chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: One week after receiving my first dose of the Pfizer vaccine, I noticed heart palpitations as I was sitting in the car on a trip. These became more frequent in the days and weeks that followed. I tried to ignore them and hoped they would just go away, but in March, while driving my daughter, my heart felt very jumpy and would not calm down. I had an uncomfortable feeling in my chest. I had no idea what was happening so I made an appointment with doctor. He listened to my heartbeat, ran an EKG, and confirmed that I was having a lot of irregular beats and referred me to a cardiologist. I saw doctor on March 31 who also listened to my heartbeat, ran an EKG and attached a week long heart monitor  to my chest to see how often the extra beats were happening. At this time, I was not having extra beats all the time, only occasionally. After the monitor, my heart palpitations became more relentless. I had trouble sleeping at times, and I noticed my heart pounding all the time. Doctor then scheduled an ultrasound on June 1. The ultrasound showed that everything about my heart was healthy and normal except that the lower chamber was beating early. She referred me to doctor who explained what could be done to fix it. I do not want to have a procedure to fix this problem. I am still hopeful that it will go away on its own. I have had several weeks of normal heartbeats but then the palpitations come back again!
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Patient received Janssen COVID-19 Vaccine on 04/02/2021 as per immunization Records Patient received first dose Pfizer COVID-19 vaccine on 8/31/2021 at the vaccine station by registered nurse patient denied and attested never receive any Covid-19 vaccine in the past  No adverse reaction reported by the patient
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: On the day after receiving the first Shingrix injection, I experienced severe pain and a red rash that began 3 inches below injection site. Rash and pain extended 6 inches down upper arm and about 3 inches across. Pain diminished after 4 days but arm still sore on sixth day. Itching was intense on day 5. Rash color faded on sixth day and itching was minimal. Overall, it felt and looked like a brief case of shingles, which I have had in the past.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Computerised tomogram head normal, Differential white blood cell count, Dizziness, Electrocardiogram normal
Clinical narrative: In the evening of 3/25/21, I felt excruitiating pain in the left shoulder/arm.  Took Tylenol 500mg at bedtime as instructed by nursing clinic that administered the vaccine earlier that day.  Over the next couple of days, pain was not improving and I was unable to reach behind with left arm.  Continued to take Tylenol 500mg as needed for pain.  On 4/1/21, experienced dizziness that resulted in going to the ER.  Imaging and blood work was performed.  D/C home same day with instructions to f/u with PCP.  Saw PCP on 4/5/21 for f/u for continued dizziness and muscle pain in left arm.  Medications prescribed. Contacted PCP regarding continued pain in left shoulder.   MRI of left shoulder ordered by PCP.  Due to MRI findings, PCP referred me to orthopedic specialist for further evaluation/SIRVA injury.  Orthopedic prescribed medication and exercise handouts.  CDC contacted me and recommended I complete an AE on VAERS concerning this information as I am still experiencing left shoulder shoulder/arm issues.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Injected limb mobility decreased, Magnetic resonance imaging joint, Metabolic function test, Myalgia
Clinical narrative: In the evening of 3/25/21, I felt excruitiating pain in the left shoulder/arm.  Took Tylenol 500mg at bedtime as instructed by nursing clinic that administered the vaccine earlier that day.  Over the next couple of days, pain was not improving and I was unable to reach behind with left arm.  Continued to take Tylenol 500mg as needed for pain.  On 4/1/21, experienced dizziness that resulted in going to the ER.  Imaging and blood work was performed.  D/C home same day with instructions to f/u with PCP.  Saw PCP on 4/5/21 for f/u for continued dizziness and muscle pain in left arm.  Medications prescribed. Contacted PCP regarding continued pain in left shoulder.   MRI of left shoulder ordered by PCP.  Due to MRI findings, PCP referred me to orthopedic specialist for further evaluation/SIRVA injury.  Orthopedic prescribed medication and exercise handouts.  CDC contacted me and recommended I complete an AE on VAERS concerning this information as I am still experiencing left shoulder shoulder/arm issues.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Shoulder injury related to vaccine administration, Troponin, Urine analysis
Clinical narrative: In the evening of 3/25/21, I felt excruitiating pain in the left shoulder/arm.  Took Tylenol 500mg at bedtime as instructed by nursing clinic that administered the vaccine earlier that day.  Over the next couple of days, pain was not improving and I was unable to reach behind with left arm.  Continued to take Tylenol 500mg as needed for pain.  On 4/1/21, experienced dizziness that resulted in going to the ER.  Imaging and blood work was performed.  D/C home same day with instructions to f/u with PCP.  Saw PCP on 4/5/21 for f/u for continued dizziness and muscle pain in left arm.  Medications prescribed. Contacted PCP regarding continued pain in left shoulder.   MRI of left shoulder ordered by PCP.  Due to MRI findings, PCP referred me to orthopedic specialist for further evaluation/SIRVA injury.  Orthopedic prescribed medication and exercise handouts.  CDC contacted me and recommended I complete an AE on VAERS concerning this information as I am still experiencing left shoulder shoulder/arm issues.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Grip strength decreased, Muscular weakness, Nervousness
