chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Injection site pain, Resuscitation, Syncope, Transfusion
Clinical narrative: My mom only had site soreness after her covid vaccine on 1/21 which resolved within a couple days. However, she died in the early morning hours of 1/25, she was fine the day before, no sign of injury.  We found her collapsed on the ground and although we tried cpr she was already dead.  She had gone to the hospital on 12/28 for shortness of breath, angina and symptomatic anemia, her ekg was unchanged and blood work normal except for anemia. The cardiologist did not think a cardiac cath was needed. Her shortness of breath improved with a blood transfusion and a dose of lasix (no heart failure).
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dyspnoea, Hypoaesthesia, Hypoaesthesia oral, Muscle tightness
Clinical narrative: Patient experienced moderate to severe symptoms of shaking, trouble breathing, jaw tightness, tightness in mouth, numbness and tingling in lips, difficulty talking, upset stomach, tremors and numbness to left side of face
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Speech disorder, Stomatitis, Tremor
Clinical narrative: Patient experienced moderate to severe symptoms of shaking, trouble breathing, jaw tightness, tightness in mouth, numbness and tingling in lips, difficulty talking, upset stomach, tremors and numbness to left side of face
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Peripheral swelling
Clinical narrative: Moderna COVID- 19 Vaccine EUA  RECIEVED INJECTION ON 01/28 AND ON 02/02 PATIENT REPORTS THAT SHE DEVELOPED SOME SWELLING IN ARM, DEVELOPED A RED SPOT BELOW INJECTION SITE THE SIZE OF A 50 CENT PIECE THAT WAS BRIGHT RED IN COLOR.  ON 02/08 SHE REPORTS THAT THE COLOR HAS LESSENED BUT STILL THE SAME SIZE. HAS BEEN APPLYING NEOSPORIN TO SITE, NO SWELLING NOW.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: About eleven hours after receiving the vaccine I was awakened during the night with itching on my back. I used calamine lotion on it and it helped. But each day (I am writing this on day six after the vaccine, the itchiness has spread to my chest and neck and expanded into a larger area on my back. I have been using topical calamine and steroid cream to reduce the itching, and oral Benadryl tablets to reduce the itching and hives.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: The patient reported that upon leaving the building after receiving the first dose of the moderna vaccine, she experienced facial tingling.  She returned to the facility and was assessed by the nurse and it was determined that no oral swelling had occurred. The physician ordered 50mg of Benadryl . The patient was reassessed and stated that no additional tingling was felt after about 18 minutes. The patient was discharged after an additional 24 minutes to her mother picking her up.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Ophthalmological examination, Vision blurred
Clinical narrative: Extreme blurry vision in left eye on 2/7.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Paraesthesia oral, Vaccine positive rechallenge
Clinical narrative: "Pfizer-Bio-Tech COVID-19 Vaccine EUA"  After receiving the Covid-19 vaccine at 12:15 pm client compliant of having tingling lip and tongue symptoms. She stated that she has anxiety and had the same symptoms with the 1st vaccine and received liquid Benadryl. He brought in a note from the allergist that the benefit outweighs the risk and individual should be given vaccine in a controlled environment. 12:15 patient received 25 mg po of Benadryl elixir by mouth 99% Sat's, 156/90,79,20; 12:20 pm v/s 158/92, 56, 20, 99%, 12:25 PM, v/s, 150/90, 56, 18, 99%. Individual was monitor for 30 minutes and stated her can barely felt the tingling in her lips and tongue. Discharge vitals at 12:43 pm 146/92, 58, 18, 98 %.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Herpes zoster, Nausea, Pain, Physical examination
Clinical narrative: Broke out in shingles two days after injection on right side of waist and abdomen.  Much pain and nausea.  No appetite.  On day #9 today with no sign of let up, although blisters have dried up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site erythema, Injection site pruritus
Clinical narrative: Itchy, and red blotches at injection site. Swollen and very hot. All 10 days later.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Catheterisation cardiac, Chest X-ray, Chest discomfort, Computerised tomogram
Clinical narrative: Within twenty-four hours I had a 102.7 degree temperature which lasted a day then gradually went away, I took Tylenol for the fever. For then next couple days just felt rundown. Then three days post vaccine I began having some chest discomfort and shortness of breath. That night around one thirteen the morning I went to Emergency Department. they took a ECG and drew labs. the ECG showed normal rhythm just a little elevated and my Blood pressure was elevated. Upon the attending physician getting my lab work back i was admitted for my triponin levels being elevated. I was taken for chest X-rays and a Cat Scan per their pulmonary embolism protocols. Both of which showed nothing.  The next day i had a Echocardiogram, and Cardiac Catheterization, and a Cardiac MRI.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Electrocardiogram, Feeling abnormal, Magnetic resonance imaging heart
