chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unknown age and gender. Since September 2014 (reported as "at the beginning of September 2014") the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose and indication were not reported). No symptoms reported. Additional information has been requested.
Sex: U
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an unspecified number of patients of unknown ages and genders. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (route, dose number, and lot number unknown). Concomitant therapies included an unspecified flu vaccine. On an unknown date the patients experienced injection site redness and soreness. The outcome of the events was unknown. Additional information is not expected because there is no permission to contact physician.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: C-reactive protein, C-reactive protein increased, Chest X-ray normal, Dyspnoea, Monocyte count increased
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 03 September 2014. A 22 year-old male subject with no significant past medical history was found to have acute pericarditis unspecified, other pericarditis and non-specific myocarditis 11, 11 and 10 days respectively after the subject had received the following vaccines on 24 March 2014: an injection of ACAM2000 (lot number, route and site of administration not reported), Typhoid, VICPs (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I of 18.25 ng/ml on 05 April 2014, an abnormal ECG on 03 April 2014 and an abnormal Echocardiogram on 04 April 2014. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Myocarditis, Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 03 September 2014. A 22 year-old male subject with no significant past medical history was found to have acute pericarditis unspecified, other pericarditis and non-specific myocarditis 11, 11 and 10 days respectively after the subject had received the following vaccines on 24 March 2014: an injection of ACAM2000 (lot number, route and site of administration not reported), Typhoid, VICPs (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I of 18.25 ng/ml on 05 April 2014, an abnormal ECG on 03 April 2014 and an abnormal Echocardiogram on 04 April 2014. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Arteriogram coronary normal, Blood creatine phosphokinase MB increased, C-reactive protein increased, Catheterisation cardiac, Chest X-ray normal
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 03 September 2014. A 22 year-old male subject with no significant past medical history was found to have acute pericarditis unspecified, other pericarditis and non-specific myocarditis 11, 11 and 10 days respectively after the subject had received the following vaccines on 24 March 2014: an injection of ACAM2000 (lot number, route and site of administration not reported), Typhoid, VICPs (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I of 18.25 ng/ml on 05 April 2014, an abnormal ECG on 03 April 2014 and an abnormal Echocardiogram on 04 April 2014. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Chest pain, Dyspnoea, Echocardiogram normal, Electrocardiogram abnormal, Exercise test
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 03 September 2014. A 22 year-old male subject with no significant past medical history was found to have acute pericarditis unspecified, other pericarditis and non-specific myocarditis 11, 11 and 10 days respectively after the subject had received the following vaccines on 24 March 2014: an injection of ACAM2000 (lot number, route and site of administration not reported), Typhoid, VICPs (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I of 18.25 ng/ml on 05 April 2014, an abnormal ECG on 03 April 2014 and an abnormal Echocardiogram on 04 April 2014. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Heart rate increased, Pain, Painful respiration, Red blood cell sedimentation rate increased, Troponin I increased
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 03 September 2014. A 22 year-old male subject with no significant past medical history was found to have acute pericarditis unspecified, other pericarditis and non-specific myocarditis 11, 11 and 10 days respectively after the subject had received the following vaccines on 24 March 2014: an injection of ACAM2000 (lot number, route and site of administration not reported), Typhoid, VICPs (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I of 18.25 ng/ml on 05 April 2014, an abnormal ECG on 03 April 2014 and an abnormal Echocardiogram on 04 April 2014. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Ventricular hypertrophy
