chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Nausea, Pain, Swelling
Clinical narrative: cellulitis developed 24 hr after injection, admitted to hospital for IV antibiotic therapy 48 hr after immunization.  R arm swollen, nauseated, ill felling; pain, but no lymphadenopathy in R axilla; extensive erythema and edema in right upper arm.  Temp 97.5; pulse 64; resp. 16; BP 127/81.  Nurse follow up on 10/05/04 states: "Confirmed diagnosis of cellulitis following pneumovax and allergy shot in R arm. Agitation, shortness of breath, and headache to symptoms." Per annual report-Upon review of discharge summary, noted that patient also had received an unspecified "allergy shot" in same arm when pneumovax was administered. DC summary states that patient was responding well to presumed cellulitis caused by staph or strep.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Redness/Itching on R Deltoid radiating across entire upper arm from the injection site. Tr:  Cephalexin PO 500mg QID for 10 days.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Blister, Rash pruritic
Clinical narrative: Pruritic blistering rash between digits of left hand, radiating to wrist beginning day after smallpox/anthrax vaccines; similar rash at right forearm/antecubitus, abdomen, left hip; much improved with use of hydrocortisone cream and otc antihistamines; no constitutional symptoms; father has psoriasis, pt with hx wintertime atopic dermatitis as child. Follow-up Information:  Description: eczema vaccinatum after primary dose vaccinia. Comment: permanent medical exemption from vaccinia.
Age: 1.19
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Urticaria
Clinical narrative: MMR given 9-23-2004 at patient's home (Amish). Prior to giving the MMR, all appropriate questions were asked regarding allergies,etc. Mother had stated child has no know allergies and is able to eat eggs. 3 hours after shot given patient developed a few hives on body. No other symptoms. 3-4 hours later that evening, more hives developed. Patient's mother called to report symptom of hives as instructed on the VIS. She was told to watch for further hives and call her Dr....Patient's mother called this RN at 11AM on the following day 9-24-2004 stating the hives were now all over the child's body. Child still has no other symptoms..no problem swallowing, or breathing.. no fever.. no other symptoms. This RN advised patient's mother to call her Dr. right away to seek advice and any treatment that he might order  (IE: benadryl,etc.) Patient's mother stated she would call her Dr. as soon as she hung up the phone from talking with this RN.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Had immunizations on 9-17-04, developed fever within 24 hours of immunizations, went to ER, elevated WBC, admitted to hospital. Mom states no problems noted at injection site.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Back pain, Chills, Feeling hot, Headache
Clinical narrative: Patient is a 33 year old male who received his 4th anthrax (AVA) on 12 Sep 04. Later that pm he stated that he felt a little sore in his back and neck and that the next morning he had increased soreness. He said that he went to work and had to leave at 11 am because he felt so bad. He stated that he had pain in his lower back that would radiate around to his hips and that his neck was also starting to get sore. At 5-6 pm that night, after eating for the first time that day, he became nauseated, had increase back, and neck pain. He also reported a headache in the front part of his head with no reports of altered sensation or visual disturbances. He stated that he felt warm and developed chills. He then went to the emergency room and while waiting in the waiting room he developed knee pain. Once seen he was given an I.V. along with some pain medication and he then developed pain in his fingers. He was released the following morning on 14th with continued but lessened pain and aching all over. He stated he took ibuprofen for that day only and by the 15th he was feeling better.   He currently reports that he is doing well with no further pain. He denies any problems with AVA # 1,2 & 3.09
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Nausea, Neck pain
Clinical narrative: Patient is a 33 year old male who received his 4th anthrax (AVA) on 12 Sep 04. Later that pm he stated that he felt a little sore in his back and neck and that the next morning he had increased soreness. He said that he went to work and had to leave at 11 am because he felt so bad. He stated that he had pain in his lower back that would radiate around to his hips and that his neck was also starting to get sore. At 5-6 pm that night, after eating for the first time that day, he became nauseated, had increase back, and neck pain. He also reported a headache in the front part of his head with no reports of altered sensation or visual disturbances. He stated that he felt warm and developed chills. He then went to the emergency room and while waiting in the waiting room he developed knee pain. Once seen he was given an I.V. along with some pain medication and he then developed pain in his fingers. He was released the following morning on 14th with continued but lessened pain and aching all over. He stated he took ibuprofen for that day only and by the 15th he was feeling better.   He currently reports that he is doing well with no further pain. He denies any problems with AVA # 1,2 & 3.09
Age: 7.0
Sex: F
Vaccine: RAB
Symptoms: Erythema, Injection site inflammation, Rash pruritic
Clinical narrative: An itchy rash all over her torso, buttocks and back - it was red, inflamed and very itchy, needing Benadryl to decrease the symptoms.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Mom called on 9/27/04 to report that child's left arm (site of immunization given) was "fiery red and rock hard...just below the shoulder down to his elbow".  Dr. called to verify that child had "non-specific reaction...10-15 cm diameter induration".