Clinical narrative: Within twenty-four hours I had a 102.7 degree temperature which lasted a day then gradually went away, I took Tylenol for the fever. For then next couple days just felt rundown. Then three days post vaccine I began having some chest discomfort and shortness of breath. That night around one thirteen the morning I went to Emergency Department. they took a ECG and drew labs. the ECG showed normal rhythm just a little elevated and my Blood pressure was elevated. Upon the attending physician getting my lab work back i was admitted for my triponin levels being elevated. I was taken for chest X-rays and a Cat Scan per their pulmonary embolism protocols. Both of which showed nothing.  The next day i had a Echocardiogram, and Cardiac Catheterization, and a Cardiac MRI.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Troponin
Clinical narrative: Within twenty-four hours I had a 102.7 degree temperature which lasted a day then gradually went away, I took Tylenol for the fever. For then next couple days just felt rundown. Then three days post vaccine I began having some chest discomfort and shortness of breath. That night around one thirteen the morning I went to Emergency Department. they took a ECG and drew labs. the ECG showed normal rhythm just a little elevated and my Blood pressure was elevated. Upon the attending physician getting my lab work back i was admitted for my triponin levels being elevated. I was taken for chest X-rays and a Cat Scan per their pulmonary embolism protocols. Both of which showed nothing.  The next day i had a Echocardiogram, and Cardiac Catheterization, and a Cardiac MRI.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong patient received product
Clinical narrative: Error: Wrong Patient (documentation in EMR).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dyskinesia, Fatigue, Feeling abnormal, Injection site pain
Clinical narrative: About 4 hours after his vaccine, the injection site starting hurting, but not bad.  He could not sleep on it at night as he felt like he was sleeping on a red hot pocker.  On Saturday he was extremely tired in the afternoon.  Had to come in from yard work as he could not function.  He also had pain in his neck and shoulders.  On Sunday he the feelings were going away, but his muscles started aching.  On Monday he felt really strange, felt like he was in a fog, and his muscles ached.  He could not get relaxed, did his normal Monday chores, laundry and house cleaning.  He then tried to relax but his muscles and nerves were very tense.  He went to bed around 9:30 on Monday, fell asleep and awoke at 2:00 AM and could not go back to sleep his muscles in his arms and legs were in spasm and his arm would jump like a shock reaction and jump off of the mattress, as well as his leg.  It was worse on the left side than the right arm.  This went on every 10-15 minutes for about 3-4 hours.  Around 4:00 AM this morning it eased off to sleep and woke up at 10 and felt better today.  He hasn't had any more of the seizure type feelings in his arms or legs.  He did speak with Moderna who told him that he was the 4th one with this reaction and to report this to us.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Muscle spasms, Muscle tightness, Myalgia, Neck pain
Clinical narrative: About 4 hours after his vaccine, the injection site starting hurting, but not bad.  He could not sleep on it at night as he felt like he was sleeping on a red hot pocker.  On Saturday he was extremely tired in the afternoon.  Had to come in from yard work as he could not function.  He also had pain in his neck and shoulders.  On Sunday he the feelings were going away, but his muscles started aching.  On Monday he felt really strange, felt like he was in a fog, and his muscles ached.  He could not get relaxed, did his normal Monday chores, laundry and house cleaning.  He then tried to relax but his muscles and nerves were very tense.  He went to bed around 9:30 on Monday, fell asleep and awoke at 2:00 AM and could not go back to sleep his muscles in his arms and legs were in spasm and his arm would jump like a shock reaction and jump off of the mattress, as well as his leg.  It was worse on the left side than the right arm.  This went on every 10-15 minutes for about 3-4 hours.  Around 4:00 AM this morning it eased off to sleep and woke up at 10 and felt better today.  He hasn't had any more of the seizure type feelings in his arms or legs.  He did speak with Moderna who told him that he was the 4th one with this reaction and to report this to us.