Clinical narrative: Dry mouth shortly after shot and still present Second day: weak arm- inability to grasp and hold things easily in the arm the vaccine was administered. Also arm was a bit shaky especially holding items roughy 5+ pounds.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Patient said she developed cold sores within hours of vaccination
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Feeling hot, Syncope
Clinical narrative: Patient is a 40 year old who came to the pharmacy  today to get her first COVID-19 immunization. She received the Pfizer shot in her right deltoid. After the shot she complained about being hot and feeling light headed. I decided to keep her in the room and observe her because she mentioned she has experienced fainting from drawing blood before which she didn't mention on her PQCF form. Her condition deteriorated in a few minutes of feeling lighted headed which led to fainting in the chair. We activated CODE WHITE and called 911 for EMS. I was with her all that time and when she fainted. Her condition did not last long and started improving  with in a few minutes. She responded when I called her name and started recovering. The whole episode took about 5 minutes. She was fully recovered when EMS arrived. She refused medical care from EMS. She waited about 15 minutes longer before letting her go.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Mobility decreased
Clinical narrative: Shortly after getting vaccinated, my arms and legs felt as if they weighed a ton. I could move, but with difficulty. This lasted for approximately 2 hours.  I have a severe phobia of needles and usually feel weak, but the heaviness has not happened before.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chest pain, Dizziness, Electrocardiogram, Headache
Clinical narrative: Blurry vision, dizzy, light headed, chest pain, pain with breathing, abdominal cramping, headache. I became dizzy, light headed, and got blurry vision within the first 5 minutes after my dose. The other symptoms started within the first hour of the vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Painful respiration, Vision blurred
Clinical narrative: Blurry vision, dizzy, light headed, chest pain, pain with breathing, abdominal cramping, headache. I became dizzy, light headed, and got blurry vision within the first 5 minutes after my dose. The other symptoms started within the first hour of the vaccine.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injected limb mobility decreased, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Possible SIRVA injury. Patient stated difficult to move arm and tingling sensation. Pain is radiating throughout shoulder and arm. Was told to self treat with Tylenol and ibuprofen until recovery by provider.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Peripheral swelling
Clinical narrative: Swelling that resulted in limited arm movement. Self treated with tylenol.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Mobility decreased, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Patient stated that her arm was swollen and had a large, orange shaped swollen lump the size of a baseball. The swollen lump had shrunk to the size of a plum but was still bruised. She also reported fevers since vaccination and pain and itchiness and tingling running up and down her entire arm since vaccination. She reported her arm being very painful and being unable to move it after vaccination.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: Patient stated that her arm was swollen and had a large, orange shaped swollen lump the size of a baseball. The swollen lump had shrunk to the size of a plum but was still bruised. She also reported fevers since vaccination and pain and itchiness and tingling running up and down her entire arm since vaccination. She reported her arm being very painful and being unable to move it after vaccination.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Appendicitis, Blood test, Ultrasound scan abnormal
Clinical narrative: One week after second dose of the Pfizer Covid vaccine, my son had terrible stomach pain which ended up being an inflamed appendix/appendicitis which resulted in an appendectomy.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chronic lymphocytic leukaemia, Lymphocyte count normal, White blood cell count increased
Clinical narrative: 1 month post vaccine patient developed Chronic Lymphoid Leukemia. Pt had a normal routine exam with her previous PCP in Dec of 2020 with no issues on her routine labs. 1 month post vaccine she did develop CLL. She is following with oncology for now and they are monitoring her labs.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymph gland infection, Myalgia
Clinical narrative: Muscle ache; headache; fatigue; infected lymph node.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site erythema, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: Large lump at the vaccination site, sore, red, swelling, extreme pain, unable to lift arms or reach
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Dizziness, Fatigue, Hyperhidrosis, Injection site erythema
