chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site pain, Local swelling, Skin warm
Clinical narrative: LEFT ARM THROBBING AT INJECTION SITE. NEXT MORNING, LOCALIZED AREA SWOLLEN AND SLIGHTLY RED. ON DAY 3, AREA WAS HOT TO THE TOUCH. WENT TO URGENT CARE CLINIC FOR TREATMENT. GIVEN ROCEPHIN 1GM IM, AND PRESCRIBED SEPTRA DS 1 TAB PO BID X10 DAYS AND DOXYCYCLINE 100MG BID X10 DAYS.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Rash papular
Clinical narrative: Fever and erythematous papular rash on torso. Fever resolved with acetaminophen in the ER, rash improved with diphenhydramine but was still present the next day.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Paraesthesia
Clinical narrative: Soreness onset shortly after vaccination.  Felt tingling during administration.  Soreness worsened over next 2 days and is helped by NSAID.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Fatigue, Hypersomnia, Irritability, Personality change
Clinical narrative: Extreme fatigue, absolutely no energy, taking extended naps and change in personality with increased irritability.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac enzymes normal, Chest X-ray normal, Electrocardiogram normal, Pain in jaw, Stress echocardiogram normal
Clinical narrative: Quote from patient email:  "At ~ 0845, began to experience tightness-type sensation in my throat, difficult to accurately describe but it was associated with a left jaw pain, somewhat of a dull ache. Because of the aching radiating to my jaw, I felt it was in my best interest to go to the ED for evaluation. While walking to the ED, the sensation in the throat, and the aching in left jaw subsided, but then recurred shortly afterwards. I subsequently had EKG's, labs, and stress echo, all of which were normal. I mentioned to the ED physicians throughout my thoughts that this was a reaction to the vaccine, and still believe this to be the case."
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Quote from patient email:  "At ~ 0845, began to experience tightness-type sensation in my throat, difficult to accurately describe but it was associated with a left jaw pain, somewhat of a dull ache. Because of the aching radiating to my jaw, I felt it was in my best interest to go to the ED for evaluation. While walking to the ED, the sensation in the throat, and the aching in left jaw subsided, but then recurred shortly afterwards. I subsequently had EKG's, labs, and stress echo, all of which were normal. I mentioned to the ED physicians throughout my thoughts that this was a reaction to the vaccine, and still believe this to be the case."
Age: 67.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Chest discomfort, Cough, Diarrhoea, Discomfort, Dizziness
Clinical narrative: Throat tightened and was sore, sinus' clogged and draining, tight band around chest - short of breath, cough, light headed, hot and cold, body pain, nausea, vomiting and diarrhea.  Pulse was 100 for 18 hours.  I was unable to move and it was difficult to speak.  My symptoms dimished slightly at 10 p.m. and I slept 20-40 min. at a time all night long with extreme discomfort. I had friends checking on me because I didn't want to go to the hospital
Age: 67.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Dyspnoea, Feeling of body temperature change, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Throat tightened and was sore, sinus' clogged and draining, tight band around chest - short of breath, cough, light headed, hot and cold, body pain, nausea, vomiting and diarrhea.  Pulse was 100 for 18 hours.  I was unable to move and it was difficult to speak.  My symptoms dimished slightly at 10 p.m. and I slept 20-40 min. at a time all night long with extreme discomfort. I had friends checking on me because I didn't want to go to the hospital
Age: 67.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Sinus congestion, Sinus disorder, Sleep disorder, Throat tightness, Vomiting
Clinical narrative: Throat tightened and was sore, sinus' clogged and draining, tight band around chest - short of breath, cough, light headed, hot and cold, body pain, nausea, vomiting and diarrhea.  Pulse was 100 for 18 hours.  I was unable to move and it was difficult to speak.  My symptoms dimished slightly at 10 p.m. and I slept 20-40 min. at a time all night long with extreme discomfort. I had friends checking on me because I didn't want to go to the hospital
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Arthralgia, Asthenia, Back pain, Condition aggravated, Confusional state
Clinical narrative: Mom states that received shots (Tdap/Menacta) on Tuesday, 9/7 @ facility, was noted to have diarrhea, fever, confusion, disorientation that afternoon. Mom states wasn't better on Wednesday, 9/8 - states he had fever, & severe weakness. on Thursday, 9/9 brought him in to facility to see MD b/c had fever, achiness. Was given a steroid to "boost immunity". Monday, 9/13 went to school; upon getting home told mom was having bad body aches and was very pale. Tuesday, 9/14 called from school b/c was nasueated and vomiting. Today not at all better: still w/ weakness, diarrhea, and fever never more than 100. 11 year 8 month old male presents with c/o Fatigue on and off- was better with the steroids. c/o Arthralgias Reported having body aches- leg pains/ sometimes his foot hurts, and sometimes his back hurts. c/o Headache for 2-3 days frontal, intermittent, mild. c/o Nasal congestion for 2 weeks stuffy in am and at night, moderate- last 6 days with thick yellow nasal discharge present. c/o Fever 101 - axillary at 100 - added a degree- on and off since immunizations last week. c/o Feeding difficulty drinking OK but not eating solids well. Denies : Cough.  Ear pain.  Sore throat.  Sick contacts.  Chest pain.  Shortness of breath.  Chest congestion.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Diarrhoea, Disorientation, Fatigue, Feeding disorder, Full blood count