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 03 September 2014. A 22 year-old male subject with no significant past medical history was found to have acute pericarditis unspecified, other pericarditis and non-specific myocarditis 11, 11 and 10 days respectively after the subject had received the following vaccines on 24 March 2014: an injection of ACAM2000 (lot number, route and site of administration not reported), Typhoid, VICPs (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I of 18.25 ng/ml on 05 April 2014, an abnormal ECG on 03 April 2014 and an abnormal Echocardiogram on 04 April 2014. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: C-reactive protein, Chest X-ray normal, Dyspnoea, Monocyte count increased, Myocarditis
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 03 September 2014. A 22 year-old male subject with no significant past medical history was found to have acute pericarditis unspecified, other pericarditis and non-specific myocarditis 11, 11 and 10 days respectively after the subject had received the following vaccines on 24 March 2014: an injection of ACAM2000 (lot number, route and site of administration not reported), Typhoid, VICPs (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I of 18.25 ng/ml on 05 April 2014, an abnormal ECG on 03 April 2014 and an abnormal Echocardiogram on 04 April 2014. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 03 September 2014. A 22 year-old male subject with no significant past medical history was found to have acute pericarditis unspecified, other pericarditis and non-specific myocarditis 11, 11 and 10 days respectively after the subject had received the following vaccines on 24 March 2014: an injection of ACAM2000 (lot number, route and site of administration not reported), Typhoid, VICPs (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I of 18.25 ng/ml on 05 April 2014, an abnormal ECG on 03 April 2014 and an abnormal Echocardiogram on 04 April 2014. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Myocarditis, Pericarditis, Troponin I increased
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 03 September 2014. A 22 year-old male subject with no significant past medical history was found to have acute pericarditis unspecified, other pericarditis and non-specific myocarditis 11, 11 and 10 days respectively after the subject had received the following vaccines on 24 March 2014: an injection of ACAM2000 (lot number, route and site of administration not reported), Typhoid, VICPs (lot number, route and site of administration not reported) and Anthrax 1 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I of 18.25 ng/ml on 05 April 2014, an abnormal ECG on 03 April 2014 and an abnormal Echocardiogram on 04 April 2014. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS, FLUX, VARZOS
Symptoms: Back pain, Condition aggravated, Injection site cellulitis
Clinical narrative: This consumer report (initial receipt 10-Sep-2014) concerns a 54 year old female patient who had a medical history of erythromycin allergy/drug reaction and back pain. Concomitant medications included etodolac and paracetamol. On approximately the 25-Aug-2014, the patient received a influenza virus vaccine (manufacturer and batch number not reported) and concomitantly received ZOSTAVAX (batch number not reported) via the subcutaneous route. On approximately the 26-Aug-2014, the patient developed cellulitis at the site of the ZOSTAVAX injection. On the 29-Aug-2014, the patient commenced cephalexin for the cellulitis. On the 02-Sep-2014, the patient developed a sudden worsening of the pain in her back. The patient went to see her physician however no lab diagnostic studies were performed. Outcome was not recovered for the back pain but recovering from cellulitis.
Age: 54.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS, FLUX, VARZOS
Symptoms: Injection site infection
Clinical narrative: This consumer report (initial receipt 10-Sep-2014) concerns a 54 year old female patient who had a medical history of erythromycin allergy/drug reaction and back pain. Concomitant medications included etodolac and paracetamol. On approximately the 25-Aug-2014, the patient received a influenza virus vaccine (manufacturer and batch number not reported) and concomitantly received ZOSTAVAX (batch number not reported) via the subcutaneous route. On approximately the 26-Aug-2014, the patient developed cellulitis at the site of the ZOSTAVAX injection. On the 29-Aug-2014, the patient commenced cephalexin for the cellulitis. On the 02-Sep-2014, the patient developed a sudden worsening of the pain in her back. The patient went to see her physician however no lab diagnostic studies were performed. Outcome was not recovered for the back pain but recovering from cellulitis.
Age: 10.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Dyspnoea, Nausea, Urticaria
Clinical narrative: Nausea, retching, dizziness, seeing floaters, hives on cheeks and bridge of nose.