Clinical narrative: Red, raised, painful and itchy at injection site. I noticed this within a few hours of receiving the injection.  Around noon the next day, I started having horrible body aches, raised temperature (99'), fatigue and dizziness. I am on day 3 and the only change is that body aches are now slight and temperature is gone. Though I am still sweating for no reason, arm is still raised, red, itchy and painful and I'm still somewhat dizzy.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: Red, raised, painful and itchy at injection site. I noticed this within a few hours of receiving the injection.  Around noon the next day, I started having horrible body aches, raised temperature (99'), fatigue and dizziness. I am on day 3 and the only change is that body aches are now slight and temperature is gone. Though I am still sweating for no reason, arm is still raised, red, itchy and painful and I'm still somewhat dizzy.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient was vaccinated last on 8/26/21 and came back to pharmacy on 8/31/21. Patient was experiencing hives and pruritis throughout his  whole body. While consulting wit the patient, his symptoms were getting worse and was recommended to see a physician for more thorough evaluation. Patient did not have a history of allergies nor was exposed to any biting insects around the area.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Aortic valve incompetence, Brain scan normal, Cardiac murmur, Echocardiogram abnormal, Vertigo
Clinical narrative: 2/13/21 severe Vertigo - starts , 3/2/21  sought medical attention dr. office,  3/8/21 second appt. to address severe vertigo,   3/8/21 heart murmur discovered at vertigo appointment, referred to head & neck dept. and referred for an echocardiogram,  and physical therapy,  3/9/21, Physical therapy appt.,   3/19/21 brain scan,  4/12/21 echocardiogram
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Vaginal bleeding began approximately 4 hours after vaccine.  Still happening the next day.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Dyspnoea, Insomnia, Pain
Clinical narrative: I woke up at around 12:22 am to chest pain radiating to my left shoulder blade and shortness of breath with a pain rating of 6/10 worsening when lying flat on my back or becoming active. I figured I slept wrong so tossed and turned and went back to bed. Later that day around 6 pm I got stung twice by a wasp on my right middle finger. Normally nothing happens but small dots appearing where I was stung but this time within 1 hour my whole right hand swelled up. I took 2 tabs of Benadryl and went home with my wife and went to bed. When I woke up around 1: 33 am my whole hand was still swollen but this time it moved all the way up to my elbow along with the chest pain radiating to my left shoulder blade. I told my wife and she told me to go to the ED in the morning when I woke back up if my hand was still swollen. I went and let them know this has never happened before and I've been stung many times in the past and not too recently. They gave me Proctosol and a prescription for it which I never filled. I never brought up the pain in my chest though because I thought maybe I slept wrong. Later in the day, my hand got better but my chest pain still remained so I tried stretching but noticed it didn't hurt when I moved my head like it normally does so got worried a little but didn't do anything about it. Later that night same thing and this time I had a very difficult time sleeping so decided to go to the ER in the am for my chest pain. While in the parking lot I ran into a nurse that works in the cardiologist dept. and explained what was going on, he said unless it feels like a heart attack they probably wouldn't do much, and unless I really think I needed to that just try and give it some more time to go away. That night it didn't hurt as bad so I never went back. It still happens off and on but not as bad but enough that I made an appointment for Sept. 4th with my family doctor to see what he thinks about it. I brought it up to my cousin who is a nurse recently and she told my young adult like myself have been developing myocarditis or pericarditis from the mRNA vaccines so I hope it's not that but find it very weird how the pain came along and the reaction I had to the wasp sting when that has never happened like that in my life before.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test abnormal, Dyspnoea, Fatigue, Fear
Clinical narrative: Headache and nausea, fatigue.  I am a half-marathon runner and could not WALK a mile the day after my first  shot.  The 2nd shot put me out for 4 days, sick on the couch.  I started trying to train for my first marathon and kept feeling worse and worse, couldn?t breath and had no energy.  I have been diagnosed with iron deficiency anemia now and my body is not absorbing and metabolizing iron even though I?m on supplements and eating a high-iron diet.  I?m also not doing any exercise right now so I don?t deplete any extra iron.  I have no doubt the vaccine has triggered something in my body and is causing me to have poor health when I was very healthy prior to it.  I was in good enough shape to plan my first marathon before it.  I am scared and have no idea what else is going on with my body and why I can?t absorb iron like I did before the shot and what else I can do at this point to make it better.   I wake up with rapid heartbeats and short of breath.  I usually am up at 6 a.m. and busy until 9 or 10 at night and cannot function like I normally do.  I need to take naps each day and get very sleepy at work.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Heart rate increased, Iron deficiency anaemia, Malaise
