chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Oropharyngeal pain, SARS-CoV-2 test positive, Streptococcus test negative
Clinical narrative: First COVID vaccine (Pfizer EL1284) received 1/5/2021. No Reaction.  Second COVID vaccine (Pfizer EL9264) received 2/2/2021. No reaction  3/15/2021 had a sore throat and thought it was allergies but since I work in home health I decided to get a COVID and strep test. Strep test came back negative. 3/16/2021 COVID test came back positive. A family friend that is a PCP told me to fill this out so you knew. I am symptomatic and have informed my work and everyone I have been in contact with they are being tested this week.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Patient received second dose of moderna. Patient approached PHN in recovery after receiving vaccien to show PHN that left mid-arm was very swollen, far below injection site above crux  of elbow. PHN observed swollen area with Doctor. Doctor had patient wait for 30 minutes for observation and instructed to contact her doctor after she is done being observed.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: Extreme difficulty breathing and severe chest pain.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue
Clinical narrative: TEMPERATURE, JOINT PAIN, CHILLS, TIREDNESS PRESENTED AFTER 24 HOURS AND LASTED 12 HOURS AFTER 40 HOURS OF TAKING THE VACCINE TOOK TYLENOL 250  TIREDNESS AND JOINT PAIN LASTED FOR 3 DAYS
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Skin warm, Throat irritation
Clinical narrative: Had initial reaction within normal expected limits (red, swelling, itchy arm at injection site); reaction lasted about 2 days then got better. Exactly one week after receiving the vaccine, arm started getting itchy again and I noticed the evening of March 15 that it was red, warm, swollen, and itchy again. March 16 the swelling intensified and itch got worse. Went into the doctor to let them look at it the morning of March 17. Slight tickle in throat, but that could be due to seasonal allergies. No fever.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypoaesthesia, Pain in extremity
Clinical narrative: Left sided arm and facial redness and numbness for 2 hours that then went away with no other issues
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Faeces discoloured, Malaise, Urine analysis
Clinical narrative: Complaining of "not feeling well" the night after the vaccination and progressively got worse in the next days to come. Patient stated that he had been having black tarry stool and after a urine dip he was identified to have blood in his urine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Livedo reticularis
Clinical narrative: Red, raised circles on arm where injection was given.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: itching rash on vaccinated arm
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Amblyopia, Diarrhoea, Feeling abnormal, Headache, Malaise
Clinical narrative: nausea, headache, diarrhea, general feeling of being unwell. Most concerning to me is the affect on my left eye and eyes in general and headache. My left eye is wandering, like a "lazy" eye. It is as if my eye floats, and when this happens I am not able to focus. With the eye is also a frontal area headache and i get an uneasy feeling in my body just prior to this happening.  My reaction started around 5 hours after the vaccine shot. It is now four days later and my symptoms are less but still present around my eyes and headache.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vision blurred
Clinical narrative: nausea, headache, diarrhea, general feeling of being unwell. Most concerning to me is the affect on my left eye and eyes in general and headache. My left eye is wandering, like a "lazy" eye. It is as if my eye floats, and when this happens I am not able to focus. With the eye is also a frontal area headache and i get an uneasy feeling in my body just prior to this happening.  My reaction started around 5 hours after the vaccine shot. It is now four days later and my symptoms are less but still present around my eyes and headache.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Local pain, swelling, redness is expected and should; subside within the next 24-72 hrs. Advised may take Tylenol for pain, apply warm compresses to site and call back if any questions.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Injection site erythema, Pyrexia
Clinical narrative: Patient got her vaccination on Monday morning, called on Wednesday 03/17 around 12:20 and reported that she saw Blood in Urine started wedneday, Has fever after vaccination and red spot at injection site.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Hot flush, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Hot Flash with Sweats, Followed by fainting, Non-responsive, Elevated blood pressure
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dizziness, Dyspnoea, Full blood count normal, Hypertension
