chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: To be clear, I am presuming at this point that this is vaccine-related as I don't have any other valid explanation for my symptoms. I began experiencing itchiness in random body locations sometime in the morning on Wednesday, December 22, 2021 (almost exactly 2 weeks after receiving my Covid booster - Moderna). After not thinking much of my itchiness, I realized I was actually breaking out in hives (or urticaria) at random intervals over my whole body. They would appear in a location, last an hour or so, slowly fade and disappear, only to reappear shortly thereafter in a new body location. I took Benadryl at night, but that did nothing for my daytime symptoms and the itchiness was awful. I sought medical attention via my PCP on Monday, December 27, 2021. She and I discussed varying degrees of treatment and we decided together to just try OTC Claritin before trying steroids. The Claritin did and continues to help manage the symptoms at a tolerable level but I do continue to have breakthrough hives. Throughout all of this the hives have been consistently worse at night between bedtime and dinner. The only other explanation aside from the vaccine that I thought may have been the cause was a women's PMS vitamin supplement called FLO Vitamins that I began taking daily about 6 days prior to my symptom onset. I have not taken these in over 2 weeks now and yet my symptoms persist. I have also noticed that I experience Dermatographia along with the hives, where my skin is now extremely sensitive to any abrasion and causes redness and hives in any minimally scraped or abraded area (for example, I reached behind the couch to get something and my forearm rubbed against the couch as I did this and had a massive area of redness and hives in that location for about an hour subsequently). I have never in my life experienced hives or Dermatographia prior to my symptom onset on December 22, 2021. I have had no recent environmental changes, nor do I suffer from any food or topical allergy normally.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Primary Series: Janssen  Booster dose: Pfizer Vaccinated: 16:59 Reaction: 17:15 Pt reports feeling "a little dizzy" 16 minutes after vaccination, reported being nervous before getting booster  Vitals: @1720: 147/84, 58, 20, O2 100% -> @1732: 140/84, 63, 20, O2 99% Pt was taken to clinic via ambulation and laid down for several minutes and reported feeling better. He was also given orange juice, water, and graham crackers. Pt reported feeling back to normal with dizziness resolved and no other adverse side effects reported or observed. Pt also reported he had not eaten or drank anything since 9:30 today and was also nervous about receiving the booster vaccine. Pt was educated to stay well hydrated day of any needlestick injection and for future vaccinations to be given laying down. Pt was able to ambulate independently with steady gait, out of facility at 17:34.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Ear pain, Facial paralysis, Herpes zoster, Laboratory test
Clinical narrative: Develope Bell?s palsy. Right side facial paralysis and throbbing pain under the ear. One doctor says could be caused by shingles outbreak without the rash. I think the vaccine triggered this. Meds steroids and antivirals. 2 weeks duration of healing my face.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological examination, Pain
Clinical narrative: Develope Bell?s palsy. Right side facial paralysis and throbbing pain under the ear. One doctor says could be caused by shingles outbreak without the rash. I think the vaccine triggered this. Meds steroids and antivirals. 2 weeks duration of healing my face.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Facial paresis
Clinical narrative: The patient reported to me a worsening of left side lower facial paresis originally experienced about 11/2020 as idiopathic Bell's Palsy.  the worsening occurred after the second Moderna vaccination.  He also reported right lower facial weakness which was a completely new symptom.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: 3 hours after the booster vaccination I experienced extreme fatigue and lightheadedness.  I laid down for several hours and felt a little better. The next 4 days I had a fever of about 101°. This was accompanied by severe headache, muscle pain, and weakness. After the four days the headache was gone, as well as the fever. However, the severe fatigue lasted for another five weeks. And as of today, I am still experiencing unusual muscle pain and weakness.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 3 hours after the booster vaccination I experienced extreme fatigue and lightheadedness.  I laid down for several hours and felt a little better. The next 4 days I had a fever of about 101°. This was accompanied by severe headache, muscle pain, and weakness. After the four days the headache was gone, as well as the fever. However, the severe fatigue lasted for another five weeks. And as of today, I am still experiencing unusual muscle pain and weakness.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria
Clinical narrative: Dermatographia on the back occurring spontaneously for the past week.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Urticaria