Clinical narrative: Mom states that received shots (Tdap/Menacta) on Tuesday, 9/7 @ facility, was noted to have diarrhea, fever, confusion, disorientation that afternoon. Mom states wasn't better on Wednesday, 9/8 - states he had fever, & severe weakness. on Thursday, 9/9 brought him in to facility to see MD b/c had fever, achiness. Was given a steroid to "boost immunity". Monday, 9/13 went to school; upon getting home told mom was having bad body aches and was very pale. Tuesday, 9/14 called from school b/c was nasueated and vomiting. Today not at all better: still w/ weakness, diarrhea, and fever never more than 100. 11 year 8 month old male presents with c/o Fatigue on and off- was better with the steroids. c/o Arthralgias Reported having body aches- leg pains/ sometimes his foot hurts, and sometimes his back hurts. c/o Headache for 2-3 days frontal, intermittent, mild. c/o Nasal congestion for 2 weeks stuffy in am and at night, moderate- last 6 days with thick yellow nasal discharge present. c/o Fever 101 - axillary at 100 - added a degree- on and off since immunizations last week. c/o Feeding difficulty drinking OK but not eating solids well. Denies : Cough.  Ear pain.  Sore throat.  Sick contacts.  Chest pain.  Shortness of breath.  Chest congestion.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Headache, Influenza virus test, Metabolic function test, Nasal congestion, Nausea
Clinical narrative: Mom states that received shots (Tdap/Menacta) on Tuesday, 9/7 @ facility, was noted to have diarrhea, fever, confusion, disorientation that afternoon. Mom states wasn't better on Wednesday, 9/8 - states he had fever, & severe weakness. on Thursday, 9/9 brought him in to facility to see MD b/c had fever, achiness. Was given a steroid to "boost immunity". Monday, 9/13 went to school; upon getting home told mom was having bad body aches and was very pale. Tuesday, 9/14 called from school b/c was nasueated and vomiting. Today not at all better: still w/ weakness, diarrhea, and fever never more than 100. 11 year 8 month old male presents with c/o Fatigue on and off- was better with the steroids. c/o Arthralgias Reported having body aches- leg pains/ sometimes his foot hurts, and sometimes his back hurts. c/o Headache for 2-3 days frontal, intermittent, mild. c/o Nasal congestion for 2 weeks stuffy in am and at night, moderate- last 6 days with thick yellow nasal discharge present. c/o Fever 101 - axillary at 100 - added a degree- on and off since immunizations last week. c/o Feeding difficulty drinking OK but not eating solids well. Denies : Cough.  Ear pain.  Sore throat.  Sick contacts.  Chest pain.  Shortness of breath.  Chest congestion.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Pain, Pain in extremity, Pallor, Pyrexia, Rhinorrhoea
Clinical narrative: Mom states that received shots (Tdap/Menacta) on Tuesday, 9/7 @ facility, was noted to have diarrhea, fever, confusion, disorientation that afternoon. Mom states wasn't better on Wednesday, 9/8 - states he had fever, & severe weakness. on Thursday, 9/9 brought him in to facility to see MD b/c had fever, achiness. Was given a steroid to "boost immunity". Monday, 9/13 went to school; upon getting home told mom was having bad body aches and was very pale. Tuesday, 9/14 called from school b/c was nasueated and vomiting. Today not at all better: still w/ weakness, diarrhea, and fever never more than 100. 11 year 8 month old male presents with c/o Fatigue on and off- was better with the steroids. c/o Arthralgias Reported having body aches- leg pains/ sometimes his foot hurts, and sometimes his back hurts. c/o Headache for 2-3 days frontal, intermittent, mild. c/o Nasal congestion for 2 weeks stuffy in am and at night, moderate- last 6 days with thick yellow nasal discharge present. c/o Fever 101 - axillary at 100 - added a degree- on and off since immunizations last week. c/o Feeding difficulty drinking OK but not eating solids well. Denies : Cough.  Ear pain.  Sore throat.  Sick contacts.  Chest pain.  Shortness of breath.  Chest congestion.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Streptococcus test, Vomiting
Clinical narrative: Mom states that received shots (Tdap/Menacta) on Tuesday, 9/7 @ facility, was noted to have diarrhea, fever, confusion, disorientation that afternoon. Mom states wasn't better on Wednesday, 9/8 - states he had fever, & severe weakness. on Thursday, 9/9 brought him in to facility to see MD b/c had fever, achiness. Was given a steroid to "boost immunity". Monday, 9/13 went to school; upon getting home told mom was having bad body aches and was very pale. Tuesday, 9/14 called from school b/c was nasueated and vomiting. Today not at all better: still w/ weakness, diarrhea, and fever never more than 100. 11 year 8 month old male presents with c/o Fatigue on and off- was better with the steroids. c/o Arthralgias Reported having body aches- leg pains/ sometimes his foot hurts, and sometimes his back hurts. c/o Headache for 2-3 days frontal, intermittent, mild. c/o Nasal congestion for 2 weeks stuffy in am and at night, moderate- last 6 days with thick yellow nasal discharge present. c/o Fever 101 - axillary at 100 - added a degree- on and off since immunizations last week. c/o Feeding difficulty drinking OK but not eating solids well. Denies : Cough.  Ear pain.  Sore throat.  Sick contacts.  Chest pain.  Shortness of breath.  Chest congestion.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Abdominal pain, Blister, Blood blister, Ecchymosis, Epistaxis
Clinical narrative: Developed subsequent fever to 103.1, myalgias, headache and abdominal pain which resolved.  On 09/10/2010, she noted blood blister on buccal mucosa, bleeding sub-buccal bullae, large ecchymosis on arms.  On 09/12 she experienced epistaxis, vaginal bleeding and rectal bleeding.  Was admitted to hospital.  Diagnosis: ITP
