chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Basophil percentage, Blood albumin decreased, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal
Clinical narrative: She developed mild swelling of her lips just after midnight on 3/3/21, which she discovered after waking up to use the restroom. She then went back to sleep. She awoke the next morning (3/3/21) to find her lips, tongue, and back of her throat were swollen so much that she couldn't talk. She came to the ED where she received 125mg Solu-Medrol , Pepcid 20mg, and Benadryl 25mg. The swelling initially improved then worsened again and she was admitted to the hospital for overnight observation. Swelling improved and she was discharged on 3/4/21.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Blood chloride increased, Blood creatinine normal, Blood galactose, Blood glucose normal, Blood potassium normal
Clinical narrative: She developed mild swelling of her lips just after midnight on 3/3/21, which she discovered after waking up to use the restroom. She then went back to sleep. She awoke the next morning (3/3/21) to find her lips, tongue, and back of her throat were swollen so much that she couldn't talk. She came to the ED where she received 125mg Solu-Medrol , Pepcid 20mg, and Benadryl 25mg. The swelling initially improved then worsened again and she was admitted to the hospital for overnight observation. Swelling improved and she was discharged on 3/4/21.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Blood sodium normal, Blood urea normal, C-reactive protein normal, C1 esterase inhibitor test, Carbon dioxide normal
Clinical narrative: She developed mild swelling of her lips just after midnight on 3/3/21, which she discovered after waking up to use the restroom. She then went back to sleep. She awoke the next morning (3/3/21) to find her lips, tongue, and back of her throat were swollen so much that she couldn't talk. She came to the ED where she received 125mg Solu-Medrol , Pepcid 20mg, and Benadryl 25mg. The swelling initially improved then worsened again and she was admitted to the hospital for overnight observation. Swelling improved and she was discharged on 3/4/21.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Complement factor C4, Eosinophil count decreased, Eosinophil percentage decreased, Glomerular filtration rate decreased, Haematocrit decreased
Clinical narrative: She developed mild swelling of her lips just after midnight on 3/3/21, which she discovered after waking up to use the restroom. She then went back to sleep. She awoke the next morning (3/3/21) to find her lips, tongue, and back of her throat were swollen so much that she couldn't talk. She came to the ED where she received 125mg Solu-Medrol , Pepcid 20mg, and Benadryl 25mg. The swelling initially improved then worsened again and she was admitted to the hospital for overnight observation. Swelling improved and she was discharged on 3/4/21.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin decreased, Immune complex assay, Lip swelling, Lymphocyte count normal, Lymphocyte percentage decreased
Clinical narrative: She developed mild swelling of her lips just after midnight on 3/3/21, which she discovered after waking up to use the restroom. She then went back to sleep. She awoke the next morning (3/3/21) to find her lips, tongue, and back of her throat were swollen so much that she couldn't talk. She came to the ED where she received 125mg Solu-Medrol , Pepcid 20mg, and Benadryl 25mg. The swelling initially improved then worsened again and she was admitted to the hospital for overnight observation. Swelling improved and she was discharged on 3/4/21.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased, Mean cell volume decreased, Mean platelet volume normal, Monocyte count increased
Clinical narrative: She developed mild swelling of her lips just after midnight on 3/3/21, which she discovered after waking up to use the restroom. She then went back to sleep. She awoke the next morning (3/3/21) to find her lips, tongue, and back of her throat were swollen so much that she couldn't talk. She came to the ED where she received 125mg Solu-Medrol , Pepcid 20mg, and Benadryl 25mg. The swelling initially improved then worsened again and she was admitted to the hospital for overnight observation. Swelling improved and she was discharged on 3/4/21.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Monocyte percentage, Neutrophil count increased, Neutrophil percentage increased, Pharyngeal swelling, Platelet count normal
Clinical narrative: She developed mild swelling of her lips just after midnight on 3/3/21, which she discovered after waking up to use the restroom. She then went back to sleep. She awoke the next morning (3/3/21) to find her lips, tongue, and back of her throat were swollen so much that she couldn't talk. She came to the ED where she received 125mg Solu-Medrol , Pepcid 20mg, and Benadryl 25mg. The swelling initially improved then worsened again and she was admitted to the hospital for overnight observation. Swelling improved and she was discharged on 3/4/21.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Protein total decreased, Red blood cell count decreased, Red blood cell sedimentation rate normal, Red cell distribution width increased, Swollen tongue