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: About 4 hours after his vaccine, the injection site starting hurting, but not bad.  He could not sleep on it at night as he felt like he was sleeping on a red hot pocker.  On Saturday he was extremely tired in the afternoon.  Had to come in from yard work as he could not function.  He also had pain in his neck and shoulders.  On Sunday he the feelings were going away, but his muscles started aching.  On Monday he felt really strange, felt like he was in a fog, and his muscles ached.  He could not get relaxed, did his normal Monday chores, laundry and house cleaning.  He then tried to relax but his muscles and nerves were very tense.  He went to bed around 9:30 on Monday, fell asleep and awoke at 2:00 AM and could not go back to sleep his muscles in his arms and legs were in spasm and his arm would jump like a shock reaction and jump off of the mattress, as well as his leg.  It was worse on the left side than the right arm.  This went on every 10-15 minutes for about 3-4 hours.  Around 4:00 AM this morning it eased off to sleep and woke up at 10 and felt better today.  He hasn't had any more of the seizure type feelings in his arms or legs.  He did speak with Moderna who told him that he was the 4th one with this reaction and to report this to us.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear congestion, Ear pain, Palpitations
Clinical narrative: 10 minutes after receiving vaccine I had sudden sharp pains in my right ear.  I have had extensive surgery in and around that ear due to cholesteatoma and perilymph fistula, and I have had some nerve damage to the balance nerve.  The bones of hearing have been removed and replaced with titanium artificial bones that do not work, so I am deaf in that ear.  These pains were severe, as if a number of steak knives were stabbing me at once, but the pain only lasted about a minute and subsided.  3 or 4 minutes later the pain recurred exactly as before but lasted a shorter duration and at a lower level of pain.  The ear felt congested the rest of the day and I avoided driving after getting home.  I have had no further problems, except that I went for more dental work on 2/8, and had a dizzy spell after getting anesthetic, maybe a little heart racing for just 5 minutes or so.
Age: 88.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Vomiting
Clinical narrative: nausea and vomiting
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: I have a 2"x 2" lump at the injection sight.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site erythema, Swelling
Clinical narrative: Noticed redness at injection site starting 2/5/21. Some swelling. Now spreading.. Will trial antibiotic on possibility this is cellulitis.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: I was just going to stand up and I felt like I was hit with a lightening bolt! It was painful and only lasted a few second.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No adverse event. AFC home was told 18 yo and over are eligible for vaccine.  sent employee that was 2 weeks shy of 18th birthday.  pharmacist did not notice age not old enough and patient received shot without incident.  patient will be 18 by 2nd dose.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Fatigue
Clinical narrative: fatigue; temperature 102.2; weak feeling started on 2/8/21 around 3:00 symptoms still present on 2/9/21 when awakening about 8:00 am felt better around 10:00 am, when filling out this report
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Aggression, Amnesia, Anger, Erythema, Hallucination
Clinical narrative: I woke up at 11:30 and was hallucinating and very angry and violent.  I was  extremely red in my face could of had a temperature.  I was yelling at my wife and children.  This is very out of character for me and woke up this morning and had trouble recalling all the events of the previous night until my wife informed me of them.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pruritus, Pain in extremity, Vaccination site pain
Clinical narrative: After experiencing expected sore arm and fatigue the day after vaccination, I was symptom free for three days.  On the evening of the fourth day I developed pain, itching and redness around the vaccination site that is still present the following day.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature increased, Pain
Clinical narrative: Temp elevated 12 hours later Next morning Temperature 99.3,  body aches, upset stomach continues with same symptoms at 10AM
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Ear swelling, Inflammation, Pruritus, Rash, Swelling