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Eye inflammation, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Fever of 103, muscle aches, extreme pain in arm of administration, headache, eyes burning
Age: 61.0
Sex: F
Vaccine: TYP
Symptoms: Asthenia, Blood pressure decreased, Dizziness, Heart rate decreased, Heart rate increased
Clinical narrative: Dizziness, unable to read newspaper, paleness,weakness, fast heart beat. Went to ex-husband's medical office to lie down. BP=110/70, Pulse low. Rested there 2 hrs. Felt weak all day
Age: 61.0
Sex: F
Vaccine: TYP
Symptoms: Pallor
Clinical narrative: Dizziness, unable to read newspaper, paleness,weakness, fast heart beat. Went to ex-husband's medical office to lie down. BP=110/70, Pulse low. Rested there 2 hrs. Felt weak all day
Age: 5.0
Sex: M
Vaccine: DT, IPV, MMR, DT, IPV, MMR, DTAP, IPV, MMR
Symptoms: Erythema, Injection site inflammation, Injection site mass, Injection site pain, Pyrexia
Clinical narrative: Large local reaction (left thigh) within 24 hours of childhood shots 12cm mg 10cm
Age: 5.0
Sex: M
Vaccine: DT, IPV, MMR, DT, IPV, MMR, DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Injection site inflammation, Injection site mass, Pyrexia
Clinical narrative: Large local reaction (left thigh) within 24 hours of childhood shots 12cm mg 10cm
Age: 5.0
Sex: M
Vaccine: DT, IPV, MMR, DT, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site reaction
Clinical narrative: Large local reaction (left thigh) within 24 hours of childhood shots 12cm mg 10cm
Age: 59.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site necrosis, Injection site pain
Clinical narrative: A report was received from another pharmaceutical company on 1/15/04 concerning a 59 year old female vaccinee who experienced redness and pain at the injection site and 2" by 2.5" necrotic area at the injection site on 11/18/02, which was considered medically significant and required surgical intervention (OMIC), after receiving influenza vaccine and Pneumovax 23 on 11/13/02 at 13:30 hours. The vaccinee has a medical history of allergy (comatose) to codeine. On 11/13/02 the vaccinee was administered influenza vaccine and pneumococcal 23v polysaccharide vaccine in the same site. The vaccinee experienced redness and pain at the injection stie an unspecified length of time following vaccination. Unspecified medical attention was sought. On 11/18/02 the vaccinee had developed a 2" by 2.5" necrotic area at the injection site, which was surgically removed 2 weeks later. The outcome of the events was not reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Herpes zoster, Medication error, Nasal congestion
Clinical narrative: From initial information received on 9/22/04 from a healthcare professional regarding an adverse event occurring, it was reported that a three year old male patient received a first dose of FLUZONE, lot number U1489AA, administered in the left thigh on 9/15/04. Six days later, on 9/21/04, the patient was seen in the physician's office with coughing, sneezing, congestion, shortness of breath, and fever (per the patient's mother). He was sent to the emergency room and was admitted to the hospital the same day. A chest x-ray showed pneumonia. The results of cultures were not available at the time of this report. The patient is currently still hospitalized and has not recovered from these events. From additional information received on 13Oct04 from a health care professional, it was reported that the pt had a cough, low grade fever and intermittent wheezing three to four days prior to being seen in the ER, where he was diagnosed with pneumonia and perscribed Azithromycin. For the next 24 hours the pt continued with a cough, but had become afebrile. He was seen by a physician on 21Sep04 and it was noted that he had some papular lesions developing on his upper extremities, left forehead and his left ear lobe seemed to be erythematous and swollen. The pt had decreased oral intake and his mother stated he probably had been urinating somewhat less than normal. He was admitted to the hospital that same day. His physical examination was normal, except for some scant mucoid rhinorrhea and a few bilateral anterior cervical lymph nodes. His chest was clear to ausculatation. He had one small papular region on the dorsal aspect of the left wrist and one on the ventral aspect near the elbow, as well as a small papula on the left upper forehead. The pt was diagnosed with probable pneumonia. The Azithromycin was continued, as well as encouraged increased oral fluids. A consulting physician expressed doubts that the papular lesions were another outbreak of shingles or HSV, since the lesions were not vesicular at that time. He did not recommend acyclovir at that time, but would reconsider antiviral therapy, along with submission of a specimen for viral isolation if the lesions became vesicular. It was not reported if the pt recovered.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Pneumonia, Pyrexia, Rash papular, Rhinorrhoea, Sneezing
Clinical narrative: From initial information received on 9/22/04 from a healthcare professional regarding an adverse event occurring, it was reported that a three year old male patient received a first dose of FLUZONE, lot number U1489AA, administered in the left thigh on 9/15/04. Six days later, on 9/21/04, the patient was seen in the physician's office with coughing, sneezing, congestion, shortness of breath, and fever (per the patient's mother). He was sent to the emergency room and was admitted to the hospital the same day. A chest x-ray showed pneumonia. The results of cultures were not available at the time of this report. The patient is currently still hospitalized and has not recovered from these events. From additional information received on 13Oct04 from a health care professional, it was reported that the pt had a cough, low grade fever and intermittent wheezing three to four days prior to being seen in the ER, where he was diagnosed with pneumonia and perscribed Azithromycin. For the next 24 hours the pt continued with a cough, but had become afebrile. He was seen by a physician on 21Sep04 and it was noted that he had some papular lesions developing on his upper extremities, left forehead and his left ear lobe seemed to be erythematous and swollen. The pt had decreased oral intake and his mother stated he probably had been urinating somewhat less than normal. He was admitted to the hospital that same day. His physical examination was normal, except for some scant mucoid rhinorrhea and a few bilateral anterior cervical lymph nodes. His chest was clear to ausculatation. He had one small papular region on the dorsal aspect of the left wrist and one on the ventral aspect near the elbow, as well as a small papula on the left upper forehead. The pt was diagnosed with probable pneumonia. The Azithromycin was continued, as well as encouraged increased oral fluids. A consulting physician expressed doubts that the papular lesions were another outbreak of shingles or HSV, since the lesions were not vesicular at that time. He did not recommend acyclovir at that time, but would reconsider antiviral therapy, along with submission of a specimen for viral isolation if the lesions became vesicular. It was not reported if the pt recovered.