Clinical narrative: She developed mild swelling of her lips just after midnight on 3/3/21, which she discovered after waking up to use the restroom. She then went back to sleep. She awoke the next morning (3/3/21) to find her lips, tongue, and back of her throat were swollen so much that she couldn't talk. She came to the ED where she received 125mg Solu-Medrol , Pepcid 20mg, and Benadryl 25mg. The swelling initially improved then worsened again and she was admitted to the hospital for overnight observation. Swelling improved and she was discharged on 3/4/21.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Tryptase, White blood cell count increased
Clinical narrative: She developed mild swelling of her lips just after midnight on 3/3/21, which she discovered after waking up to use the restroom. She then went back to sleep. She awoke the next morning (3/3/21) to find her lips, tongue, and back of her throat were swollen so much that she couldn't talk. She came to the ED where she received 125mg Solu-Medrol , Pepcid 20mg, and Benadryl 25mg. The swelling initially improved then worsened again and she was admitted to the hospital for overnight observation. Swelling improved and she was discharged on 3/4/21.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Fatigue, Myalgia
Clinical narrative: Chills Fever of 101.8 Nausea Muscle Aches Fatigue Trouble Breathing Dizziness  Symptoms gradually subsided over 24 hours.  Used a rescue inhaler for the breathing troubles, took extra strength tylenol for the fever.   Slept for 18 solid hours from 9pm on March 7th till 3 pm on March 8th - had been napping most of the day before 9pm.Fever and fatigue were the last symptoms to resolve.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Chills Fever of 101.8 Nausea Muscle Aches Fatigue Trouble Breathing Dizziness  Symptoms gradually subsided over 24 hours.  Used a rescue inhaler for the breathing troubles, took extra strength tylenol for the fever.   Slept for 18 solid hours from 9pm on March 7th till 3 pm on March 8th - had been napping most of the day before 9pm.Fever and fatigue were the last symptoms to resolve.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: No problems initially.  9 to 10 days post vaccine  site started to itch. Looked like a mosquito bite for a couple days.  by day 3 was the diameter of a softball.  Itchy, red and warm to touch.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Injection site pain, Pain
Clinical narrative: Muscle tenderness on injection site (upper left arm) after about an hour - lasted 3 days Body aches all over - took already prescribed Oxycodone - lasted 5 days Tired/Weakness - rested & slept - lasted over a week
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Choking sensation, Dysphagia, Dysphonia, Full blood count, Headache
Clinical narrative: Patient begin to experience throat tightening, sensation of need to clear throat frequently,  voice hoarseness, trouble swallowing, choking sensation and headache 45 minutes after receiving 2nd moderna vaccine.   Patient took Benadryl 50 mg OTC and went to ED.  Treated with racemic epinephrine, IV benadyl, IV decadron, IV pepcid.  Given script for epipen by ED provider, but has not needed to use.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Throat clearing, Throat tightness
Clinical narrative: Patient begin to experience throat tightening, sensation of need to clear throat frequently,  voice hoarseness, trouble swallowing, choking sensation and headache 45 minutes after receiving 2nd moderna vaccine.   Patient took Benadryl 50 mg OTC and went to ED.  Treated with racemic epinephrine, IV benadyl, IV decadron, IV pepcid.  Given script for epipen by ED provider, but has not needed to use.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chest X-ray normal, Chills, Cough
Clinical narrative: Approximately 5 hours after receiving my first Moderna vaccine I developed a cough, fever, chills, runny nose. I assumed these were  some of the symptoms as a result of the vaccine. I monitored my fever for several hours. The cough persisted for the next 9 plus days and I didn't have any desire to eat or drink liquids. I lost my taste and smell during this 9 day period. On February 25 my wife and I took a Covid-19 self test at pharmacy. Also on this same date I went to urgent care My wife was concerned about my labored breathing.  My vitals were checked and I requested a chest xray. I was given 2 prescriptions. 1 for Prednisone 20mg and Ventolin.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dyspnoea, Pyrexia, Rhinorrhoea, Thirst decreased
Clinical narrative: Approximately 5 hours after receiving my first Moderna vaccine I developed a cough, fever, chills, runny nose. I assumed these were  some of the symptoms as a result of the vaccine. I monitored my fever for several hours. The cough persisted for the next 9 plus days and I didn't have any desire to eat or drink liquids. I lost my taste and smell during this 9 day period. On February 25 my wife and I took a Covid-19 self test at pharmacy. Also on this same date I went to urgent care My wife was concerned about my labored breathing.  My vitals were checked and I requested a chest xray. I was given 2 prescriptions. 1 for Prednisone 20mg and Ventolin.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Myalgia, Pyrexia
Clinical narrative: Fever moderate muscle pain  moderate  weakness  confusion
