chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Cough, Rash, Rash generalised, Rhinorrhoea
Clinical narrative: Rash on stomach and face with cough and runny nose. Rash spread all over body.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Exposure during pregnancy
Clinical narrative: Varicella titer was obtained for pre-employment requirements. Results showed no immunity. Previous immunization documentation was received after the titer was run, showing one previous Varicella vaccine in 2016. Prospective employee was notified about the negative immunity and that a second Varicella was required per CDC recommendations. Status of pregnancy was discussed and employee wanted to delay the vaccine off until tested for pregnancy. Appointment was re-scheduled for the following week. Employee came in on 11/22/17 and status of pregnancy was asked again. She stated no and circled no on the VARIVAX consent form. Vaccine was administered on 11/22/17. On 12/7/18, employee contacted this office to state she should not have received the vaccine because she was pregnant. Referred to her OB provider for counseling. No adverse results as of yet. Unsure of gestation, but probably early in 1st trimester.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Left Shoulder hurts when I raise it or try to sleep on it.
Sex: U
Vaccine: HEP, HEPA, HPV9, MMR, MMRV, PPV, RV5, VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, an unspecified number of patients were vaccinated with and incorrect stored dose of ROTATEQ lot # M046000 with expiration date on 27-JUN-2018 (strength and route were not reported) for prophylaxis, however no adverse effects reported. Other suspect therapies incorrectly stored reported were GARDASIL 9 Lot # N013695 with expiration date on 21-MAR-2019 and Lot # N018273 with expiration date on 17-JUN-2019; PNEUMOVAX 23 lot # N011305 with expiration date on 20-JAN-2019 and Lot # M029681 with expiration date on 22-JAN-2018; VAQTA lot # M031806 with expiration date on 30-MAR-2018; M-M-R II lot # reported as R56789 (expiration date not reported); RECOMBIVAX HB lot # M033096 with expiration date on 31-MAR-2018 , Lot # M020926 with expiration date on 11-AUG-2018 and ) lot # N009802 with expiration date on 19-DEC-2019. Also PROQUAD vaccine with lot # reported as # E98765 and ZOSTAVAX with reported lot # as E34567. It was reported that the vaccines were exposed to temperature of 9°C to 25 °C centigrades grades range for a time frame of 45 hours and 17 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. Lot # E34567 is an invalid lot number for ZOSTAVAX. Lot # E98765 in an invalid lot number for PROQUAD. Lot # R56789 is an invalid lot number for M-M-R II.
Age: 34.0
Sex: M
Vaccine: HPV9
Symptoms: Chills, Fatigue, Feeling abnormal, Muscular weakness, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 34 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 17-NOV-2017, the patient was vaccinated with GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 19-NOV-2017, the patient began experiencing extreme fatigue. On 20-NOV-2017, the patient experienced fever and chills.  On 21-NOV-2017, the patient stated that he had severe weakness in his legs and talso reported hat his legs felt like jello (feeling abnormal). The reporter stated that it was unknown if this was patient's first dose of GARDASIL 9 series. The reporter stated that the patient sought medical attention. On 22-NOV-2017, the patient went to the pharmacy to report all the above mentioned events. Furthermore the patient did not received treatment to the aforementioned events. The outcome of muscular extreme fatigue, fever, chills, severe weakness in his legs and feeling abnormal was reported as resolving. Additionally, the reporter did not provide causality assessment between the events and vaccination with GARDASIL 9.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia, Underdose, Wrong technique in product usage process
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist. A 71-year-old female patient of an unspecified race and ethnicity received the first dose of PREVNAR 13 on an unspecified date, in 2016, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. It was reported that the patient received only a quarter of the vaccine. On an unspecified date, in 2016, after the vaccination, the patient developed pneumonia. The vaccine was not injected properly (no possible immunity obtained). Clinical outcome was unknown at time of this report. The information on the lot number has been requested.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: M
Vaccine: MENB
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable other-HCP, parent's patient, via Pfizer sales representative. A male patient of an unknown age and ethnicity/race received the first dose of TRUMENBA at single dose on unknown date for immunization. Medical history and concomitant medication were unknown. On unknown  date the  patient experienced cellulitis from the shoulder to elbow. The outcome of the event was unknown. The information on the lot number has been requested.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 0.58
Sex: M
Vaccine: FLU4
Symptoms: Hypersensitivity, Pruritus, Rash erythematous, Skin exfoliation
