chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Death, Respiratory arrest, Unresponsive to stimuli
Clinical narrative: described as "felt like I was hit by a truck," fevers, chills, cardiac arrest, death
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Inflammation, Nodule, Urticaria
Clinical narrative: Sporadic random hives throughout body. Some mild and some severe. Finger joints sore. Inflamed red nodules on left index finger. Looks like nodules developing on other finger.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Insomnia, Pain
Clinical narrative: Chills, body aches, and fever started at 9pm and got worse over the next 3 hours; Fever rose to 102 degrees F by midnight then fell to 100.6 degrees by 7am on 5/5/21; Trouble sleeping from midnight to 7am; Headache, fatigue, body aches, and fever of 100 degrees from 7am until 7pm on 5/5/21; Symptoms subsided around 10pm and were totally gone by the next morning
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills, body aches, and fever started at 9pm and got worse over the next 3 hours; Fever rose to 102 degrees F by midnight then fell to 100.6 degrees by 7am on 5/5/21; Trouble sleeping from midnight to 7am; Headache, fatigue, body aches, and fever of 100 degrees from 7am until 7pm on 5/5/21; Symptoms subsided around 10pm and were totally gone by the next morning
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Patient reported having a nosebleed for 3 days.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Chest pain, Electrocardiogram, Laboratory test
Clinical narrative: Chest pains, upper respiratory discomfort, tighness in upper body chest area, difficulty using upper limbs like opening a drawer or putting on socks became more and more painful.  stiffness in neck area.   Pain when breathing in deep.  Complications with ordinary movements like twist to put on seat belt. Terrible pain when trying to lift arms. When laying down or getting up was very painful and got worse over next few days.  Could not perform regular household duties like dishes or laundy due to muscle pain in chest when scrubbing even lightly or lifting arms to try and fold or hang up a shirt.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: Chest pains, upper respiratory discomfort, tighness in upper body chest area, difficulty using upper limbs like opening a drawer or putting on socks became more and more painful.  stiffness in neck area.   Pain when breathing in deep.  Complications with ordinary movements like twist to put on seat belt. Terrible pain when trying to lift arms. When laying down or getting up was very painful and got worse over next few days.  Could not perform regular household duties like dishes or laundy due to muscle pain in chest when scrubbing even lightly or lifting arms to try and fold or hang up a shirt.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Painful respiration, Upper respiratory tract irritation, X-ray
Clinical narrative: Chest pains, upper respiratory discomfort, tighness in upper body chest area, difficulty using upper limbs like opening a drawer or putting on socks became more and more painful.  stiffness in neck area.   Pain when breathing in deep.  Complications with ordinary movements like twist to put on seat belt. Terrible pain when trying to lift arms. When laying down or getting up was very painful and got worse over next few days.  Could not perform regular household duties like dishes or laundy due to muscle pain in chest when scrubbing even lightly or lifting arms to try and fold or hang up a shirt.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Anger, Anxiety, Dyskinesia, Heart rate increased
Clinical narrative: Racing mind; accelerated heart rate; outbursts of uncontrollable screaming and anger; trouble staying in one place as if I couldn't control my own body movements; severe anxiety with desire to escape. None of these symptoms had been experienced in my past. The events looped in cycles for approximately 5-6 hours. Thought I might be losing my mind. No treatment or medical attention given other than having friends watch over me, and forcing myself to drink plenty of fluids. Outcome: back to normal the next day.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Screaming, Tachyphrenia
Clinical narrative: Racing mind; accelerated heart rate; outbursts of uncontrollable screaming and anger; trouble staying in one place as if I couldn't control my own body movements; severe anxiety with desire to escape. None of these symptoms had been experienced in my past. The events looped in cycles for approximately 5-6 hours. Thought I might be losing my mind. No treatment or medical attention given other than having friends watch over me, and forcing myself to drink plenty of fluids. Outcome: back to normal the next day.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Fall, Foaming at mouth, Heart rate increased, Hyperhidrosis