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: After about 15H after the vaccine I strayed to feel very tired and started having severe body aches, chills, sweating  and my teeth were hurting.  By 2pm I had 102.5F /103F which lasted all day. At 1am I was in unbearable body ache  and 103F  that I took Tylenol  and finally got some relief.  The following morning I felt better still with 100F and body aches but better.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: After about 15H after the vaccine I strayed to feel very tired and started having severe body aches, chills, sweating  and my teeth were hurting.  By 2pm I had 102.5F /103F which lasted all day. At 1am I was in unbearable body ache  and 103F  that I took Tylenol  and finally got some relief.  The following morning I felt better still with 100F and body aches but better.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell?s Palsy, right side of face, affect eyelid, cheek, lips, tongue
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swelling underarm lymph node
Sex: U
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: First night (2/26) woke up very itchy all over body, no visible rash.  Today (3/9)  woke up with COVID arm ring around injection site; brighter red ring with bruise-y red inside. About 1 inch tall and 2 inches wide. No pain to touch, maybe slightly warm?
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The child did not have an adverse reaction, he was fine after receiving the vaccine and had no side effects.  The child was inadvertently given the vaccine at a mass event. Upon verifying information with mother of  the child, she insists that he was born in 2005 despite the fact that he has a complete immunization record with date birth 01/26/2006.  Mother also insists that the child receive his second dose of Moderna regardless of his age and current ACIP recommendations.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia, Tenderness
Clinical narrative: fever, body aches, chills, fatigue, tender arm
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Impaired work ability, Pain, Pruritus, Pyrexia
Clinical narrative: Fever; body aches; chills; hives on stomach; itching on hands.  Missed 1 day of work
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Fever; body aches; chills; hives on stomach; itching on hands.  Missed 1 day of work
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Eye irritation, Facial pain, Headache, Limb discomfort
Clinical narrative: headache, arm feels too heavy, legs feels heavy, neck hurts, face hurts, eyes on fire, back hurts, and hands hurts
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: headache, arm feels too heavy, legs feels heavy, neck hurts, face hurts, eyes on fire, back hurts, and hands hurts
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, itching, and warmth at the injection site
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Pharyngeal hypoaesthesia
Clinical narrative: Complained of mouth and throat numbness . Checked by EMS VSS. Cleared by EMS and NP
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Headache, Injection site induration, Injection site pain
Clinical narrative: severe headache,  chills, achy bones,  injection site very hard, painful and itchy still. These symptoms were nearly as bad as the ones I had when I had Covid Nov/2020.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus
Clinical narrative: severe headache,  chills, achy bones,  injection site very hard, painful and itchy still. These symptoms were nearly as bad as the ones I had when I had Covid Nov/2020.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Tremor
Clinical narrative: Uncontrollable shaking chills for 45 minutes.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Nausea
Clinical narrative: Began feeling dizzy and nauseated.   Started vomiting at approximately 5:00pm and continued until 6:30 or 7:00pm. I could not open my eyes because of the extreme dizziness. Chills Sweating I was able to sleep for a few hours and woke up at 10:00pm and the symptoms had subsided. I woke up with a headache on Sunday morning.  That went away and have not had any symptoms since
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Began feeling dizzy and nauseated.   Started vomiting at approximately 5:00pm and continued until 6:30 or 7:00pm. I could not open my eyes because of the extreme dizziness. Chills Sweating I was able to sleep for a few hours and woke up at 10:00pm and the symptoms had subsided. I woke up with a headache on Sunday morning.  That went away and have not had any symptoms since
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Injection site erythema, Injection site mass
Clinical narrative: Approximately 6- 7 days  after I received my 1 dosage my left arm began to hurt where I had received my vaccine. I noticed a very large area on my arm (about 7-8 inch circular area) that was very red, raised and extremely hot. My arm hurts pretty bad and have also had a headache for about a week. I do not feel well (tired and stomach issues)
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site warmth, Malaise, Pain in extremity
Clinical narrative: Approximately 6- 7 days  after I received my 1 dosage my left arm began to hurt where I had received my vaccine. I noticed a very large area on my arm (about 7-8 inch circular area) that was very red, raised and extremely hot. My arm hurts pretty bad and have also had a headache for about a week. I do not feel well (tired and stomach issues)
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: moderate nausea, chills, fever
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Fatigue, Headache