Clinical narrative: On Wednesday night when mom was changing infants cloths she noticed child was starting to get a red patchy rash on back. Today rash has spread to abdomen, face, and a little on legs. Rash is raised and scaly feeling. Mom states he itches his face. No other symptoms noted. Mom states she is allergic to eggs and does not take the flu vaccine. Mom is concerned infant may be allergic to eggs as well. Mom states infant has an appt to see his PCP on 12/13/2017 for the rash. Mom will let us know if PCP feels rash is an allergic reaction to the flu vaccine. Mom will take infant to ER if symptoms worsen or if new symptoms develop. Discussed symptoms of a severe allergic reaction with mom.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left shoulder erythema slightly warm to touch approximately 7 cm starting 6 days after vaccination.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: The injection hurt immediately. It hurt the next day and the pain has never subsided. The pain is most intense at the injection site. My shoulder has hurt on the left side towards my neck, through my shoulder. I returned to Pharmacy and told the tech about the pain a couple of days later. He recommended icing the site. It has been 3 1/2 months and I don't have relief. I occasionally take a TYLENOL to lessen the pain. My husband is tired of me complaining. I am tired of complaining.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Confusional state, Crying, Fall, Loss of consciousness
Clinical narrative: The patient was brought in by his mother to receive a flu shot with the rest of the family. The patient's mother stated that he had received flu shots in the past and had no adverse effects from the shots. The flu shot was administered IM in the patient's right deltoid. After receiving the flu shot the patient sat down in a chair to wait while his family members received flu shots. After approximately one to two minutes of sitting down, the patient lost consciousness and fell to the floor. The patient remained unconscious for approximately five to ten seconds while in a tense posture with his arms pulled tightly to the front of his chest. The patient then quickly regained consciousness and began crying. The patient was initially confused but regained normal mentation almost immediately. 911 was called and a paramedic team arrived on scene to assess the patient.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Blood creatine phosphokinase normal, Borrelia test negative, Full blood count normal, Injection site pain
Clinical narrative: Over the two days after the shot. Patient developed severe pain at the site of injection (left arm) that has persisted. Over the next 3 weeks, she developed bilateral thigh pain and lower back pain. She also developed upper arm pain on the opposite side.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: Over the two days after the shot. Patient developed severe pain at the site of injection (left arm) that has persisted. Over the next 3 weeks, she developed bilateral thigh pain and lower back pain. She also developed upper arm pain on the opposite side.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Erythema, Peripheral swelling
Clinical narrative: Patient received the flu vaccine on 12/5/17, of note-patient has extreme anxiety and took 3 people to restrain her. The next day, the mother noticed the arm red and swollen. She made appt. on 12/6/17, picture was taken of left arm.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: Pain, swelling, erythema at injection site; pain radiating into shoulder and neck; symptoms worst 2 days after receiving vaccine; pain improving spontaneously.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Pain, swelling, erythema at injection site; pain radiating into shoulder and neck; symptoms worst 2 days after receiving vaccine; pain improving spontaneously.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Rash macular
Clinical narrative: The patient noticed her arm was red and blotchy this morning. The patient is taking Benadryl to help with the redness. She was instructed to call us or her doctor if anything worsened.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient presented to our clinic with redness, swelling, itching, and pain at the injection site. Vaccine was administered in different location (about 30 minutes from our location). Patient had rapid onset of symptoms (about 2 hours). Patient seen by provider, reaction outlined with marker and given ED precautions as well as Benadryl for itching and Tylenol for pain. Patient PCM also contacted via email.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Condition aggravated, Gastrooesophageal reflux disease, Headache, Hyperhidrosis
Clinical narrative: Pt had experienced sore arm for a few days. She also had general weakness for 2-3 weeks. She had on-and-off headaches, fever/sweat (questionable, due to ongoing menopause symptoms), and nausea (she also has acid reflux). She still feels "not totally recovered".
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Menopausal symptoms, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Pt had experienced sore arm for a few days. She also had general weakness for 2-3 weeks. She had on-and-off headaches, fever/sweat (questionable, due to ongoing menopause symptoms), and nausea (she also has acid reflux). She still feels "not totally recovered".
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient's right arm became swollen and red, the redness went about halfway or three quarters of the way down her arm, from her shoulder to the elbow. No other activity was mentioned by mom. We did refer to an allergist in gig harbor for more extensive testing, starting with a consult first, we have yet to receive the chart notes from that visit which happened within the last three weeks to our knowledge. Will be following up with mom this week to see how the visit went.