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Haemorrhage, Headache, Idiopathic thrombocytopenic purpura, Immunoglobulins increased, Myalgia
Clinical narrative: Developed subsequent fever to 103.1, myalgias, headache and abdominal pain which resolved.  On 09/10/2010, she noted blood blister on buccal mucosa, bleeding sub-buccal bullae, large ecchymosis on arms.  On 09/12 she experienced epistaxis, vaginal bleeding and rectal bleeding.  Was admitted to hospital.  Diagnosis: ITP
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Platelet count decreased, Pyrexia, Rectal haemorrhage, Vaginal haemorrhage
Clinical narrative: Developed subsequent fever to 103.1, myalgias, headache and abdominal pain which resolved.  On 09/10/2010, she noted blood blister on buccal mucosa, bleeding sub-buccal bullae, large ecchymosis on arms.  On 09/12 she experienced epistaxis, vaginal bleeding and rectal bleeding.  Was admitted to hospital.  Diagnosis: ITP
Age: 60.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Erythema, Fatigue, Pruritus
Clinical narrative: Exhaustion and weakness.  On Wednesday, 9/15/2010, I began to get red and itchy dots on body. Have applied antihistamine to dots.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin discolouration, Skin tightness, Skin warm, Swelling
Clinical narrative: Pt has a red discoloration over her right bicep.  Area was swollen, warm to the touch, and the skin felt slightly tighter than non-affected areas, which pt said developed around 10pm on 9/15/10.  Recommended taking Ibuprofen on a regular basis (pt had an Rx for 800mg, recommended using this), and to seek medical help if unresolved after 3-5 days or if area or symptoms worsen.
Age: 1.52
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Erythema surrounding injection site approx. size of softball. Was febrile 9/15 to 101.7. Went to ED 9/15. No exudate from site, pain with ambulation - favoring leg.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Dyspnoea, Pruritus, Urticaria
Clinical narrative: Shortly after receiving vaccine, became SOB, with chest tightness; & hives covering body; transferred by ambulance to ER; Txed with BENADRYL & SOLU-MEDROL; has recovered with minimal itching.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Powder component admin. with sterile water instead of with liquid component which is supplied with vaccine. (MENVEO).
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Erythema, Insomnia
Clinical narrative: Had chills, sleeplessness night after shot. Slight sick to stomach. Was starting to feel better after sleep. Loose BM x 2, advised to contact MD if ill feeling continued.
Age: 44.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Malaise, Musculoskeletal stiffness, Pain
Clinical narrative: General body aches, fever, neck stiffness malaise - 10cmx15cm of redness swelling of LD site vaccine given.
Age: 44.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: General body aches, fever, neck stiffness malaise - 10cmx15cm of redness swelling of LD site vaccine given.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Patient developed urticaria (hives) on body 24 hours after getting vaccines PENTACEL; ROTATEQ, Hep B and PREVNAR 13.
Sex: U
Vaccine: DTAPIPV, MMR
Symptoms: Urticaria, Wheezing
Clinical narrative: Child received vaccines & fluoride dental varnish. Left clinic & returned with facial urticaria & wheezing.
Age: 4.0
Sex: M
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Fatigue, Headache, Pyrexia, Somnolence
Clinical narrative: Pt had a headache & was sleepy. Pt had a T 103 later in the evening - MOTRIN brought it down - pt. had a fever today plus headache & fatigue T101-102 today MOTRIN gave relief.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13
Symptoms: Crying, Erythema, Eye pruritus, Ocular hyperaemia, Rash
Clinical narrative: Received vaccines around 12:10pm, cried a lot therefore eyes and ears red when leaving. In car while driving home itchy eyes and saw rash on arm. When returned to our office approx 12:55 pm (+) pinkish macular rash on chest, (L) volar surface of lower arm, ears red and splotchy. Children's Benadryl Ttsp PO taken without difficulty with cup of H20. Playful and rash decreased after 25 minutes.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13
Symptoms: Rash macular
Clinical narrative: Received vaccines around 12:10pm, cried a lot therefore eyes and ears red when leaving. In car while driving home itchy eyes and saw rash on arm. When returned to our office approx 12:55 pm (+) pinkish macular rash on chest, (L) volar surface of lower arm, ears red and splotchy. Children's Benadryl Ttsp PO taken without difficulty with cup of H20. Playful and rash decreased after 25 minutes.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Rash
Clinical narrative: Pt reported next morning after shot, she developed extensive swelling on her left arm. It extended to her underarm and rash across chest. Reaction went away after 2 days.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Influenza like illness, Pyrexia
Clinical narrative: Patient came to pharmacy and said that he had a reaction to the FLUZONE HD when he had a temperature spike of 103 degrees F. He said that he had flu-like symptoms, a fever & shivering.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 2 days ago patient received Hep B #3 and Pneumo #3 in right thigh; Mom noticed redness site of injection after 7 hours; today notices also swelling and mild increasing redness; patient playful, active; no fever.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Pain
Clinical narrative: Body aches, set SOB, chest tightness approx 4 hrs after vaccine better in am - residual achiness.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Large local reaction w/erythema, induration at site of immun. 11 x 13 cm.