Clinical narrative: High fever, 101.5, chills, upset stomach, headache, body aches, joint aches, fatigue.   Onset of symptoms was 7 hours after vaccination, escalated to it's worst by midnight, consistent high fever with all symptoms through 11:00 a.m. next day, then symptoms began to subside and were gone 7 hours later.  Sore arm and fatigue lasted through the next day.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: High fever, 101.5, chills, upset stomach, headache, body aches, joint aches, fatigue.   Onset of symptoms was 7 hours after vaccination, escalated to it's worst by midnight, consistent high fever with all symptoms through 11:00 a.m. next day, then symptoms began to subside and were gone 7 hours later.  Sore arm and fatigue lasted through the next day.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Hypersomnia
Clinical narrative: Body aches, headache, chills, sweating, fever, extreme fatigue (Shot on Friday, began on Monday evening)  About 6 days after the shot (Wednesday) I had the chills, a slight fever (99.1) and was so fatigued I slept for 20 hours straight, woke up for about 3 hours and then slept for an additional 10 hours.  I had the chills and sweats so bad that the sheets and mattress were soaked when I woke up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches, headache, chills, sweating, fever, extreme fatigue (Shot on Friday, began on Monday evening)  About 6 days after the shot (Wednesday) I had the chills, a slight fever (99.1) and was so fatigued I slept for 20 hours straight, woke up for about 3 hours and then slept for an additional 10 hours.  I had the chills and sweats so bad that the sheets and mattress were soaked when I woke up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Rhinorrhoea, Sneezing
Clinical narrative: Pfizer vaccine  sudden onset dramatic sneezing and runny nose March 6-8 very painful lower back started March 7 and continues as of today
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Diabetic foot, Sepsis
Clinical narrative: Per the EUA, cases of COVID-19 vaccination that result in hospitalization or death are to be reported. This patient received Pfizer vaccine  on 2/26/2021. Patient is admitted for sepsis secondary left diabetic foot ulcer.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Rash macular
Clinical narrative: no reaction initially; removed bandaid (red color, put on after injection) two days later. Noticed slight hardening at the site. March 7: Pale red blotch where bandaid had been,.  Slight itchyness.  March 9: approx 2 inch diam. slight hardness under the skin, blotchy patch same.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Full blood count
Clinical narrative: high BP, palpitations , dizziness, light headedness that lasted for 4-5 weeks after the 2 nd dose of vaccine on jan 7 2021
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Hypertension, Metabolic function test, Palpitations, Urine analysis
Clinical narrative: high BP, palpitations , dizziness, light headedness that lasted for 4-5 weeks after the 2 nd dose of vaccine on jan 7 2021
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Palpitations
Clinical narrative: 3/1/2021  Caller with hx of Afib corrected by surgery woke up at 06:00 this morning with a racing heart like she feels used to feel with her afib. She is also dizzy and having a hard time breathing (observed from exertion of talking while on the call).  No hospital care yet, but a nurse friend said her HR seems irregular to her.   3/2/2021 Follow up call:   Still has difficulty breathing  Patient can't really explain. Felt like she did  when had A-fib.  Palpitations largely Tired This AM, but did not sleep well tonight. Call into Cardiologist for possible appt and further care.   3/7/2021 Follow up call:  Caller is feeling a lot better this week. She is still mildly SOB but her Afib episode seems to have resolved. She has been in continuous contact with her Cardiologist and has an appt. this upcoming Tuesday. They did say on the phone she is not the first person to report this event to them after receiving the COVID vaccine. Caller provides DOB so that this AE can be adequately reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Impaired work ability, Pain in extremity, Pyrexia
Clinical narrative: Fever; chills; headache; arm pain.    missed one day of work
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Injection site pain, Pain in extremity
Clinical narrative: Patient received Janseen COVID vaccine. The first 1/2 of the vaccine was given easily IM to the left deltoid and then the patient complained of severe arm pain, tensed her muscles, and the last 0.25ml was difficult to inject. Then the patient became hypotensive 90/45, dizzy, and felt like she was going to pass out. She was laid in the supine position, given a cool cloth for her forehead and monitored for approx. 45 minutes. Her blood pressure remained 90/60, 96/56 at discharge. Her heart rate ranged from 55-65, regular. Her son came to take her home as we did not feel comfortable with the patient driving. The patient was continuously monitored by the NPs and APCT. She ambulated without difficulty and was discharged home. She was given information for V-safe to report her reaction and advised to follow up in the ER for any SOB, difficulty breathing, difficulty swallowing, syncope, CP, etc.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Tenderness
Clinical narrative: Red tenderness of left arm, fatigue
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Photophobia, Retching, SARS-CoV-2 test negative