Clinical narrative: Day 2, evening, had mild itching in many places on my body.  (not injection site).  The itching increased for two more days and my neck and ear canals swelled up.  The 3rd night was worst--I would wake up scratching and ear canals were swelled closed.  On Day 4 morning, I observed rashes all over my body and intense itching.  (not the injection site).  I went to doc who said this was an unusual and serious allergic reaction to the vaccine.  I intend to visit an allergist prior to 2nd shot. I am very worried about the severity of the inflammation that I experienced.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash that occurred on bilateral arms. EMS was on standby and assessed patient. EKG normal. No medications provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness postural
Clinical narrative: approx. 10 minutes after vaccine client stood up to throw something away and got dizzy. "I think it's an old people thing, I don't think it was related to the shot at all." Her vital signs were monitored and she was given water to drink. After a few minutes she was able to walk to her car accompanied by a nurse. No other problems noted.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Injection site pain
Clinical narrative: Injection site pain- 3 days Fatigue and weakness-3 days
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Severely swollen, red/hot, itchy area around injection site. Site first the size of a lime eventually growing to the size of a small apple. Continues to be swollen and itch 6 days after injection
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Throat irritation
Clinical narrative: Systemic: Other- Itchy Throat and tingling Tounge
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Pruritus, Skin warm
Clinical narrative: There was a delayed reaction, not from bandaid, began to itch day 7 after injection, Day 8-9 became hard, red 2 inch in diameter hot spot that lasted 2-3 days that she treated w/ benadryl and resolved
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Myalgia, Pain in extremity
Clinical narrative: severely sore arm muscles up and down arm.  lasted three days, disappeared, then returned three days later.  Hard to lift anything and extremely sore muscles all up and down arm.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immediate post-injection reaction, Pain
Clinical narrative: Patient complained of immediate pain near shoulder joint after vaccination. There was a note on the Allergic Reaction record to call patient "about injection." Patient called 2/9/21 at 11:13 am to inquire about injection by Nurse. Patient states her arm started hurting within 3 minutes after injection and was focal. Per patient, her shoulder has been hurting since the day of injection, but it is much improved currently. She reports pain with palpation and upward movement, but again significantly improved. Reports taking Tylenol once to alleviate pain but has not taken any more pain medication so as not to interfere with antibody response to vaccine. Instructed to report symptoms to PHP for follow-up
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiomegaly, Chest X-ray abnormal, Conjunctival disorder, Dyspnoea, Oxygen saturation
Clinical narrative: Periorbital swelling, conjunctival inflammation, facial and neck swelling, shortness of breath. Patient was treated on 2/5/21 with Depo-Medrol 80mg IM, Prednisone 40mg daily x  5 days, Augmentin 875mg 1 tab po bid x 10 days.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Periorbital swelling, Swelling, Swelling face
Clinical narrative: Periorbital swelling, conjunctival inflammation, facial and neck swelling, shortness of breath. Patient was treated on 2/5/21 with Depo-Medrol 80mg IM, Prednisone 40mg daily x  5 days, Augmentin 875mg 1 tab po bid x 10 days.
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Mobility decreased, Paralysis
Clinical narrative: Palsy in left arm. Unable to move it beyond 90 degrees. Neurologist advised against second shot.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No adverse effects noted. Patient received COVID-19 vaccine along with other vaccines on the same day.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: A week after I received the vaccine, I developed a knot on the injection site that is fairly large, sore and warm to the touch.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Confusional state, Dizziness, Fatigue, Memory impairment
Clinical narrative: Employee states on 2/2/2021 started feeling tired, fatigued and running low grade temperature; on 2/5/2021 started to feel lightheaded, experienced mild confusion, running low grade temperature; started to experience mild memory issues, i.e. forgetting simple directions of previous places visited and difficulty in spelling common words; notified EH, on 2/9/2021 she was evaluated by her primary care physician and he is currently running lab tests.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever, chills, extreme body pain, extreme fatigue
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Saturday Morning 2/6/21: I Began experiencing Itching on the "Left Stomach Area" - Upon Examination I noticed A Rash In The Area. The Rash Has Spread To Both Legs - The Left Leg Seems To Have The Heavier Rash.