Clinical narrative: Patient within 5 minutes after receiving injection was being monitored and began to slump forward in the chair.  The patient quickly became completely unconscious and was helped to the floor.  The patient was presenting with seizure like symptoms, foaming at the mouth and loss of body functions.  Patient remained unconscious for 1 minute or less before regaining consciousness.  He was able to speak immediately after.  Patient had a rapid heart rate and was sweating.  Patients blood pressure was elevated as well.  Patients blood sugar was tested and was 146.  911 was called immediately at time of emergency and when they arrived they help that patient sit up.  They took the patient to the emergency room since he did not immediately regain all functions and this vitals remained elevated.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Patient within 5 minutes after receiving injection was being monitored and began to slump forward in the chair.  The patient quickly became completely unconscious and was helped to the floor.  The patient was presenting with seizure like symptoms, foaming at the mouth and loss of body functions.  Patient remained unconscious for 1 minute or less before regaining consciousness.  He was able to speak immediately after.  Patient had a rapid heart rate and was sweating.  Patients blood pressure was elevated as well.  Patients blood sugar was tested and was 146.  911 was called immediately at time of emergency and when they arrived they help that patient sit up.  They took the patient to the emergency room since he did not immediately regain all functions and this vitals remained elevated.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Gastric haemorrhage, Haematochezia
Clinical narrative: The day of the vaccine, in the evening, I got severe stomach cramps and then I got diarrhea really bad. The cramps went on all night into the next day. They were so painful - like labor pain. The next day, I had a GI hemorrhage - it was clots of blood coming out of the digestive system. I contacted my regular practitioner doctor and sent him a picture of the clots and he instructed me to go to ER. I ended up going to Urgent Care. I went to the Urgent Care on Saturday or Sunday. The Urgent Care doctor there thought I had food poisoning. But that day I didn't eat anything - I just had had ginger ale, cranberries and cashews. He was puzzled as to why I had these symptoms. He gave me medication to stop the cramping in my stomach.  Medication is: Hyoscyamine. I used it even two weeks after the fact because I would occasionally get real bad stomach cramps. I was also referred to get a colonoscopy - haven't been able to get in yet. The GI hemorrhaging lasted two or three days and then disappeared.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Peripheral swelling, Skin warm
Clinical narrative: Swollen and hot left arm, Headache.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Pt became dizzy/lightheaded after receiving his covid vaccine and then watching his mother receive her covid vaccine. Pt was instructed to lie down on exam table, mother brought patient juice, cold compress applied to head and neck. Pt mother notes pt last ate around noon. After 15-20 min patient felt better. Was able to leave clinic with mother as escort without incident.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Raised itchy red rash just below injection site. About the size of an egg today.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd vaccination before 24 days.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood glucose normal, Dizziness, Nausea, Presyncope
Clinical narrative: Near syncope in parking lot after COVID vaccine. Walked out of hospital entrance, felt dizzy, sat down, and passed out for ~1 minute, met by code team and brought to ED. Pt reports epigastric pain x3 days w/ N/V; h/o pancreatitis, abdominal cancer w/ colostomy. POC BG: 111; A&Ox1 . VS @1409: Temp 98.2F, BP 134/96, HR 67, SpO2 99%, RR 18.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Near syncope in parking lot after COVID vaccine. Walked out of hospital entrance, felt dizzy, sat down, and passed out for ~1 minute, met by code team and brought to ED. Pt reports epigastric pain x3 days w/ N/V; h/o pancreatitis, abdominal cancer w/ colostomy. POC BG: 111; A&Ox1 . VS @1409: Temp 98.2F, BP 134/96, HR 67, SpO2 99%, RR 18.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Local reaction, Nervousness
Clinical narrative: localized site reaction- patient very nervous .. told to use ice and diphenhydramine
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstrual disorder
Clinical narrative: Since the vaccine I have had irregular periods 45-60 days apart and they are very irregular.  I have bleeding in between for days  at a time and cramping. Before the vaccine I had a period 28-30 days apart that were regular and predictable. Before the vaccine I never had spotting or cramping between periods.
Age: 36.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Dyspnoea, Endotracheal intubation, Pharyngeal swelling, Respiratory distress, Urticaria
Clinical narrative: Patient received second dose of covid, developed shortness of breath, hives and throat swelling.  Patient had minor urticaria with first dose.  Patient in severe distress, intubated for airway protection.  Treated with benadryl and epi by EMS.