Age: 10.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Dizziness, Nausea, Retching, Urticaria, Vitreous floaters
Clinical narrative: Nausea, retching, dizziness, seeing floaters, hives on cheeks and bridge of nose.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Local swelling, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 44 year old female patient. Medical history and drug reactions or allergies were reported as none. On 08-SEP-2014, the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, (lot number K009107) intramuscularly in the left arm (indication also reported as age appropriate). Concomitant therapies included FLUVIRIN administered in her left arm about one inch apart from PNEUMOVAX 23. On 09-SEP-2014, the patient began to experience lots of pain at the site of PNEUMOVAX 23 and difficulty in moving her arm. On 09-SEP-2014, ice was applied to the site of administration. Laboratory studies performed was reported as none. The outcome of difficulty in moving her arm and she began to experience lots of pain at the site of PNEUMOVAX 23 was reported as not recovered. The causality of the events was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 44 year old female patient. Medical history and drug reactions or allergies were reported as none. On 08-SEP-2014, the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, (lot number K009107) intramuscularly in the left arm (indication also reported as age appropriate). Concomitant therapies included FLUVIRIN administered in her left arm about one inch apart from PNEUMOVAX 23. On 09-SEP-2014, the patient began to experience lots of pain at the site of PNEUMOVAX 23 and difficulty in moving her arm. On 09-SEP-2014, ice was applied to the site of administration. Laboratory studies performed was reported as none. The outcome of difficulty in moving her arm and she began to experience lots of pain at the site of PNEUMOVAX 23 was reported as not recovered. The causality of the events was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Exposure during pregnancy, Pregnancy test negative
Clinical narrative: I was pregnant at the time I received the vaccination.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Eye irritation, Fatigue, Musculoskeletal pain, Ocular hyperaemia
Clinical narrative: Eyes became red and irritated, high level of fatigue began and shoulders, arms and upper back pain very noticeable.  By 6:30 PM exhaustion was evident and I slept for 3 hours.   I have never had any problems with any vaccination.  I am robust and in good health.  I would think a senior citizen in a frail condition would have had a scary and very unpleasant situation.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Eyes became red and irritated, high level of fatigue began and shoulders, arms and upper back pain very noticeable.  By 6:30 PM exhaustion was evident and I slept for 3 hours.   I have never had any problems with any vaccination.  I am robust and in good health.  I would think a senior citizen in a frail condition would have had a scary and very unpleasant situation.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Headache, Injection site erythema, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: This spontaneous report as received from a medical assistant via field representative refers to a 30 year old female patient. The patient's medical history included "has severe asthma". "A week ago" (approximately on 04-SEP-2014), the patient was vaccinated with a dose of PNEUMOVAX 23, 1 shot, (route: unspecified if subcutaneous or intramuscular (IM), lot # and expired date were not reported) due to "high risk for pneumonia". Concomitant therapy was not reported. The reporter reported that "A patient received PNEUMOVAX 23, and called on the same day (approximately on 04-SEP-2014) reporting injection-site redness, sore shoulder, stiff neck and said she felt terrible, and was in a lot of pain, including a headache." The patient was hospitalized for 2 days at an unspecified location. The patient sought medical attention. The outcome of adverse events was reported as recovered on an unspecified date. The relationship between adverse events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: This spontaneous report as received from a medical assistant via field representative refers to a 30 year old female patient. The patient's medical history included "has severe asthma". "A week ago" (approximately on 04-SEP-2014), the patient was vaccinated with a dose of PNEUMOVAX 23, 1 shot, (route: unspecified if subcutaneous or intramuscular (IM), lot # and expired date were not reported) due to "high risk for pneumonia". Concomitant therapy was not reported. The reporter reported that "A patient received PNEUMOVAX 23, and called on the same day (approximately on 04-SEP-2014) reporting injection-site redness, sore shoulder, stiff neck and said she felt terrible, and was in a lot of pain, including a headache." The patient was hospitalized for 2 days at an unspecified location. The patient sought medical attention. The outcome of adverse events was reported as recovered on an unspecified date. The relationship between adverse events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Erythema, Local swelling, Pain in extremity
Clinical narrative: Swelling, redness, pain in arm with temp of 100.1.