Age: 71.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: PT STATED THE RASH APPEARED ABOUT 5 TO 6 DAYS AGO FROM (TODAY'S DATE: 12/11/17@ 4:46PM). PT'S ARMS DEVELOPED RASH & ARE VERY RED & EXTREMELY "ITCHY". BUT ITCHINESS IS STARTING TO SUBSIDE A BIT. PT ALSO DEVELOPED RASH & TINY BUMPS ON THE FOLLOWING AREA(S): BREAST (AROUND THE NIPPLES), ANKLES UP TO KNEES BUT NOT ITCHING.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Chest discomfort, Myalgia
Clinical narrative: Chest pressure, diffuse myalgias that developed an hour after getting vaccine, lasted 2 weeks, resolved spontaneously.
Age: 22.0
Sex: F
Vaccine: FLUC4, TDAP, VARCEL
Symptoms: Dizziness, Fatigue, Injection site rash
Clinical narrative: Pt called pharmacy about 24 hours after receiving vaccinations stating she awoke the next day with a rash on the back of her left arm. She said the rash had worsened over the day and was raised. She said she felt "fatigued" and "like she may faint" but not dizzy.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: In the evening after getting vaccine, I experienced lightheadedness, and was "woozy." Woke up with  dizziness the next morning, and symptoms lasted until mid-day the following day. So a little more than 48 hours of feeling woozy/dizzy. Never before had a reaction to a vaccine, so thought I'd report it. Began full vegetarian diet eight months prior.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient states she has had increasing soreness in left arm approximately 1 week after vaccination along with decreased range of motion in affected arm. Patient has not sought medical care.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Aphthous ulcer, Constipation, Injection site swelling
Clinical narrative: Constipation following vaccine and up to date. Have been giving her fiber rich foods, prune juice, prune puree, unfiltered apple juice but no change. Will add probiotics. Swollen at injection site same day, bump still lightly raised on thigh to this date. Canker sore developed in mouth and noticed on December 5th.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Enema administration, Intussusception, Polymerase chain reaction positive, Rotavirus test positive, Ultrasound abdomen abnormal
Clinical narrative: Patient was diagnosed with an intussusception 10 days after receiving the vaccine. It was reduced with 1 air enema and has not recurred.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: Patient describes burning sensation immediately after receiving injection that since then has not decreased in pain severity. It radiates down her arm to her fingertips. It is painful for her to cross her arm to the other side of her body. She describes her arm as a "dead shoulder". She does state that TYLENOL ES does seem to help the pain, and she does notice the pain when she forgets to take her medicine. She is going to plan on continue to take APAP and attempt to use her arm more to dissipate the pain.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Rash vesicular
Clinical narrative: Extensive rash developed following fever. Fever started "a couple" days after initial vaccination and rash started after that. Rash was quite extensive and had the appearance of modified varicella. Patient was treated with supportive care and proper isolation was discussed. Patient recovered without incident.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough, Crying, Dysphonia, Dyspnoea, Erythema
Clinical narrative: The day of the shot my arm became painful, red, and swollen by the3rd day I was having the beginning of shortness of breath. Within a week more tachycardia, then hoarseness, coughing, and some whezzing. This has been going on now for 2 mons. First they treated it like a flare up of my COPD from the shot but it hasn't gone away. I've been on antibiotics and prednisone, breathing treatments. I've been to the hospital 2x and kept once. I have 3 appts. With my PCP and with my Lung Dr. I can't do the simplest tasks. Everything makes me out of breath. Its been very hard.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of personal independence in daily activities, Myocardial necrosis marker normal, Nuclear magnetic resonance imaging normal, Pain in extremity, Peripheral swelling
Clinical narrative: The day of the shot my arm became painful, red, and swollen by the3rd day I was having the beginning of shortness of breath. Within a week more tachycardia, then hoarseness, coughing, and some whezzing. This has been going on now for 2 mons. First they treated it like a flare up of my COPD from the shot but it hasn't gone away. I've been on antibiotics and prednisone, breathing treatments. I've been to the hospital 2x and kept once. I have 3 appts. With my PCP and with my Lung Dr. I can't do the simplest tasks. Everything makes me out of breath. Its been very hard.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Scan with contrast normal, Tachycardia, Wheezing, X-ray normal