Age: 36.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Acute respiratory distress syndrome, Chest discomfort, Dysphagia, Dyspnoea, Endotracheal intubation
Clinical narrative: Patient received second dose of covid, developed shortness of breath, hives and throat swelling.  Patient had minor urticaria with first dose.  Patient in severe distress, intubated for airway protection.  Treated with benadryl and epi by EMS.
Age: 36.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Extubation, General physical health deterioration, Hypersensitivity, Intensive care, Sedation
Clinical narrative: Patient received second dose of covid, developed shortness of breath, hives and throat swelling.  Patient had minor urticaria with first dose.  Patient in severe distress, intubated for airway protection.  Treated with benadryl and epi by EMS.
Age: 36.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: Patient received second dose of covid, developed shortness of breath, hives and throat swelling.  Patient had minor urticaria with first dose.  Patient in severe distress, intubated for airway protection.  Treated with benadryl and epi by EMS.
Age: 36.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Hyperventilation, Pruritus, Stridor, Throat irritation
Clinical narrative: Patient received second dose of covid, developed shortness of breath, hives and throat swelling.  Patient had minor urticaria with first dose.  Patient in severe distress, intubated for airway protection.  Treated with benadryl and epi by EMS.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Feeling abnormal, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever, nausea, abdominal pain, brain fog
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Syncope
Clinical narrative: Patient who has a history of fainting came in for a Covid-19 vaccine. Patient fainted right after getting the shot. Medics were called. Patient is okay after a few minutes of rest. Patient's father brought him home
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Condition aggravated
Clinical narrative: Arthritis flared up really bad.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt received Moderna vaccine and is only 17. We did not realize at first dose appointment on 3/26/2021 and realized when he came back for his second appointment on 4/23/2021. Per CDC recommendation and with patient and parent approval, second dose was administered and patient is doing well.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site mass, Injection site pruritus, Nausea
Clinical narrative: Severe headache , nausea for fist couple of days. At 1 week Covid arm started. Itch at injection site, dime sized lump that wasn't there previous days, redness. As of today, lump is red and about 3-4 across. Still itchy.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vertigo, Vomiting
Clinical narrative: First day after very tired that night started throwing up for three nights with extreme vertigo and exhaustion, stop throwing up after three days , got medicine for the vertigo four days after shot took it for three days slowly the vertigo went away but just reappeared today
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Cerebrovascular accident, Computerised tomogram normal, Echocardiogram, Magnetic resonance imaging abnormal
Clinical narrative: Went into emergency room on 5/5/2021. MRI came back with results of stroke. Has something to do with carotid artery. I don't know much else right now. The stroke effected the left side of his brain.. plaque can get in there? His right arm is still weak
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: Went into emergency room on 5/5/2021. MRI came back with results of stroke. Has something to do with carotid artery. I don't know much else right now. The stroke effected the left side of his brain.. plaque can get in there? His right arm is still weak
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Computerised tomogram neck, Headache, Lumbar puncture, Orgasm abnormal
Clinical narrative: Low grade headache Sex headache at orgasm.  Requiring emergency visit for medication to calm down pain.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fever (101), chills, muscle aches, headache, strong fatigue.  I had Covid-19  in Oct, 2020.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Fever (101), chills, muscle aches, headache, strong fatigue.  I had Covid-19  in Oct, 2020.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin warm
Clinical narrative: Patient received vaccination on 5/2.  Patient presented to pharmacy 5/6 with red upper left arm and stated it was hot to touch.  Referred patient to her PCP.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Patient states she felt numbness in her tongue and numbness and tingling in her left arm. She waited at the pharmacy past 15 mins to ensure to greater reaction. She stated she felt rushed by her parents and her body may have reacted from the urgency. Patient felt fine and comfortable before leaving pharmacy.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd vaccination given a week early at 05/1/2021 and it should be given at 05/08/2021
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Lethargy, Pyrexia
Clinical narrative: Fever 102, headache and lethargic