Age: 45.0
Sex: F
Vaccine: FLUN4
Symptoms: Eye pruritus
Clinical narrative: Patient had itchiness of the eyes shortly after receiving Flumist until the time the patient took some Benadryl at around 9PM the same day.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Patient developed urticarial rash several hours after receiving DTaP, MMR, Varivax. Rash was on arms, legs and abdomen. No wheezing, coughing or GI symptoms.  She was given Benadryl in office and instructed to continue x 2 days.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Pyrexia, Tremor
Clinical narrative: Started with chills, I shook so bad, that I couldn't hold anything.  Began to run a fever 102.3. Morning of 9/17/2014 fever is gone, but I'm feeling very tired.  This is my fourth flu shot.  This is the first time I ever had any reaction.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Ear pain, Myalgia
Clinical narrative: Within an hour of vaccine severe muscle ache in shoulders, radiating to neck and head with bilateral ear pain and bilateral anckle pain.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Haematochezia, Intussusception, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Patient presented with bloody stools and emesis and had intussusception confirmed on ultrasound
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Buring and stinging at injection site immediately after injection.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, warmth, and tenderness at site of injection.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Diarrhoea, Vomiting
Clinical narrative: Vomiting, diarrhea, temperature of 100.1. Could definitely be coincidence and not related to vaccine. No other family member is/has been I'll and I am a nurse. Around sick people all the time.
Age: 39.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: pain, swelling, redness at site of injection. Fever 102.3 with chills, glands in RT neck beginning to swell.
Age: 39.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: pain, swelling, redness at site of injection. Fever 102.3 with chills, glands in RT neck beginning to swell.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Middle insomnia, Pain in extremity
Clinical narrative: Reports that she felt fine until 3 days after receiving the Tdap. Reports that she has developed serve pain in that arm. States it wakes her from sleep. Is taking Ibuprofen product for pain relief. Referred to PCP.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Patient received FLUVIRIN and PNEUMOVAX 23 on 9/16. She reported a swollen arm (softball size) around injection site. She was treated at ER and then released.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Convulsion
Clinical narrative: Generalized seizure for approximately 1 minute. Temp 99
Age: 2.0
Sex: M
Vaccine: FLUN4, HEPA
Symptoms: Epistaxis, Underdose
Clinical narrative: Pt received 1/2 dose in (L) nostril, following 1/4 dose in (R) nostril began to bleed from (R) nostril. Dr examined and could not determine site of bleed.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, heat, and hardness about the size of a 50-cent piece at the injection site.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Extreme Dizziness, waves of nausea, no vomiting. Symptoms lasted thru 9/12/2014 subsiding each day
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Complement factor, Full blood count, Influenza like illness, Injection site erythema
Clinical narrative: SWELLING LEFT UPPER ARM, FELT LIKE FLU SYMPTOMS, JOINT PAIN, LOW GRADE FEVER, ACHINESS, AREA HOT TO TOUCH AND VERY RED.  9/16 AREA WORSE WITH RED STREAK DOWN ARM.  9/17 WORSE YET, DX WITH SERUM SICKNESS.  NOT RECOVERED YET, AT HOME AND WILL SEE MD 9/18.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site streaking, Injection site swelling, Injection site warmth, Metabolic function test, Pain
Clinical narrative: SWELLING LEFT UPPER ARM, FELT LIKE FLU SYMPTOMS, JOINT PAIN, LOW GRADE FEVER, ACHINESS, AREA HOT TO TOUCH AND VERY RED.  9/16 AREA WORSE WITH RED STREAK DOWN ARM.  9/17 WORSE YET, DX WITH SERUM SICKNESS.  NOT RECOVERED YET, AT HOME AND WILL SEE MD 9/18.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Red blood cell sedimentation rate, Serum sickness, Urine analysis
Clinical narrative: SWELLING LEFT UPPER ARM, FELT LIKE FLU SYMPTOMS, JOINT PAIN, LOW GRADE FEVER, ACHINESS, AREA HOT TO TOUCH AND VERY RED.  9/16 AREA WORSE WITH RED STREAK DOWN ARM.  9/17 WORSE YET, DX WITH SERUM SICKNESS.  NOT RECOVERED YET, AT HOME AND WILL SEE MD 9/18.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Patient describes fevers and chills for 7 hours approximately.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, redness about 8 inches in diameter, pain, soreness. I recommended pt to take ibuprofen and apply ice or a cold compress to arm. Pt contacted the next day and said her symptoms improved. Called pt and she said she was better.