Clinical narrative: Feb 25, 2021 had dry heaves, severe headache, same thing next day and my eyes are sensitive to light and giving me a constant  headache and sick to my stomach.  Have called my doctor but she has no information for me other than go to the hospital.  The symtoms  are still going on today  March 9, 2021.  I do not have dry heaves but sunlight gives me a constant headache and nothing over the counter works for my headache or my stomach.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Irritable bowel syndrome, Nausea
Clinical narrative: Became nauseous with headache within one hour of getting vaccine, developed irritable bowels third day after, and became extremely hot the morning of the fourth day after the vaccine and again on the seventh day after the vaccine.  The nauseous, headaches, and irritable bowels subsided by fourth day after the vaccine.  Did not receive any treatment.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Visual impairment
Clinical narrative: On or about 06 March I began to experience slight dizziness, and noticed that SOME things I was seeing were apparently moving. A neighbor is experiencing very SIMILAR symptoms. He is also 77 years old, and had his MODERNA booster shot about a week or so before I had mine, and we chatted this morning, so I concluded that our symptoms APPEAR to be related to the MODERNA booster.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia
Clinical narrative: Patient received first dose of vaccine at 0940 am.  At 0945 patient complained  of feeling  like having difficulty swallowing to Observation nurse, Dr. with patient. Patient was given Epinephrine via Quick-Dose Pen in left thigh.  Patient connected to monitor and B/P 179/90, HR 117, RR 22, pulse ox 99.   At 0950 patient states she is beginning to feel a bit better, swallowing a bit easier.   0955 Rapid Response Team called and notified of situation. ER charge nurse notified of  situation.    1005  B/P 170/88, HR 99 RR 22 pulse ox 100.  Patient given Benadry 50 mg po by RN. 1015 Patient states her swallowing is again becoming more difficult.  Given second dose Epinephrine via Quick-Pen by RN.   Rapid  Response Team arrived and assumed care.  ED charge RN notified of patient status.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Dizziness, Injection site erythema, Injection site induration
Clinical narrative: Pt. reports Sat. night developed chills, was dizzy and vision was "bad, like my eyes were tired and had trouble focusing them and just wanted to go to bed", Reports woke up with same symptoms and also had some confusion and had red swollen hard area on L arm were vaccine was given and it is still red and swollen today.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Visual impairment
Clinical narrative: Pt. reports Sat. night developed chills, was dizzy and vision was "bad, like my eyes were tired and had trouble focusing them and just wanted to go to bed", Reports woke up with same symptoms and also had some confusion and had red swollen hard area on L arm were vaccine was given and it is still red and swollen today.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Rash, Tremor
Clinical narrative: Severe chills lasting a couple of hours entire body shakes, headache lasting 24 hours, fatigue lasting 24 hours, full body rash still in progress
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Blood test normal, Injection site inflammation, Injection site pruritus
Clinical narrative: Shoulder area around injection site was swollen, inflamed, itchy and very warm to touch. My doctor looked at it and prescribed Z-pac antibiotic as he thought it might be infected. While the symptoms subsided a bit, they did not go away until after the antibiotic was used up. Since then I have had much loss of strength in both arms while trying to use them reaching above my head. I have to push my left arm up with my right hand to get dishes off the second shelf in the cupboard. The doctor then took blood samples and did a urine analysis but found nothing. He sent me to the ER to have a CT scan of the abdomin and IV fluids. While there they took more blood samples and found nothing. I am also having lower back pains
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Musculoskeletal stiffness, Urine analysis normal
Clinical narrative: Shoulder area around injection site was swollen, inflamed, itchy and very warm to touch. My doctor looked at it and prescribed Z-pac antibiotic as he thought it might be infected. While the symptoms subsided a bit, they did not go away until after the antibiotic was used up. Since then I have had much loss of strength in both arms while trying to use them reaching above my head. I have to push my left arm up with my right hand to get dishes off the second shelf in the cupboard. The doctor then took blood samples and did a urine analysis but found nothing. He sent me to the ER to have a CT scan of the abdomin and IV fluids. While there they took more blood samples and found nothing. I am also having lower back pains
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Immediate post-injection reaction, Pruritus, Skin warm
Clinical narrative: patient reports having itchiness immediately following the vaccination same day.  She then noticed a red spot that seemed to grow to about 5-6 inches in diameter and was warm to the touch.  She went to her local provider to have it looked at and was prescribed azithromycin antibiotic in case it was infection based and not just a localized allergic reaction.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Immediate injection site reaction. Erythematous and swollen to 1-1.5 inches around injection site. Patient reports no other symptoms - no itching, no pain, no difficulty breathing. Patient was given 50 mg of oral diphenhydramine and an ice pack and observed for 30 minutes after vaccination.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node palpable, Lymphadenopathy