Age: 100.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: she was given 2 doses same day . No reaction . Facility  has 4 buildings. in every building , consents were filled and facility checking temp, billed then given to residents and staff for pharmacists and  nurses to go through  the consents and administer. for the memory care building since patients were cognitive, team was reassured by director to keep consents and nurses at facility took patients temp  and to go based on facility master copy that Nurse accompanied by another nurse took CVS team to memory care , they were asking our immunizers to go to room number .... and immunize Mrs ...., immunizer will verify name on bracelet and immunize,.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Mobility decreased
Clinical narrative: 1. About 3 hours after the injection, pain at the injection site. 2. About 10 hours after the injection, experience headache, chills, fevers,  nausea, extreme exhaust, and unable to move the arm of injection. 3.  All symptoms resolved 48 hours after the injection.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: 1. About 3 hours after the injection, pain at the injection site. 2. About 10 hours after the injection, experience headache, chills, fevers,  nausea, extreme exhaust, and unable to move the arm of injection. 3.  All symptoms resolved 48 hours after the injection.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Feaver, chills, body aches, headache.  Took motron Pasted in 3 days
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Pallor
Clinical narrative: Pt experienced dizziness and became pale, blood pressure was found to be elevated to 175/84 @1340. Previous dose of COVID vaccine had created a similar response but she had just adjusted medications and attributed it to that. In this case she had taken all her medications. Took rx medication for high BP while being monitored but BP increased to 201/104. Her PCP was notified and she took a second dose of her BP medication. By 1500 her BP had improved to 155/89 and she was no longer dizzy. Taken home with instructions to follow up with PCP if symptoms return or worsen.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Nausea, Vertigo
Clinical narrative: Vertigo and nausea started Sunday Jan 31 and has persisted. Worse in a.m. upon arising. Still have lingering symptoms.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Blood pressure increased, Heart rate increased
Clinical narrative: Systemic: Other- lost vision, elevated blood pressure and pulse, returned to normal quickly thereafter administration
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Computerised tomogram normal, Fatigue, SARS-CoV-2 test
Clinical narrative: 12/22/2020 vaccination 1/2/2021 I woke up and felt exhausted, groggy.  1/3-1/4 still felt exhausted.  1/6 this is abnormal. I went to work and felt 'weak'.  Effort to do normal activities at work. transported to ER.  Prescribed zofran.  symptoms subsided by sat. I started to feel better and maneuver better.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, X-ray normal
Clinical narrative: 12/22/2020 vaccination 1/2/2021 I woke up and felt exhausted, groggy.  1/3-1/4 still felt exhausted.  1/6 this is abnormal. I went to work and felt 'weak'.  Effort to do normal activities at work. transported to ER.  Prescribed zofran.  symptoms subsided by sat. I started to feel better and maneuver better.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: I had the first dose of the vaccine for COVID 19 on 1/7/2021 and since I experience strong itching all over the body sporadically. Almost always it starts on my back and axilla and then spread throughout my body. I have had it on the sole of my feet, on my legs specifically. It is a strong itch. There are days where it is stronger than others. To alleviate the itching symptoms, I take a Benadryl 50mg, this is the only way I feel relief.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: Nausea and light headed on Feb 7, day of shot. Light headache and more severe muscle and join pain on Feb 8.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site inflammation, Injection site pruritus
Clinical narrative: I observed an inflamed itchy area just below the injection site on Day 9. The inflammation broadened and spread downward over the next two days, reaching about 7 inches in length and 3 inches in width by Day 11. I consulted a dermatologist then. She recommended a double strength dose of Zyrtec and application of Triamcinolone ointment to the inflamed area.  Over the next two days, this therapy halted the spread and reduced the inflammation, so that it was essentially gone by Day 13.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Extreme dizziness and nausea
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Myalgia