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Hypotonia, Stupor, Syncope
Clinical narrative: Patient received 2 month shots 3/22/04, Pediarix, HIB and PCV7. On 3/23/04, she developed an unexplained hypotonic/hyporesponsive episode, she was rushed into the office and subsequently transported via life flight. No etiology was discovered. The patient recovered.  Nurse follow up on 11/01/04 states: "vaso vagal response."
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Back pain, Headache, Hypersensitivity, Laboratory test abnormal
Clinical narrative: 10-15 minutes after injection, paresthesia right arm, myalgia, arthralgia, HA, back pain. Benadryl 50, EPI .5, Solumedrol 62.5. Transported via ambulance to ED. Symptoms progressed; repeat some meds and Pepcid IV (Solumedrol, Benadryl). Admit overnight for observation. ED doctor consulted with manufacturer regarding reaction. Diagnosed as probable hypersensitivity reaction.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Myalgia, Paraesthesia
Clinical narrative: 10-15 minutes after injection, paresthesia right arm, myalgia, arthralgia, HA, back pain. Benadryl 50, EPI .5, Solumedrol 62.5. Transported via ambulance to ED. Symptoms progressed; repeat some meds and Pepcid IV (Solumedrol, Benadryl). Admit overnight for observation. ED doctor consulted with manufacturer regarding reaction. Diagnosed as probable hypersensitivity reaction.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Coma, Cyanosis, Dyspnoea, Hypotension, Listless
Clinical narrative: Six hours after administration, child developed fever 101, became listless, unresponsive and bluish. Was taken to ER and recovered completely within 10-15 minutes. Was admitted because of the fever. Discharge Summary received on 12/15/2004 states final diagnosis was ALTE and hypotensive response to vaccine. Additional symptoms include gasping and tremor.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Pyrexia, Tremor
Clinical narrative: Six hours after administration, child developed fever 101, became listless, unresponsive and bluish. Was taken to ER and recovered completely within 10-15 minutes. Was admitted because of the fever. Discharge Summary received on 12/15/2004 states final diagnosis was ALTE and hypotensive response to vaccine. Additional symptoms include gasping and tremor.
Age: 1.7
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Cough, Irritability, Swelling face, Urticaria, Wheezing
Clinical narrative: Within 20 minutes of receiving his routine vaccines, the patient began to cough and wheeze, became fussy, and then developed hives and facial swelling. His symptoms resolved after admnistering IM Epinephrine, Diphenhydramine, and oral Atenolol.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Feeling hot, Haematuria, Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: Large local reaction to AVA #6 see attached also microscopic hematuria. Service member received AVA#6 on 18Sep in the right triceps region. He received no other vaccines simultaneously, was well at the time and taking no medications. Vaccination was given according to correct FDA schedule. By the evening of 19Sep04 upper rt arm was swollen, hot and red. On 20Sep04 symptoms were worse and erythema extended to the mid forearm on posterior side. Reports he had slight nausea 2 days after immunization that resolved but no other systemic symptoms. States had minor local reactions to other anthrax immunizations. Today member presents with swelling and erythema in extending beyond elbow. Complains of pain in the right elbow and shoulder also. Tingling in the right 3rd-5th fingers experienced last night has subsided.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Nausea, Pain, Paraesthesia, Vaccine positive rechallenge
Clinical narrative: Large local reaction to AVA #6 see attached also microscopic hematuria. Service member received AVA#6 on 18Sep in the right triceps region. He received no other vaccines simultaneously, was well at the time and taking no medications. Vaccination was given according to correct FDA schedule. By the evening of 19Sep04 upper rt arm was swollen, hot and red. On 20Sep04 symptoms were worse and erythema extended to the mid forearm on posterior side. Reports he had slight nausea 2 days after immunization that resolved but no other systemic symptoms. States had minor local reactions to other anthrax immunizations. Today member presents with swelling and erythema in extending beyond elbow. Complains of pain in the right elbow and shoulder also. Tingling in the right 3rd-5th fingers experienced last night has subsided.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Herpes simplex, Vaccine positive rechallenge
Clinical narrative: Reproducible herpes simplex lesions on upper lip. Service member experienced a cluster of fever blisters on upper lip 7-10 days after AVA#1. The lesions were reproduced and increased 7-10 days after AVA #2. He states he has no prior history of these lesions and had no intimate contact with others that were infected. He sought no treatment and they resolved in 2 weeks. He had no other systemic symptoms.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Oedema, Pruritus, Urticaria
Clinical narrative: Hives (giant) on left arm and forearm with intense pruritus and moderate edema of entire upper extremity.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Feeling hot, Oedema, Pain
Clinical narrative: Left arm swollen, red, warm to touch with 3cm in diameter. No Tx except ice and Motrin for pain if needed.