Age: 21.0
Sex: M
Vaccine: HEPAB, HPV4, TDAP, VARCEL
Symptoms: Pruritus, Rash erythematous, Rash generalised, Rash papular, Rash vesicular
Clinical narrative: On July 17th 2014 the patient received the following vaccines: Tdap, Hep A-Hep B, HPV, and VZV. Five days later, patient noticed a vesicular/ papular/ erythematosus rash on his whole body, including the palms and some mucus membrains. The most affected are was the back and all the lesions were very pruritic. Patient was treated by PCP with Calamine lotion and oral antihistaminic, PCP informed the patient that lesions were the result of an adverse reaction to the VZV vaccine. The lesions subsided seven days later. Patient is seen today and there is no evidence of any lesions. No vaccines given today.
Age: 21.0
Sex: M
Vaccine: HEPAB, HPV4, TDAP, VARCEL
Symptoms: Skin lesion, Vaccination complication
Clinical narrative: On July 17th 2014 the patient received the following vaccines: Tdap, Hep A-Hep B, HPV, and VZV. Five days later, patient noticed a vesicular/ papular/ erythematosus rash on his whole body, including the palms and some mucus membrains. The most affected are was the back and all the lesions were very pruritic. Patient was treated by PCP with Calamine lotion and oral antihistaminic, PCP informed the patient that lesions were the result of an adverse reaction to the VZV vaccine. The lesions subsided seven days later. Patient is seen today and there is no evidence of any lesions. No vaccines given today.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site warmth, Local reaction
Clinical narrative: Localized reaction, pt had red inflamed area where shot occurred that was warm to the touch. Pt came back on 9/6 and reaction was much better. Pt was followed up with the next day and reaction had improved.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Feeling cold, Mobility decreased, Musculoskeletal chest pain, Myalgia, Nightmare
Clinical narrative: Patient is a 65 year old left handed female who presents for right sided lateral rib and pleuritic pain. About 1 day after the pneumonia shot, she developed body aches and pains and she "hurt so bad" that she had to force herself to get up, felt feverish and cold. This improved spontaneously within 72 hours and she was able to go back to usual work and activities. The PNEUMOVAX site was unremarkable with no redness or tenderness. She states she had a similar reaction with the flu shot. About 1-1.5 week later: She started with left shoulder scapular muscular pain, worse with left shoulder movement "like you overused," 'so sore" and she could not lift her left arm >90 degrees. No redness, swelling or warmth. She had this for about one week. She states that it improved spontaneously and she shows me full ROM of the left shoulder. On Thursday, she had sudden sensation of right postero-lateral lung/rib pain, apparent with trunk movement and deep breathing. She could hardly sit or move. States that having had history of pleuritis and history of rib fracture, she states this is "like pleurisy." She denies cough, anterior chest pain, dyspnea, wheezing or hemoptysis. She denies ear pain, sore throat, nasal or sinus congestion. The patient denies fever, chills, sweats or rash. Friday and Saturday she had sharp pains. She was seen at clinic on Saturday. PERCOCET gave her nightmares (could not drive with that); ADVIL helped, as well as cool compresses. Since Sunday, generally better, just felt sore. Also tender to touch. No skin changes, redness or swelling.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pleuritic pain, Pyrexia, Tenderness
Clinical narrative: Patient is a 65 year old left handed female who presents for right sided lateral rib and pleuritic pain. About 1 day after the pneumonia shot, she developed body aches and pains and she "hurt so bad" that she had to force herself to get up, felt feverish and cold. This improved spontaneously within 72 hours and she was able to go back to usual work and activities. The PNEUMOVAX site was unremarkable with no redness or tenderness. She states she had a similar reaction with the flu shot. About 1-1.5 week later: She started with left shoulder scapular muscular pain, worse with left shoulder movement "like you overused," 'so sore" and she could not lift her left arm >90 degrees. No redness, swelling or warmth. She had this for about one week. She states that it improved spontaneously and she shows me full ROM of the left shoulder. On Thursday, she had sudden sensation of right postero-lateral lung/rib pain, apparent with trunk movement and deep breathing. She could hardly sit or move. States that having had history of pleuritis and history of rib fracture, she states this is "like pleurisy." She denies cough, anterior chest pain, dyspnea, wheezing or hemoptysis. She denies ear pain, sore throat, nasal or sinus congestion. The patient denies fever, chills, sweats or rash. Friday and Saturday she had sharp pains. She was seen at clinic on Saturday. PERCOCET gave her nightmares (could not drive with that); ADVIL helped, as well as cool compresses. Since Sunday, generally better, just felt sore. Also tender to touch. No skin changes, redness or swelling.