Clinical narrative: The day of the shot my arm became painful, red, and swollen by the3rd day I was having the beginning of shortness of breath. Within a week more tachycardia, then hoarseness, coughing, and some whezzing. This has been going on now for 2 mons. First they treated it like a flare up of my COPD from the shot but it hasn't gone away. I've been on antibiotics and prednisone, breathing treatments. I've been to the hospital 2x and kept once. I have 3 appts. With my PCP and with my Lung Dr. I can't do the simplest tasks. Everything makes me out of breath. Its been very hard.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: I woke up a short amount of time after going to sleep on the 3rd of December to awaken with what I believed to be a spider bite. I had a welt approximately the size of a nickel on the back of my left thigh, an area that was covered with clothing. I applied some hydrocortisone cream and went back to sleep. On the night of the 4th, I woke up with much more severe welts and hives. There was one the size of a half dollar on my coccyx, 6-7 smaller ones (about the size of a pencil eraser) covering my left and right butt cheek, four approximately half dollar sized welts going down my left thigh. Additionally there was somewhat circular patch of hives approximately three inches in diameter on my left butt cheek. All of these areas were covered with clothing while I slept. The worst reaction occurred on Tuesday night. I had been asleep for about two hours when I woke up to patches of welts covering my arms, and hives engulfing my lower legs. I had a welt the size of my smallest finger on my abdomen and up my back and similar hives and welts as the previous night. I considered seeking emergency care, but my symptoms subsided with BENADRYL and hydrocortisone cream.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Nuclear magnetic resonance imaging
Clinical narrative: Patient received vaccine on 9/18/17 had muscle soreness next day which became worse over the next 4 days. Went to the hospital for treatment hospital referred patient to primary care physician. Patient went to see Dr. who referred patient to a neurologist. Patient has been going to physical therapy for seven weeks now. Neurologist told patient she has a virus in her radial nerve caused by the flu vaccine given on 9/18/2017. Patient notified Board of Health who called me on 12/08/2017, I later spoke to the patient and gathered this information.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient has had extreme pain in her left arm, having a hard time lifting her arm above her head, also complaining of shooting pain in her left arm. This has persisted since the morning after her immunizations and does not seem to be improving.
Age: 71.0
Sex: M
Vaccine: FLUA3
Symptoms: Muscular weakness, Musculoskeletal pain, Myalgia, Pain
Clinical narrative: Muscle pain in left arm, a dull continuous pain, a feeling of weakness in left hand. Treatments-10 days of prednisone, 10 days of PT. Some better-still a soreness in shoulder.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Swelling
Clinical narrative: Localized swelling 3 cm in diameter starting 13 days after injection with pain. No redness or signs of infection.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Nausea
Clinical narrative: Shortly after getting MenB and MCV4, patient felt dizzy and nauseous. Did not eat this morning, given juice and observed in clinic until symptoms resolved. Normal vital signs BP: 108/76, HR: 88, RR: 20, SPO2: 98%, Blood Sugar 98.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, TYP
Symptoms: Expired product administered, Injection site erythema, Injection site pain
Clinical narrative: 12-15-17 Parents of pt. notified that KINRIX was expired by 2 days. Discussed drug company info, CDC and ACIP. No problems but achy arms. 12-7-17 Mother called to say rt deltoid had red area about 2 inches in diameter. No complaints from child, no fever or breathing difficulty. 12-8-17 Spoke to mom. Redness decreasing.
Age: 86.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal discomfort, Body temperature increased, Chills, Feeling cold, Loss of personal independence in daily activities
Clinical narrative: Later afternoon-1st shivers-Total Body, no control as of convulses-upset stomach-couldn't hold head up- 103 degree Temp. Totally non functional. Freezing cold. Could not get warm. Went to bed. Subsided in approx 2-3 Hrs. It was worse that Flu-which I've had many years ago as a teen and once 30yrs ago.
Age: 86.0
Sex: F
Vaccine: UNK
Symptoms: Posture abnormal, Seizure
Clinical narrative: Later afternoon-1st shivers-Total Body, no control as of convulses-upset stomach-couldn't hold head up- 103 degree Temp. Totally non functional. Freezing cold. Could not get warm. Went to bed. Subsided in approx 2-3 Hrs. It was worse that Flu-which I've had many years ago as a teen and once 30yrs ago.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Contusion, Injection site urticaria, Pain, Pruritus, Swelling
Clinical narrative: Had GARDASIL shot on 11/27. On 11/29 started getting large, swollen, itchy hives that lasted 15 min. and left a sore spot (like a bruise) for 24-48 hours after. Hives have continued for past two weeks. Occur at random times but nearly every night after shower. The hives/welts are smaller and last a shorter length of time 4-5 min. and are less itchy. These occur all over the body, not just at the injection site.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Had GARDASIL shot on 11/27. On 11/29 started getting large, swollen, itchy hives that lasted 15 min. and left a sore spot (like a bruise) for 24-48 hours after. Hives have continued for past two weeks. Occur at random times but nearly every night after shower. The hives/welts are smaller and last a shorter length of time 4-5 min. and are less itchy. These occur all over the body, not just at the injection site.