Age: 39.0
Sex: M
Vaccine: MMR, TD
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Temp to 100.3 days after administration. Pain/redness/swelling involving all of upper arm where vaccine injected into deltoid. Limited history and very poor English.
Age: 7.5
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: No adverse reaction only to report that he was diagnosed with varicella 9/20/04 over 100 lesions-not ill. No temp.
Age: 6.0
Sex: F
Vaccine: PNC
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Severe swelling at deltoid area warm to touch, slightly red, no pain.
Age: 14.0
Sex: F
Vaccine: UNK
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Right arm swollen, warm red, raised, anti-inflammatory and antihistamine given.
Age: 1.58
Sex: M
Vaccine: DTAP, PNC, VARCEL
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Urticarial wheal at injection site of varicella vaccine within 5 minutes of injection.
Age: 1.02
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: 4x2cm red area at site of varicella injection right thigh.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cough, Erythema, Pruritus, Rash macular, Rhinorrhoea
Clinical narrative: Red hives/blotches, violent sneezing, runny nose, coughing, wheezing, red race, wanting shoe off to scratch feet. Breathing treatment and dose of Benadryl, started immediately after shot. Lasted approximately 2 hours.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Sneezing, Urticaria, Wheezing
Clinical narrative: Red hives/blotches, violent sneezing, runny nose, coughing, wheezing, red race, wanting shoe off to scratch feet. Breathing treatment and dose of Benadryl, started immediately after shot. Lasted approximately 2 hours.
Age: 1.54
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Rash vesicular
Clinical narrative: Developed vesicular papular rash on the trunk and legs.
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Infection, Oedema
Clinical narrative: swelling, redness, infection. Rx Keflex.
Age: 1.53
Sex: M
Vaccine: DTAP, PNC
Symptoms: Febrile convulsion, Pyrexia, Vomiting
Clinical narrative: Received Dtap/Prevnar 9/15. 9/15 with high temp, vomiting, febrile seizure seen at ER (Hx of febrile seizure). Pedi. neuro. consult arranged.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Rash pruritic, Skin ulcer
Clinical narrative: On evening that vaccine was given pt noted pruritic area on upper extremities which when scratched resulted in erythematous raised linear lesions. Sensation and confluent lesions progression on abdomen.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Pyrexia, Tenderness
Clinical narrative: Delayed hypersensitivity Rxn with large erythematous, well demarcated patch 12x6cm very tender, plus fever.
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Developed herpes zoster of right arm-treated in office 6/13/03 with Zovirax and Keflex. Rechecked on 6/20/03 resolved.
Age: 0.51
Sex: F
Vaccine: DTAP, PNC
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Red, raised, feverish area around injection site, no other symptoms.
Age: 1.51
Sex: M
Vaccine: DTAP, PNC
Symptoms: Unevaluable event
Clinical narrative: REACTION NOT STATED
Age: 16.0
Sex: M
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: Pt developed urticaria (hives) 1-2 hours after receiving his 5th dose of rabies vaccine on 9/21/04. History of bats exposure. Treated with Benadryl 50 mg po. Hives cleared in 1-2 hours. No other problems the lot no was the same as the previous 4 injections, a sibling received 5 doses of the same lot number without any reaction.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Eye movement disorder, Feeling hot, Hyperhidrosis, Irritability
Clinical narrative: Fussy the evening of the shots, woke mom at 7 AM with fists clenched, eyes moving, foaming at mouth x 3-5 minutes, then groggy, no color change: felt warm and sweaty. Mom called doctor on call and came to clinic. Had another seizure on the way home. Sent to  Hospital.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Musculoskeletal stiffness, Salivary hypersecretion, Somnolence
Clinical narrative: Fussy the evening of the shots, woke mom at 7 AM with fists clenched, eyes moving, foaming at mouth x 3-5 minutes, then groggy, no color change: felt warm and sweaty. Mom called doctor on call and came to clinic. Had another seizure on the way home. Sent to  Hospital.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, raised, feverish area around injection site, redness spread from injection site up to groin and around back of thigh.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, raised, feverish area around injection site. No other symptoms.