Clinical narrative: pea size node palpable left clavicular region; almond size node palpable left axillary region
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Body chills and Aches for approximately 18 t 24 hours
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever, headache, nausea aches
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Pain in extremity, Pruritus
Clinical narrative: Red, itchy, sore, sollen, background of red becoming yellow and blue Started just before bed tie feeling sore and itchy. Put cream on and went to bed.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood glucose normal, Dizziness, Haematocrit normal, Haemoglobin normal
Clinical narrative: Event as reported in employee's own words:  "I experienced LUQ abdominal pain,nausea, vomiting after the 1st dose of the Moderna vaccine which lasted for almost 2 weeks, mostly mild in intensity. I received my 2nd dose on Jan 23rd, by Tuesday Jan 26th I started having the above symptoms again with mild to moderate intensity of the abdominal pain. This persisted longer and I reached out to my primary care team to be checked for pancreatitis. I was advised by my primary care team to get seen at the ER which I did last Feb 9th. It did show my lipase level elevated which the ER providers said a "little bumped". US of my pancreas did not show it swollen/inflamed. I was discharged the same day. The LUQ pain improving but still there. "  ED Summary: "The patient is a 53-year-old woman with history of type 2 diabetes, medication induced pancreatitis 10 years ago who presents for abdominal pain.  Patient's pain is concerning for medication/vaccine induced pancreatitis versus cholelithiasis versus cholecystitis versus gastritis versus colitis versus peptic ulcer disease.  Pancreatitis most likely as labs obtained showed an elevated lipase (94 units/L) and normal liver function tests and bilirubin.  Patient has normal white blood cell count as well as hemoglobin and hematocrit.  Patient had normal blood glucose on arrival then was feeling slightly woozy at time of evaluation following her right upper quadrant ultrasound and had a blood glucose of 85 after being n.p.o. in the ED for approximately 3 hours.  Patient given crackers and juice with good response.  Right upper quadrant ultrasound showed no bile duct dilation, no gallstones, normal gallbladder, normal pancreas and stable known left renal cyst and known simple hepatic cyst." Patient discharged home on low-fat diet until symptoms resolve and PRN acetaminophen for pain.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lipase increased, Nausea, Ultrasound pancreas normal, Vomiting, White blood cell count normal
Clinical narrative: Event as reported in employee's own words:  "I experienced LUQ abdominal pain,nausea, vomiting after the 1st dose of the Moderna vaccine which lasted for almost 2 weeks, mostly mild in intensity. I received my 2nd dose on Jan 23rd, by Tuesday Jan 26th I started having the above symptoms again with mild to moderate intensity of the abdominal pain. This persisted longer and I reached out to my primary care team to be checked for pancreatitis. I was advised by my primary care team to get seen at the ER which I did last Feb 9th. It did show my lipase level elevated which the ER providers said a "little bumped". US of my pancreas did not show it swollen/inflamed. I was discharged the same day. The LUQ pain improving but still there. "  ED Summary: "The patient is a 53-year-old woman with history of type 2 diabetes, medication induced pancreatitis 10 years ago who presents for abdominal pain.  Patient's pain is concerning for medication/vaccine induced pancreatitis versus cholelithiasis versus cholecystitis versus gastritis versus colitis versus peptic ulcer disease.  Pancreatitis most likely as labs obtained showed an elevated lipase (94 units/L) and normal liver function tests and bilirubin.  Patient has normal white blood cell count as well as hemoglobin and hematocrit.  Patient had normal blood glucose on arrival then was feeling slightly woozy at time of evaluation following her right upper quadrant ultrasound and had a blood glucose of 85 after being n.p.o. in the ED for approximately 3 hours.  Patient given crackers and juice with good response.  Right upper quadrant ultrasound showed no bile duct dilation, no gallstones, normal gallbladder, normal pancreas and stable known left renal cyst and known simple hepatic cyst." Patient discharged home on low-fat diet until symptoms resolve and PRN acetaminophen for pain.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pallor
Clinical narrative: Post vaccination lightheaded, pale. Placed supine, felt better. No local injection site reaction, hives, SOB, tongue swelling, palpatations. Lungs CTAB. Sat up drank water and ate a banana.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Rash below injection site on left arm
Sex: U
Vaccine: VARZOS
Symptoms: Death, Haemorrhage intracranial, Headache, Intraventricular haemorrhage, Mental status changes
