disoriented, lethargic, and having trouble staying awake. He wanted to sleep. His blood pressure was 40mm systolic compared to 80mm systolic prior to the vaccinations. He was given oxygen, and an Epipen was administered. The pt was transported to the ER. On examination in the ER, the pt was somewhat unresponsive and needed a lot of stimulation to get him to wake up. He was erythematous all over but the hives had resolved. His vital signs were stable and he was treated with IV fluids, a second dose of epinephrine, Zantac, Zyrtec, and Solumedrol. By 17:00pm, the pt's erythema had resolved. His diagnosis was anaphylactic reaction likely secondary to the MMR II vaccine. The pt's recovery status was reported as being recovered on 01Jun06, the date of discharge from the hospital. The pt was discharged with a steroid for five days, a proton pump inhibitor, antihistamine for one month and an Epipen. Per the reporter, the pt had received a first dose of MMR vaccine, lot number 642645/0527M, on 29Aug02 with no problems. Per the other manf, the records of testing prior to release of Lot 649811/0491R in question have been rechecked and found to be satisfactory. The lot 649811/0491R met the requirements and was released by the regulatory agency. The event of anaphylactic reaction was considered by the other manf to be immediately life threatening, disabling and other important medical event (OMIC).