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Medical facility gave #2 Pfizer apr 30.  today I see on video R arm from shoulder to wrist not quite twice normal size, symmetric swelling, I do not see the  site. There is NO pain and ROM is normal shoulder.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: PFIZER - BIONTECH COVID-19 EUA
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Incorrect route of product administration, Mobility decreased, Pain
Clinical narrative: Patient states her vaccine was injecting too high. Immediately after injection she was experiencing discomfort. Later in the evening the discomfort became extremely painful and has not resolved. She cannot move her arm at all.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: Patient states her vaccine was injecting too high. Immediately after injection she was experiencing discomfort. Later in the evening the discomfort became extremely painful and has not resolved. She cannot move her arm at all.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: client arrived to observation tent. After recieving vaccine c/o of dizzines . Client was placed on grass. EMS and doctor paged to observation site. VS taken at 2:10. 97%02 HR -68 116/81. Client is then placed to chair and states he stills feels dizzy. Client was then placed back to supine position. Then reassed to see if he was stable to sit. Client states he dont feel confident driving home. Wife was called and picked client wife picked up at 3:13. AOX4.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: The shot was given up by my shoulder. About 3 days later, I noticed my arm had swollen from my shoulder to down a little pasted my elbow to my forearm. I have noticed the swelling is slowing in spreading down my arm. It is currently about halfway down my forearm.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Headache
Clinical narrative: Very bad headache piercing my eyes
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Hyperhidrosis, Hypotension
Clinical narrative: Approximately 10 minutes after vaccine, patient was feeling "odd" and asked for water. He had sweating and then a chill. Checked his BP and it was low, systolic 99. After about 5 minutes of speaking to patient, re-checked BP and it was 113/89. Patient was feeling much better.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Feeling hot, Headache, Nausea
Clinical narrative: Woke out of sleep with bad  chills.  Had fever because my body was very hot.  I had body aches.  I didn't roll over onto my sore arm.  I had a headache.  I only got out of bed to use bathroom, couldn't eat anything for 1 day.  symptoms remained for about 24 hours.  3 hours into it i took tylenol -that helped.     In the beginning I felt nauseous.  I knew it would end, but it was very difficult during that time.   It took about 2 days after to feel back to normal.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: Woke out of sleep with bad  chills.  Had fever because my body was very hot.  I had body aches.  I didn't roll over onto my sore arm.  I had a headache.  I only got out of bed to use bathroom, couldn't eat anything for 1 day.  symptoms remained for about 24 hours.  3 hours into it i took tylenol -that helped.     In the beginning I felt nauseous.  I knew it would end, but it was very difficult during that time.   It took about 2 days after to feel back to normal.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Pain, Pain in extremity
Clinical narrative: 2nd shot about 11 am on 4/15. A few hours after shot, arm pain, took one ibuprofen. First night: fever, severe chills, vomit, aches. No treatment. Next morning, symptoms less (no more vomiting), tired,. Took ibuprofen. Gradually most symptoms faded, but felt tired. Soon diarrhea presents. After week and a half, see primary care Rosin. Took stool sample. No treatment, in fact retold not to take anything OTC for symptom.. Advised to eat blueberries and stay hydrated. Test results a few days later rules out all causes. No treatment recommended.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Stool analysis, Vomiting
Clinical narrative: 2nd shot about 11 am on 4/15. A few hours after shot, arm pain, took one ibuprofen. First night: fever, severe chills, vomit, aches. No treatment. Next morning, symptoms less (no more vomiting), tired,. Took ibuprofen. Gradually most symptoms faded, but felt tired. Soon diarrhea presents. After week and a half, see primary care Rosin. Took stool sample. No treatment, in fact retold not to take anything OTC for symptom.. Advised to eat blueberries and stay hydrated. Test results a few days later rules out all causes. No treatment recommended.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Patient came in to get his second pfizer vaccine. He waited his 15 minutes of observation, I told him his time was up and he walked around the pharmacy area a little bit and talked with one of the technicians. He left the store and passed out in the parking lot. An ambulance was called because he was not coherent and the EMS said his blood pressure was over 200 systolic. We informed them he was a diabetic but we weren't told what his blood sugar level was before taking him to the hospital.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Injection site inflammation, Injection site pain
Clinical narrative: 102.1 F fever, headache, muscle aches, fatigue, irritability, diarrhea, inflammation, and pain at injection site
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Irritability, Myalgia, Pyrexia
