chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Swelling face, Swollen tongue
Clinical narrative: Within 15-minutes of vaccination, the patient reported swollen lips, tongue, eyes, or face. EMS monitored patient's condition on-site. No further details were given.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Diarrhoea, Fatigue, Pain
Clinical narrative: Pfizer COVID-19 Vaccine EUA  Pt received 1st dose of vaccine on 1/31/21. Afterwards, she developed a slight cough and chest pressure. Pressure is worse with deep breathing. Denies chest pain. Denies SOB or wheezing. Pt also had episode of loose stool x 1. States she has had an anaphylactic reaction in past, but it did not feel the same. Pt took diphenhydramine 50 mg PO before receiving her vaccine after consulting her PCP.  When pt presented to convenient care, vitals WNL. Pt given methylpredisolone 125 mg IM x 1. Pt prescribed epinephrine 0.3 mg injectable 2-pak kit. Provider recommended pt not receive the 2nd dose of vaccine unless PCP says otherwise. Pt discharged to home.  2/1/21: Pt continued to endorse loose stools, fatigue, and body aches.  2/2/21: Pt's PCP told her not to receive 2nd dose of vaccine.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: Ache body, Nocuous, Right arm sore, slight head ache
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient received 1cc of Moderna  COVID vaccine. Patient was notified, advised of potential side effects and what to do if they occurred. State of MD was notified.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Redness, itchiness, firmness on injection site (2 inches diameter)
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Headache, Petechiae, Pruritus, Rash
Clinical narrative: Rash began on left leg on 01/14/21; rash progressively spread to entire both legs and left neck; became very itchy and nothing over-the-counter (topical or oral) helped or reversed symptoms; rash continued for over 5 weeks; also experienced dull, around-the-clock headache during this time;  On the morning of 02/21/21 awoke to petechial rash on bilateral eyelids, cheeks, left and right neck; went to urgent care; placed on steroids- Steroid IM injection given on 02/21/21, Medrol Dose pack started on 02/22/21- all symptoms resolved quickly with steroid dosing
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Uterine dilation and curettage
Clinical narrative: Wife did not know she was pregnant at the time, had the vaccine and miscarried the child at 12 weeks. OBGYN stated baby had miscarried 2-3 weeks earlier. D&C procedure performed 2/23 to remove remains of fetus.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Ventricular extrasystoles
Clinical narrative: 1 to 2 minutes after injection began having heart palpitations and PVCs. Lasted 1 hour No treatment was required
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen and sore lymph nodes in armpits - neck and groin area.   not resolved at this time
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Loss of consciousness, Pain in extremity, Unresponsive to stimuli
Clinical narrative: Moderna COVID-19 Vaccine EUA  Approximately 3 minutes after her vaccine pt became unconscious and unresponsive for a short time. Pt was quickly awoken by RN. Pt states that she has a history of syncope following venipuncture that she forgot to disclose. Approximately 15 post episode pt stated that her vision had been restored but her hearing still felt "off". Pt was given 12 oz water, crackers and juice. Pt called roommate to pick her up to bring her home. Approximately 25 minutes later, pt reports some left arm pain but was feeling better. At 1345 pt was discharged by her own choice and left with her roommate. Pt still felt "off" but reported that this was likely just due to anxiety. Pt and roommate given instructions to go to nearest ER if symptoms returned.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Injection site erythema, Injection site pain
Clinical narrative: Two weeks after her injection, patient reported noticing after her morning shower a 2" slight redness at site of Moderna injection and "tender." Her temp has been "98.6 or 99.2." No itching or firmness, oozing or lines at the site. Not hot to the touch. No signs of illness. She stated that this reaction was not there before that day on 2/24/21. The first Moderna injection was on 2/9/21.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Death, Pain, Pyrexia, Unresponsive to stimuli
Clinical narrative: pt woke up at 0400 with fever, chills, and body aches progressing over 4 hours to the point when she became unresponsive. husband called 911, pt was declared dead at the time of EMS arrival around 1200
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autopsy, Chills, Death, Influenza, Pain
Clinical narrative: pt woke up at 0400 with fever, chills, and body aches progressing over 4 hours to the point when she became unresponsive. husband called 911, pt was declared dead at the time of EMS arrival around 1200
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Toxicologic test, Unresponsive to stimuli
Clinical narrative: pt woke up at 0400 with fever, chills, and body aches progressing over 4 hours to the point when she became unresponsive. husband called 911, pt was declared dead at the time of EMS arrival around 1200