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: Generalized maculopapular rash to trunk with upper extremities. Very itchy starting 1-2 after vaccine. No fever. No fatigue. No vesicles.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site reaction
Clinical narrative: Large local reaction in area of injection left thigh 5" x 7" : started within 24 hours of injection.
Age: 1.14
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Erythema, Pruritus, Rash papular, Rash vesicular, Skin ulcer
Clinical narrative: Erythematous skin lesions, noted 9/19/04. PE erythematous papulo-vesicular lesions on trunk and  ext and on hairline lesions sparse. Benadryl for itching.
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Dyspnoea, Erythema, Pyrexia, Tremor
Clinical narrative: Around 1915 on 9/21, he began to shake all over. Seemed alert ware, breathing seemed labored. T 100.2. Area red on right thigh where vaccine given. Shaking stopped within 30 minutes.
Age: 77.0
Sex: F
Vaccine: PPV, TD
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Right shoulder, down to mid way of elbow red, swollen and warm to touch.
Age: 30.0
Sex: M
Vaccine: MMR
Symptoms: Erythema, Feeling hot, Injection site nodule, Myalgia, Pain
Clinical narrative: PC: fever to 101. Per pt, pain, warmth, redness at sight slight swelling at *:30 am . Temperature 100.0. Positive myalgia. Erythema and small nodules at injection site.
Age: 30.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Swelling
Clinical narrative: PC: fever to 101. Per pt, pain, warmth, redness at sight slight swelling at *:30 am . Temperature 100.0. Positive myalgia. Erythema and small nodules at injection site.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Erythema, Nausea, Pain
Clinical narrative: 1-2 days after receiving vaccination in left deltoid, she developed redness, pain in the upper arm, also nausea and diarrhea.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Feeling hot, Pain, Pyrexia
Clinical narrative: Redness occurred 24 hours after injections positive for warmth: Tylenol used for pain and fever.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Feeling hot, Pain, Swelling
Clinical narrative: After receiving DTaP in left leg: following day experienced warmth and redness. 48 hours later became very swollen, red and warm, painful. Mother using Tylenol. Afebrile. Physicians office treated with Keflex due to reaction versus cellulitis.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: 9/22: 2 mm localized erythema (DTaP) site. 9/23/04: pt brought back in 11cm horizontal 10 cm vertical erythema to left deltoid DTaP injection site. (DTaP only)
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Lethargy, Pallor, Pyrexia, Urticaria
Clinical narrative: A few hours past immunization on 4/20/04, he developed fever 100.8 , very pale, lethargic x 3 days. 3 days past immunization, had high pitched shrill crying x 10 days. Also had "hives" on torso. Pediatrician recommended ped. dt from now on. Also wants immunization given once at a time.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Joint range of motion decreased, Pain, Pruritus, Pyrexia, Swelling
Clinical narrative: Feverish, itchy, first few days. 9/17/04 and 9/18/04, swelling and itching in right wrist and hand. 9/20, swelling in knees and ankles-- worsen in 2 days. Right knee and ankle more swollen than left, some pain with squating.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Pollakiuria, Pyrexia
Clinical narrative: Within 15 minutes of injection, felt dizzy. Had fever of 101 F in the evening, upset stomach, shaky. Had diarrhea and increased urination. Symptoms gone after 12 hours.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Tremor
Clinical narrative: Within 15 minutes of injection, felt dizzy. Had fever of 101 F in the evening, upset stomach, shaky. Had diarrhea and increased urination. Symptoms gone after 12 hours.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Anorexia, Crying, Dyspnoea, Pyrexia
Clinical narrative: Child immunized on 8/19 PM. Fever at 103.7 by 2300 on 8/19. Given infant Tylenol with results repeatedly over the course of 4 days. Able to get temp to 99 degrees on 8/20 x 1 hours. Developed raised red rash on 8/21 covering body. Inconsolable crying 8/19 - 8/23. Refusing to eat. Difficulty breathing: "wheezing". No further information is available. Mail that is sent returns. Moved with no forwarding address.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash erythematous, Wheezing
Clinical narrative: Child immunized on 8/19 PM. Fever at 103.7 by 2300 on 8/19. Given infant Tylenol with results repeatedly over the course of 4 days. Able to get temp to 99 degrees on 8/20 x 1 hours. Developed raised red rash on 8/21 covering body. Inconsolable crying 8/19 - 8/23. Refusing to eat. Difficulty breathing: "wheezing". No further information is available. Mail that is sent returns. Moved with no forwarding address.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Hot, red, painful swelling encompassing shoulder where shot was given. Area receded quickly to 15 cm x 15 cm area. Reaction was at site of DTaP vaccination.
Age: 36.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Pyrexia
Clinical narrative: Mild erythema and edema at injection site 2 days after immunization. Low grade temp 99 degrees F. Treated with anti-inflammatories and anti-histamine.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Right arm/shoulder red warm swollen.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Rash papular, Urticaria
Clinical narrative: 2 month old pt here for routine check up, physical exam entirely normal. Pediarix, Hib, and Prevnar administered: Baby immediately turned bright red. Spina Papules or hives.  Child spontaneously recovered.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Had a varicella rash on abdomen and chest 5-6 lesions-one in diaper area resolved in 3-4 days. Occurred after 3rd week of Varivax admin.