Clinical narrative: After the first injection, I noticed mild mouth tingling, but nothing else, did not report as it was so mild and it was more notable in retrospect.  A week after the first injection developed vertigo for the first time in my life.  This lasted about a week had mostly resolved when I got the second dose.  Immediately upon receiving the second dose I felt faint.  I went to the observation area and when the feeling got stronger, reported it.  My blood pressure was taken and although I always have normal blood pressure, it was extremely high - 195/100.  My heart was racing.  I was observed for longer because of this, and was asked to lie down.  The faint feeling and high blood pressure lasted 30 min, at which time it started to improve and was sent home.  I persisted in having bouts of feeling faint (but never fainting) in the days and weeks following, joined with shortness of breath which started the second day after the second injection. I also had the normal fever, aches and pains for 4 days.  It is now a month after the second injection, and while the faintness and vertigo are mostly gone,  I have persistent shortness of breath.  Prior to the vaccine I had an albuterol inhaler that I would use 1-5 times a year for allergies.  Almost never used it.  I began having to use it multiple times daily after the second dose of the vaccine.  I am not on a steroid inhaler.  I have never had shortness of breath like this before.  I was examined at the doctors office, not much can be seen that is wrong.   An allergist believes that I did not have an allergy because my blood pressure was high instead of low as in anaphylaxis.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Liver function test normal, Palpitations, Renal function test normal, Thyroid function test normal
Clinical narrative: After the first injection, I noticed mild mouth tingling, but nothing else, did not report as it was so mild and it was more notable in retrospect.  A week after the first injection developed vertigo for the first time in my life.  This lasted about a week had mostly resolved when I got the second dose.  Immediately upon receiving the second dose I felt faint.  I went to the observation area and when the feeling got stronger, reported it.  My blood pressure was taken and although I always have normal blood pressure, it was extremely high - 195/100.  My heart was racing.  I was observed for longer because of this, and was asked to lie down.  The faint feeling and high blood pressure lasted 30 min, at which time it started to improve and was sent home.  I persisted in having bouts of feeling faint (but never fainting) in the days and weeks following, joined with shortness of breath which started the second day after the second injection. I also had the normal fever, aches and pains for 4 days.  It is now a month after the second injection, and while the faintness and vertigo are mostly gone,  I have persistent shortness of breath.  Prior to the vaccine I had an albuterol inhaler that I would use 1-5 times a year for allergies.  Almost never used it.  I began having to use it multiple times daily after the second dose of the vaccine.  I am not on a steroid inhaler.  I have never had shortness of breath like this before.  I was examined at the doctors office, not much can be seen that is wrong.   An allergist believes that I did not have an allergy because my blood pressure was high instead of low as in anaphylaxis.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin reaction
Clinical narrative: Mild cutaneous reaction on upper left arm developed just below injection site  on Day 9 post vaccine.  Erythematous, pruritic area has expanded to approximately 7 cm length by 4 cm width.   Have taken cetirizine 5mg orally daily and hydrocortisone 1% cream topically twice daily since reaction developed.  Pruritis and redness improving.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Throat tightness
Clinical narrative: tightness in throat, hot, dizzy EMS called and pt refused to go to hospital reaction resolved
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: I don't know if I was given Adacel or Boostrix but I know it was a Tdap Vaccine. Approximately ~16 hours after getting my Tdap shot I started to feel symptoms of a normal immune response (fatigue, mild chills, etc). This proceeded to get much worse over the next 12 hours, resulting in a fever of 102F at 2am, approximately 36 hours after the vaccine. I have had Tdap vaccines before and never had this intense of an immune response. I am submitting this report because I had 2 doses of the Moderna COVID vaccine on 12/30/20 and 1/27/21 and what I felt after this Tdap vaccine was significantly worse than what I experienced after both of my COVID vaccines. I wonder if I got this Tdap too close to my last COVID vaccine, or if I had such a robust immune response to the COVID vaccine that now all my immune response to other vaccines are more robust as well? I am assuming the symptoms I am having (fever, chills, fatigue, body aches) are an immune response because I don't have any other respiratory symptoms or related ADE. The symptoms are decently controlled with schedule use of OTC Ibuprofen and Acetaminophen.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: pt was found unresponsive. Was hospitalized and kept overnight. Discharged approx 28 hours after admit.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Confusional state, Dysarthria, Incontinence, Pyrexia