Clinical narrative: Diffuse Urticaria and L upper face angioedema starting about 2 days after vaccine
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Patient listed no allergies to medication or history of immunization reactions. This was her Pfizer booster after receiving both doses of the initial Pfizer vaccine series. About 2 minutes after injection, the injection site swelled in a dime-sized dome. It was not red and didn't hurt/itch, per the patient. After about 30 minutes the swelling went down and the patient said she felt fine.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Headache, Hypertension, Hypoaesthesia
Clinical narrative: Extremely high blood pressure, dizzy, numbness, confused, headaches
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear discomfort, Lymph node palpable, Lymphadenitis, Lymphadenopathy
Clinical narrative: about 24 to 36 hours after vaccination, after a low grade fever and some chills, I developed a large lump under my left armpit.  This large swelling remained for about a week,  and once it diminished, there is still palpable inflamation of lymphnodes and tissues under arm.  Additionally, about 1 week after vaccine, significant Tinnitus and a feeling of pressure in the left ear started, and is still continuing
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: about 24 to 36 hours after vaccination, after a low grade fever and some chills, I developed a large lump under my left armpit.  This large swelling remained for about a week,  and once it diminished, there is still palpable inflamation of lymphnodes and tissues under arm.  Additionally, about 1 week after vaccine, significant Tinnitus and a feeling of pressure in the left ear started, and is still continuing
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Discomfort, Erythema, Mechanical urticaria, Pruritus, Rash
Clinical narrative: About 2 weeks after receiving my Moderna booster, I started getting intense itching and rashes. They are extremely discomforting for about a half hour, then the go away, only to return in another part of my body later on. It's been going on for about 2 weeks now, and it has not improved.   I took Zyrtec over the counter, which helped a bit, but the second I stop - the intense rashes and itching resumes. I am a 23 (now 24) year old man, with no prior allergies or health conditions.   I went to urgent care today (1/3/22) and she performed a dermatographia test on me - meaning she scraped my arm with a wooden stick to see if I would react. My arm immediately got very itchy and red - showing that I react to touch.  This is unlike anything I have ever experienced, and literally nothing in my life has changed in the last month to explain this (other than the booster vaccine).   I am so uncomfortable, and am constantly itching, which only makes it worse because my skin is reacting to the touch/itching.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Oral herpes, Pain in extremity, Pyrexia
Clinical narrative: Fever 102 Cold sore where one was never located previously  Cold chills Sore arm
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Bilateral tinnitus developed 2 weeks after J&J vaccination and has persisted.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Benign neoplasm of bladder, Cystoscopy abnormal, Laboratory test normal, Nephrolithiasis, Urological examination abnormal
Clinical narrative: Came home after 10am injection. At around 12 noon that day had severe vaginal bleeding, thick blood with little stones. After 3 hours we called GYN doctor.  She told me to go to MD and blood tests and other tests to see if there is a vaginal infection. If there is, go immediately to the ER.   I had tests at MD, and they told the doctor that there is no infection. Dr. told me, that since it was a holiday, to call the hospital the next day and make an appointment with a urologist.   Urologist performed many tests, including cystoscopy, where he discovered a tumor in the bladder. Dr. thought tumor was cancerous. Got a second opinion from PRIVATE who also performed surgery and took out 3cm tumor which was found to be non cancerous. Follow ups for the next year to ensure no cancer in bladder. I had another cystoscopy performed by same Dr. in November 2021 and he wants 3 more cystoscopies this year (2022).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Came home after 10am injection. At around 12 noon that day had severe vaginal bleeding, thick blood with little stones. After 3 hours we called GYN doctor.  She told me to go to MD and blood tests and other tests to see if there is a vaginal infection. If there is, go immediately to the ER.   I had tests at MD, and they told the doctor that there is no infection. Dr. told me, that since it was a holiday, to call the hospital the next day and make an appointment with a urologist.   Urologist performed many tests, including cystoscopy, where he discovered a tumor in the bladder. Dr. thought tumor was cancerous. Got a second opinion from PRIVATE who also performed surgery and took out 3cm tumor which was found to be non cancerous. Follow ups for the next year to ensure no cancer in bladder. I had another cystoscopy performed by same Dr. in November 2021 and he wants 3 more cystoscopies this year (2022).