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dry mouth, Injection site paraesthesia, Nausea, Paraesthesia
Clinical narrative: Approximately 15-20  minutes post vaccination patient began to feel "tingly" in his right arm extending from injection site to hand and all the the way up to his cheek.  Moments later he began to have the same tingly feeling bilaterally in his feet.  Shortly thereafter he also had some slight nausea/unsettled stomach feeling and also complained of dry mouth.  Patient remained on-site for an additional 30 minutes before leaving the site.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 101.3 for 20 hours
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Injection site pruritus, Injection site rash, Lip swelling, Swelling face
Clinical narrative: Within 15-minutes of vaccination, the patient reported rash, hives, itchiness, and potential swollen lips, tongue, eyes or face. EMS monitored the patient on-site. No further details were provided from clinical site.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Within 15-minutes of vaccination, the patient reported rash, hives, itchiness, and potential swollen lips, tongue, eyes or face. EMS monitored the patient on-site. No further details were provided from clinical site.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pain, Pyrexia
Clinical narrative: Prolonged joint pain in hips, knees, ankles and feet.  In the last month, I have only had 4 days of no pain. I did not have joint pain before getting the second dose of the COVID-19 vaccine.  Approximately 12 1/2 hours after receiving the vaccine, I ran a low grade temp of 99.9, had chills, rigors, aching, and joint pain.  Fever went away the next day. Joint pain remained.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Body temperature decreased, Feeling hot, Pyrexia
Clinical narrative: Around 9 hrs. after injection got a fever that eventually went to 103F. Lasted from 6PM till 5AM when the temperature came down to 100.1F. Back to normal by 9AM. No nausea or chills with the fever just very hot with loss of balance and strength Until early morning.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Pain in extremity, Shoulder injury related to vaccine administration, X-ray
Clinical narrative: Shoulder soreness, day after shot. Arm soreness and painful for over two weeks with severe pain and arm mobility pain began after three and diagnosis of SIRVA, shoulder injury related to vaccination administration four weeks after vaccination.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site reaction, Skin lesion, Skin reaction
Clinical narrative: "COVID Arm" - a large red lesion around the injection site.  Approximately 2" wide and 3 1/4" tall.  No pain, itching or swelling at this time.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Myalgia, Pain in extremity
Clinical narrative: Muscular ache in left arm beginning the next morning and lasting for about 2 days. Secondary reaction first noticed 10 days after injection: Redness and swelling at the injection site. Warm to the touch.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin, Vaginal haemorrhage
Clinical narrative: I received my first dose of the Moderna COVIDI19 vaccine on 12/29/2020 not knowing I was pregnant.  I took a home pregnancy test the week of 1/3/2021, which came back positive.  On 1/17/2021, I started having some spotting and saw my OBGYN on 1/18/2021.  My OBGYN did a transvaginal ultrasound and estimated I was about 5 weeks pregnant.  I went for bloodwork prescribed by my OBGYN on 1/18 and 1/20 to measure my HcG levels.  By 1/20-1/21 the bleeding became heavy and my HcG levels dropped.  I had a follow up appointment with my OBGYN on 2/3/2021 where they performed another transvaginal ultrasound and more bloodwork to confirm that I had miscarried.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness for more than three weeks
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Crying, Dysarthria, Eye movement disorder, Movement disorder
Clinical narrative: Ballspalsy, right side Eye and facial movement issues, it started gradually a week and a half after my dose my eye was not blinking in sync with my left eye, gradually started to go down to my face where my lips my cheek or my eyebrows were not moving when I was talking all my words were slurred and off to the side of my mouth. When smiling one side trip the far far left the other side stay still. My job had me go to a doctors up where they diagnosed me with Bell?s palsy it and the doctor advised me to report this. My treatment plan is antiviral medication and steroids, Valacyclovir 1gm tid, methylprednisolone 4grams qid. I am very upset and heartbroken every time I look in the mirror I cry because I cannot recognize my face I did read online that Pfizer did have side effects of bells palsy but I never thought I would get it given my age and good medical history. I would love for someone to reach out to me I need to know what happens from here.   As a result I have been off of work for a couple days.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fever, body aches, fatigue