Clinical narrative: 102.1 F fever, headache, muscle aches, fatigue, irritability, diarrhea, inflammation, and pain at injection site
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Nausea
Clinical narrative: Have loss of appetite, feel continually nauseous
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Amenorrhoea
Clinical narrative: Absence of menstrual cycle SINCE vaccine #1. Not pregnant. Had normal menses prior to vaccinations.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Electrocardiogram normal, Feeling hot, Hypoaesthesia, Paraesthesia
Clinical narrative: After the first shot on March 6 but much worse right after the second shot I developed hot feet, numb, and prickly sensation up the lower leg. the left arm also feels numb. It is worse at night. I did blood work, EKG and went to emergency room but all seems normal. Still suffering from the same issues.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosed varicose vein, Thrombosis, Ultrasound Doppler
Clinical narrative: Blood clot, left leg
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Myalgia
Clinical narrative: Muscle pain the following day- took 1000 mg of Tylenol twice, a red circle appeared around injection site on third day the size of a nickel, on 05/04 the circle grew to a half dollar size and is itchy. Took a Benadryl and applied hydrocortisone cream as needed. On 05/06 the circle grew larger (we outlined it in pen to monitor) and there's more of a dark red ring on the outside and less red in the center. It continues to itch and is tender to the touch.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Chest discomfort, Lip swelling, Pruritus, Swollen tongue
Clinical narrative: Swelling lips, tongue swelling, asthma started  to tighten chest,  itchy hands, feet, umber arms, around the waist,  treated with over the counter antihistamines for two weeks.  Very sensitive to things I am allergic too.  Hope it goes away.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Aphasia, Blood pressure increased, Body temperature increased, Computerised tomogram
Clinical narrative: Patient felt lightheaded after the vaccine. She was asked to stay seated for about 15 minutes and then sent home. Once home she progressively had more symptoms including lightheadedness, confusion, fatigue, unconsciousness, expressive aphasia, loss of bladder and bowel control, elevated temperature, increased pulse, increased respirations, increased blood pressure, dehydration, stroke like symptoms with no evidence of stroke, loss of motor coordination
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Coordination abnormal, Dehydration, Dizziness, Echocardiogram
Clinical narrative: Patient felt lightheaded after the vaccine. She was asked to stay seated for about 15 minutes and then sent home. Once home she progressively had more symptoms including lightheadedness, confusion, fatigue, unconsciousness, expressive aphasia, loss of bladder and bowel control, elevated temperature, increased pulse, increased respirations, increased blood pressure, dehydration, stroke like symptoms with no evidence of stroke, loss of motor coordination
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Laboratory test, Loss of consciousness, Neurological symptom
Clinical narrative: Patient felt lightheaded after the vaccine. She was asked to stay seated for about 15 minutes and then sent home. Once home she progressively had more symptoms including lightheadedness, confusion, fatigue, unconsciousness, expressive aphasia, loss of bladder and bowel control, elevated temperature, increased pulse, increased respirations, increased blood pressure, dehydration, stroke like symptoms with no evidence of stroke, loss of motor coordination
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory rate increased, Urinary incontinence, X-ray
Clinical narrative: Patient felt lightheaded after the vaccine. She was asked to stay seated for about 15 minutes and then sent home. Once home she progressively had more symptoms including lightheadedness, confusion, fatigue, unconsciousness, expressive aphasia, loss of bladder and bowel control, elevated temperature, increased pulse, increased respirations, increased blood pressure, dehydration, stroke like symptoms with no evidence of stroke, loss of motor coordination
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Deep vein thrombosis, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Patient presented to her PCP office on 04/20 reporting that on 04/16 she received her 2nd Pfizer vaccine and the following day on 04/17 she started feeling muscle aches, fatigue and R calf pain from high ankle to the back of knee. On 04/18, all symptoms except the calf pain resolved. She continued to have 1-2/10  calf pain w/o skin changes but mild R > L enlargement of the lower leg. Reported a 3 hour car ride on 04/18 after the calf pain had already started. Denied chest pain, shortness of breath or palpitations. On exam, vital signs stable, right lower leg diffusely tender to palpation and noted to be 4 cm larger in circumference than the left side.  Patient was sent for an urgent outpatient duplex ultrasound of her right lower extremity. Ultrasound showed distal DVT in right peroneal veins. She was immediately instructed to discontinue the use of the Nuva ring and started on Xarelto 15 mg BID, with good symptom improvement. Was followed up in clinic on 05/05 with plan to transition to the Xarelto 20 mg QD on 05/13 for a total of 3 months of anticoagulation.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Tenderness, Ultrasound Doppler abnormal