Age: 43.0
Sex: M
Vaccine: HEP, HEPA, PPV
Symptoms: Activities of daily living impaired, Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: Spiked fever evening of injections, was in bed the next day with fever & Lt arm pain. Two days later Lt arm swollen, redness of upper arm.
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Incorrect drug dosage form administered
Clinical narrative: Powder component admin. with sterile water instead of with liquid component which is supplied with vaccine. (MENVEO).
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Pt. had a 3cm x 3cm soft tissue swelling of left upper arm area felt warm to the touch, no fever noted by patient some pain & discomfort noted in (L) arm pt advised on therapeutic modalities for symptom relief.
Age: 23.0
Sex: F
Vaccine: SMALL, YF
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase normal, Blood human chorionic gonadotropin negative, Cardiac enzymes normal, Chest pain
Clinical narrative: Immunization Clinic calls at 3PM re 23 y/o Airman with onset of chest pain today around 1:30 PM s/p receipt of primary SPV with YF (live virus vaccines) yesterday morning (approx. 30 hours post-immunization). NP returns call to Airman and advises her to go to ED immediately for work-up and evaluation of new onset chest pain. She denies any prior personal cardiac history or any history of cardiac events in her immediate family at < 50 years of age. She is not a smoker. Her height is 72" and her weight is 200 lb.
Age: 23.0
Sex: F
Vaccine: SMALL, YF
Symptoms: Dyspepsia, Dyspnoea, Electrocardiogram normal, Respiration abnormal, Ultrasound scan normal
Clinical narrative: Immunization Clinic calls at 3PM re 23 y/o Airman with onset of chest pain today around 1:30 PM s/p receipt of primary SPV with YF (live virus vaccines) yesterday morning (approx. 30 hours post-immunization). NP returns call to Airman and advises her to go to ED immediately for work-up and evaluation of new onset chest pain. She denies any prior personal cardiac history or any history of cardiac events in her immediate family at < 50 years of age. She is not a smoker. Her height is 72" and her weight is 200 lb.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Blood pressure increased, Hemiparesis, Hypertension, Hypoaesthesia, Induration
Clinical narrative: 6/9/10 PA note: Veteran presents with chief complaint of L arm numbness/tingling. He was given a PNEUMOVAX 23 in L arm earlier this morning by nurse and thinks he may be having reaction. Hypertension, uncontrolled. Muscle weakness left side, rule out TIA or embolic event. From nursing note: Veteran ambulatory to clinic with complaint of pain and discomfort in Rt deltoid. PNEUMOVAX 23 was given to him this AM in that arm. No redness noticed, but movement was difficult and painful. From urgent care note: This 57 y/o male presents with: to uc per w/c sent for eval of increased BP. Reported from nurse that pt presented to clinic c/o left arm weakness, states he received a PNEUMOVAX 23 vaccine in that arm this am. Upon eval found to have BP of 201/125 rechecked in 5 min 158/108. On admit to UC pt is a/o, calm and cooperative. Denies any chest pains, dizziness, or headache. Speech is clear. States left arm is weak and feels like he cannot move it, pt was able to lift it and exercise it upon request. BP 203/129 p 100 on admit. BP recheck in 2 minutes 189/93 p 99. From June 10 PA note: Left upper arm hot, red and swollen in the area of the injection site. Elevated tempskin mildly indurated and tender to touch. Cellulitis. KEFLEX 500mg po BID x 14 days Prednisone 10mg po q day x 2. Ice pak x 20min. QID PRN pain. From June 11 PA note: Pt is here with chief complaint of chronic pain issues, reports the cellulitis is much improved. Symptoms: numbness tingling, hot skin, cellulitis at site.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site cellulitis, Injection site discomfort, Injection site erythema, Injection site pain
Clinical narrative: 6/9/10 PA note: Veteran presents with chief complaint of L arm numbness/tingling. He was given a PNEUMOVAX 23 in L arm earlier this morning by nurse and thinks he may be having reaction. Hypertension, uncontrolled. Muscle weakness left side, rule out TIA or embolic event. From nursing note: Veteran ambulatory to clinic with complaint of pain and discomfort in Rt deltoid. PNEUMOVAX 23 was given to him this AM in that arm. No redness noticed, but movement was difficult and painful. From urgent care note: This 57 y/o male presents with: to uc per w/c sent for eval of increased BP. Reported from nurse that pt presented to clinic c/o left arm weakness, states he received a PNEUMOVAX 23 vaccine in that arm this am. Upon eval found to have BP of 201/125 rechecked in 5 min 158/108. On admit to UC pt is a/o, calm and cooperative. Denies any chest pains, dizziness, or headache. Speech is clear. States left arm is weak and feels like he cannot move it, pt was able to lift it and exercise it upon request. BP 203/129 p 100 on admit. BP recheck in 2 minutes 189/93 p 99. From June 10 PA note: Left upper arm hot, red and swollen in the area of the injection site. Elevated tempskin mildly indurated and tender to touch. Cellulitis. KEFLEX 500mg po BID x 14 days Prednisone 10mg po q day x 2. Ice pak x 20min. QID PRN pain. From June 11 PA note: Pt is here with chief complaint of chronic pain issues, reports the cellulitis is much improved. Symptoms: numbness tingling, hot skin, cellulitis at site.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Muscular weakness, Pain, Paraesthesia