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pruritus, Injection site rash, Pain in extremity
Clinical narrative: Arm sore for day or two and tired immoedially after first shot On day 9 left arm sore, red rash around shot area and itching.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hypoaesthesia, Injection site pain, Limb discomfort
Clinical narrative: Pt felt arm soreness 4 hours later than felt fatigued, leg heaviness, arm heaviness, and then felt faint with black spots in eyes and numbness down left extremity. Symptoms are still persisting 5 days later today 2/25/21.  PT did not knowingly have COVID prior.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vitreous floaters
Clinical narrative: Pt felt arm soreness 4 hours later than felt fatigued, leg heaviness, arm heaviness, and then felt faint with black spots in eyes and numbness down left extremity. Symptoms are still persisting 5 days later today 2/25/21.  PT did not knowingly have COVID prior.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Patient may have inadvertently received 1cc of Moderna COVID vaccine instead of 0.5cc. Patient was notified, advised of potential side effects and treatment if needed.  State of MD was notifed.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dyspnoea, Flushing, Pain
Clinical narrative: The next morning, I  looked flushed and short of breath and had a temp pain was severe in my arm and all over. couldn't eat. Last night i was able to eat a little but it was hard to get down. i wasnt tasting things right.  called Dr said to take a couple of Tylenol and to call vaers for advice. Was very weak.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: The next morning, I  looked flushed and short of breath and had a temp pain was severe in my arm and all over. couldn't eat. Last night i was able to eat a little but it was hard to get down. i wasnt tasting things right.  called Dr said to take a couple of Tylenol and to call vaers for advice. Was very weak.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dysphonia, Pyrexia
Clinical narrative: fever (101), epigastric pain, voice weakness.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Malaise, Palpitations, Supraventricular tachycardia
Clinical narrative: Around 0530 on 2/25/2021 reported heart started to race.  Received second dose of vaccine on 2/24/2021.  Stated he did not feel good but the heart racing started the next morning.  Came into medical for BP check.  HR 159, ECG done, SVT at 153.  Dr. able to convert to normal HR with vagal maneuver.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Full blood count normal, Influenza virus test negative, Pyrexia, Rash
Clinical narrative: FAST HEARTBEAT FEVER RASH ALL OVER FATIGUE
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Streptococcus test negative, Tachycardia
Clinical narrative: FAST HEARTBEAT FEVER RASH ALL OVER FATIGUE
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Fever (100.8), headache, nausea.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chills, Pyrexia
Clinical narrative: 11 hours after vaccine at Hospital, started to get a severe case of chills.   Almost uncontrollable for 1 and 1/2 hours.  major soreness of joints and low grade fever which lasted most of the night.  Temperature was 100 this morning, but has gone done some now.  Beginning to feel better slow but sure! This is the second vaccine booster.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Hypoaesthesia, Swelling
Clinical narrative: Numbness  in neck began within 5 minutes of injection.  10 minutes later she started have difficulty with exhalation, tightness in the chest, and sensation of neck swelling.  Patient was given 0.5 mL of epinephrine and EMS was called.  Patient began to improve within 5 minutes of epinephrine injection.  She refused to go to the ER.  She was given 25 mg of Benadryl and was monitored for 20 minutes before going home with a friend picked her up.  Patient signed an AMA for both the EMS and clinic.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: really sore right arm
Age: 56.0
Sex: M
Vaccine: DF
Symptoms: Incorrect dose administered, Underdose, Wrong technique in product usage process
Clinical narrative: Patient given under-diluted dose of vaccine due to measurement error with syringe.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Mental status changes
Clinical narrative: Altered mental status
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Electrocardiogram, Malaise, Presyncope
Clinical narrative: Vaso-vagal syncope after shot. Continued to feel unwell after 10 min monitoring time. Transported to hospital for further evaluation. Discharged after approximate 2 hours observation.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram QRS complex abnormal, Electrocardiogram QRS complex prolonged, Hypertension, Nausea
Clinical narrative: patient reported feeling faint, got lightheaded, dizzy, nauseated
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus rhythm
Clinical narrative: patient reported feeling faint, got lightheaded, dizzy, nauseated
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Disorganised speech, Dry throat, Fatigue