Age: 30.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Pericarditis, Troponin I increased
Clinical narrative: This case was initially submitted by Sanofi Pasteur (mfg# 2017SA178016) Initial solicited report received on 21 September 2017 from an investigator (Defense Health Agency) in the trial. A 30 year-old male subject with dizziness/fainting spells, headaches and no other significant medical history.  The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 02 March 2017. On 11 March 2017, 09 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified. For subject, Troponin I value 00.06 abnormal done on 12 March 2017, ECG abnormal done on 12 March 2017, Echocardiogram abnormal done on 12 March 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the event, I30.9 acute pericarditis, unspecified was not reported. Relationship to investigational product according to company: associated List of documents held by sender: none. Follow up information received on 25 September 2017: Lab data was updated as on 12 March 2017, the troponin I results within 30 days post small pox vaccination was abnormal with highest value 0.06 ng/ml. Follow up information received on 28 September 2017. On 12 March 2017 (previously reported as 11 March 2017), 10 days after receiving the ACAM2000 on 02 March 2017, the subject was diagnosed with I30.9 acute pericarditis, unspecified. Additional information will be requested from the investigator.  Note: There is no reporter causality assessment as this is a safety surveillance (data mining, noninterventional) study. Follow up information received on 27NOV2017 from Sanofi-Aventis: On 12MAR2017, the subject had ECG showing borderline "T" abnormalities in inferior nodes with right axis deviation. Additional notes revealed a NSR of 85, T-wave inversion in V3 but no other acute changes. The echocardiogram performed on the same day, 12MAR2017, demonstrated pericardial effusion. on 13MAR2017, a follow up ECG showed STE in anterior/lateral leads clearly with early repolarization. Physician's impressions noted that the subject complained of nausea, migraines, and intermittent photophobia since the initial training regimen. The subject had episodes 1-2 times/month which worsened when lying flat, and he felt dizzy upon standing too fast or with sudden positional changes. It was also reported that the subject had Brain MRI which showed no evidence of significant intracranial abnormality or associated T2 signal abnormality. Patient was administered another type of medication for vertigo that appeared to help.
Age: 30.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Dizziness postural, Echocardiogram abnormal, Electrocardiogram ST segment elevation, Electrocardiogram T wave inversion, Electrocardiogram repolarisation abnormality
Clinical narrative: This case was initially submitted by Sanofi Pasteur (mfg# 2017SA178016) Initial solicited report received on 21 September 2017 from an investigator (Defense Health Agency) in the trial. A 30 year-old male subject with dizziness/fainting spells, headaches and no other significant medical history.  The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 02 March 2017. On 11 March 2017, 09 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified. For subject, Troponin I value 00.06 abnormal done on 12 March 2017, ECG abnormal done on 12 March 2017, Echocardiogram abnormal done on 12 March 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the event, I30.9 acute pericarditis, unspecified was not reported. Relationship to investigational product according to company: associated List of documents held by sender: none. Follow up information received on 25 September 2017: Lab data was updated as on 12 March 2017, the troponin I results within 30 days post small pox vaccination was abnormal with highest value 0.06 ng/ml. Follow up information received on 28 September 2017. On 12 March 2017 (previously reported as 11 March 2017), 10 days after receiving the ACAM2000 on 02 March 2017, the subject was diagnosed with I30.9 acute pericarditis, unspecified. Additional information will be requested from the investigator.  Note: There is no reporter causality assessment as this is a safety surveillance (data mining, noninterventional) study. Follow up information received on 27NOV2017 from Sanofi-Aventis: On 12MAR2017, the subject had ECG showing borderline "T" abnormalities in inferior nodes with right axis deviation. Additional notes revealed a NSR of 85, T-wave inversion in V3 but no other acute changes. The echocardiogram performed on the same day, 12MAR2017, demonstrated pericardial effusion. on 13MAR2017, a follow up ECG showed STE in anterior/lateral leads clearly with early repolarization. Physician's impressions noted that the subject complained of nausea, migraines, and intermittent photophobia since the initial training regimen. The subject had episodes 1-2 times/month which worsened when lying flat, and he felt dizzy upon standing too fast or with sudden positional changes. It was also reported that the subject had Brain MRI which showed no evidence of significant intracranial abnormality or associated T2 signal abnormality. Patient was administered another type of medication for vertigo that appeared to help.