Clinical narrative: 6/9/10 PA note: Veteran presents with chief complaint of L arm numbness/tingling. He was given a PNEUMOVAX 23 in L arm earlier this morning by nurse and thinks he may be having reaction. Hypertension, uncontrolled. Muscle weakness left side, rule out TIA or embolic event. From nursing note: Veteran ambulatory to clinic with complaint of pain and discomfort in Rt deltoid. PNEUMOVAX 23 was given to him this AM in that arm. No redness noticed, but movement was difficult and painful. From urgent care note: This 57 y/o male presents with: to uc per w/c sent for eval of increased BP. Reported from nurse that pt presented to clinic c/o left arm weakness, states he received a PNEUMOVAX 23 vaccine in that arm this am. Upon eval found to have BP of 201/125 rechecked in 5 min 158/108. On admit to UC pt is a/o, calm and cooperative. Denies any chest pains, dizziness, or headache. Speech is clear. States left arm is weak and feels like he cannot move it, pt was able to lift it and exercise it upon request. BP 203/129 p 100 on admit. BP recheck in 2 minutes 189/93 p 99. From June 10 PA note: Left upper arm hot, red and swollen in the area of the injection site. Elevated tempskin mildly indurated and tender to touch. Cellulitis. KEFLEX 500mg po BID x 14 days Prednisone 10mg po q day x 2. Ice pak x 20min. QID PRN pain. From June 11 PA note: Pt is here with chief complaint of chronic pain issues, reports the cellulitis is much improved. Symptoms: numbness tingling, hot skin, cellulitis at site.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm, Tenderness
Clinical narrative: 6/9/10 PA note: Veteran presents with chief complaint of L arm numbness/tingling. He was given a PNEUMOVAX 23 in L arm earlier this morning by nurse and thinks he may be having reaction. Hypertension, uncontrolled. Muscle weakness left side, rule out TIA or embolic event. From nursing note: Veteran ambulatory to clinic with complaint of pain and discomfort in Rt deltoid. PNEUMOVAX 23 was given to him this AM in that arm. No redness noticed, but movement was difficult and painful. From urgent care note: This 57 y/o male presents with: to uc per w/c sent for eval of increased BP. Reported from nurse that pt presented to clinic c/o left arm weakness, states he received a PNEUMOVAX 23 vaccine in that arm this am. Upon eval found to have BP of 201/125 rechecked in 5 min 158/108. On admit to UC pt is a/o, calm and cooperative. Denies any chest pains, dizziness, or headache. Speech is clear. States left arm is weak and feels like he cannot move it, pt was able to lift it and exercise it upon request. BP 203/129 p 100 on admit. BP recheck in 2 minutes 189/93 p 99. From June 10 PA note: Left upper arm hot, red and swollen in the area of the injection site. Elevated tempskin mildly indurated and tender to touch. Cellulitis. KEFLEX 500mg po BID x 14 days Prednisone 10mg po q day x 2. Ice pak x 20min. QID PRN pain. From June 11 PA note: Pt is here with chief complaint of chronic pain issues, reports the cellulitis is much improved. Symptoms: numbness tingling, hot skin, cellulitis at site.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Bronchitis, Defaecation urgency, Diarrhoea, Dyspepsia
Clinical narrative: 39 year-old (current age) ARNG WM who was in his usual state of good health prior to deployment to foreign country in 2004. Based on patient recall, he received 9 anthrax vaccines over a 28-month period due to lack of documentation of immunizations in medical records. He reports receipt of doses 1-3 over a 3-month period in early 2002; receipt of doses 4-6 over a 3-month period around March 2003, and receipt of his last 3 doses (doses 7-9) over a 3-month period between June and August 2004 (documented), within 3 months of deployment to foreign country. Starting the day of his "second doses" (#2, 5 and 8), he noted headaches, joint aches, fatigue and urgency to have bowel movement following meals. He denies worsening of these symptoms with subsequent doses and denies occurrence of these symptoms following doses #3, 6 and 9. These symptoms resolved after 3 days. He denies any unusual local reactions at anthrax vaccination sites until his last dose (#9) of anthrax vaccine in Aug 2004; he noted an area of about 2-3' of redness, swelling and tenderness, which lasted < 1 week. SM reports that he was told after receipt of his smallpox vaccine in July 2004, he did not have "a good reaction", so he was given a 2nd dose. SM reports he had a robust response to the second dose with normal site progression and no prolonged systemic or local symptoms. He denies rashes or other systemic symptoms (other than those symptoms listed above) within 30 days of anthrax and smallpox vaccine receipt. He denies prior history of, or subsequent history of vaccine reactions. He was well on the days of vaccine receipt, without recent antecedent illnesses. He denies antecedent travel, animal or tick exposure, food, insect or latex allergies. At that time, his past medical history was negative and he was not taking any prescription or OTC medications on a routine basis. He was smoking a cigar or pipe about once per week and drank about 2 drinks daily. Family history is significant for diabetes, sarcoidosis, and hyperlipidemia. At that time, his exposure history included working at 9/11 site x 3 week activation. During his deployment to foreign country between Nov 2004 and Nov 2005, SM reports the onset of a number of symptoms, but due to mission priority, he did not seek evaluation, or if he was evaluated and treated, there are no records accessible. He is unable to recall the exact timeline or details of symptom onset. The following symptoms occurred during SM's deployment to foreign country: 1) Joint pain and generalized muscle aches 2) Swelling of extremities 3) Fatigue 4) Diarrhea, dyspepsia 5) Bronchitis, episode of pneumonia 6) Sinus infections, with associated headaches 7) Nosebleeds 8) Rashes, skin peeling