Clinical narrative: Headache and nausea, fatigue.  I am a half-marathon runner and could not WALK a mile the day after my first  shot.  The 2nd shot put me out for 4 days, sick on the couch.  I started trying to train for my first marathon and kept feeling worse and worse, couldn?t breath and had no energy.  I have been diagnosed with iron deficiency anemia now and my body is not absorbing and metabolizing iron even though I?m on supplements and eating a high-iron diet.  I?m also not doing any exercise right now so I don?t deplete any extra iron.  I have no doubt the vaccine has triggered something in my body and is causing me to have poor health when I was very healthy prior to it.  I was in good enough shape to plan my first marathon before it.  I am scared and have no idea what else is going on with my body and why I can?t absorb iron like I did before the shot and what else I can do at this point to make it better.   I wake up with rapid heartbeats and short of breath.  I usually am up at 6 a.m. and busy until 9 or 10 at night and cannot function like I normally do.  I need to take naps each day and get very sleepy at work.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Nausea, Somnolence
Clinical narrative: Headache and nausea, fatigue.  I am a half-marathon runner and could not WALK a mile the day after my first  shot.  The 2nd shot put me out for 4 days, sick on the couch.  I started trying to train for my first marathon and kept feeling worse and worse, couldn?t breath and had no energy.  I have been diagnosed with iron deficiency anemia now and my body is not absorbing and metabolizing iron even though I?m on supplements and eating a high-iron diet.  I?m also not doing any exercise right now so I don?t deplete any extra iron.  I have no doubt the vaccine has triggered something in my body and is causing me to have poor health when I was very healthy prior to it.  I was in good enough shape to plan my first marathon before it.  I am scared and have no idea what else is going on with my body and why I can?t absorb iron like I did before the shot and what else I can do at this point to make it better.   I wake up with rapid heartbeats and short of breath.  I usually am up at 6 a.m. and busy until 9 or 10 at night and cannot function like I normally do.  I need to take naps each day and get very sleepy at work.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt presented for 2nd dose in series. Vaccine was administered after confirming vaccine given for 1st dose. Overlooked pt age of 15.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested COVID (+) after being fully vaccinated
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Beginning with  itching and redness near bicep on 8/27 and by the morning of 8/28, the rash had spread to the entire upper left arm, to the elbow bend. As on the evening of 8/31, the rash/itching had receded to around the injection site and part of the bicep.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Lymphadenopathy, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: 6 hours after vaccine my Tongue and gums became tingly (pins and needles) numbness, neck stiffness, swollen  left underarm with hard painful bulge, over all joint pain,  left arm numbness and swelling, fever .    1 week after vaccine still continue with the  painful hard bulge from left underarm arm and Neck numbness and stiffness.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Peripheral swelling, Pyrexia
Clinical narrative: 6 hours after vaccine my Tongue and gums became tingly (pins and needles) numbness, neck stiffness, swollen  left underarm with hard painful bulge, over all joint pain,  left arm numbness and swelling, fever .    1 week after vaccine still continue with the  painful hard bulge from left underarm arm and Neck numbness and stiffness.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Ear discomfort, Ear, nose and throat examination, Immune-mediated adverse reaction
Clinical narrative: Moderate to severe ear ringing the day after dose 1.  The ringing has not stopped in four weeks and the left ear has worsened and feels clogged but no pain in either just a constant loud ringing.  Scheduled appt with ENT and said my ears were fine, slight hearing loss in left ear, and inflammation of my inner ear likely caused by the immune response to the vaccine which is causing the ringing.  Do not know if will go away short or long term, or ever.  Prescribed a heavy dose of prednisone over two week period.  After one week, the problem of ringing in my left ear remains at the same level and sometimes worse than previous.  I was recommended not to take the second dose as it could possibly amplify the issue even more.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Middle ear inflammation, Tinnitus, Tympanometry, Vaccination complication
Clinical narrative: Moderate to severe ear ringing the day after dose 1.  The ringing has not stopped in four weeks and the left ear has worsened and feels clogged but no pain in either just a constant loud ringing.  Scheduled appt with ENT and said my ears were fine, slight hearing loss in left ear, and inflammation of my inner ear likely caused by the immune response to the vaccine which is causing the ringing.  Do not know if will go away short or long term, or ever.  Prescribed a heavy dose of prednisone over two week period.  After one week, the problem of ringing in my left ear remains at the same level and sometimes worse than previous.  I was recommended not to take the second dose as it could possibly amplify the issue even more.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site reaction, Rash erythematous