Clinical narrative: Dizziness, Lightheaded, Chills, the first time I had to stop because couldn't drive, I had spasm's around the injection site, Generalized Numbing, the symptoms of the fisrt dose lasted one week. I don't like to take medicine and I had no choice but take Panadol every 4 hours and apply ice to treat the muscular pain. I went to emergency and was told that I had an urine infection  (which is very rare on me), and was treated with antibiotics.   With the second dose I took acetaminophen 500 mg befor the vaccine, that helped because the day of the shot I didn't have pain, but the numbness was like if I couldn't connect my body to the brain. Couldn't talk properly, sleep 2 hours during the day, is funny that I applied ice on the injection site (Me thinking) but the pain doesn't go away, when the ice melts I notice that I applied the ice on the wrong arm. That's what I mean when I talk about numbness. Fever of 39.8F and Chills even today . Some cough and dry throat (Dryness can be because I'm a teacher) and constant tiredness.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Pain in extremity, Pyrexia, Urinary tract infection
Clinical narrative: Dizziness, Lightheaded, Chills, the first time I had to stop because couldn't drive, I had spasm's around the injection site, Generalized Numbing, the symptoms of the fisrt dose lasted one week. I don't like to take medicine and I had no choice but take Panadol every 4 hours and apply ice to treat the muscular pain. I went to emergency and was told that I had an urine infection  (which is very rare on me), and was treated with antibiotics.   With the second dose I took acetaminophen 500 mg befor the vaccine, that helped because the day of the shot I didn't have pain, but the numbness was like if I couldn't connect my body to the brain. Couldn't talk properly, sleep 2 hours during the day, is funny that I applied ice on the injection site (Me thinking) but the pain doesn't go away, when the ice melts I notice that I applied the ice on the wrong arm. That's what I mean when I talk about numbness. Fever of 39.8F and Chills even today . Some cough and dry throat (Dryness can be because I'm a teacher) and constant tiredness.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis
Clinical narrative: Dizziness, Lightheaded, Chills, the first time I had to stop because couldn't drive, I had spasm's around the injection site, Generalized Numbing, the symptoms of the fisrt dose lasted one week. I don't like to take medicine and I had no choice but take Panadol every 4 hours and apply ice to treat the muscular pain. I went to emergency and was told that I had an urine infection  (which is very rare on me), and was treated with antibiotics.   With the second dose I took acetaminophen 500 mg befor the vaccine, that helped because the day of the shot I didn't have pain, but the numbness was like if I couldn't connect my body to the brain. Couldn't talk properly, sleep 2 hours during the day, is funny that I applied ice on the injection site (Me thinking) but the pain doesn't go away, when the ice melts I notice that I applied the ice on the wrong arm. That's what I mean when I talk about numbness. Fever of 39.8F and Chills even today . Some cough and dry throat (Dryness can be because I'm a teacher) and constant tiredness.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Feeling abnormal, Lymphadenopathy, Migraine
Clinical narrative: Painful arm (could not move at all), fever, chills, migraine headache, unable to sleep, stomach cramps, body aches, swollen lymph nodes under armpit, brain fog. (Previously had Covid in December)
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: Painful arm (could not move at all), fever, chills, migraine headache, unable to sleep, stomach cramps, body aches, swollen lymph nodes under armpit, brain fog. (Previously had Covid in December)
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Bone pain, Burning sensation, Myalgia
Clinical narrative: Extreme pain and burning sensation in abdomen (Day 4-6), extreme pain (bone/joints/muscles) in left arm (Day 6-8)
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Extreme pain and burning sensation in abdomen (Day 4-6), extreme pain (bone/joints/muscles) in left arm (Day 6-8)
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Vertigo
Clinical narrative: Developed vertigo, dizziness, spinning sensation and continued HA.  Symptoms started insidiously about 1 week after second dose, became daily around week 3
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Electrocardiogram, Laboratory test
Clinical narrative: 10 minutes after vaccination she developed mid-sternal chest tightness.  No other allergic symptoms or SOB
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Missed period
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Feeling hot, Nausea, Palpitations
Clinical narrative: Felt hot,  burning sensation across chest, palpitations,  dizziness,  having sensation of everything smelling sweet,  tingling in hands and feet,  hands shaking, slight nausea.  Evaluated by  EMS. Had not eaten  given water and  tea.  Ate protein bar.   Feeling better,  symptoms resolved.  Discharged home at 9:45am.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Tremor