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Epistaxis, Erythema, Fatigue, Foreign travel, Headache
Clinical narrative: 39 year-old (current age) ARNG WM who was in his usual state of good health prior to deployment to foreign country in 2004. Based on patient recall, he received 9 anthrax vaccines over a 28-month period due to lack of documentation of immunizations in medical records. He reports receipt of doses 1-3 over a 3-month period in early 2002; receipt of doses 4-6 over a 3-month period around March 2003, and receipt of his last 3 doses (doses 7-9) over a 3-month period between June and August 2004 (documented), within 3 months of deployment to foreign country. Starting the day of his "second doses" (#2, 5 and 8), he noted headaches, joint aches, fatigue and urgency to have bowel movement following meals. He denies worsening of these symptoms with subsequent doses and denies occurrence of these symptoms following doses #3, 6 and 9. These symptoms resolved after 3 days. He denies any unusual local reactions at anthrax vaccination sites until his last dose (#9) of anthrax vaccine in Aug 2004; he noted an area of about 2-3' of redness, swelling and tenderness, which lasted < 1 week. SM reports that he was told after receipt of his smallpox vaccine in July 2004, he did not have "a good reaction", so he was given a 2nd dose. SM reports he had a robust response to the second dose with normal site progression and no prolonged systemic or local symptoms. He denies rashes or other systemic symptoms (other than those symptoms listed above) within 30 days of anthrax and smallpox vaccine receipt. He denies prior history of, or subsequent history of vaccine reactions. He was well on the days of vaccine receipt, without recent antecedent illnesses. He denies antecedent travel, animal or tick exposure, food, insect or latex allergies. At that time, his past medical history was negative and he was not taking any prescription or OTC medications on a routine basis. He was smoking a cigar or pipe about once per week and drank about 2 drinks daily. Family history is significant for diabetes, sarcoidosis, and hyperlipidemia. At that time, his exposure history included working at 9/11 site x 3 week activation. During his deployment to foreign country between Nov 2004 and Nov 2005, SM reports the onset of a number of symptoms, but due to mission priority, he did not seek evaluation, or if he was evaluated and treated, there are no records accessible. He is unable to recall the exact timeline or details of symptom onset. The following symptoms occurred during SM's deployment to foreign country: 1) Joint pain and generalized muscle aches 2) Swelling of extremities 3) Fatigue 4) Diarrhea, dyspepsia 5) Bronchitis, episode of pneumonia 6) Sinus infections, with associated headaches 7) Nosebleeds 8) Rashes, skin peeling
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Myalgia, Nonspecific reaction, Oedema peripheral, Pneumonia, Rash
Clinical narrative: 39 year-old (current age) ARNG WM who was in his usual state of good health prior to deployment to foreign country in 2004. Based on patient recall, he received 9 anthrax vaccines over a 28-month period due to lack of documentation of immunizations in medical records. He reports receipt of doses 1-3 over a 3-month period in early 2002; receipt of doses 4-6 over a 3-month period around March 2003, and receipt of his last 3 doses (doses 7-9) over a 3-month period between June and August 2004 (documented), within 3 months of deployment to foreign country. Starting the day of his "second doses" (#2, 5 and 8), he noted headaches, joint aches, fatigue and urgency to have bowel movement following meals. He denies worsening of these symptoms with subsequent doses and denies occurrence of these symptoms following doses #3, 6 and 9. These symptoms resolved after 3 days. He denies any unusual local reactions at anthrax vaccination sites until his last dose (#9) of anthrax vaccine in Aug 2004; he noted an area of about 2-3' of redness, swelling and tenderness, which lasted < 1 week. SM reports that he was told after receipt of his smallpox vaccine in July 2004, he did not have "a good reaction", so he was given a 2nd dose. SM reports he had a robust response to the second dose with normal site progression and no prolonged systemic or local symptoms. He denies rashes or other systemic symptoms (other than those symptoms listed above) within 30 days of anthrax and smallpox vaccine receipt. He denies prior history of, or subsequent history of vaccine reactions. He was well on the days of vaccine receipt, without recent antecedent illnesses. He denies antecedent travel, animal or tick exposure, food, insect or latex allergies. At that time, his past medical history was negative and he was not taking any prescription or OTC medications on a routine basis. He