Clinical narrative: Large, circular, red rash that appeared at the injection site. This continued for 3 days. There was also a lump under my skin at the injection site that is still there today (8/31/2021). It has decreased in size but is still noticeable.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: Extreme exhaustion and brain fog constantly throughout the day without a source or reason. Symptoms have lasted until present day. Caffeine and more sleep do not help reduce the continual tiredness.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Fully vaccinated employee tested positive for covid-19
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Guillain-Barre syndrome, Hypoaesthesia, Nerve conduction studies, Pain in extremity
Clinical narrative: Reactivation of GBS symptoms - numbness, tingling, pain from toes to thighs. Extreme pain that gabapentin did not control. Numb fingertips.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Reactivation of GBS symptoms - numbness, tingling, pain from toes to thighs. Extreme pain that gabapentin did not control. Numb fingertips.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Eye movement disorder, Facial paralysis, Facial paresis
Clinical narrative: The left face is paralyzed, unable to perceive the movement of the muscles The left eyelids cannot be closed completely. While closing the eyes, and there is no pressure on the left eye. The left lip is uncontrollable, and water will flow down when drinking There is no sense of muscle movement on the left face when smiling
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Incoherent, Pallor, Presyncope
Clinical narrative: pfizer covid vaccine was given about 4:30pm and patient was instructed to stay in store for 15 minutes.  she and her party left the vaccination room and headed down the aisle to get a drink from the refrigerated section.  her mother said she became weak and nearly passed out.  mother saw me and asked me for help.  she carried her back to the waiting area and sat her on a chair.    she was awake but looked pale and seemed somewhat incoherent.  she was clammy.  she said she was breathing fine and appeared to be breathing fine, and there was no sign of swelling.   she was given some water.  i called the paramedics and  described what happened.  the paramedics arrived within approximately 10 minutes of the start of the incident.  she never passed out while i was watching her but mom said she felt she had passed out at the start of the incident.  the paramedics spent about 10 minutes with her at which time i returned to my duties in the pharmacy.   when they were done i went back to find out what they had determined.  the patient and her mother did not opt for transportation to the hospital and they said she was better now.  she was visibly better.  paramedics advised them what to do if her condition began to worsen.  they went home at that time.  i called later in the evening, about 9 pm to check on her condition.  mam said she was doing better.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Moderna - Covid-19  administered
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Back pain, Chills, Cough
Clinical narrative: 8/12/2021 RAN A FEVER THE DAY AFTER. Chills, headache, back pain, stomachache 8/15/2021 C/O HEADACHE AND EAR PAIN 8/16/2021 C/O HEADACHE, EAR PAIN, AND ABDOMINAL PAIN 8/17/2021 TOOK TO PEDIATRICIAN BILATERAL EAR INFECTION AND SINUS INFECTION - ANTIBIOTICS STARTED FOR 10DAYS- COUGH STARTED THAT EVENING
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Ear infection, Ear pain, Headache, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: 8/12/2021 RAN A FEVER THE DAY AFTER. Chills, headache, back pain, stomachache 8/15/2021 C/O HEADACHE AND EAR PAIN 8/16/2021 C/O HEADACHE, EAR PAIN, AND ABDOMINAL PAIN 8/17/2021 TOOK TO PEDIATRICIAN BILATERAL EAR INFECTION AND SINUS INFECTION - ANTIBIOTICS STARTED FOR 10DAYS- COUGH STARTED THAT EVENING
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: 8/12/2021 RAN A FEVER THE DAY AFTER. Chills, headache, back pain, stomachache 8/15/2021 C/O HEADACHE AND EAR PAIN 8/16/2021 C/O HEADACHE, EAR PAIN, AND ABDOMINAL PAIN 8/17/2021 TOOK TO PEDIATRICIAN BILATERAL EAR INFECTION AND SINUS INFECTION - ANTIBIOTICS STARTED FOR 10DAYS- COUGH STARTED THAT EVENING
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Cough, Headache, Joint swelling, Musculoskeletal pain, Nasal congestion
Clinical narrative: 8/11/2021 BILAT LEG, ANKLE, & FEET SWELLING. PAIN UN LEFT SHOULDER BLADE 8/12/2021 LEFT ARM PAIN AND SWELLING, SWELLING TO BILAT LEF, ANKLE & FEET CONTINUED 8/13/2021 SWELLING CONTUNYED TO LOWER EXTREMITIES 8/14/2021 SORE THROAT STARTED 8/15/2021 SORE THROAT CONTINUED 8/16/2021 SORE THROAT CONTINUED HEADACHE NASAL CONGESTION AND DRAINAGE 8/17/2021 SORE THROAT CONTINUED HEADACHE NASAL CONGESTION AND DRAINAGE GETTING  WORSE 8/18/2021 SAME 8/19/2021 SAME 8/20/2021 VIRTUAL VISIT SAME WITH COUGHING
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Oropharyngeal pain, Pain in extremity, Peripheral swelling, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: 8/11/2021 BILAT LEG, ANKLE, & FEET SWELLING. PAIN UN LEFT SHOULDER BLADE 8/12/2021 LEFT ARM PAIN AND SWELLING, SWELLING TO BILAT LEF, ANKLE & FEET CONTINUED 8/13/2021 SWELLING CONTUNYED TO LOWER EXTREMITIES 8/14/2021 SORE THROAT STARTED 8/15/2021 SORE THROAT CONTINUED 8/16/2021 SORE THROAT CONTINUED HEADACHE NASAL CONGESTION AND DRAINAGE 8/17/2021 SORE THROAT CONTINUED HEADACHE NASAL CONGESTION AND DRAINAGE GETTING  WORSE 8/18/2021 SAME 8/19/2021 SAME 8/20/2021 VIRTUAL VISIT SAME WITH COUGHING