Clinical narrative: pt was found unresponsive. Was hospitalized and kept overnight. Discharged approx 28 hours after admit.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash macular, Swelling face
Clinical narrative: After shot was administered we drove to the next door parking lot. By the time we arrived the right side of my face was red like someone slapped me and started to swell on the right side of my face and eye area. I had red splotches on my neck. We called a nurse over to our vehicle and I was immediately given 50mg of Benadryl and some apple juice to take it with. I was asked to stay to be monitored a total of 1 hour. Although the swelling and redness did not go down in that hour, it did not progress and get any worse. It took another 1/2 and hour for the swelling to start to go down.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Injection site pain, Muscle spasms, Nausea
Clinical narrative: Nausea lasted 2 days. Injection site pain lasted 2 days. Chills lasted 2 days. Upper back pain and spasms lasted 3 days.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Injection site swelling, Throat tightness
Clinical narrative: Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Embolic stroke
Clinical narrative: Acute Embolic Stroke (Diagnostic Code I63.9)
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Pain, Vomiting
Clinical narrative: Pt has been vomiting and experiencing extreme body aches, headache and SOB
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Myalgia, Pain in extremity
Clinical narrative: Sore arm shortly after the vaccination.  Muscle soreness in the area of the injection site, large red bumps, severe itchiness and swollen arm in the injection site (did not appear until 3/17...6 days after the initial shot).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Sore arm shortly after the vaccination.  Muscle soreness in the area of the injection site, large red bumps, severe itchiness and swollen arm in the injection site (did not appear until 3/17...6 days after the initial shot).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Computerised tomogram, Electrocardiogram, Painful respiration, Pleurisy
Clinical narrative: Hospitalization  Pleuritis  with Extreme pain upon breathing. Controlled with intravenous narcotics, oral agents at discharge Intermittent Atrial fibrillation
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vascular dissection
Clinical narrative: Hospitalization  Pleuritis  with Extreme pain upon breathing. Controlled with intravenous narcotics, oral agents at discharge Intermittent Atrial fibrillation
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Dyspnoea, Myalgia, Pyrexia
Clinical narrative: fever, chills, myalgias, SOB, increase in baseline cough. Some symptoms improving after 24 hours of onset but SOB and increase in cough still present at 72 hours post-vaccination.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Headache-Medium
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: She got the vaccine, she had no effects, and no reaction whatsoever. The husband had no side effects either.   On 3/16/21 they were on their way to go to bed and the bedroom is upstairs and she was fine, she was in the bedroom getting ready for bed, and her husband followed 15 minutes later and when he got upstairs she was sitting in a chair next to the bed, and he noticed that when he spoke with her that she did not speak clearly back, and was very low tone, not much loudness to her speech.  He didn't think much about it, and he talked with her again and noticed that she seemed to be having some difficulty talking, but he could understand what she was saying if he paid close attention.  He then realized that something was wrong, and asked her how she felt and she said she felt strange.  She was trying to take a pair of socks off and could not reach them.  She tried to lift her leg to put one knee over the other for her to remove them and was not able to do that.  He helped her take the socks off, she wanted to put some cream on her foot and was not able to do so, which is her usual routine.  He put that on her foot while he was talking to her, and her speech was different than it was earlier.  She was wearing a turtle neck shirt and was not able to take it off to get dressed for bed.  Her husband assisted in dressing her to get ready for bed.  He was thinking that she may have been having a mini-stroke.  She tried to get up from the chair and was not able to get up on her own.  He went to try to help her to lift her and it was hard.  When she did get her bottom up off the chair she stayed in a bent position and was not able to stand up.  He put her back down on the chair and tried some more times, and ultimately able to get up and he was able to get her into the bed (the chair was next to the bed).  She could sit on the edge of the bed, but was not able to move her legs on her own to get into the bed.  He struggled to get her in the bed and was not in a mood to talk and just leaned over on one side to try to go to sleep.  He told her he was going to get the walker in the basement for her to use.  