Clinical narrative: bilateral intraventricular intracranial hemorrhage; death; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information about concomitant medication, current condition and historical condition was unknown. On or around 13-NOV-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered sudden onset headache, altered mentation and intracranial bilateral intraventricular bleed and was diagnosed with bilateral intraventricular intracranial hemorrhage. As a direct and proximate result of these injuries, the pt suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the pt suffered significant medical expenses, severe pain and suffering, other damages, and ultimately death on 21-DEC-2018. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered serious and dangerous side effects, including death, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the company's conduct, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of bilateral intraventricular intracranial hemorrhage was considered as not recovered. The cause of death was unknown. It was unknown if an autopsy was performed. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Bilateral intraventricular intracranial hemorrhage was considered as disabling. Upon internal review, bilateral intraventricular intracranial hemorrhage was considered as medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Had pain in my arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had pain in arm still 4 days later.  The reporter asked was that ok or did not mean should not get second shot.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Reaction on my arm. / It took two or three weeks to get over the redness; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was recovered/resolved.   It was unknown if the reporter considered the erythema of extremities to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient never had the chicken pox but insurance wanted to had the shingle vaccine  The patient received Shingrix and had arm redness. The patient was worried and it took two or three weeks to get over the redness.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got shingles; This case was reported by a consumer and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient took part in a shingles research program. The patient received Shingrix and had Shingles. The reporter doctor told it would had been more severe had not had the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Immediate post-injection reaction, Pruritus
Clinical narrative: itch; felt giddy; This case was reported by a consumer and described the occurrence of pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (case of Shingles 2 years ago). Concurrent medical conditions included latex allergy and immunocompromised.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, immediately after receiving Shingrix, the patient experienced pruritus and felt giddy. The patient was treated with diphenhydramine hydrochloride (Benadryl Liquid) and cetirizine. On an unknown date, the outcome of the pruritus and felt giddy were recovered/resolved.   It was unknown if the reporter considered the pruritus and felt giddy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and immediately began itching. The patient felt giddy. The reporter wants to verify there was no latex in the formulation. The reporter reported the immunizer was concerned and administered Benadryl liquid adult dose and after receiving the Benadryl the immunizer watched for about 20 minutes and then went home.  The patient taking 1 0r 2 tablets of Cetirizine. The reporter did not give permission to contact HCP and was long winded, fast talker and hard to follow.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Impaired work ability, Pain
Clinical narrative: Chills; sweats; headache; body aches.   Missed one day of work
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lactation disorder, Maternal exposure during breast feeding
Clinical narrative: I was a breastfeeding mother at the time of the vaccine. About three days after my first vaccine, my milk supply went down. After my second vaccine my milk supply was pretty much nothing. I did choose not to nurse for the first three days after having my vaccines on both occasions. During those three days I did pump and freeze the milk. After those first three days from getting the vaccine I did resume breastfeeding as normal.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Malaise, Nausea
Clinical narrative: Woke up  the morning after the shot not feeling well, very nauseous.  Eventually threw up several times.  Remained tired through out the day and ran a low grade fever. By the evening developed the chills and felt like I could not get warm.  Went to bed early and slept 12 hours.  Did get extremely warm during the night. Next day felt better but still very tired and lacked my usually energy.  Things started to feel back to normal by Sunday evening.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Woke up  the morning after the shot not feeling well, very nauseous.  Eventually threw up several times.  Remained tired through out the day and ran a low grade fever. By the evening developed the chills and felt like I could not get warm.  Went to bed early and slept 12 hours.  Did get extremely warm during the night. Next day felt better but still very tired and lacked my usually energy.  Things started to feel back to normal by Sunday evening.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Extreme swollen lymph nodes in my armpit
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: Chills, fever 101, Body aches, fatigue, Headache, nausea, swollen glands, SOB. started on 2/27 gradually improved and then a week later on 3/6/21 experienced body aches, chills , fever, chest tightness, headache which has resolved by 3/8/21..