Clinical narrative: Patient presented to her PCP office on 04/20 reporting that on 04/16 she received her 2nd Pfizer vaccine and the following day on 04/17 she started feeling muscle aches, fatigue and R calf pain from high ankle to the back of knee. On 04/18, all symptoms except the calf pain resolved. She continued to have 1-2/10  calf pain w/o skin changes but mild R > L enlargement of the lower leg. Reported a 3 hour car ride on 04/18 after the calf pain had already started. Denied chest pain, shortness of breath or palpitations. On exam, vital signs stable, right lower leg diffusely tender to palpation and noted to be 4 cm larger in circumference than the left side.  Patient was sent for an urgent outpatient duplex ultrasound of her right lower extremity. Ultrasound showed distal DVT in right peroneal veins. She was immediately instructed to discontinue the use of the Nuva ring and started on Xarelto 15 mg BID, with good symptom improvement. Was followed up in clinic on 05/05 with plan to transition to the Xarelto 20 mg QD on 05/13 for a total of 3 months of anticoagulation.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Erythema, Fatigue, Headache
Clinical narrative: Chills, low grade fever 96.5, bad body pain, sleepy, thirsty. headache.  Lasted all day Saturday 4-10-21. Sunday 4-11-21 no energy, tired. My right arm had a large pink shadow on my skin, arm was sore for 3 days. By  Monday 4-12-21 I was ok.  1 week later had a pea size nodule under my  right arm.  It was sore.  It went away after 2 days.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Pain, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: Chills, low grade fever 96.5, bad body pain, sleepy, thirsty. headache.  Lasted all day Saturday 4-10-21. Sunday 4-11-21 no energy, tired. My right arm had a large pink shadow on my skin, arm was sore for 3 days. By  Monday 4-12-21 I was ok.  1 week later had a pea size nodule under my  right arm.  It was sore.  It went away after 2 days.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: Chills, low grade fever 96.5, bad body pain, sleepy, thirsty. headache.  Lasted all day Saturday 4-10-21. Sunday 4-11-21 no energy, tired. My right arm had a large pink shadow on my skin, arm was sore for 3 days. By  Monday 4-12-21 I was ok.  1 week later had a pea size nodule under my  right arm.  It was sore.  It went away after 2 days.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Petechiae
Clinical narrative: Petechiae present on the chin and increasing in severity 4 days after vaccination. Started 5/6/21 at 5pm. No prior trauma to area. Spontaneous presentation.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives on arms, chest, face including mouth which are very itchy
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, General physical condition abnormal, Heart rate increased
Clinical narrative: Approx. 15 minutes post injection. Increased pulse rate of 120, chest pains, slight difficulty breathing, very shaky and lightheaded.  Not short of breath, he was able to have meaningful conversation. He appeared in pain. He did indicate an history of stress induced seizure.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Approx. 15 minutes post injection. Increased pulse rate of 120, chest pains, slight difficulty breathing, very shaky and lightheaded.  Not short of breath, he was able to have meaningful conversation. He appeared in pain. He did indicate an history of stress induced seizure.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Carpal tunnel syndrome, Hypoaesthesia, Manipulation, Pain, Pain in extremity
Clinical narrative: 4 days after receiving the vaccine, I woke up with slight pins and needles sensation; and some numbness in my thumb, index finger and middle finger of my right hand. These sensations gradually increased. Worked Sunday and Monday. On Tuesday, I woke up with those symptoms plus pain in those fingers and an intense burning pain at the base of my right palm. After ibuprofen, it improved some. Went to work. As I was working, pins and needles sensation started in left pinkie finger, ring finger and pinkie finger of right hand. I was advised to go seek medical care. After an assessment, I was told it was carpal tunnel. I have had no prior history of this and I've never experienced these symptoms before. I was given a brace for each wrist.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Physical examination
Clinical narrative: 4 days after receiving the vaccine, I woke up with slight pins and needles sensation; and some numbness in my thumb, index finger and middle finger of my right hand. These sensations gradually increased. Worked Sunday and Monday. On Tuesday, I woke up with those symptoms plus pain in those fingers and an intense burning pain at the base of my right palm. After ibuprofen, it improved some. Went to work. As I was working, pins and needles sensation started in left pinkie finger, ring finger and pinkie finger of right hand. I was advised to go seek medical care. After an assessment, I was told it was carpal tunnel. I have had no prior history of this and I've never experienced these symptoms before. I was given a brace for each wrist.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: HIV test, Hepatitis viral test, Injury associated with device