He brought up the walker and put in by the bed, and informed her that it was there, and reached to see where it was in the event that she needed to use it through the night.  She did get up around 3:15 this morning to use the bathroom and her husband asked if she needed assistance, and she said that she was able to get up and go to the bathroom, and moved her legs just slow and was able to use the walker.  She was feeling much better at that time.  She got up one more time during the night and was not in need of the walker and was back to bed.  This morning when they got up at 8:00 Am and she was back to her normal self.   She came down the steps and was like nothing had ever happened.  They called her son who works in the hospital and he told them to call us to see if there were any other people that had the same reaction.    She stated while he was giving me this information that she did not recall a lot of the events that he was telling me.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations, Throat tightness
Clinical narrative: Vaccine administered at 1145. At 1200 patient reported that her heart was racing, dizziness, lightheadedness, and throat feeling "tight." BP 110/70. Symptoms progressed. 911 Called. EpiPen administered in L thigh at 1210. 1211 BP 112/60, still complaining of "throat swelling" and lightheadedness. EMS arrived at 1213 and transported patient by ambulance to Hospital emergency department at 1217.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia oral, Oropharyngeal pain, Paraesthesia, Throat tightness
Clinical narrative: Within 10 minutes got  blurred vision and felt like going to faint.   happened 3 times during first 30 minutes happened 3 times.  Felt like throat was tight when swallowing .   Face started to tingle and numbness lips and tongue for about 5 minutes , Tightness in throat for  2 hours . went back to Cvs  and stayed for a an hour .   Felt like swelling of throat for the first night .   2 days had a sore throat ,  little by little went away.    took 3 days to swallow normal.    Called her doctor for advice on second short
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Within 10 minutes got  blurred vision and felt like going to faint.   happened 3 times during first 30 minutes happened 3 times.  Felt like throat was tight when swallowing .   Face started to tingle and numbness lips and tongue for about 5 minutes , Tightness in throat for  2 hours . went back to Cvs  and stayed for a an hour .   Felt like swelling of throat for the first night .   2 days had a sore throat ,  little by little went away.    took 3 days to swallow normal.    Called her doctor for advice on second short
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Laboratory test
Clinical narrative: After receiving the first dose on February 12, 2021 I noticed more fatigue. I had labs on February 15th. My tacrilimus increased slightly and my CMV viral load increased. After the 2nd dose on March 12, 2021, the fatigue was slightly worse. When labs were done again on March 15th, the tacilimus increased again and Dr reduced the dosage.The CMV increased more. There were no changes to the anti-viral med. Dr was also notified but have not heard back from her.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: The day after vaccination I had fever chills and my Lymph node in my right armpit got swollen as big as a golf ball. It was sore, the pain was constant and went down after a week and half.  I had a phone consult with my doctor, No symptoms after the first dose of vaccine.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Livedo reticularis
Clinical narrative: Red heated circular rash on upper arm near injection site
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pain
Clinical narrative: Pain at site of injection, beginning in the evening, first noticed around 8:30 pm. Upon going to bed, noted a slight headache. Upon waking around 5:30 am, noted general achiness over my body, slight headache continuing. Around 6:00 am, took Tylenol for the headache and body pain, by 11:00 am headache has gone, body achiness has largely subsided.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Sudden syncope - under one minute
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed level of consciousness, Pulse abnormal, Pulse absent
Clinical narrative: Pt. was vaccinated on 3/17/21 at 0924. At 0940, pt. had bounded carotid pulse and decrease level of consciousness. Pt. progressed to having no pulse and chest compressions were given for about 1 minute. Pt. was given 6L of O2 and 9-1-1 was called. Pt. regained consciousness at 0945. BP 140/90, HR 62. Ambulance arrived at 0953 and pt. was assessed by EMT. Pt.?s daughter provided pt.?s medical history. Pt. has history of passing out, atrial fibrillation and seizures. Pt. left via ambulance at 1003.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure decreased, Feeling abnormal