was smoking a cigar or pipe about once per week and drank about 2 drinks daily. Family history is significant for diabetes, sarcoidosis, and hyperlipidemia. At that time, his exposure history included working at 9/11 site x 3 week activation. During his deployment to foreign country between Nov 2004 and Nov 2005, SM reports the onset of a number of symptoms, but due to mission priority, he did not seek evaluation, or if he was evaluated and treated, there are no records accessible. He is unable to recall the exact timeline or details of symptom onset. The following symptoms occurred during SM's deployment to foreign country: 1) Joint pain and generalized muscle aches 2) Swelling of extremities 3) Fatigue 4) Diarrhea, dyspepsia 5) Bronchitis, episode of pneumonia 6) Sinus infections, with associated headaches 7) Nosebleeds 8) Rashes, skin peeling
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Sinus headache, Sinusitis, Skin exfoliation, Swelling, Tenderness
Clinical narrative: 39 year-old (current age) ARNG WM who was in his usual state of good health prior to deployment to foreign country in 2004. Based on patient recall, he received 9 anthrax vaccines over a 28-month period due to lack of documentation of immunizations in medical records. He reports receipt of doses 1-3 over a 3-month period in early 2002; receipt of doses 4-6 over a 3-month period around March 2003, and receipt of his last 3 doses (doses 7-9) over a 3-month period between June and August 2004 (documented), within 3 months of deployment to foreign country. Starting the day of his "second doses" (#2, 5 and 8), he noted headaches, joint aches, fatigue and urgency to have bowel movement following meals. He denies worsening of these symptoms with subsequent doses and denies occurrence of these symptoms following doses #3, 6 and 9. These symptoms resolved after 3 days. He denies any unusual local reactions at anthrax vaccination sites until his last dose (#9) of anthrax vaccine in Aug 2004; he noted an area of about 2-3' of redness, swelling and tenderness, which lasted < 1 week. SM reports that he was told after receipt of his smallpox vaccine in July 2004, he did not have "a good reaction", so he was given a 2nd dose. SM reports he had a robust response to the second dose with normal site progression and no prolonged systemic or local symptoms. He denies rashes or other systemic symptoms (other than those symptoms listed above) within 30 days of anthrax and smallpox vaccine receipt. He denies prior history of, or subsequent history of vaccine reactions. He was well on the days of vaccine receipt, without recent antecedent illnesses. He denies antecedent travel, animal or tick exposure, food, insect or latex allergies. At that time, his past medical history was negative and he was not taking any prescription or OTC medications on a routine basis. He was smoking a cigar or pipe about once per week and drank about 2 drinks daily. Family history is significant for diabetes, sarcoidosis, and hyperlipidemia. At that time, his exposure history included working at 9/11 site x 3 week activation. During his deployment to foreign country between Nov 2004 and Nov 2005, SM reports the onset of a number of symptoms, but due to mission priority, he did not seek evaluation, or if he was evaluated and treated, there are no records accessible. He is unable to recall the exact timeline or details of symptom onset. The following symptoms occurred during SM's deployment to foreign country: 1) Joint pain and generalized muscle aches 2) Swelling of extremities 3) Fatigue 4) Diarrhea, dyspepsia 5) Bronchitis, episode of pneumonia 6) Sinus infections, with associated headaches 7) Nosebleeds 8) Rashes, skin peeling
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Chills, Erythema, Oedema peripheral, Pyrexia
Clinical narrative: 62 yof was admitted with left upper arm erythema and swelling. She received pneumonia vaccine and same evening developed fever, chills and blistering rash. She was started on IV Vancomycin and Cefepime. Patient was advised not to receive PNEUMOVAX vaccine in the future.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: 62 yof was admitted with left upper arm erythema and swelling. She received pneumonia vaccine and same evening developed fever, chills and blistering rash. She was started on IV Vancomycin and Cefepime. Patient was advised not to receive PNEUMOVAX vaccine in the future.
Age: 2.0
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Pyrexia
Clinical narrative: Fever to 103 for 2 days. Treated with acetaminophen, ibuprofen.
Age: 45.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: CSF protein increased, CSF test, CSF white blood cell count negative, Guillain-Barre syndrome
Clinical narrative: C/O lower extremity weakness, onset after vaccination of H1N1 then suddenly worsened over 4 day prior to hospitalization on 12/21/09. Losing ability to walk and stand with frequent falls. Lumbar puncture and neurology consult determined patient had GUILLAIN BARRE SYNDROME.
Age: 45.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Dysstasia, Fall, Gait disturbance, Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: C/O lower extremity weakness, onset after vaccination of H1N1 then suddenly worsened over 4 day prior to hospitalization on 12/21/09. Losing ability to walk and stand with frequent falls. Lumbar puncture and neurology consult determined patient had GUILLAIN BARRE SYNDROME.