Clinical narrative: Accidental needlestick after administering  to patient. After vaccinating the patient, I went to put the safety clip on and accidentally pricked my thumb.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction reported expect that the patient is not yet 18 years
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Patient reported hive-like rash that started on lower legs that started about 8-12 hours after her first immunization. Over the next few days it spread over about 90% of her body, with the exception of her calves. She was prescribed prednisone and triamcinolone 0.1% cream on 4/5/2021. Rash started to improve after about 1 week of applying triamcinolone twice daily. It took about 3-4 weeks for rash to completely resolve.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Throat irritation, Tongue pruritus
Clinical narrative: 1557: Pt went up to nursing staff ~15 minutes after vaccine administration, to report tongue and throat itching. VS assessed: BP 169/101, HR 109, O2 99%. Pt then c/o chest pain and discomfort, was seen gripping chest for relief. Code MET called 1602: Code MET team transported pt to ER for higher level of care Pt received diphenhydramine  PO and methylprednisolone  IV in the ED
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Approximately 1 week later, the patient reported a raised red area around where she thought she had the vaccination. She reported a mild redness the day after the shot that resolved, then a more severe reaction occurred a week later.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Syncope
Clinical narrative: Patient fainted 15 minutes after receiving vaccine; based on  witness report, patient regained consciousness right after falling (patient was caught and did not receive injury from fall).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Fatigue, Feeling of body temperature change, Neck pain
Clinical narrative: Achy pain in shoulders and neck. Very tired, worn out feeling. Chest tightness. No fever but very cold then hot.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Achy pain in shoulders and neck. Very tired, worn out feeling. Chest tightness. No fever but very cold then hot.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood triglycerides normal, Computerised tomogram abnormal, Lipase increased, Pancreatitis
Clinical narrative: Pancreatitis confirmed by lipase >40,000 and CT imaging. Symptoms began on 4/30/21, which was 6 days following vaccine administration. The patient was hospitalized for 5 days and discharged in good condition. No cause was identified of pancreatitis. Patient has no history of pancreatitis and does not drink alcohol.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Mental impairment
Clinical narrative: Gradual loss of mental function, mostly short term memory. Started post-vaccine dose 1 and continued through dose 2 until today. Extremely minimal, but unambiguously noticable.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lethargy, Pain, Rash, Skin laceration
Clinical narrative: CUT HIMSELF WHILE SHAVING; CHEST RASH; SHAKING; HEADACHE; LETHARGIC; ACHEY; This spontaneous report received from a consumer concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included epilepsy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included lamotrigine for epilepsy, and levetiracetam for epilepsy.  On 04-MAR-2021, the subject experienced lethargic. On 04-MAR-2021, the subject experienced achey. On 04-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced shaking. On 10-MAR-2021, the subject experienced chest rash. On 16-APR-2021, the subject experienced cut himself while shaving. Treatment medications (dates unspecified) included: loratadine, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cut himself while shaving on APR-2021, chest rash on 13-MAR-2021, and headache on MAR-2021, and the outcome of lethargic, achey and shaking was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as case assessed as non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: CUT HIMSELF WHILE SHAVING; CHEST RASH; SHAKING; HEADACHE; LETHARGIC; ACHEY; This spontaneous report received from a consumer concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included epilepsy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included lamotrigine for epilepsy, and levetiracetam for epilepsy.  On 04-MAR-2021, the subject experienced lethargic. On 04-MAR-2021, the subject experienced achey. On 04-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced shaking. On 10-MAR-2021, the subject experienced chest rash. On 16-APR-2021, the subject experienced cut himself while shaving. Treatment medications (dates unspecified) included: loratadine, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cut himself while shaving on APR-2021, chest rash on 13-MAR-2021, and headache on MAR-2021, and the outcome of lethargic, achey and shaking was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: ROTATEQ that underwent the temperature excursion could have been administered to patients.; No additional AE's.; This spontaneous report was received from a licensed practical nurse and refers to am unknown number patients of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On an unknown date, the patients was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # T033510 with expiration date of 28-DEC-2021, for prophylaxis (specific dose was not reported).  