Clinical narrative: Patient states he "felt weird", tingly all over and extremely anxious. Patient was brought to observation for continued care. vs: P-92 r-16 b/p 174/92.  Repeat b/p after 15 minutes was 124/90. Patient feeling much better. Now states he had been very anxious about receiving vaccine.  B/P cuff recycled  it did not measure correctly- air in cuff. Repeated and up to 170/90, patient states it went up because he was worried about the cuff. Refused to have any more vital signs. Ambulated in unit, did well. Discharged home after 30 minutes.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain, Pyrexia
Clinical narrative: Diarrhea, body aches, and fever.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Fatigue, Flatulence, Full blood count
Clinical narrative: 3/7/2021  at 2am  woke with liquid diarrhea, nausea and vomiting, and severe headache.  She took Advil once late afternoon 3/7.  Headache lasted a couple of days.   Vomiting lasted 24 hr.  Three liquid diarrhea stools/hr for 24 hr, then liquid stools approx once every hour to hour and a half.  Started Imodium on 3/9 and continued to have  liquid diarrhea stools 5-6 times in 24 hours.  Reports significant bloating and gas.   Last Imodium dose 3/12.  Diarrhea stopped 3/13.   She had severe fatigue from 3/7 until 3/13.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lipids, Metabolic function test, Nausea, SARS-CoV-2 antibody test
Clinical narrative: 3/7/2021  at 2am  woke with liquid diarrhea, nausea and vomiting, and severe headache.  She took Advil once late afternoon 3/7.  Headache lasted a couple of days.   Vomiting lasted 24 hr.  Three liquid diarrhea stools/hr for 24 hr, then liquid stools approx once every hour to hour and a half.  Started Imodium on 3/9 and continued to have  liquid diarrhea stools 5-6 times in 24 hours.  Reports significant bloating and gas.   Last Imodium dose 3/12.  Diarrhea stopped 3/13.   She had severe fatigue from 3/7 until 3/13.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 3/7/2021  at 2am  woke with liquid diarrhea, nausea and vomiting, and severe headache.  She took Advil once late afternoon 3/7.  Headache lasted a couple of days.   Vomiting lasted 24 hr.  Three liquid diarrhea stools/hr for 24 hr, then liquid stools approx once every hour to hour and a half.  Started Imodium on 3/9 and continued to have  liquid diarrhea stools 5-6 times in 24 hours.  Reports significant bloating and gas.   Last Imodium dose 3/12.  Diarrhea stopped 3/13.   She had severe fatigue from 3/7 until 3/13.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Myalgia
Clinical narrative: Swelling, itchiness at injection site. Muscle aches. Swelling, itchiness, subside but reappear after a few days and it is still present 2 weeks after injection
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Cough, Pruritus, Wheezing
Clinical narrative: 67 year old female with PMH of HTN, HFpEF, history of DVT, obesity, migraines, gastroparesis, Sicca symptoms, asthma, chronic bronchitis, and GERD who presents with anaphylactic reaction s/p COVID vaccine administration.   Received COVID vaccine across the street (<1 minute EMS ride)  C/o itching, cough, and wheezing shortly after  No respiratory distress or hypoxia en route  Received IM epi (2 weeks expired) and Benadryl PTA  Symptoms improving now  Has extensive allergy list  Review of Systems     10 point ROS completed and negative except noted in HPI above  Physical Exam/Objective  Vitals & Measurements last 24 hours  VITAL SIGNS  Temp C:       36.3 DegC  Heart Rate:       87 bpm  Resp Rate:       16 br/min  BP #1:       139 / 59 mmHg  SpO2 (%):       99 %  O2 Device:       Room air     Height CM: 152.4 cm  Ideal Body Weight: 45.5 kg     General: NAD, well-nourished Eyes: No scleral icterus, EOMI HENT: Normocephalic, atraumatic, no airway edema Neck: Supple, intact range of motion Respiratory: Lungs CTAB, symmetric chest wall expansion, no wheezes, speaking in full sentences Cardiovascular: RRR, no murmur, +2 peripheral pulses Abdomen: Soft, NTTP, non-distended Musculoskeletal: No gross deformity Integumentary: Intact, warm, dry, no rashes Neurologic: A&O x 3,  no focal deficits Psychiatric: Cooperative, appropriate mood and affect  Medical Decision Making     67 year old female with extensive PMH including asthma, chronic bronchitis, and GERD who presents with anaphylactic reaction s/p COVID vaccine administration. Has long list of allergies. On exam, airway intact, no respiratory distress, no wheezing, speaking in full sentences, C/o subjective itching and cough that is starting back up.   IV methylprednisone  IV famotidine  Albuterol PRN  Benadryl PRN  Observe  Rx EpiPen upon discharge     Re-Assessment  Observed for >4 hours  Symptoms resolved  Counseled patient on EpiPen use and gave strict return precautions  Has albuterol and Benadryl in her purse  Has had many reactions in the past and is very familiar with how to manage them  Discharge home with daughter
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Nausea, Pyrexia
Clinical narrative: Extreme headache, fever, nausea, leg cramps
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: passed out  VOMITING DIDN'T TAKE TYLENOL couldn't open mouth PRESSURE TOP OF HEAD
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on left/right arm and  to lower ribs. Continues to spread to right wrist. Consulted MD and was prescribed mometasone furoate0.1%. Has helped some but hasn't cleared completely.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site nodule, Lymphadenopathy, Pruritus, Skin warm