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, rest.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: When reconstituting the Pfizer vaccine, 0.8ml of sterile saline was used instead of 1.8 of sterile saline. Pt was given 0.3 ml of reconstituted vaccine as above.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Some soreness.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Electrocardiogram, Hypoaesthesia
Clinical narrative: At 12:02 patient complained about slight tingling to his left arm. Vital signs WNL for patient. Denies any shortness of breath. Water given. DR. informed with order to monitor. At 12:20 patient became nauseated, but it went away after couple of minutes. At 12:15 pm patient c/o tingling and pain to his left arm. At 12:30 pm patient denied any tingling but c/o pain and numbness to his left arm. DR. informed.  Dr evaluated - here in clinic EKG + F/U appt in 1-2 days with physician. Patient  8/16/2021: Pt was taken into exam room EKG performed. Reading to be WN Pt. was c/o chest pain, slight difficulty breathing; numbness in (L) arm, pain in (L) arm; felt that he was slightly dizzy Following EKG patient stated no more chest pain; no difficulty breathing. Was offered option of calling an ambulance for transport to ER - patient declined. Patient was set up for follow-up MD appointment on Wednesday 8/18 and agreed to this plan. EKG attached.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Paraesthesia
Clinical narrative: At 12:02 patient complained about slight tingling to his left arm. Vital signs WNL for patient. Denies any shortness of breath. Water given. DR. informed with order to monitor. At 12:20 patient became nauseated, but it went away after couple of minutes. At 12:15 pm patient c/o tingling and pain to his left arm. At 12:30 pm patient denied any tingling but c/o pain and numbness to his left arm. DR. informed.  Dr evaluated - here in clinic EKG + F/U appt in 1-2 days with physician. Patient  8/16/2021: Pt was taken into exam room EKG performed. Reading to be WN Pt. was c/o chest pain, slight difficulty breathing; numbness in (L) arm, pain in (L) arm; felt that he was slightly dizzy Following EKG patient stated no more chest pain; no difficulty breathing. Was offered option of calling an ambulance for transport to ER - patient declined. Patient was set up for follow-up MD appointment on Wednesday 8/18 and agreed to this plan. EKG attached.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Posture abnormal, Unresponsive to stimuli
Clinical narrative: >client noted dropping phone & papers and slumped a little >client was not responding to verbal commands but his eyes were open >client was transferred from chair to cot and the client was able to answer questions. vitals taken. on call MD contacted >assessed by MD, legs elevated until BP Increased. >Alert & oriented X 5; able to walk around the room unassisted >client refused water or crackers; advised client to eat >Advised client to have somebody pick him up
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Cough, Retching, Throat irritation, Vomiting
Clinical narrative: 10:20 AM Vaccine given - Pfizer 1st Dose 10:25 pt in BR coughing, heaving, vomiting, I went in to assist and he said his throat was itchy and he felt like he needed to cough and vomit and symptoms started right after vaccine  Moved to exam room, continued coughing   BP: 150/84 10:33 am  10:30am 50mg Benedryl 50mg given IM R deltoid, within 15 minutes coughing decreased and then stopped  Emergency services had already been called. pt advised  even though s/s decreased still needs ER evaluation as When Benedryl wears off COVID vaccine is still in his system. Pt agreeable and EMS transported pt to hospital VIA ambulance. Pt alert and oriented. L/n aware and present. Benedryl 50mg/ml Lot #080014 x 812022 1ML administered IM R deltoid
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Frustration tolerance decreased, Oropharyngeal pain
Clinical narrative: fever, fatigue, cough, sore throat, frustration, wheezing
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive, Wheezing
Clinical narrative: fever, fatigue, cough, sore throat, frustration, wheezing
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Left arm pain (chronic)
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Mother called last week to report  that in the car on the way home from our office the patient  report feeling  light - headed and did have a syncopal episode with brief  (a few  seconds) of LOC . No localized site symptoms. No other SX.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Pruritus, Pyrexia, Rash erythematous, Tremor
Clinical narrative: pt had rash/red skin Itchiness - 20 minutes post vaccine upon  follow up on 8/31/21 pt states she continues to have rash, itchiness accompanied by fever, metallic taste in mouth and shakiness. Pt rec 1 dose of Benadryl at Pharmacy - will F/U with MD
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Urticaria
Clinical narrative: 8/7/21 Patient had headache and was tired. 8/8/21 Patient said hives appeared everywhere Patient Felt hyped up patient went to ER - received medications antihistamine + steroids.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient Recieved VacciNe from An vial.that shouldve been "wasted" on 8/5/2021. No furtheR sxs since Recieving the vacciNe on 8/10/2021
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Moderna Covid-19 vaccine
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Moderna COVID-19 vaccine  administered
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired   Moderna-COVID  19 administered