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to 4 unspecified patients of unknown gender and age. On an unknown date, the patients experienced swelling and redness at the injection site (also reported as injection site reaction involving swelling and redness) after receiving ZOSTAVAX. It was reported that one of the patients visited their unspecified physician on an unspecified date and was prescribed an unspecified steroid treatment for the swelling and redness at the injection site. It was unspecified if the other 3 patients that complained of injection site reaction involving swelling after receiving and redness had visited their physicians or/and received the treatment for the events. The outcome of swelling and redness at the injection site was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness/tingling right hand/fingers.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Neuralgic amyotrophy, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Patient presented 9/9/14 for care due to persistent severe intermittent arm pain following vaccine administration. Dx Brachial Plexus Neuritis in hospital.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to unspecified number of patients. No medical history and concurrent conditions reported. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (dose number and route not reported) lot number not specified. No concomitant therapies reported. The reporter stated that over the past 5 to 6 years the patient experienced soreness at the site of PNEUMOVAX 23 administration that was relieved by an increase in movement of arm described as playing tennis or going bowling. The outcome of the event was unknown. The causality of the events was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Measles antibody negative, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, via a company representative, concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. Patient was reported as otherwise healthy. On an unknown date the patient was vaccinated with MMR II (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The medical assistant reported that patient was vaccinated with MMR II on an unknown date, had "low measles titers". The patient had not suffered any other adverse effects. At the time of the report the outcome was unknown. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: TD
Symptoms: Pain, Pyrexia
Clinical narrative: Patient complained of body aches and fever
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient. Medical history and concurrent conditions were not reported. In 2011, the patient was vaccinated with ZOSTAVAX lot # J016258, expiration date 26-FEB-2015, 0.65 ml, subcutaneous in the left arm. The pharmacist reported that the patient was inadvertently vaccinated with a second dose of ZOSTAVAX on 08-SEP-2014. No adverse effects reported. Additional information is not expected. No allowed to contact physician.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Injection site swelling, Joint swelling, Local swelling, Pyrexia
Clinical narrative: Shots yesterday and low fev. Now rash spreading and swelling of both ankles and thighs. At 8:30 pm 9/16 swelling nearly gone after giving children's BENADRYL. Back an 9/17.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pt got fever of 102.1 around 9PM 9/15/14 also experienced pain at injection site also redness and swelling. By 9/16 temp of 99 degrees in the morning and no fever 9/17/14.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Discussed giving FLUZONE HD with patient but she ended up receiving FLUVIRIN.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Blood in stool noted w/in 4 hours of receiving vaccines.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Nausea, Pruritus
Clinical narrative: Swollen arm at site of injection, tenderness. Warm. Patient felt nauseated. Little itching. Advised patient to go to ER. Given FLUVIRIN and PNEUMOVAX. Reaction due to PNEUMOVAX.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, soreness, itching, lumo in area of injection on left arm