Clinical narrative: Tennis ball size (diameter) knot at injection site, very itchy and hot to the touch. Sore lymph nodes under arm, on the same arm as the injection.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood test, Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: Heart was in A-fib, blood clot formed and had a Left Posterior Parietal Stroke
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Heart was in A-fib, blood clot formed and had a Left Posterior Parietal Stroke
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: cheeks red,   caller states this is her cousin who just texted her to say her symptoms resolved
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: 4" round red circle developed on patient's left arm approximately one week after receiving vaccine
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Fatigue, Hypoaesthesia oral, Pruritus
Clinical narrative: Numbness in mouth, lips teeth, Redness in face, itching on face and head, rash across arms and chest. Joint pain, fatigue. Took Benadryl went to bed.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Numbness in mouth, lips teeth, Redness in face, itching on face and head, rash across arms and chest. Joint pain, fatigue. Took Benadryl went to bed.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Death, General physical health deterioration
Clinical narrative: Deceased Narrative: This was a 77 yo F with h/o HFpEF, afib (warfarin), COPD, obesity hypoventilation syndrome, OSA on BiPAP, T2DM, RA, L-sided follicular bronchitis and newly diagnosed probably malignant pulmonary process. Patient was admitted to facility 9/26-10/15 for acute on chronic hypercarbic respiratory failure with persistent O2 requirement despite treatment for CAP, COPD and CHF exacerbation. Patient then underwent high dose steroid taper per Rheum. Patient presented an overall poor state of health and was at high risk of complications with any procedures and was not a candidate for systemic therapy for a malignancy based on functional status. Patient was accepting of terminal diagnosis and transitioned to comfort measures at home.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Acute left ventricular failure, Deep vein thrombosis, Pleural effusion, Pulmonary embolism
Clinical narrative: Pulmonary Embolism Narrative: Patient was hospitalized with acute pulmonary embolis on 2/12/2021. Was started on Eloquis and discharged on 2/15/2021, with primary diagnosis of acute PE and BLE DVT. Secondary diagnosis of acute systolic heart failure with bilateral pleural effusions. On 2/17 we got notification that patient was placed on hospital.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: death Narrative: Pt received 1st moderna covid vaccine 2/12/2021 and passed away of unknown causes 2/12/2021 Pt 76 year old with AAA,HTN,CKD,COPD
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Dizziness, Pulseless electrical activity, Resuscitation, Syncope
Clinical narrative: cardiac arrest Narrative: Per medics, Patient was gardening when he stated he felt dizzy and collapsed. Wife started CPR until medics arrived. Patient arrived at the hospital after 20min of pulseless V tach and 10 min of PEA.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Ventricular tachycardia
Clinical narrative: cardiac arrest Narrative: Per medics, Patient was gardening when he stated he felt dizzy and collapsed. Wife started CPR until medics arrived. Patient arrived at the hospital after 20min of pulseless V tach and 10 min of PEA.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: death Narrative: Patient received COVID vaccine # 1 on 1/6/2021, on 1/23/21 his wife reported to the facility that he passed away. Notes in database do not mention cause of death or where death occurred. There are no scanned records in database with any detail either.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Cardiac failure acute, Cardiac failure congestive, Condition aggravated, Cough
Clinical narrative: Narrative: Dose #1 of vaccine was administered 2/6/21, per daughter's report patient became ill 3 days later (cough) and was taken to local hospital and was discharged with diagnosis of CAP, NSTEMI and acute on chronic CHF exacerbation. Discharged home on hospice where he passed away at home on 2/20/21.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Malaise, Pneumonia
Clinical narrative: Narrative: Dose #1 of vaccine was administered 2/6/21, per daughter's report patient became ill 3 days later (cough) and was taken to local hospital and was discharged with diagnosis of CAP, NSTEMI and acute on chronic CHF exacerbation. Discharged home on hospice where he passed away at home on 2/20/21.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient died unrelated to covid vaccine Narrative: The patient had advanced Alzheimer's disease and severe dementia. Patient received the first dose of Moderna vaccine on 1/7/2021 and no adverse reaction was reported. Placed in hospice care and passed away on 1/29/2021. Cause of death not documented. No indication that death was related to COVID 19 vaccination.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death Narrative: Patient was outpatient. There was no information or document notes about reactions, underlying or active conditions between the time patient came in for the first Pfizer dose and their death.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug reaction with eosinophilia and systemic symptoms, Rash