Age: 30.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Migraine, Nausea, Nuclear magnetic resonance imaging brain normal, Pericardial effusion, Pericarditis
Clinical narrative: This case was initially submitted by Sanofi Pasteur (mfg# 2017SA178016) Initial solicited report received on 21 September 2017 from an investigator (Defense Health Agency) in the trial. A 30 year-old male subject with dizziness/fainting spells, headaches and no other significant medical history.  The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 02 March 2017. On 11 March 2017, 09 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified. For subject, Troponin I value 00.06 abnormal done on 12 March 2017, ECG abnormal done on 12 March 2017, Echocardiogram abnormal done on 12 March 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the event, I30.9 acute pericarditis, unspecified was not reported. Relationship to investigational product according to company: associated List of documents held by sender: none. Follow up information received on 25 September 2017: Lab data was updated as on 12 March 2017, the troponin I results within 30 days post small pox vaccination was abnormal with highest value 0.06 ng/ml. Follow up information received on 28 September 2017. On 12 March 2017 (previously reported as 11 March 2017), 10 days after receiving the ACAM2000 on 02 March 2017, the subject was diagnosed with I30.9 acute pericarditis, unspecified. Additional information will be requested from the investigator.  Note: There is no reporter causality assessment as this is a safety surveillance (data mining, noninterventional) study. Follow up information received on 27NOV2017 from Sanofi-Aventis: On 12MAR2017, the subject had ECG showing borderline "T" abnormalities in inferior nodes with right axis deviation. Additional notes revealed a NSR of 85, T-wave inversion in V3 but no other acute changes. The echocardiogram performed on the same day, 12MAR2017, demonstrated pericardial effusion. on 13MAR2017, a follow up ECG showed STE in anterior/lateral leads clearly with early repolarization. Physician's impressions noted that the subject complained of nausea, migraines, and intermittent photophobia since the initial training regimen. The subject had episodes 1-2 times/month which worsened when lying flat, and he felt dizzy upon standing too fast or with sudden positional changes. It was also reported that the subject had Brain MRI which showed no evidence of significant intracranial abnormality or associated T2 signal abnormality. Patient was administered another type of medication for vertigo that appeared to help.
Age: 30.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Photophobia, Troponin I increased, Vertigo
Clinical narrative: This case was initially submitted by Sanofi Pasteur (mfg# 2017SA178016) Initial solicited report received on 21 September 2017 from an investigator (Defense Health Agency) in the trial. A 30 year-old male subject with dizziness/fainting spells, headaches and no other significant medical history.  The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 02 March 2017. On 11 March 2017, 09 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified. For subject, Troponin I value 00.06 abnormal done on 12 March 2017, ECG abnormal done on 12 March 2017, Echocardiogram abnormal done on 12 March 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the event, I30.9 acute pericarditis, unspecified was not reported. Relationship to investigational product according to company: associated List of documents held by sender: none. Follow up information received on 25 September 2017: Lab data was updated as on 12 March 2017, the troponin I results within 30 days post small pox vaccination was abnormal with highest value 0.06 ng/ml. Follow up information received on 28 September 2017. On 12 March 2017 (previously reported as 11 March 2017), 10 days after receiving the ACAM2000 on 02 March 2017, the subject was diagnosed with I30.9 acute pericarditis, unspecified. Additional information will be requested from the investigator.  Note: There is no reporter causality assessment as this is a safety surveillance (data mining, noninterventional) study. Follow up information received on 27NOV2017 from Sanofi-Aventis: On 12MAR2017, the subject had ECG showing borderline "T" abnormalities in inferior nodes with right axis deviation. Additional notes revealed a NSR of 85, T-wave inversion in V3 but no other acute changes. The echocardiogram performed on the same day, 12MAR2017, demonstrated pericardial effusion. on 13MAR2017, a follow up ECG showed STE in anterior/lateral leads clearly with early repolarization. Physician's impressions noted that the subject complained of nausea, migraines, and intermittent photophobia since the initial training regimen. The subject had episodes 1-2 times/month which worsened when lying flat, and he felt dizzy upon standing too fast or with sudden positional changes. It was also reported that the subject had Brain MRI which showed no evidence of significant intracranial abnormality or associated T2 signal abnormality. Patient was administered another type of medication for vertigo that appeared to help.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Pericardial disease, Pericarditis, Troponin I increased