Age: 1.33
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events. Wellness nurse inadvertently administered a 0.5mL dose of Fluarix (GSK) to a 19 month old before realizing that the vaccine was only licensed for use in people age 3 years and older.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Itching and rash developed and swelling of site.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Dizziness, Loss of consciousness, Pallor
Clinical narrative: Became dizzy after vaccine- rested for about 8 min sat up and was feeling good then suddenly became pale- passed out and had a seizure.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong drug administered
Clinical narrative: Pt was administered the incorrect vaccine. Given Menactra and not HPV.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Dizziness, Vertigo
Clinical narrative: Vertigo, dizziness, temp 102. Got some Meclizine. 9/17/2014 Temp 100. Stayed home from work. 9/17/2014 2:00 pm symptoms resolved.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Abdominal distension, Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: DISTENDED ABDOMEN, 102 FEVER, BODY ACHE, LOCAL INJECTION SITE ERYTHEMA, SORENESS AND WARMTH.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: DISTENDED ABDOMEN, 102 FEVER, BODY ACHE, LOCAL INJECTION SITE ERYTHEMA, SORENESS AND WARMTH.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Abdominal discomfort, Chills, Local swelling, Malaise, Mass
Clinical narrative: DISTENDED ABDOMEN, 102 FEVER, BODY ACHE, LOCAL INJECTION SITE ERYTHEMA, SORENESS AND WARMTH.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Nodule, Oropharyngeal pain, Pruritus generalised, Pyrexia, Rash erythematous
Clinical narrative: DISTENDED ABDOMEN, 102 FEVER, BODY ACHE, LOCAL INJECTION SITE ERYTHEMA, SORENESS AND WARMTH.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Vision blurred, Visual acuity reduced
Clinical narrative: DISTENDED ABDOMEN, 102 FEVER, BODY ACHE, LOCAL INJECTION SITE ERYTHEMA, SORENESS AND WARMTH.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: 3 X 6 INCH ERYTHEMA RASH ON UPPER LEFT ARM, STARTING ABOUT AN INCH OR MORE AWAY FROM CENTER OF ARM (INJECTION SITE).
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Flushing, Rash erythematous
Clinical narrative: Red raised rash to bilateral arms several hours after receiving vaccination.  Face also flushed.  Rash gone in 1-2 days.
Age: 64.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Pt called pharmacy on 9/17/2014 at 9:30am stating arm at injection site was swelling and inflammation at injection site. Told patient to apply a cold compress to site and recommend analgesic (i.e. APAP) and antihistamine if no contraindication or drug interaction and to also contact PCP. If it gets worse to seek medical attention. I contacted the PCP however office is closed on Wednesday. Will try again next day. Patient came in at 2:45pm to show arm. Arm was bruised and red around injection site. She did state she bruised easily.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Egg shaped and egg size local reaction at injection site; red, swollen, warm, tender.
Age: 30.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Patient with severe pain to right arm, redness, tender to touch. Also with fever.
Age: 28.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injected limb mobility decreased, Pain in extremity, Pruritus, Swelling
Clinical narrative: Arm pain, swelling, redness, itching and difficulty lifting left arm. Patient missed appointment for evaluation. Itching still present after 5 days, but swelling and redness have subsided after 5 days.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Urticaria
Clinical narrative: Hives covering stomach and back. Benadryl at onset and followed up by physician visit.
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Skin reaction
Clinical narrative: Patient came in and had a minor dermatologic reaction to Zostavax.  It had a redness associated with itching and a slight swelling at injection site.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Tachycardia
Clinical narrative: Tachycardia at 130 bmp. Then I took a beta blocker and was fine.
Age: 65.0
Sex: M
Vaccine: FLU4, TDAP, VARZOS
Symptoms: Back pain, Chills, Headache, Insomnia, Nausea
Clinical narrative: CHILLS, NAUSEA, HEADACHE, ACHY FEELING -BACK AND LEGS MORE SO THAN THE REST OF HER, INSOMNIA.
Age: 65.0
Sex: M
Vaccine: FLU4, TDAP, VARZOS
Symptoms: Pain in extremity
Clinical narrative: CHILLS, NAUSEA, HEADACHE, ACHY FEELING -BACK AND LEGS MORE SO THAN THE REST OF HER, INSOMNIA.