Clinical narrative: Felt hot,  burning sensation across chest, palpitations,  dizziness,  having sensation of everything smelling sweet,  tingling in hands and feet,  hands shaking, slight nausea.  Evaluated by  EMS. Had not eaten  given water and  tea.  Ate protein bar.   Feeling better,  symptoms resolved.  Discharged home at 9:45am.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Hypotension, Nausea, Presyncope
Clinical narrative: 29M hx HTN who obtained his first COVID vaccine. Few minutes after receiving the vaccine, he reported to  provider that he felt warm and dizzy. He was immediately brought to the enclosed first responder area where he mentioned additional sx of nausea.   Vasovagal response, Dizziness, Hypotension, nausea
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dyschromatopsia, Vision blurred, Vitreous floaters
Clinical narrative: Tuesday Night - Interior of right eye had multiple color blockage (size of thumbnail) in lower section of eye that blocked out what I was seeing with horizontal orientation.  Wednesday Morning - shape was reduced to 1/3 its previously stated size, vertical orientation, depending on what I was looking at the color changed, but still blocked out portions of what I looked at.  Wednesday Morning - shape was 1/4 the original size, vertical orientation, varied in colors, but still blocking images completely
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations, Throat tightness
Clinical narrative: Woke up during the night gasping for air. Throat felt like it was closing in heart, racing.  Duration several hours.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Oral pruritus, Pruritus, Tongue pruritus
Clinical narrative: I received the 2nd dose of Moderna at 8:30am at the clinic for employees. I began to feel itching and numbness in my face starting around 8:55am. By 9:30am the itching had spread to my whole face, lips, roof of the mouth and tongue. The supervising nurse followed protocol and alerted our health team as well as 911. I was transported to Hospital ER via ambulance where I was treated with Benadryl and ZyTEC at 10:30. I was observed by the staff for any more adverse reactions, and was cleared to be released at 12:30pm.  At no point did I have trouble breathing, and all my vitals were stable throughout the event.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Developed redness, pain, warmth, mild swelling, mild itching in 10 cm area on left arm at vaccine site, occurred 2 weeks after injection, lasted for 5 days.  Was treated for cellulitis, due to underlying diabetes, but I favor this being a delayed injection reaction.  No systemic symptoms, no fever, no chills, no other rashes.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: Developed redness, pain, warmth, mild swelling, mild itching in 10 cm area on left arm at vaccine site, occurred 2 weeks after injection, lasted for 5 days.  Was treated for cellulitis, due to underlying diabetes, but I favor this being a delayed injection reaction.  No systemic symptoms, no fever, no chills, no other rashes.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: "Covid arm" - 8 days post-vaccine (1st dose), I had a reaction on my upper arm, near the vaccine site.  Reaction was red, swollen, feverish, itchy - approx 2" x 3" oval.  24 hours later & it's still present, however all reactions while still present have lessened somewhat.  I'm using an antihistamine topically (day) and orally (night).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: "Covid arm" - 8 days post-vaccine (1st dose), I had a reaction on my upper arm, near the vaccine site.  Reaction was red, swollen, feverish, itchy - approx 2" x 3" oval.  24 hours later & it's still present, however all reactions while still present have lessened somewhat.  I'm using an antihistamine topically (day) and orally (night).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Condition aggravated, Dysphagia, Hypertension
Clinical narrative: Within 15-minutes of vaccination, the patient reported difficulty swallowing, No difficulty breathing, pain, or other complaints voiced. EMS evaluated the patient on-site. The patient was hypertensive (208/103). EMS noted that the patient was visibly anxious and that they elected to be transported to Emergency Department for evaluation. When contacted for medical records, ED stated that the patient never was checked into the hospital and did not have records available. Assumed lost to follow-up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Peripheral swelling, Rash, Swelling face
Clinical narrative: within first 24 hours had expected reaction of chills, and flu like symptoms, but 9 days later face became swollen and right arm was swollen as well . MD treating with course of prednisone and she is improved .  now states that after first dose she had a rash on her chest that she never shared with clinic staff at second appointment
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest X-ray normal, Chest pain, Electrocardiogram, Myocardial necrosis marker
Clinical narrative: Resident became pale with c/o chest pain followed by emesis.  Heart rate  Tachy at 142/min.  Resident indicates pain to mid-sternum radiating to right shoulder.  States right arm has been sore since #2 COVID vaccine on 2/16/2021.   BP 120/88, Pusle 142, Resp 20, Oxygen saturation 99% on room air,  Aspirin 325mg given and supplemental Oxygen applied.  Resident was subsequently transferred to the local ER.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pallor, Tachycardia, Vomiting