Clinical narrative: Initial solicited report received on 21 September 2017 from an investigator in a trial. A 22 year-old male subject with no significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000, (lot number, site of administration not reported) on 11 April 2017. On 22 April 2017, 11 days after vaccination the subject was diagnosed with disease of pericardium, unspecified and on 27 April 2017, 16 days after vaccination the subject was diagnosed with acute pericarditis, unspecified. For subject, Troponin I value 00.99, abnormal done on 21 April 2017, ECG not performed, Echocardiogram normal done on 24 April 2017. MRI of brain, spinal cord, heart, Lumbar puncture were not performed. The subject's treatments were not reported. The outcome of the events, disease of pericardium, unspecified and acute pericarditis, unspecified were not reported. Relationship to investigational product according to company: associated. List of documents held by sender: none. Follow up information received on 25 September 2017: Lab data was updated as, on 21 April 2017 the troponin I results within 30 days post smallpox vaccination was abnormal with highest value 0.99 ng/ml. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow up information received on 27NOV2017 from Sanofi-Aventis: On 24APR2017, the subject had echocardiogram which showed normal LV size and function, with EF 55-65% and normal diastolic parameter. No significant valvular disease, aortic stenosis or aortic regurgitation were seen. There was, however, mild tricuspid regurgitation with no evidence of tricuspid stenosis. There was no evidence of pulmonic valve stenosis or significance regurgitation.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram abnormal, Ejection fraction normal, Pericardial disease, Pericarditis, Tricuspid valve incompetence
Clinical narrative: Initial solicited report received on 21 September 2017 from an investigator in a trial. A 22 year-old male subject with no significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000, (lot number, site of administration not reported) on 11 April 2017. On 22 April 2017, 11 days after vaccination the subject was diagnosed with disease of pericardium, unspecified and on 27 April 2017, 16 days after vaccination the subject was diagnosed with acute pericarditis, unspecified. For subject, Troponin I value 00.99, abnormal done on 21 April 2017, ECG not performed, Echocardiogram normal done on 24 April 2017. MRI of brain, spinal cord, heart, Lumbar puncture were not performed. The subject's treatments were not reported. The outcome of the events, disease of pericardium, unspecified and acute pericarditis, unspecified were not reported. Relationship to investigational product according to company: associated. List of documents held by sender: none. Follow up information received on 25 September 2017: Lab data was updated as, on 21 April 2017 the troponin I results within 30 days post smallpox vaccination was abnormal with highest value 0.99 ng/ml. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow up information received on 27NOV2017 from Sanofi-Aventis: On 24APR2017, the subject had echocardiogram which showed normal LV size and function, with EF 55-65% and normal diastolic parameter. No significant valvular disease, aortic stenosis or aortic regurgitation were seen. There was, however, mild tricuspid regurgitation with no evidence of tricuspid stenosis. There was no evidence of pulmonic valve stenosis or significance regurgitation.
Age: 22.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Troponin I increased
Clinical narrative: Initial solicited report received on 21 September 2017 from an investigator in a trial. A 22 year-old male subject with no significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000, (lot number, site of administration not reported) on 11 April 2017. On 22 April 2017, 11 days after vaccination the subject was diagnosed with disease of pericardium, unspecified and on 27 April 2017, 16 days after vaccination the subject was diagnosed with acute pericarditis, unspecified. For subject, Troponin I value 00.99, abnormal done on 21 April 2017, ECG not performed, Echocardiogram normal done on 24 April 2017. MRI of brain, spinal cord, heart, Lumbar puncture were not performed. The subject's treatments were not reported. The outcome of the events, disease of pericardium, unspecified and acute pericarditis, unspecified were not reported. Relationship to investigational product according to company: associated. List of documents held by sender: none. Follow up information received on 25 September 2017: Lab data was updated as, on 21 April 2017 the troponin I results within 30 days post smallpox vaccination was abnormal with highest value 0.99 ng/ml. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow up information received on 27NOV2017 from Sanofi-Aventis: On 24APR2017, the subject had echocardiogram which showed normal LV size and function, with EF 55-65% and normal diastolic parameter. No significant valvular disease, aortic stenosis or aortic regurgitation were seen. There was, however, mild tricuspid regurgitation with no evidence of tricuspid stenosis. There was no evidence of pulmonic valve stenosis or significance regurgitation.