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Moderna- Covid-19 administered
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Moderna COVID-19 administered
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Moderna vaccine administered
Age: 4.0
Sex: F
Vaccine: DTAP, DTAPIPV, HEPA, HIBV
Symptoms: Inappropriate schedule of product administration, Pyrexia
Clinical narrative: The patient received infanrix on 8/26/21 in addition to Kinrix. Mother was notified of error per Dr and was informed of minimal rash or increased side effects. No effects from imm and stable child had a fever of 101.4 on 8/26/21 that responded to tylenol
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Chest discomfort, Chest pain, Diarrhoea, Disorientation
Clinical narrative: 08/11/21 3:20-3:47 p.m. Pain at left arm injection site; pain radiating into chest; tightness in chest; tightness in jaw; tightness in throat; dry mouth; numbness in upper left arm radiating into lower arm up to wrist area. 3:47 p.m - Lightheaded; dizzy, naseaus; tightness in jaw. 3:55 p.m. heavy legs, naseaus. 8/12/21 Naseau and vomitting, more pain at injection site from 7:40 a.m. to 10:00 a.m 10:20 a.m. Pains in lower abdomen; gas.  11:30 am - Disoriented. 11:55 am, Diarrhea. 1:00 p.m. Fatigue, metallic tast in mouth, sleepy. 2:05 pm Migraine Headache. 2:30 p.m. (and into the evening night's sleep) Feber of 100. Slept for 2 hours. 8:00 p.m. naseau, headache, pain in teeth and jaw, still fever. 8:30 p.m Low back
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Dysgeusia, Fatigue, Flatulence
Clinical narrative: 08/11/21 3:20-3:47 p.m. Pain at left arm injection site; pain radiating into chest; tightness in chest; tightness in jaw; tightness in throat; dry mouth; numbness in upper left arm radiating into lower arm up to wrist area. 3:47 p.m - Lightheaded; dizzy, naseaus; tightness in jaw. 3:55 p.m. heavy legs, naseaus. 8/12/21 Naseau and vomitting, more pain at injection site from 7:40 a.m. to 10:00 a.m 10:20 a.m. Pains in lower abdomen; gas.  11:30 am - Disoriented. 11:55 am, Diarrhea. 1:00 p.m. Fatigue, metallic tast in mouth, sleepy. 2:05 pm Migraine Headache. 2:30 p.m. (and into the evening night's sleep) Feber of 100. Slept for 2 hours. 8:00 p.m. naseau, headache, pain in teeth and jaw, still fever. 8:30 p.m Low back
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Injection site pain, Limb discomfort, Migraine
Clinical narrative: 08/11/21 3:20-3:47 p.m. Pain at left arm injection site; pain radiating into chest; tightness in chest; tightness in jaw; tightness in throat; dry mouth; numbness in upper left arm radiating into lower arm up to wrist area. 3:47 p.m - Lightheaded; dizzy, naseaus; tightness in jaw. 3:55 p.m. heavy legs, naseaus. 8/12/21 Naseau and vomitting, more pain at injection site from 7:40 a.m. to 10:00 a.m 10:20 a.m. Pains in lower abdomen; gas.  11:30 am - Disoriented. 11:55 am, Diarrhea. 1:00 p.m. Fatigue, metallic tast in mouth, sleepy. 2:05 pm Migraine Headache. 2:30 p.m. (and into the evening night's sleep) Feber of 100. Slept for 2 hours. 8:00 p.m. naseau, headache, pain in teeth and jaw, still fever. 8:30 p.m Low back
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Nausea, Pain, Pain in jaw, Pyrexia
Clinical narrative: 08/11/21 3:20-3:47 p.m. Pain at left arm injection site; pain radiating into chest; tightness in chest; tightness in jaw; tightness in throat; dry mouth; numbness in upper left arm radiating into lower arm up to wrist area. 3:47 p.m - Lightheaded; dizzy, naseaus; tightness in jaw. 3:55 p.m. heavy legs, naseaus. 8/12/21 Naseau and vomitting, more pain at injection site from 7:40 a.m. to 10:00 a.m 10:20 a.m. Pains in lower abdomen; gas.  11:30 am - Disoriented. 11:55 am, Diarrhea. 1:00 p.m. Fatigue, metallic tast in mouth, sleepy. 2:05 pm Migraine Headache. 2:30 p.m. (and into the evening night's sleep) Feber of 100. Slept for 2 hours. 8:00 p.m. naseau, headache, pain in teeth and jaw, still fever. 8:30 p.m Low back
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Somnolence, Throat tightness, Toothache, Vomiting
Clinical narrative: 08/11/21 3:20-3:47 p.m. Pain at left arm injection site; pain radiating into chest; tightness in chest; tightness in jaw; tightness in throat; dry mouth; numbness in upper left arm radiating into lower arm up to wrist area. 3:47 p.m - Lightheaded; dizzy, naseaus; tightness in jaw. 3:55 p.m. heavy legs, naseaus. 8/12/21 Naseau and vomitting, more pain at injection site from 7:40 a.m. to 10:00 a.m 10:20 a.m. Pains in lower abdomen; gas.  11:30 am - Disoriented. 11:55 am, Diarrhea. 1:00 p.m. Fatigue, metallic tast in mouth, sleepy. 2:05 pm Migraine Headache. 2:30 p.m. (and into the evening night's sleep) Feber of 100. Slept for 2 hours. 8:00 p.m. naseau, headache, pain in teeth and jaw, still fever. 8:30 p.m Low back
Sex: U
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Smear test
Clinical narrative: -Localized Redness, Pain, Swelling at injection site. -Headache daily since vaccine