Clinical narrative: Resident became pale with c/o chest pain followed by emesis.  Heart rate  Tachy at 142/min.  Resident indicates pain to mid-sternum radiating to right shoulder.  States right arm has been sore since #2 COVID vaccine on 2/16/2021.   BP 120/88, Pusle 142, Resp 20, Oxygen saturation 99% on room air,  Aspirin 325mg given and supplemental Oxygen applied.  Resident was subsequently transferred to the local ER.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cold sweat, Dizziness, Feeling hot, Vital signs measurement
Clinical narrative: Felt lightheaded, dizzy, hot clammy, feeling pressure in chest. HR down to 28. BP 90/40. Laid on back with feet elevated. 911 called. EMS evaluated and pt was better and signed for no transport.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram, Deafness neurosensory
Clinical narrative: Patient suffered sudden sensorineural hearing loss in right ear within hours of vaccination. On audiometry, right ear pure tone average declined from baseline of 31 dB to 64 dB, word recognition score from 88% to 44%. No vertigo.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oral pain, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Dose #2       The patient received Moderna COVID-19 Vaccine 0.5 ml IM.       MVX (Manuf); Lot#; Exp Date: MOD; 006M20A; 07/12/2021       Date/Time:Feb 18,2021@16:37       Administration         Anatomic site: Left Deltoid       Vaccine administered by protocol without complications. The patient was       advised to remain in the facility for 15 minutes post vaccination.   Vet developed an itchy red-purple  rash all over his body and pains lasting seconds from rough of mouth and radiating to temple that happens every 10 min to every few hours.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Muscular weakness, Pain
Clinical narrative: Patient was fine during the day, but then woke up with arms and legs weak and hurting all over her body. She then fell and had to be taken to the ER.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, visual
Clinical narrative: the patient's husband reported that around 3am, the patient woke to visual hallucinations that lasted throughout the night. The hallucinations were reported to have stopped around 8am on 2/25/21. the patient does report remembering most of her hallucinations.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, X-ray limb normal
Clinical narrative: Progressive pain and swelling in bilateral toes and feet.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Eye swelling, Headache, Lymphadenopathy, Nasal congestion
Clinical narrative: 2/6 & 2/7 sore arm, 2/12-2/13 body aches, 2/14-2/15 ping pong sized lump under left armpit & left side lymph nodes in neck swollen, sore jaw on left side.  Nausea, headache, congested, runny nose, face/eyes swollen/itchy.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pain in jaw, Rhinorrhoea
Clinical narrative: 2/6 & 2/7 sore arm, 2/12-2/13 body aches, 2/14-2/15 ping pong sized lump under left armpit & left side lymph nodes in neck swollen, sore jaw on left side.  Nausea, headache, congested, runny nose, face/eyes swollen/itchy.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: 2/6 & 2/7 sore arm, 2/12-2/13 body aches, 2/14-2/15 ping pong sized lump under left armpit & left side lymph nodes in neck swollen, sore jaw on left side.  Nausea, headache, congested, runny nose, face/eyes swollen/itchy.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations, Paraesthesia, Throat tightness
Clinical narrative: 11:52 Nurse alerted by Client that she felt like her heart was racing. 11:53 Client taken for further assessment. Client also reports tingling in the fingers. Client was offered water which was taken and a seat by an open door for air. Client removed mask. Vitals taken: BP 185/100, Pulse 136. 11:59 Vitals taken: O Sat 99% Pulse 162. Client experiencing faintness and dizziness. EMT assessed Client further. 12:01 Client reports a slight tightness in her throat but reports the dizziness is lessening. Client reports no difficulty breathing. Vitals taken: O Sat 99% Pulse 142. 12:04 Vitals taken: BP 163/108, Pulse 128. 12:06 Vitals taken: O Sat 99%, Pulse 118. Client reports dizziness and tightness in the throat is lessening and feeling better. 12:08 Vitals taken: Pule 100, O Sat 98%. 12:11 Client reports no dizziness and the tightness in her throat is getting better. BP 157/99 Pulse 98. 12:15 Client reports that she feels well enough to leave. Client did decide to take a Benadryl due to a little tightness remaining. Client denied feeling any other previous issues or dizziness. Client given a 25mg (one tablet) of Benadryl. Education given regarding Benadryl taken. Client is here with her husband and daughter. Husband was present and Client felt well enough to leave. Client was able to ambulate to the car unassisted and her husband was able to drive her home