Sex: F
Vaccine: HEP
Symptoms: Injection site mass, Pain
Clinical narrative: 08/4/04 received lot, dose, no event, manufacturer, different lot number than 2nd dose. 9/13/04 2nd dose, small amount soreness, several days after noted lump, not sore, area now getting smaller, small lump after injection, area getting smaller.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site pain
Clinical narrative: Persistent deep sharp pain at vaccination site occurring episodically increased with exercise overhead reaching initially accompanied by left axillary LAD Sxs x 18 mo.
Age: 3.0
Sex: M
Vaccine: DTAPH, MMR, VARCEL
Symptoms: Blister, Injection site erythema, Injection site oedema
Clinical narrative: Left thigh red swollen with clear blisters. Warm compresses 1gm Rocephin.
Age: 12.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, TD, VARCEL
Symptoms: Syncope
Clinical narrative: Pt was walking out mom said pt was passing out, Dr and mom carried pt to room, rs. taken, all normal. Approx is 15min. Pt was able to get up, drank some water then left.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Feeling hot, Injection site oedema
Clinical narrative: Dtap and MMR given on 7/21/04, Rxn on 7/23/04 with swollen left upper arm, hot to touch. Tx with Benadryl for allergy received 6, 25mg p T4-6 hours. Tylenol 160mg 15ml-9 1/2 tsp every 4-6 hours. Instructed to go to ER if condition worsens.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Oedema
Clinical narrative: Received Anthrax vaccine on 18Sep04. Noticed excessive swelling reaction on 20Sep04, went to med check and received prescription Cephalex. Swelling progressed went to family physician and received methyl prednisone.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pyrexia, Urticaria
Clinical narrative: Small hives by 4:30 PM on 9-27-04. Stomach, legs and ankles.  Fever, judged by mother, 101.
Age: 54.0
Sex: F
Vaccine: TTOX, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Client presented to the Health Department on Tuesday, with a complaint of a possible vaccine reaction.  Client stated that on Sunday, 9-26-2004, at around 8pm, she noticed that her left upper arm had a circular reddish area that was warm to the touch and raised.  Client also stated that she was experiencing a dull achey pain from her shoulder extending downward to the elbow area.  Cllient was able to relieve pain with OTC Tylenol.  Today, Tuesday, September 28, 2004, the client states that the signs and symptoms that were present on Sunday are diminishing.  The area is presenting with less color, less pain and less warmth and less raisiing of the area.  She did state that the area was about the same size.  The area is measuring 90x60mm at this time.
Age: 13.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Convulsion, Disorientation, Dyspnoea, Eye movement disorder, Flushing
Clinical narrative: About 10:10 am patient went to get her two final series of Hep A and Hep B.  When she was done a few minutes later she came over to me and said she didn't feel good and her head hurt. When I got up from my seat she feel over. I tried to sit her up and her eyes where rolling and her body temp was very hot her face was red. Then I help her sit and all of a sudden she went into convulsions made a funny gasping sound like she couldn't get any air then she went completely out. When she came to her eyes where dilated and she was very disoriented. It took about 20 minutes before we could get her to look at us with out her eyes wondering, and to have her skin cool to the touch. About 1 hour after she said her head didn't hurt, but she still was a little lathargic. The nurse was with us the whole 30 mins, she did not have to administer any thing to her.
Age: 13.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Headache, Lethargy, Loss of consciousness, Malaise, Mydriasis
Clinical narrative: About 10:10 am patient went to get her two final series of Hep A and Hep B.  When she was done a few minutes later she came over to me and said she didn't feel good and her head hurt. When I got up from my seat she feel over. I tried to sit her up and her eyes where rolling and her body temp was very hot her face was red. Then I help her sit and all of a sudden she went into convulsions made a funny gasping sound like she couldn't get any air then she went completely out. When she came to her eyes where dilated and she was very disoriented. It took about 20 minutes before we could get her to look at us with out her eyes wondering, and to have her skin cool to the touch. About 1 hour after she said her head didn't hurt, but she still was a little lathargic. The nurse was with us the whole 30 mins, she did not have to administer any thing to her.