Clinical narrative: painful rash, and drug induced hypersensitivity syndrome.; painful rash, and drug induced hypersensitivity syndrome.; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 57 or 58-year-old patient of unknown gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 28-MAY-2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (dose, dose number, route, anatomical site of vaccination, lot # and expiration date were not provided). On an unknown date (reported as subsequently), the patient was treated by health care providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) used: painful rash and drug induced hypersensitivity syndrome (drug reaction with eosinophilia and systemic symptoms). The outcome of drug reaction with eosinophilia and systemic symptoms and rash was unknown. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Upon internal review, drug reaction with eosinophilia and systemic symptoms was considered a medically significant event.
Sex: U
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: numbness; This case was reported by a consumer via interactive digital media and described the occurrence of numbness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included oral herpes (Doctor confirmed the diagnosis as shinglesblisters.) and blister. Previously administered products included Shingles shot (received on an unknown date) and Mouthwash (need to do mouthwash sloushes in mouth 3 or 4 times a day).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced numbness. On an unknown date, the outcome of the numbness was unknown.   It was unknown if the reporter considered the numbness to be related to Shingles vaccine.  Additional details provided as follow: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient never heard about shingles in mouth. The patient received original shingles shot which was came out a year or so before the shingles episode. The patient stated, one time occurrence of shingles was enough for him/her. The patient also received new shingles shot but still had numbness.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR048290:same reporter US-GLAXOSMITHKLINE-US2021AMR048290:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: slightly sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date 1st dose was received refer case no US2021AMR058889).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. Six months after 1st vaccination patient had recived second dose of vaccine and had almost no side effects other than a slightly sore arm. The reporter enquired was it normal to have almost no side effect after the second shot. This case has been linked with US2021AMR058889 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR058889:same patient - 1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Having it; Painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient stated that had shot but it did not stop from having shingles now for 15 months and it was still painful. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The reporter's friends husband had a vaccination and still got shingles. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient got shingles as side effect to the shingles shot. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: got the shingles about 2 years later/ Suspected vaccination failure; Shingles; Awful. Two trips to the E.R.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feels awful. On an unknown date, the outcome of the vaccination failure, shingles and feels awful were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient had the shingles shot about 3 years before the date of reporting and about 2 years later the patient experienced the shingles and was awful. The patient had two trips to the emergency room (ER). This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule and laboratory confirmation for shingles were unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Diarrhoea
Clinical narrative: Dehydration; Orthostatic positive with liquid watery stool/continues with liquid stool; Frequent diarrhea defined as hourly stool; A spontaneous report was received from a nurse practitioner concerning a 48-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dehydration, frequent diarrhea defined as hourly stool, orthostatic positive with liquid watery stool/continues with liquid stool.  The patient had a history of colon cancer with a colon resection. No relevant concomitant medications were reported.  On 04 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot: not provided) for prophylaxis of COVID-19 infection.  On 06 Feb 2021, the patient had frequent diarrhea defined as hourly stool. On 09 Feb 2021, she was hospitalized for 48 hours due to dehydration. She was doing fine. On 13 Feb 2021, despite the medications she was back to orthostatic positive with liquid watery stool. On 08 Mar 2021, patient continued with liquid stool. Treatment included cholestyramine, fiber, loperamide hydrochloride.  