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Patient had first dose on 1/27/21. This second dose was given before the recommended 28 days on 2/19/21. A third dose was given on 2/24/21 without knowledge that the second dose had been given.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Periarthritis
Clinical narrative: Pt. c/o shoulder pain more than 1-2 weeks after vaccine was admistered. Per pt. she was diagnosed with frozen shoulder at urgent care and her attending physician stated it was likely caused by the vaccine
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Lymphadenopathy, Pain, Skin warm
Clinical narrative: 2-24-21 at 6:30am; rash under the injection site, sore, slight swelling, hot to touch. size of an orange. possible swollen lymph nodes recommended antihistamine (benadryl, claritin, or zyrtec), ibuprofen for swelling. recommended drawing a circle around the affected area to see improvement/worsening size verbalized understanding
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: No side effects from shot #1 on 1/24.    Second shot on 2/22 = approx. 14 hours after shot I started with chills for 2 hours, then had about 18 hours of a low grade (100.3) temp., dizziness & slight headache - then had sweats when it broke, then I was fit as a fiddle.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation
Clinical narrative: Painful brain zaps - about 4 in the middle of the night.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, SARS-CoV-2 test negative
Clinical narrative: Loss of taste. Onset was approximately 2/15/2021 to present (2/25/2021)
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Chest tightness and shortness of breath
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Dizziness, Paraesthesia
Clinical narrative: Felt lightheaded, tingling. Described feeling as if her ears were going to cave in and had "hearing change". BP 70/90. HR 60. Medics on site. Evaluated. Once feeling better able to leave clinic on her own.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Eye contusion, Eye swelling
Clinical narrative: Eye swelling and black eye
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Insomnia, Nausea
Clinical narrative: I have not been treated professionally for adverse effects.  Symptoms include extreme soreness in the arm where the shot was given coupled with a radiating pain from the upper arm to my hand. I also have had a low-grade headache, nausea, chills, fatigue and sleeplessness, though I am very tired.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: I have not been treated professionally for adverse effects.  Symptoms include extreme soreness in the arm where the shot was given coupled with a radiating pain from the upper arm to my hand. I also have had a low-grade headache, nausea, chills, fatigue and sleeplessness, though I am very tired.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pruritus
Clinical narrative: After I received the first dose, I left observation after 15 minutes. At about 9:00am (30min after I received my shot) my face felt numb and itchy for about 2 hours. I did not report this reaction to any health professional because I did not believe it was severe enough for treatment.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Injection site pain, Nausea
Clinical narrative: Nausea, light headedness, disorientation, muscle soreness at injection site.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Itchy rash around the injection site, red and swollen around injection site about the size of a large orange, sore and hard to touch. I did not treat it or go to the doctor, it gradually started getting better. Still have slight reaction as of today, 02/25/2021.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Itchy rash around the injection site, red and swollen around injection site about the size of a large orange, sore and hard to touch. I did not treat it or go to the doctor, it gradually started getting better. Still have slight reaction as of today, 02/25/2021.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: 1-22-21 @ 10:20am 2-19-21 @ 10:20am Moderna LOT # 029L20A Moderna LOt # 023M20 redness about 3inches in diameter at the injection site traveling downward started 2-20-21 recommended antihistamines, to ice (10mins on/10 mins off), and to draw a line around the area to compare improvement or worsening of the affected area; verbalized understanding.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Troponin increased
Clinical narrative: Chest pain
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Loss of personal independence in daily activities
Clinical narrative: Patient reports no issues with original vaccination.  "Good Shot" administered in the deltoid muscle  away from bursa. Ten days after vaccination reports limited motion with discomfort in shoulder with some transit pain  vaccinated left  arm.  "Interfering with quality of life".  Condition has persisted since onset with no improvement at this time.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: itchy, red and swollen at vaccine site
Age: 72.0
Sex: F
Vaccine: FLUA4, PPV, VARZOS
Symptoms: Influenza virus test negative, Injection site erythema, Injection site swelling, Pain, Pneumonia
Clinical narrative: Extreme all over body pain,  fever 103.7.  Arm swollen below injection site and turned red for several days.