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID19 INFECTION; This spontaneous report received from a health care professional concerned a 61 year and 8 months old white female of unknown ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-smoker, and other pre-existing medical conditions included no drug abuse or illicit use, no recent history of exposure to a person with Covid infection. The patient did not have past history of similar event. The patient did not had adverse event after any previous vaccination. The patient did not had any history of allergy to vaccine, drug, or food. The patient did not had any pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days, with cause, no family history of any disease (relevant to vaccination) or allergy. The patient was not breastfeeding at the time of report. On 25-Mar-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020 and expiry: Unknown) frequency 1 total, 0.5 ml, administered on left arm for prophylactic vaccination. No concomitant medications were reported.  On 06-Aug-2021, the patient experienced cold, with running nose and felt tired. On 07-Aug-2021, Laboratory data included: Covid-19 PCR test, was tested Positive on 9-Aug-2021 (confirmed clinical vaccination failure and confirmed covid19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid19 infection was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210846649 and 20210846822.  Additional information was received from health care professional on 26-Aug-2021. The following information was updated and incorporated into the case narrative:  Multiple patient changed to Single patient case, Patient information (age, gender, name, race) Past medical history, Event onset date, Lab test, product Dose, route of admin, site of vaccination, RRT of event suspected clinical vaccination failure changed to confirmed clinical vaccination failure. Events cold, with running nose and felt tired subsumed under confirmed covid19 infection.; Sender's Comments: V2: This follow-up adds: Multiple patient changed to Single patient case, Patient information, past medical history, Event onset date, Lab test, product Dose, route of admin, site of vaccination, RRT of event suspected clinical vaccination failure changed to confirmed clinical vaccination failure.   20210846435-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure . Follow-up received regarding Clinical Details. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Patient came in office for  6-mos well child visit was given vaccine. 7/14/21 returned to office with hives over the entire body
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Describe Event, Problem or Product Use Error: [Pfizer vaccine] use for COVID-19 under Emergency Use Authorization (EUA):pt fully vaccinated and tested positive for covid 8/27/2021. hospitalized 8/30/2021 - received tocilizumb and remdesivir, dexamethasone, Oxygen
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: I was diagnosed for the first time with atrial fibrillation I have received 2nd Moderna vaccination 4/6/21
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Long QT syndrome, Syncope
Clinical narrative: My daughter took the covid vaccine. Her second dose was on June 2.2021. She was diagnosed with long QT syndrome on July 27, 2031. Could this be have caused by the Pfizer vaccine. This is what she took. She had couple of fainting episodes. She was diagnosed at hospital. We want to make sure the vaccine did. It cause this. Is there a correlation between that two things. The heart containing cause by the covid vaccine cause long qt syndrome.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Hypersomnia, Musculoskeletal disorder, Nodule, Peripheral swelling
Clinical narrative: Patient came to the ER because she had a cut from glass table and since it has been a long time since she had her tetanus booster they gave her one. The patient questioned the nurse that was giving her the vaccine because she was giving it more on the back of her arm and the RN stated no this area is fine. She got the vaccine and went home. She woke up the next day and could not move her arm so she took some over the counter pain meds and a muscle relaxer and slept most of the day Friday but tried to see her PCP on Friday because she was told if she has any issues to follow up with her PCP. She went to her PCP on Saturday and her PCP did not think it was a normal allergic reaction. The patient came on Saturday 8/28/21 and showed me her arm/shoulder which was warm to touch and swollen around her upper arm/red across her chest. She even has a knot close to her neck. Her PCP gave her some medication but wanted to her inform the place where she got the shot. I informed her that we would be happy to see her but she stated she is not sure what else they will do for her at this time since her PCP gave her some medications in the office.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Skin laceration, Skin warm
Clinical narrative: Patient came to the ER because she had a cut from glass table and since it has been a long time since she had her tetanus booster they gave her one. The patient questioned the nurse that was giving her the vaccine because she was giving it more on the back of her arm and the RN stated no this area is fine. She got the vaccine and went home. She woke up the next day and could not move her arm so she took some over the counter pain meds and a muscle relaxer and slept most of the day Friday but tried to see her PCP on Friday because she was told if she has any issues to follow up with her PCP. She went to her PCP on Saturday and her PCP did not think it was a normal allergic reaction. The patient came on Saturday 8/28/21 and showed me her arm/shoulder which was warm to touch and swollen around her upper arm/red across her chest. She even has a knot close to her neck. Her PCP gave her some medication but wanted to her inform the place where she got the shot. I informed her that we would be happy to see her but she stated she is not sure what else they will do for her at this time since her PCP gave her some medications in the office.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Want to report late/extended menstrual cycle after getting Pfizer/Biontech vaccine.