Age: 18.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Myocarditis, Pericarditis, Troponin I increased
Clinical narrative: Initial solicited report received from an investigator (Defense Health Agency) in the trial on 21 September 2017. An 18 year-old male subject with dizziness/fainting spells and no other significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 21 July 2017. On 31 July 2017, 10 days after vaccination the subject was diagnosed with I30.9 acute pericarditis,  unspecified and I51.4 myocarditis, unspecified. The lab data included, ECG- Abnormal, and Echocardiogram - Normal, Troponin I result abnormal 0.14, all three done were on 31 July 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the events, I30.9 acute pericarditis, unspecified and I51.4 myocarditis, unspecified was not reported. Relationship to investigational product according to company: associated List of documents held by sender: none. Follow up information received on 25 September 2017: Lab data was updated as, on 31 July 2017 the troponin I results within 30 days post small pox vaccination was abnormal with highest value 0.14 ng/ml. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow up information received on 27NOV2017 from Sanofi-Aventis: On 31JUL2017, the subject had an abnormal ECG which showed NSR with left ventricular hypertrophy, early repolarization and QT/QTc = 380/416ms. Cardiologist notes included: ECG showed diffuse concave STE with J-point notching, incomplete RBBB, no significant PR depression or elevation, and large peaked T-wave. No significant ectopy or arrhythmia or telemetry. Echocardiogram performed on the same day, 31JUL2017, indicated cavity size was normal, RVSF, LVDF parameters and wall motion were normal. Wall thickness was at the upper limits of normal. SF was normal. The estimated EF was 60-65%. No pericardial effusion was seen. Impressions: Client felt dizzy and lightheaded several months prior to vaccination where he was diagnosed with a an upper respiratory infection with a cough, nose bleed, night sweats, headache, sore throat, nasal congestion and nasal discharge. Patient was administered Lactated Ringers, Acetaminophen, Flonase, Claritin, Cepacol, and oral hydration. Extremely high levels of CK were found but started to dissipate two (2) days later. It was noted that subject's lightheadedness restarted again during another training exercise a month later with a diagnosis of Chondrocostal junction syndrome.
Age: 18.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Bundle branch block right, Echocardiogram normal, Ejection fraction normal, Electrocardiogram PR interval, Electrocardiogram QT shortened
Clinical narrative: Initial solicited report received from an investigator (Defense Health Agency) in the trial on 21 September 2017. An 18 year-old male subject with dizziness/fainting spells and no other significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 21 July 2017. On 31 July 2017, 10 days after vaccination the subject was diagnosed with I30.9 acute pericarditis,  unspecified and I51.4 myocarditis, unspecified. The lab data included, ECG- Abnormal, and Echocardiogram - Normal, Troponin I result abnormal 0.14, all three done were on 31 July 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the events, I30.9 acute pericarditis, unspecified and I51.4 myocarditis, unspecified was not reported. Relationship to investigational product according to company: associated List of documents held by sender: none. Follow up information received on 25 September 2017: Lab data was updated as, on 31 July 2017 the troponin I results within 30 days post small pox vaccination was abnormal with highest value 0.14 ng/ml. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Follow up information received on 27NOV2017 from Sanofi-Aventis: On 31JUL2017, the subject had an abnormal ECG which showed NSR with left ventricular hypertrophy, early repolarization and QT/QTc = 380/416ms. Cardiologist notes included: ECG showed diffuse concave STE with J-point notching, incomplete RBBB, no significant PR depression or elevation, and large peaked T-wave. No significant ectopy or arrhythmia or telemetry. Echocardiogram performed on the same day, 31JUL2017, indicated cavity size was normal, RVSF, LVDF parameters and wall motion were normal. Wall thickness was at the upper limits of normal. SF was normal. The estimated EF was 60-65%. No pericardial effusion was seen. Impressions: Client felt dizzy and lightheaded several months prior to vaccination where he was diagnosed with a an upper respiratory infection with a cough, nose bleed, night sweats, headache, sore throat, nasal congestion and nasal discharge. Patient was administered Lactated Ringers, Acetaminophen, Flonase, Claritin, Cepacol, and oral hydration. Extremely high levels of CK were found but started to dissipate two (2) days later. It was noted that subject's lightheadedness restarted again during another training exercise a month later with a diagnosis of Chondrocostal junction syndrome.