Age: 5.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Gastric dilatation, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: DISTENDED STOMACH, BODY ACHE, FEVER, INJECTION SITE REACTION ERYTHEMA, SWELLING, WARMTH.
Age: 5.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: DISTENDED STOMACH, BODY ACHE, FEVER, INJECTION SITE REACTION ERYTHEMA, SWELLING, WARMTH.
Age: 5.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Chills, Local swelling, Malaise, Pyrexia, Rash erythematous
Clinical narrative: DISTENDED STOMACH, BODY ACHE, FEVER, INJECTION SITE REACTION ERYTHEMA, SWELLING, WARMTH.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Chest X-ray abnormal, Computerised tomogram head, Computerised tomogram thorax abnormal, Cough, Decreased appetite
Clinical narrative: Patient started coughing about 2 hours after his vaccinations. He was fussy that evening and through the night. The following day mom noticed he was 'more lethargic' and 'had less of an appetite'. approximately 24 hours after his immunizations he started with profuse continuous vomiting, she called her pediatricians office for guidance and conservative measures were tried. The following day 9/22 he seemed better in the morning and again had an episode of vomiting, repeatedly and then collapsed. 911 was called, CPR was initiated, EMS intubated the child on arrival. He was ultimately found to have aspiration pneumonia, was intubated for about 9 - 10 days and was evaluated with found intracranial abnormalities both acute and subacute possibly due to the resuscitation attempts or delayed appropriate intubation or underlying pathophysiology not yet clarified.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Endotracheal intubation, Irritability, Lethargy, Nervous system disorder, Nuclear magnetic resonance imaging brain
Clinical narrative: Patient started coughing about 2 hours after his vaccinations. He was fussy that evening and through the night. The following day mom noticed he was 'more lethargic' and 'had less of an appetite'. approximately 24 hours after his immunizations he started with profuse continuous vomiting, she called her pediatricians office for guidance and conservative measures were tried. The following day 9/22 he seemed better in the morning and again had an episode of vomiting, repeatedly and then collapsed. 911 was called, CPR was initiated, EMS intubated the child on arrival. He was ultimately found to have aspiration pneumonia, was intubated for about 9 - 10 days and was evaluated with found intracranial abnormalities both acute and subacute possibly due to the resuscitation attempts or delayed appropriate intubation or underlying pathophysiology not yet clarified.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pneumonia aspiration, Resuscitation, Syncope, Vomiting
Clinical narrative: Patient started coughing about 2 hours after his vaccinations. He was fussy that evening and through the night. The following day mom noticed he was 'more lethargic' and 'had less of an appetite'. approximately 24 hours after his immunizations he started with profuse continuous vomiting, she called her pediatricians office for guidance and conservative measures were tried. The following day 9/22 he seemed better in the morning and again had an episode of vomiting, repeatedly and then collapsed. 911 was called, CPR was initiated, EMS intubated the child on arrival. He was ultimately found to have aspiration pneumonia, was intubated for about 9 - 10 days and was evaluated with found intracranial abnormalities both acute and subacute possibly due to the resuscitation attempts or delayed appropriate intubation or underlying pathophysiology not yet clarified.
Age: 16.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Abdominal distension, Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: DISTENDED ABDOMEN, BODY ACHE, FEVER, LOCAL INJECTION SITE ERYTHEMA, SORENESS, WARMTH.
Age: 16.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: DISTENDED ABDOMEN, BODY ACHE, FEVER, LOCAL INJECTION SITE ERYTHEMA, SORENESS, WARMTH.
Age: 16.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Abdominal discomfort, Abdominal distension, Chills, Local swelling, Malaise
Clinical narrative: DISTENDED ABDOMEN, BODY ACHE, FEVER, LOCAL INJECTION SITE ERYTHEMA, SORENESS, WARMTH.
Age: 16.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: DISTENDED ABDOMEN, BODY ACHE, FEVER, LOCAL INJECTION SITE ERYTHEMA, SORENESS, WARMTH.