Clinical narrative: COVID-19 Vaccine; Nine days after receiving the vaccine, I noticed slight soreness in the injection site muscle. When I got out of the shower the next morning, my arm had a red circle at the injection site.   I had no other symptoms.  The redness faded during the day.  A  friend of mine is a nurse who said I should report this, even though the symptoms were very mild.  Later, I remembered scratching my arm before the redness occurred.  My skin is dry during winter, so I hadn't made any connection to the vaccine site.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Paraesthesia oral
Clinical narrative: Flushing of the face, tingling of the lips on date of shot 2/9/21.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: Very bad injection site arm pain starting 4 pm 2/08 and continues. Sever chills started 2 am 2/09/21, stopped 8 am 2/09. Fever of 100 started about 5am 2/09 and continues. Very bad whole body aches started 1am 2/09 and continues.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site rash, Pruritus, Swelling
Clinical narrative: One week after the shot I developed a small red itchy bump.  It went away after 2 days.  Then a week after that I developed a rash about 2 inches below the place where I received the shot.  No bump, no itch, just a rash which is where I am right now.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: My lips, face, and neck went tingly and semi-numb. It's a feeling similar to when your foot falls asleep.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Paraesthesia oral
Clinical narrative: My lips, face, and neck went tingly and semi-numb. It's a feeling similar to when your foot falls asleep.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Loss of consciousness
Clinical narrative: Shortness of breath and loss of consciousness about 10 hours after receiving vaccine.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Rash, Rash pruritic
Clinical narrative: Experienced heat rash looking rash that appeared first on my torso then preceded to cover the rest of my body. Back, bilateral upper and lower extremities and lips. The rash is periodically itchy and inflamed. Benadryl 25mg daily at night with no relief.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling face
Clinical narrative: Face swelling and sore arm 10 days after first shot
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Swelling, Urticaria
Clinical narrative: Tingling throughout arm and into shoulder blade on 2 occasions throughout the day. Eyes felt swollen a few hours after receiving vaccine between 1-2 pm. Symptoms went away. At around 11pm I got welts and hives all over my body but they were particularly prevalent at the vaccine site. No change in routine throughout the day nor a change in food. Largely went away by the next day around 1pm. Still experiencing slight itchiness.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Eye movement disorder, Palpitations
Clinical narrative: Systemic: Other- Eye quivering, heart raced, quickly returned to normal-Mild
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cluster headache, Fatigue, Myalgia
Clinical narrative: Extreme joint and muscle pain, cluster headaches, fatigue, chills.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Gait disturbance, Headache, Hyperacusis
Clinical narrative: Bad headache    Throwing up Severe chills      Could barley walk and move Severe body aches    Skin hurts so bad-wanted to rip it off Severe stomach pain   Very sensitive to sound, lights and smells Vision blurry Fever
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Pain, Pain of skin, Parosmia, Photophobia
Clinical narrative: Bad headache    Throwing up Severe chills      Could barley walk and move Severe body aches    Skin hurts so bad-wanted to rip it off Severe stomach pain   Very sensitive to sound, lights and smells Vision blurry Fever
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Bad headache    Throwing up Severe chills      Could barley walk and move Severe body aches    Skin hurts so bad-wanted to rip it off Severe stomach pain   Very sensitive to sound, lights and smells Vision blurry Fever
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood culture negative, Blood glucose increased, C-reactive protein normal, CD4/CD8 ratio, Differential white blood cell count
Clinical narrative: Primarily pruritic rash. Started on the left arm near injection site. Exacerbated by day of onset of rash after spending time in a hot tub. Urticaria rash present prior to exposure to warm water. Urticaria at first even though 4 days after vaccination. Then started on right arm. Later spread to trunk, upper legs (anterior & posteriorly), then neck, scalp line (face spared, as were palms and soles of feet). Rash was distinct maculopapules, no pustules, no vesicles, no petechiae; + blanching. No other systemic symptoms, no other physical exam findings, + dermatographia. Started on medrol dose pack on 1/30/2021. Seen in ED on 2/1/2021 and hospitalized until 2/6. Seen in ED again 2/7/2021. Treatment History: 2/1 - 2/6/2021 Ceftriaxone 1 gm IVP on 2/1 Famotidine 20 mg IVP Q12 hrs Benadryl 50 mg IVP Q6 hrs prn Hydroxyzine oral prn Ativan oral prn Methylprednisolone 40 mg Q6 hrs x 4 doses, then 40 mg Q12 hrs x 3 days Discharged pn Prednisone 40 mg BID x 4 days, 30 mg BID x 4 days, 20 mg BID x 4 days, 10 mg BID x 4 days, 10 mg daily x 4 days  Also given betamethasone dipropionate augmented 0.05% topically BID prn 2/7  Changed to zyrtec from hydroxyzine