Age: 45.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Muscular weakness, Neurological examination abnormal
Clinical narrative: C/O lower extremity weakness, onset after vaccination of H1N1 then suddenly worsened over 4 day prior to hospitalization on 12/21/09. Losing ability to walk and stand with frequent falls. Lumbar puncture and neurology consult determined patient had GUILLAIN BARRE SYNDROME.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician and an office manager concerning a 22 weeks male patient who on 30-APR-2010 was vaccinated with the first dose of ROTATEQ (lot # 664881/1521Y). On 15-JUL-2010, the patient received his second dose per oral of the vaccine (lot # 663908/0176Y). Concomitant therapy included PENTACEL (lot # C3622A) and PREVNAR 13 (lot # E49136). On 01-AUG-2010, the patient's mother reported that the patient had poor intake and had vomiting. On 02-AUG-2010, the patient was seen by the physician. The patient had bloody stool and was cranky. He was taken to the hospital and was admitted for intussusception. The patient was treated with barium/air contrast enema and an abdominal x-ray was performed with no results provided. Therapy with ROTATEQ was discontinued. The office manager did not have the patient's discharge summary and did not know when the patient was discharged from the hospital. On 10-AUG-2010 the patient had a follow-up visit and he had recovered. On 27-AUG-2010, the patient recovered from intussusception. On 30-AUG2010 the patient was seen for his 76 month well visit and at that time, ROTATEQ was not given to the patient. Additional information has been requested.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal X-ray, Barium double contrast, Haematochezia, Hypophagia, Intussusception
Clinical narrative: Information has been received from a physician and an office manager concerning a 22 weeks male patient who on 30-APR-2010 was vaccinated with the first dose of ROTATEQ (lot # 664881/1521Y). On 15-JUL-2010, the patient received his second dose per oral of the vaccine (lot # 663908/0176Y). Concomitant therapy included PENTACEL (lot # C3622A) and PREVNAR 13 (lot # E49136). On 01-AUG-2010, the patient's mother reported that the patient had poor intake and had vomiting. On 02-AUG-2010, the patient was seen by the physician. The patient had bloody stool and was cranky. He was taken to the hospital and was admitted for intussusception. The patient was treated with barium/air contrast enema and an abdominal x-ray was performed with no results provided. Therapy with ROTATEQ was discontinued. The office manager did not have the patient's discharge summary and did not know when the patient was discharged from the hospital. On 10-AUG-2010 the patient had a follow-up visit and he had recovered. On 27-AUG-2010, the patient recovered from intussusception. On 30-AUG2010 the patient was seen for his 76 month well visit and at that time, ROTATEQ was not given to the patient. Additional information has been requested.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Vomiting
Clinical narrative: Information has been received from a physician and an office manager concerning a 22 weeks male patient who on 30-APR-2010 was vaccinated with the first dose of ROTATEQ (lot # 664881/1521Y). On 15-JUL-2010, the patient received his second dose per oral of the vaccine (lot # 663908/0176Y). Concomitant therapy included PENTACEL (lot # C3622A) and PREVNAR 13 (lot # E49136). On 01-AUG-2010, the patient's mother reported that the patient had poor intake and had vomiting. On 02-AUG-2010, the patient was seen by the physician. The patient had bloody stool and was cranky. He was taken to the hospital and was admitted for intussusception. The patient was treated with barium/air contrast enema and an abdominal x-ray was performed with no results provided. Therapy with ROTATEQ was discontinued. The office manager did not have the patient's discharge summary and did not know when the patient was discharged from the hospital. On 10-AUG-2010 the patient had a follow-up visit and he had recovered. On 27-AUG-2010, the patient recovered from intussusception. On 30-AUG2010 the patient was seen for his 76 month well visit and at that time, ROTATEQ was not given to the patient. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Anaphylactic reaction, Oropharyngeal pain, Throat tightness
Clinical narrative: Initial report and a copy of the patient's vaccination consent release form were received on 13 September 2010 from a health care professional. A 68-year-old female patient had received a first dose intramuscular deltoid injection of FLUZONE High-Dose, lot number U3600AA on 02 September 2010 at 10:00 AM and progressively over the next few hours (not immediately), she developed a very sore throat. She presented to the emergency room and was found to have throat constriction thought to be from an anaphylactic reaction. According to the vaccination consent release form, the patient had no concurrent illness and she had not experienced any adverse reactions following prior vaccinations. The patient's medical history was negative for latex sensitivity and serious allergies to medications and food. The patient had not received any vaccines within four weeks of FLUZONE High-Dose. The reporter considered the seriousness criteria for this event to be life-threatening. Outcome was recovered (date not reported). The reporter for this case is the same as for case number 2010-04971, -04973, -04974, -04975, -04976, -04977, -04978, -04979, -04980, -04981 and -04982. Documents held by sender: Immunization consent form.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Anaphylactic reaction, No reaction on previous exposure to drug, Oropharyngeal pain, Throat tightness
Clinical narrative: Initial report and a copy of the patient's vaccination consent release form were received on 13 September 2010 from a health care professional. A 68-year-old female patient had received a first dose intramuscular deltoid injection of FLUZONE High-Dose, lot number U3600AA on 02 September 2010 at 10:00 AM and progressively over the next few hours (not immediately), she developed a very sore throat. She presented to the emergency room and was found to have throat constriction thought to be from an anaphylactic reaction. According to the vaccination consent release form, the patient had no concurrent illness and she had not experienced any adverse reactions following prior vaccinations. The patient's medical history was negative for latex sensitivity and serious allergies to medications and food. The patient had not received any vaccines within four weeks of FLUZONE High-Dose. The reporter considered the seriousness criteria for this event to be life-threatening. Outcome was recovered (date not reported). The reporter for this case is the same as for case number 2010-04971, -04973, -04974, -04975, -04976, -04977, -04978, -04979, -04980, -04981 and -04982. Documents held by sender: Immunization consent form.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Anaphylactic reaction, Chest discomfort, Dysgeusia, Nausea
Clinical narrative: Initial report received from a health care professional on 13 September 2010. A 67-year-old female patient received on 02 September 2010 at 1:00 PM a deltoid intramuscular (IM) injection of FLUZONE High-Dose, lot number U3600AA. On the 02 September 2010 within a few hours after the vaccination, the patient developed life threatening symptoms of nausea, chest tightening and altered taste. She was seen in the Emergency Department and it was determined that she had an anaphylactic reaction. The outcome was reported as recovered. Documents held by sender: None.