No adverse effects were reported.    It was stated that the vaccines underwent a temperature excursion of 2°C to 8°C (8.7°C) for 0 hours 52 minutes 30 seconds; (8.7°C) for 0 hours 21 minutes 0 seconds; and 2°C to 8°C (8.7°C) for 0 hours 52 minutes 30 seconds; (8.7°C) for 0 hours 21 minutes 0 seconds. No previous temperature excursion was done. The call was because of a "data logger".  No further information provided.            On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion on MMR II 10 degrees Celsius/ had been administered to a patient.; This spontaneous report was received from a nurse and refers to a 12-month- old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 26-APR-2021, the patient was vaccinated with incorrectly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) therapy type rHA, lot # S037503 with expiration date reported on 04-DEC-2021, but upon internal validation it was established as 20-NOV-2021 (exact dose, route of administration were unknown) for prophylaxis. The vaccine underwent temperature excursion of 10 degrees Celsius for 11 minutes. No adverse events were reported. Digital data logger was involved.
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: No additional AE details were available.; an adult patient was administered the pediatric dose of RECOMBIVAX; This spontaneous report was received from a medical assistant and refers to a 46 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions were not reported. On 22-APR-2021, an adult patient was vaccinated with pediatric dose of hepatitis b vaccine (recombinant) (thimerosal free) (RECOMBIVAX HB) lot # R034547, expiration date not reported, but upon internal validation established as 09-JUN-2021, 0.5 milliliter of 5 microgram (route of administration was not reported), for prophylaxis (underdose). No additional adverse event details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; other zoster-related conditions; This spontaneous report was received from a lawyer and refers to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On or about 01-SEP-2011, the patient was vaccinated at the pharmacy with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, route, dosage schedule, lot number and expiration date were not reported).  On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated for shingles, and other zoster-related conditions.  As a direct and proximate result, the patient suffered and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: caller could not clarify the type of reaction; This spontaneous report has been received from a female consumer of unknown age referring herself. Concomitant medication, pertinent medical history, and drug reactions/allergies were unknown.  On an unknown date, the patient was vaccinated with shingles vaccine Zoster Vaccine Live (ZOSTAVAX) for shingles prophylaxis (formulation, strength, dose, route, lot#, and expiration date were not reported), but she was unable to clarify whether it was a Merck vaccine or not.   On an unknown date, the patient experienced a reaction, she could not clarify the type of reaction (ill-defined disorder). It was unknown if lab diagnostics or studies were performed or the patient had sought medical attention. No further details were given. The outcome of the event was unknown.  The causality between the event and the vaccine was not reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: administration of expired PNEUMOV AX 23.; No additional edverse events reported; This spontaneous non-valid report was received from a pharmacist who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On an unknown date, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, exact dose, route of administration and anatomical location were not reported; lot number S018405 was confirmed to be valid, expiration date was not reported but upon internal validation process, it was established as 28-MAR-2021 for prophylaxis.  The reporter asked if the patient would need to be revaccinated. No additional adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S018405; expirationdate: 28-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; an expired dose of ROTATEQ was administered to a patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was reported.  On 29-APR-2021, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2ml, orally, once, lot # 1660948 was confirmed to be valid, expiration date 22-MAR-2021, for prophylaxis. It was also reported that the vaccine had never undergone a temperature excursion. No additional adverse event was reported.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE at time of call; patient was inadvertently administered a dose of ROTATEQ after the product's labeled expiry of 4/29/2021; This spontaneous report was received from a medical assistant who refers to a 4-month-old patient of an unknown gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 03-MAY-2021, the patient was vaccinated inadvertently with expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, orally, for prophylaxis, lot # 1660993, expiry date 29-APR-2021 (formulation, concentration, dose number and frequency were not reported). No additional adverse event was reported. No product quality complaint (PQC) was involved.