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Eosinophil percentage, Fibrin D dimer, Full blood count, Injection site rash, Lymphocyte count
Clinical narrative: Primarily pruritic rash. Started on the left arm near injection site. Exacerbated by day of onset of rash after spending time in a hot tub. Urticaria rash present prior to exposure to warm water. Urticaria at first even though 4 days after vaccination. Then started on right arm. Later spread to trunk, upper legs (anterior & posteriorly), then neck, scalp line (face spared, as were palms and soles of feet). Rash was distinct maculopapules, no pustules, no vesicles, no petechiae; + blanching. No other systemic symptoms, no other physical exam findings, + dermatographia. Started on medrol dose pack on 1/30/2021. Seen in ED on 2/1/2021 and hospitalized until 2/6. Seen in ED again 2/7/2021. Treatment History: 2/1 - 2/6/2021 Ceftriaxone 1 gm IVP on 2/1 Famotidine 20 mg IVP Q12 hrs Benadryl 50 mg IVP Q6 hrs prn Hydroxyzine oral prn Ativan oral prn Methylprednisolone 40 mg Q6 hrs x 4 doses, then 40 mg Q12 hrs x 3 days Discharged pn Prednisone 40 mg BID x 4 days, 30 mg BID x 4 days, 20 mg BID x 4 days, 10 mg BID x 4 days, 10 mg daily x 4 days  Also given betamethasone dipropionate augmented 0.05% topically BID prn 2/7  Changed to zyrtec from hydroxyzine
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphocyte percentage increased, Metabolic function test normal, Neutrophil percentage increased, Pallor, Rash
Clinical narrative: Primarily pruritic rash. Started on the left arm near injection site. Exacerbated by day of onset of rash after spending time in a hot tub. Urticaria rash present prior to exposure to warm water. Urticaria at first even though 4 days after vaccination. Then started on right arm. Later spread to trunk, upper legs (anterior & posteriorly), then neck, scalp line (face spared, as were palms and soles of feet). Rash was distinct maculopapules, no pustules, no vesicles, no petechiae; + blanching. No other systemic symptoms, no other physical exam findings, + dermatographia. Started on medrol dose pack on 1/30/2021. Seen in ED on 2/1/2021 and hospitalized until 2/6. Seen in ED again 2/7/2021. Treatment History: 2/1 - 2/6/2021 Ceftriaxone 1 gm IVP on 2/1 Famotidine 20 mg IVP Q12 hrs Benadryl 50 mg IVP Q6 hrs prn Hydroxyzine oral prn Ativan oral prn Methylprednisolone 40 mg Q6 hrs x 4 doses, then 40 mg Q12 hrs x 3 days Discharged pn Prednisone 40 mg BID x 4 days, 30 mg BID x 4 days, 20 mg BID x 4 days, 10 mg BID x 4 days, 10 mg daily x 4 days  Also given betamethasone dipropionate augmented 0.05% topically BID prn 2/7  Changed to zyrtec from hydroxyzine
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash maculo-papular, Rash pruritic, Tryptase, Urticaria, White blood cell count increased
Clinical narrative: Primarily pruritic rash. Started on the left arm near injection site. Exacerbated by day of onset of rash after spending time in a hot tub. Urticaria rash present prior to exposure to warm water. Urticaria at first even though 4 days after vaccination. Then started on right arm. Later spread to trunk, upper legs (anterior & posteriorly), then neck, scalp line (face spared, as were palms and soles of feet). Rash was distinct maculopapules, no pustules, no vesicles, no petechiae; + blanching. No other systemic symptoms, no other physical exam findings, + dermatographia. Started on medrol dose pack on 1/30/2021. Seen in ED on 2/1/2021 and hospitalized until 2/6. Seen in ED again 2/7/2021. Treatment History: 2/1 - 2/6/2021 Ceftriaxone 1 gm IVP on 2/1 Famotidine 20 mg IVP Q12 hrs Benadryl 50 mg IVP Q6 hrs prn Hydroxyzine oral prn Ativan oral prn Methylprednisolone 40 mg Q6 hrs x 4 doses, then 40 mg Q12 hrs x 3 days Discharged pn Prednisone 40 mg BID x 4 days, 30 mg BID x 4 days, 20 mg BID x 4 days, 10 mg BID x 4 days, 10 mg daily x 4 days  Also given betamethasone dipropionate augmented 0.05% topically BID prn 2/7  Changed to zyrtec from hydroxyzine
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Has dose #1 of Moderna on 1/3/2021 and about 1-1.5 weeks later developed rash. Rash resolved. Had dose #2 of Moderna on 2/2/2021 and about 24-48 hours later developed a hive like rash that worsened despite taking benadryl and zyrtec. Rash is from chest up to head. + itching. No fevers, No redness at injection site. Patient evaluated at clinic on 2/9/2021. Given Solu medrol and prednisone.