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate increased, Lip swelling, Palpitations, Peripheral swelling
Clinical narrative: Pounding heart, fast heart beat, slight swelling of lips and hands
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Significant impairment/ extreme exhaustion consisting of substantial disruption of the ability to conduct daily normal life functions. I was to the point where I could not walk due to severe exhaustion accompanied with some achyness in muscles.  This has NEVER happened to me.  Very concerning to me. Next day I was fine.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: 10 days after Booster shot hives started on body and would come and go in different places and were extremely itchy and red. Lasted approximately 1-2 weeks before contacting allergist and symptoms are still showing but have lessened.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Dizziness, Electrocardiogram, Extrasystoles, Palpitations
Clinical narrative: cardiac arrhythmia , multiple PVC's, bigeminy. symptoms of palpitations, occasional dizziness, per cardiologist start taking propranolol
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: cardiac arrhythmia , multiple PVC's, bigeminy. symptoms of palpitations, occasional dizziness, per cardiologist start taking propranolol
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus
Clinical narrative: Vaccinated: 11:17 am. Reaction: 11:27 am. Patient reported dizziness and ringing in ears. Vitals: 142/86, 84 and 18. Patient stabilized and released from vaccination site.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient requested Janssen vaccine online but due to miscommunication received Moderna vaccine.  First dose of covid vaccine.  No medical adverse events so far reported.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Lymphadenopathy, Pain
Clinical narrative: Dizzy,extreme tiredness,diarrhea, vomiting, body aches, lymph nodes in right under arm swollen (and still after four days) all symptoms lasted approximately 36 hrs except the swelling
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Vomiting
Clinical narrative: Dizzy,extreme tiredness,diarrhea, vomiting, body aches, lymph nodes in right under arm swollen (and still after four days) all symptoms lasted approximately 36 hrs except the swelling
Age: 30.0
Sex: M
Vaccine: UNK
Symptoms: Grip strength decreased, Impaired driving ability, Injected limb mobility decreased, Joint range of motion decreased, Pain in extremity
Clinical narrative: Received annual flu vaccine and had left arm pain a few hours after.  Pain continues and ROM is decreased. Painful to lift arm up, pain while trying to steer vehicle, pain while trying to lift objects such as gallon of milk, painful to sleep. 01/03/22 seen by provider and steroid injection was given.
Age: 30.0
Sex: M
Vaccine: UNK
Symptoms: Sleep disorder
Clinical narrative: Received annual flu vaccine and had left arm pain a few hours after.  Pain continues and ROM is decreased. Painful to lift arm up, pain while trying to steer vehicle, pain while trying to lift objects such as gallon of milk, painful to sleep. 01/03/22 seen by provider and steroid injection was given.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Fever, body aches, headache, chills, nausea, sore arm, swelling and redness at injection site  and rash on left arm.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: Fever, body aches, headache, chills, nausea, sore arm, swelling and redness at injection site  and rash on left arm.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Head injury, Syncope, Tinnitus
Clinical narrative: Felt extremely dizzy, fainted twice in the morning after receiving the vaccine. Heard a loud ringing in my ears for about 20 minutes (possibly from hitting my head after fainting and falling). Did not receive medical attention. An hour later, I felt completely fine and have not had any similar episodes since.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstruation irregular
Clinical narrative: Random menstrual bleeding mid cycle began 2 days after first shot,  irregular long periods ever since.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine receved; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine receved) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 06-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine receved). On 06-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine receved) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  No treatment medications were provided.  No adverse event was reported.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Booster dose of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 06-Dec-2021 at 4:17 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 06-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine). On 06-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine) to be not related.    Concomitant product information was not provided. Treatment information was not provided. After receiving the booster dose of Moderna COVID-19 Vaccine, the patient did not have any immediate issues and had not contained CCHD to notify of any adverse reactions/events It was reported that patient was at high risk of occupational/institutional exposure to COVID-19.   This case was linked to MOD-2021-407228 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Booster dose of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 06-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine). On 06-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Fatigue, Heart rate, Heart rate increased