Age: 13.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Pyrexia
Clinical narrative: About 10:10 am patient went to get her two final series of Hep A and Hep B.  When she was done a few minutes later she came over to me and said she didn't feel good and her head hurt. When I got up from my seat she feel over. I tried to sit her up and her eyes where rolling and her body temp was very hot her face was red. Then I help her sit and all of a sudden she went into convulsions made a funny gasping sound like she couldn't get any air then she went completely out. When she came to her eyes where dilated and she was very disoriented. It took about 20 minutes before we could get her to look at us with out her eyes wondering, and to have her skin cool to the touch. About 1 hour after she said her head didn't hurt, but she still was a little lathargic. The nurse was with us the whole 30 mins, she did not have to administer any thing to her.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Agitation, Crying, Irritability, Pyrexia
Clinical narrative: Information has been received from a physician concerning his son who was vaccinated with a dose of hepatitis B virus vaccine (+ HIB conjugate vaccine (lot # 643604/0694M). It was reported that the patient expired after receiving the vaccine. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested. The physician stated that his son prior to being vaccinated was in perfect health and believes that his son's death was vaccine related. Additional information has been requested.  Follow up on 10/28/04 states: "There was no illness at the time of vaccination. After vaccination that day the pt developed a fever, was irritable and difficult to console. The pt became more and more agitated and was crying. At this point the physician was taking care of his son and he administered ibuprofen.  He was last seen at about 4:30am. On 01/18/03 at 8:30AM the pt's mother, who is a nurse, returned home and "found their son blue". He was apneic and pulseless. Emergency was called immediately and within minutes CPR was administered. when the pt arrived at the hospital, his temperature was 99 degrees (after 1 hour of CPR). The physician believes the temperature was taken rectally but was not sure. He also indicated that this was during the winter and a 99 degree fever was "abnormal". On 01/18/03 at 10:07AM the pt died. The physician stated that he had found his son on his side and since his son was not able to turn over on his own at the time, he thinks his son had a febrile seizure. The physician stated that the official pathology reported named "positional ashyxiation" as the cause of death.  However, he does not believe this because his son was able to "hold his own head". He indicated that the information he and his wife provided at the time probably contributed to the diagnosis of positional asphyxiation. He felt that since this information was provided at a time of crisis he does not believe all of the information provided was accurate. It was noted that the pt's siblings had no adverse events following prior vaccinations. No product quality complaint was involved. The physician believes that his son's death was vaccine related. Additional information has been requested."
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Asphyxia, Cyanosis, Pyrexia
Clinical narrative: Information has been received from a physician concerning his son who was vaccinated with a dose of hepatitis B virus vaccine (+ HIB conjugate vaccine (lot # 643604/0694M). It was reported that the patient expired after receiving the vaccine. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested. The physician stated that his son prior to being vaccinated was in perfect health and believes that his son's death was vaccine related. Additional information has been requested.  Follow up on 10/28/04 states: "There was no illness at the time of vaccination. After vaccination that day the pt developed a fever, was irritable and difficult to console. The pt became more and more agitated and was crying. At this point the physician was taking care of his son and he administered ibuprofen.  He was last seen at about 4:30am. On 01/18/03 at 8:30AM the pt's mother, who is a nurse, returned home and "found their son blue". He was apneic and pulseless. Emergency was called immediately and within minutes CPR was administered. when the pt arrived at the hospital, his temperature was 99 degrees (after 1 hour of CPR). The physician believes the temperature was taken rectally but was not sure. He also indicated that this was during the winter and a 99 degree fever was "abnormal". On 01/18/03 at 10:07AM the pt died. The physician stated that he had found his son on his side and since his son was not able to turn over on his own at the time, he thinks his son had a febrile seizure. The physician stated that the official pathology reported named "positional ashyxiation" as the cause of death.  However, he does not believe this because his son was able to "hold his own head". He indicated that the information he and his wife provided at the time probably contributed to the diagnosis of positional asphyxiation. He felt that since this information was provided at a time of crisis he does not believe all of the information provided was accurate. It was noted that the pt's siblings had no adverse events following prior vaccinations. No product quality complaint was involved. The physician believes that his son's death was vaccine related. Additional information has been requested."
Age: 0.4
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Contusion, Injection site cyst
Clinical narrative: Chronic red elevated nodule that turned into large keloid type hypertrophic nodule.
Age: 0.4
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Erythema, Hypertrophy, Injection site mass, Injection site reaction, Keloid scar
Clinical narrative: Chronic red elevated nodule that turned into large keloid type hypertrophic nodule.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Face oedema, Urticaria
Clinical narrative: Information has been received from the mother of a 4 year old male with a gelatin allergy who on 5/18/04 was vaccinated SC with a second dose of MMR (lot number not reported). On 5/18/04, 5 minutes after the vaccination, the patient began coughing. The mother noted that the patient's face became swollen and he developed hives all over his body, although, were concentrated around the area of injection. At the recommendation of the patient's physician, the mother took the patient for a 15 minute walk. There was no change in the patient's condition when they returned, and the physician administered a steroidal Benadryl injection. The patient's symptoms resolved quickly after the injection, and he was prescribed unspecified steroids for 5 days. Cough, facial swelling and hives were considered to be immediately life-threatening. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion, Medication error, Unintended pregnancy
Clinical narrative: Information has been received through the manufacturer pregnancy registry from a physician concerning a 30 year old female who on 9/3/04 at 8 weeks and 1 days pregnant, was vaccinated with a dose of varicella virus vaccine live (lot number not known). No symptoms were noted. Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that on 9/13/04 the patient experienced a spontaneous abortion. Post miscarriage, instead of a D&C procedure, the patient was given misoporstol, unknown if oral or vaginal suppository. The reporter was unsure, but believed that the client came to the ER on 9/13/04, and she was not hospitalized, but sent to the on-site clinic. Additional information has been requested. Follow up 03/03/05: Patient has not recovered from the adverse event(s).