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pain, Pyrexia
Clinical narrative: Chills, fever 101, Body aches, fatigue, Headache, nausea, swollen glands, SOB. started on 2/27 gradually improved and then a week later on 3/6/21 experienced body aches, chills , fever, chest tightness, headache which has resolved by 3/8/21..
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Nasopharyngitis, Pulmonary function test, Pyrexia
Clinical narrative: I just wanna report I don't know if Coincidence to getting 1st Vaccine But I had a Horrible cough trouble breathing like my COPD came on right after the Vaccine I felt feverish and had cough cold symptoms for 3 weeks. Called Dr to get prednisone usually works but it didn't touch this. Started feeling better just before my 2nd dose. No problem with 2nd dose. Could be a Coincidence that I was sick 2 days after the Vaccine with my COPD So I am not sure if other COPD'rs experienced this. Dr. Recommended ER but I refused. Had to ride it out. Over the counter cough syrup with cough drops and my inhalers. Pro Air Albuterol. With Nebulizer treatments
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: I just wanna report I don't know if Coincidence to getting 1st Vaccine But I had a Horrible cough trouble breathing like my COPD came on right after the Vaccine I felt feverish and had cough cold symptoms for 3 weeks. Called Dr to get prednisone usually works but it didn't touch this. Started feeling better just before my 2nd dose. No problem with 2nd dose. Could be a Coincidence that I was sick 2 days after the Vaccine with my COPD So I am not sure if other COPD'rs experienced this. Dr. Recommended ER but I refused. Had to ride it out. Over the counter cough syrup with cough drops and my inhalers. Pro Air Albuterol. With Nebulizer treatments
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Nausea, Body aches, joint aches, tiredness, chills, light headed.  Feeling "off".  No treatment
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Nausea, Body aches, joint aches, tiredness, chills, light headed.  Feeling "off".  No treatment
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Cough, Insomnia, Pyrexia
Clinical narrative: CHILLS, INSOMNIA, FEVER, CHEST DISCOMFORT, COUGH
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Antiacetylcholine receptor antibody positive, Diplopia, Eyelid ptosis, Jaw disorder, Myasthenia gravis
Clinical narrative: Myasthenia Gravis, treatment and outcome pending. Ptosis, vertical diplopia, jaw fatigue Positive acetylcholine receptor binding, receptor modulating and receptor blocking antibodies
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: The client tested positive for COVID-19 on 3/8/21 with symptoms beginning on 3/6/21.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever. Chills. Nausea. Body aches. Head ache.  Tylenol.  48 hours.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chills, Nausea, Night sweats
Clinical narrative: Temp 102 for 8 hrs., pain and itching in right arm, chills, night sweats, soreness and pain in joints, nausea ; aing about 36 hours
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Temp 102 for 8 hrs., pain and itching in right arm, chills, night sweats, soreness and pain in joints, nausea ; aing about 36 hours
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever and chills worse than ever previously experienced, body aches, headache, urinary tract infection.., Extreme fatigue.  First 3 days were excessive..nearly went to emergency Dr. Prescribed antibiotics for uti..improved in 1 to 2 days Other Symptoms eased but lasted 7 days, including extreme fatigue
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection, Urine analysis
Clinical narrative: Fever and chills worse than ever previously experienced, body aches, headache, urinary tract infection.., Extreme fatigue.  First 3 days were excessive..nearly went to emergency Dr. Prescribed antibiotics for uti..improved in 1 to 2 days Other Symptoms eased but lasted 7 days, including extreme fatigue
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever 102+, chills, aches, headache, nausea, heart rate 135 at rest.  Symptoms began 8 hours after injection and lasted for 48 hours.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Fever 102+, chills, aches, headache, nausea, heart rate 135 at rest.  Symptoms began 8 hours after injection and lasted for 48 hours.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Itching  all over the body and temporary random red rash  on arms and legs.