Age: 72.0
Sex: F
Vaccine: FLUA4, PPV, VARZOS
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Extreme all over body pain,  fever 103.7.  Arm swollen below injection site and turned red for several days.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram abnormal, Hypertension, Sinus bradycardia
Clinical narrative: Within 15-minutes of vaccination, the patient reported SOB and felt that they were having difficulty taking deep enough breaths. EMS evaluated patient on-site. Patient was hypertensive (182/89) with a FSBG of 85 mg/dL. 12-lead EKG  was unremarkable with sinus bradycardia without ectopy. ETCO2 values are within normal limits with square waveform. EMS transported patient to hospital. On arrival, patient noted her condition was probably due to anxiety and left without seeing a physician.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Vertigo
Clinical narrative: Chills, triggered my vertigo.  I took an additional meclazine and slept until it wore off.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased
Clinical narrative: Blood Sugar dropped on the 1st shot and this time also for a few hours
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: Patient did fine the day of vaccination (2-23-21), but fell at 5:40am the next morning, and then fell again at 7:40am.  As a result of the falls was less responsive after that
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Vaccine positive rechallenge
Clinical narrative: flu like symptoms after the 1st dose / same symptoms after the second dose / were more severe; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (received 1st dose on an unknown date and experienced flu lie symptoms. For the tolerance of 1st dose, refer linked case US2021010485).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's friend. The age at vaccination was not reported. After receiving Shingrix, the patient had flu like symptoms, and they were more severe than the after 1st dose. The reporter did not consent to follow-up. This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021010484:same reporter US-GLAXOSMITHKLINE-US2021010485:same patient, 1st dose
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Exposure via skin contact, Underdose
Clinical narrative: A lot of liquid running down the front and back of her arm; concerned there was a leak around the hub around the needle; concerned there was a leak around the hub around the needle; A spontaneous report was received from a consumer, who was also a 67-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  There was a lot of liquid running down the front and back of arm (exposure via skin contact) and the patient was concerned that there was a leak around the hub around the needle (device connection issue, underdose).  The patients' medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (batch number: 013L20A) on 16 Jan 2021.  On 13 FEB 2021 at 1 pm, the patient received their second dose of mRNA-1273 (batch number: 039K20A) for prophylaxis of COVID-19 infection.   During the second dose, there was a lot of liquid running down the front and back of the patient's arm.  She was concerned that there was a leak around the hub around the needle.  The patient asked if she would have the same immunity effect if she did not receive the full second dose.   Treatment information was not provided.  The action taken with mRNA-1273 in response to the events was not applicable.  The events, there was a lot of liquid running down the front and back of arm and concerned that there was a leak around the hub around the needle, were considered recovered/resolved on 16 Feb 2021.; Reporter's Comments: This report refers to a case of Underdose due to a leak around the hub around the needle for mRNA-1273, lot # 039K20A with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: patient received less than half the dose; experienced a needle and syringe detached; A spontaneous report was received from a physician concerning a patient who experienced a needle and syringe detached and patient received less than half the dose.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.    Treatment information was not provided.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the event(s) was not reported.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273 (lot # unknown) with no associated AEs reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received another Moderna dose two days later; A spontaneous report was received from a consumer regarding his wife, an 81-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and then accidentally got the dose again two days later/inappropriate schedule of vaccine.  The patient's medical history included Alzheimer's Disease. Concomitant medications were reported as unknown Alzheimer's drugs.   On 17 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.    On 19 Jan 2021, the husband reported that the patient wandered off and received a second dose. Lot number for second dose reported as 013L20A.  Treatment information was not provided.   Action taken with mRNA-1273 was not applicable.  The outcome of the events, patient accidentally received the first dose twice, is reported as resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot number 013L20A for second dose) with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Vaccination site bruising, Vaccination site cellulitis, Vaccination site pain
Clinical narrative: now bump is from shoulder to elbow; looks bruised in the middle; dark outline of red; was itchy; burned; cellulitis; big red bump; A spontaneous report was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis (vaccination site cellulitis), big red bump (vaccination site reaction), bump is from shoulder to elbow (peripheral swelling), burned (vaccination site pain), looks bruised in the middle (vaccination site bruising), dark outline of red (erythema), and was itchy (vaccination site pruritis).  The patient's medical history was not provided. No relevant concomitant medications were reported.       On 03 Feb 2021 the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.    On 10 Feb 2021, The patient experienced vaccination cellulitis (big red bump) and pruritus (itchy) with seriousness criteria of hospitalization  Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the event is unknown; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site reaction
Clinical narrative: now bump is from shoulder to elbow; looks bruised in the middle; dark outline of red; was itchy; burned; cellulitis; big red bump; A spontaneous report was received from a Consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis (vaccination site cellulitis), big red bump (vaccination site reaction), bump is from shoulder to elbow (peripheral swelling), burned (vaccination site pain), looks bruised in the middle (vaccination site bruising), dark outline of red (erythema), and was itchy (vaccination site pruritis).  The patient's medical history was not provided. No relevant concomitant medications were reported.       On 03 Feb 2021 the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.    On 10 Feb 2021, The patient experienced vaccination cellulitis (big red bump) and pruritus (itchy) with seriousness criteria of hospitalization  Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the event is unknown; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported event, a causal relationship cannot be excluded.