Sex: U
Vaccine: HEPA
Symptoms: Mania, Rash
Clinical narrative: This case was reported by a physician to a sales representative and described the occurrence of manic episodes in a patient who received hepatitis A vaccine. On an unspecified date, the patient received a dose of hepatitis A vaccine (dose number not specified). At an unspecified time following the administration of hepatitis A vaccine, the patient experienced manic episodes and a reticulated skin rash. The outcome of the events is unknown. Comment: Manic episodes assessed as medically serious (OMIC).  Follow up on 10/29/04 states: "On an unspecified date, the pt received a dose of Vaqta (dose # not specified). At an unspecified time following the administration of Vaqta, the pt experienced manic episodes and a reticulated skin rash. The outcome of the events is unknown.  Comment: Manic episodes assessed as medically serious by manufacturer.  This case has been voided from the manufacturer's database because the pt received another manufacturer's vaccine."
Age: 25.0
Sex: F
Vaccine: TD
Symptoms: Convulsion, Muscle spasms, Opisthotonus
Clinical narrative: From initial information received on 9/22/04 from a nurse practitioner regarding an adverse event occurring in the USA, it was reported that a female patient (born in 1979, age at the time of the event not reported) received a booster dose of TD ADS ADULT, lot number U1025AA, administered in the right deltoid and a TUBERCULIN PPD skin test, lot number 007D3P. administered in the right forearm on an unspecified date. Following the administration of the products, the patient also had blood drawn. Approximately ten minutes after receiving the TD ADS ADULT product, the patient experienced a generalized seizure with rigidity and tonic spasms in her legs, arms, and neck. After a minute, the patient became clonic and arched her back. The duration of the symptoms was reported as five minutes. Emergency services was contacted, but the patient refused to go to the emergency department. The patient was fine when seen for a 48 hour follow up visit and she was scheduled to follow up with a neurologist. It was reported that the patient recovered from these events. (OMIC) From additional information received on 28Oct04 from the initial reporter, it was reported that the TD ADS Adult was administered IM and the Tuberculin PPD was administered ID. Both products were administered on 14Sep04 at 11:00AM. The pt reported having a cousin with an adult onset seizure disorder. No other information was provided at this time. From additional information received on 12Nov04 from a nurse practictioner, it was reported that the pt denied further seizure or seizure like activity. Reportedly, the pt has not yet made an appt with a neurologist. The reporter stated that because this facility is not the pt's primary care site, their contact with the pt is limited and for further information direct contact with the pt is probably best.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: CSF test abnormal, Cough, Irritability, Meningitis, Mouth ulceration
Clinical narrative: High temperature, irritability, stiff neck, sneezing, coughing, congestion. Duration approximately 1 week; required hospitalization. Sore inside of mouth. Discharge summary states viral infection, meningitis. msv
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Musculoskeletal stiffness, Nasal congestion, Pyrexia, Sneezing, Viral infection
Clinical narrative: High temperature, irritability, stiff neck, sneezing, coughing, congestion. Duration approximately 1 week; required hospitalization. Sore inside of mouth. Discharge summary states viral infection, meningitis. msv
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying
Clinical narrative: Excessive crying continuous; greater than 3 hours.
Age: 1.39
Sex: F
Vaccine: DTP, HIBV, IPV, MMR
Symptoms: Buccoglossal syndrome, Convulsion, Diarrhoea, Eye disorder, Haematochezia
Clinical narrative: Vomiting on 9/11/04. Diarrhea on 9/12/04. Four seizures on 9/13/04. Required hospitalization for 2 days. She had a brain wave test, CT Scan, blood work and spinal tap which all came back clear. Now she is on phenobarbital.  Nurse follow up on 11/01/04 states: "Groggy; Eyes flutter; Lip smacking; Perioral cyanosis; Diarrhea."
Age: 1.39
Sex: F
Vaccine: DTP, HIBV, IPV, MMR
Symptoms: Pallor, Somnolence, Vomiting
Clinical narrative: Vomiting on 9/11/04. Diarrhea on 9/12/04. Four seizures on 9/13/04. Required hospitalization for 2 days. She had a brain wave test, CT Scan, blood work and spinal tap which all came back clear. Now she is on phenobarbital.  Nurse follow up on 11/01/04 states: "Groggy; Eyes flutter; Lip smacking; Perioral cyanosis; Diarrhea."
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Cellulitis, Ecchymosis, Injection site oedema
Clinical narrative: Developed cellulitis of upper arm after immunizatino requiring hospitalization and IV antibiotics.  Nurse follow up on 10/13/04 states: "Swelling of L upper extremity and ecchymosis in center of L deltoid - DTaP injection site. "
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Hepatic failure, Hepatitis, Hypothermia, Sepsis, Shock
Clinical narrative: Within 72 hours of vaccine administration, hypothermia, shock like episode, recorded temperature 93 degrees F.  Nurse follow up on 10/05/04 states: "Hepatitis, Sepsis, Impending liver failure."