The seriousness criterion for the event dehydration was hospitalization.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event of dehydration was resolved on an unknown date in Feb 2021. The outcome of the event, frequent diarrhea defined as hourly stool was considered as resolved. The outcome of the event, orthostatic positive with liquid watery stool/continues with liquid stool was not resolved.  The reporter did not provide an assessment for the events dehydration, frequent diarrhea defined as hourly stool, orthostatic positive with liquid watery stool/continues with liquid stool.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Patient was erroneously given Pfizer instead of Moderna for dose 2. Patient was contacted to notify patient and to follow-up if patient had any side effects. No side effects noted by patient during call.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Dizziness, Hypotension, Loss of consciousness
Clinical narrative: 103 temperature,  loss of consciousness, low BP.  Dizziness.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches and fever
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Allergic sinusitis, Cardiac disorder, Cough, Heart rate increased
Clinical narrative: I immediately had an increase in heart rate to 110 bpm.  after getting the injection.  I sat for 30 minutes instead of the 15. My heart rate still continued to stay high.  I drove home and continued to monitor my heart rate.  My heart rate stayed elevated for the remainder of the evening.  The lowest was around 99 bpm when I retired to bed.  Woke the next morning with a heart rate in the 80's.  Normally my resting heart rate is around 62 bpm. Within 24 hours, my heart rate was back to normal. As of today, my heart rate is back to normal.    I have a slight cough, but I believe that is due to my sinus allergies.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Immediate post-injection reaction, Throat irritation
Clinical narrative: Janssen COVID-19 Vaccine EUA Patient received J&J COVID vaccination at 1430 on 3/10. Patient reports immediately feeling "scratchy throat and hoarse voice." Patient took 50 mg Benadryl PO, then went to urgent care where she received 10 mg dexamethasone PO and 40 mg famotidine PO. Patient reports symptomatic improvement, but continued scratchiness to throat and "voice sounding off."  Patient presented to the ED and received 0.3 mg IM epinephrine.  Epinephrine administered with significant symptomatic improvement. No findings of angioedema on exam. Patient breathing comfortably without signs of impending airway compromise. Patient observed for 4 hours following epinephrine administration. Hoarseness resolved.  Patient discharged home.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Vasovagal syncope
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chest discomfort, Dizziness, Ear disorder, Immediate post-injection reaction
Clinical narrative: Received vaccine stood up immediately felt light headed, off balance, tachycardia, weak in the knees.  Sat for 15 minute taking deep breaths and symptoms resolve.  8-10 hour late at bedtime felt all above symptoms again plus heighten hearing and tunnel vision.  Again took deep breaths and symptoms resolved  For the week after was having chest tightness, frequently but has become intermittent.  PCP thinks may be anxiety.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Tachycardia
Clinical narrative: Received vaccine stood up immediately felt light headed, off balance, tachycardia, weak in the knees.  Sat for 15 minute taking deep breaths and symptoms resolve.  8-10 hour late at bedtime felt all above symptoms again plus heighten hearing and tunnel vision.  Again took deep breaths and symptoms resolved  For the week after was having chest tightness, frequently but has become intermittent.  PCP thinks may be anxiety.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Chills, Fatigue, Headache
Clinical narrative: The injection was painful going in. No other symptoms on the day-of. The following day, the injection sight was painful to the touch. I had body and muscle aches in my full body including neck, back, abdomen area, legs, and arms. I had a headache most of the day. I had the chills throughout the full day and had on and off nausea. I was extremely tired and stayed in bed almost all day. 2 days after the vaccine, all of these symptoms were gone except the injection sight is still slightly tender 4 days later.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Nausea, Neck pain, Pain
Clinical narrative: The injection was painful going in. No other symptoms on the day-of. The following day, the injection sight was painful to the touch. I had body and muscle aches in my full body including neck, back, abdomen area, legs, and arms. I had a headache most of the day. I had the chills throughout the full day and had on and off nausea. I was extremely tired and stayed in bed almost all day. 2 days after the vaccine, all of these symptoms were gone except the injection sight is still slightly tender 4 days later.