Sex: F
Vaccine: HPV9, UNK
Symptoms: Injection site pain
Clinical narrative: Palpable area (2 cm) at injection site that is subcutaneous and tender; Palpable area (2 cm) at injection site that is subcutaneous and tender; Information has been received from FDA (VAERS # 842809) on 23-OCT-2020.  This spontaneous report was received from a physician referring to a 12 years old White female patient. The patient's concurrent condition included achondroplasia. The patient was allergy to doxycycline, polmyxin. The patient's concomitant therapies included meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) and diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL).     On 29-AUG-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) (manufacturer reported as ; lot # ARDE5523 is an invalid lot number for  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).  Lot number ARDE5523 does not match any Company product as confirmed by Lot Verification team) dose 1, intramuscular in the left arm for prophylaxis.      In 2019, the patient experienced palpable area (2 cm) at injection site that was subcutaneous and tender. The outcome of both events reported as not recovered. The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) was not provided.  Follow-up information was received from the same reporter on 03-FEB-2021. The lot number of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) was reported as 1602284 and it has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date not reported, but upon internal validation established as 26-SEP-2021. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no documented reaction to receiving this vaccine; vaccine exposure, freezer left open; This spontaneous report has been received from a registered nurse and refers to 4-year-old male patient. The patient had no known allergies, no listed medical conditions and no illness at the time of the vaccination. His concomitant medication included diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (QUADRACEL).   On 17-DEC-2020, the patients was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) T023917 has been verified as a valid lot number, expiration date reported as 09-JAN-2022, first dose, via subcutaneous route in right arm for prophylaxis (exact dose was not reported). The excursion was due to the freezer was left open. It was reported that the vaccine was ok to use. It was unknown if the digital data logger was involved. The patient had no documented reaction to receiving this vaccine.; Sender's Comments:  US-009507513-2012USA008918:
Sex: U
Vaccine: HEPA, RV5
Symptoms: Product storage error
Clinical narrative: Improperly stored administered Rotateq and Vaqta; This spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.     On unknown dates, the patients were vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA), lot number T014836 with expiration date 17-JUL-2021 (dose, strength, anatomical location and route of administration were not provided) and improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, lot number 1691141 with expiration date 01-NOV-2021 (dose, strength and anatomical location were not provided); both administered for prophylaxis.  The temperature and timeframes were: below 36ºF (33.8F) for 0 hours 28 minutes and 0 seconds, below 36ºF (33.8F) for 7 hours 9 minutes and 0 seconds,  below 36ºF (33.4F) for 23 hours 59 minutes and 0 seconds and below 36ºF (33.8F) for 24 hours 0 minutes and 0 seconds.  All excursions were detected through data logger and was confirmed that were previous temperature excursions. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014836; expirationdate: 17-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 66.0
Sex: M
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 66 year old patient who was inadvertently vaccinated with GARDASIL 9; No additional AE reported; This spontaneous report was received from a reporter of unspecified qualifications and refers to a 66-year-old male patient. His pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T008152, expiration date 21-JUN-2022 (formulation, strength, exact dose, anatomical location and route of administration were not reported) for prophylaxis (product administered to patient of inappropriate age). The outcome was not reported. No additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008152; expirationdate: 21-JUN-2022; 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
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE/PQC was reported; that the patient received his first dose of GARDASIL 9 when he was 14 years of age on 24-JUL-2019 and did not receive his second dose of GARDASIL 9 until he was 15 years of age on 27-JUL-2020; This spontaneous report was received from a patient's mother and refers to a 15-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 24-JUL-2019, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscular injection (dose, lot #, expiration date were not reported) to prevent human papilloma virus (HPV). On 27-JUL-2020, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No adverse event was reported. The reporter asked if there were any other information on the dosing schedule of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) to support the patient receiving his second dose 3 days late.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: an improperly stored vaccine was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.      On 25-JAN-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength and route of administration were not reported, lot # S035534 is an invalid lot # for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot # S035534 is a valid lot # for olmesartan medoxomil (OLMESARTAN), expiration date was reported as 04-NOV-2021) 1 injection (1 dosage form) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of above 9 degree Celsius (13.4 degree Celsius) for a time frame of 2 hours and 9 minutes, as recorded by the digital data logger. There were no previous temperature excursions.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: Shingles; ill defined disorder; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of an unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 05-FEB-2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for the long-term prevention of singles and zoster-related conditions. Subsequently on an unknown date, the patient was treated for singles and other zoster related injuries( ill-defined disorder). The outcome of herpes zoster and ill-defined disorder was unknown. The reporter considered herpes zoster and ill-defined disorder to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: U
Vaccine: HEPA, UNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional AE reported; inadvertently received a 3rd dose of VAQTA; This spontaneous report was received from a licensed practical nurse (LPN) and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On an unknown date in September 2019, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, lot # T017179 was confirmed to be valid, expiration date was 26-OCT-2021, 1 ml (route of administration and anatomical location were not reported) for prophylaxis. On an unknown date in November 2020, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA). On 20-JAN-2021 (also reported as two weeks ago), the patient was inadvertently vaccinated with the third dose of hepatitis a vaccine, inactivated (VAQTA) (inappropriate schedule of product administration). No additional adverse events was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T017179; expirationdate: 26-OCT-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