Clinical narrative: hands and feet are like burning on fire; dermatographia that skin raises into welts, swells and inflames; green phlegm; 101 degree of fever; extreme fatigue; sore throat; high heart rate of 140; rash; allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), BURNING SENSATION (hands and feet are like burning on fire), MECHANICAL URTICARIA (dermatographia that skin raises into welts, swells and inflames), SPUTUM DISCOLOURED (green phlegm) and HEART RATE INCREASED (high heart rate of 140) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 017B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation (1 episode of atrial fibrillation) in 2015 and COVID-19 on 23-Dec-2020.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), HEART RATE INCREASED (high heart rate of 140), RASH (rash) and HYPERSENSITIVITY (allergic reaction). On an unknown date, the patient experienced BURNING SENSATION (hands and feet are like burning on fire), MECHANICAL URTICARIA (dermatographia that skin raises into welts, swells and inflames), SPUTUM DISCOLOURED (green phlegm), PYREXIA (101 degree of fever) and FATIGUE (extreme fatigue). At the time of the report, OROPHARYNGEAL PAIN (sore throat), BURNING SENSATION (hands and feet are like burning on fire), MECHANICAL URTICARIA (dermatographia that skin raises into welts, swells and inflames), SPUTUM DISCOLOURED (green phlegm), HEART RATE INCREASED (high heart rate of 140), RASH (rash), HYPERSENSITIVITY (allergic reaction), PYREXIA (101 degree of fever) and FATIGUE (extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101 degree of fever the first night. On an unknown date, Heart rate: 140 (High) high heart rate of 140. On an unknown date, Streptococcus test: negative (Negative) strep culture turned out negative.         No concomitant medication was reported. The treatment medication were Steroid and Antibiotic.   This case was linked to MOD-2021-435774 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes:
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Mechanical urticaria, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: hands and feet are like burning on fire; dermatographia that skin raises into welts, swells and inflames; green phlegm; 101 degree of fever; extreme fatigue; sore throat; high heart rate of 140; rash; allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), BURNING SENSATION (hands and feet are like burning on fire), MECHANICAL URTICARIA (dermatographia that skin raises into welts, swells and inflames), SPUTUM DISCOLOURED (green phlegm) and HEART RATE INCREASED (high heart rate of 140) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 017B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation (1 episode of atrial fibrillation) in 2015 and COVID-19 on 23-Dec-2020.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), HEART RATE INCREASED (high heart rate of 140), RASH (rash) and HYPERSENSITIVITY (allergic reaction). On an unknown date, the patient experienced BURNING SENSATION (hands and feet are like burning on fire), MECHANICAL URTICARIA (dermatographia that skin raises into welts, swells and inflames), SPUTUM DISCOLOURED (green phlegm), PYREXIA (101 degree of fever) and FATIGUE (extreme fatigue). At the time of the report, OROPHARYNGEAL PAIN (sore throat), BURNING SENSATION (hands and feet are like burning on fire), MECHANICAL URTICARIA (dermatographia that skin raises into welts, swells and inflames), SPUTUM DISCOLOURED (green phlegm), HEART RATE INCREASED (high heart rate of 140), RASH (rash), HYPERSENSITIVITY (allergic reaction), PYREXIA (101 degree of fever) and FATIGUE (extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101 degree of fever the first night. On an unknown date, Heart rate: 140 (High) high heart rate of 140. On an unknown date, Streptococcus test: negative (Negative) strep culture turned out negative.         No concomitant medication was reported. The treatment medication were Steroid and Antibiotic.   This case was linked to MOD-2021-435774 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes:
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Sputum discoloured, Streptococcus test
Clinical narrative: hands and feet are like burning on fire; dermatographia that skin raises into welts, swells and inflames; green phlegm; 101 degree of fever; extreme fatigue; sore throat; high heart rate of 140; rash; allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), BURNING SENSATION (hands and feet are like burning on fire), MECHANICAL URTICARIA (dermatographia that skin raises into welts, swells and inflames), SPUTUM DISCOLOURED (green phlegm) and HEART RATE INCREASED (high heart rate of 140) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 017B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation (1 episode of atrial fibrillation) in 2015 and COVID-19 on 23-Dec-2020.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), HEART RATE INCREASED (high heart rate of 140), RASH (rash) and HYPERSENSITIVITY (allergic reaction). On an unknown date, the patient experienced BURNING SENSATION (hands and feet are like burning on fire), MECHANICAL URTICARIA (dermatographia that skin raises into welts, swells and inflames), SPUTUM DISCOLOURED (green phlegm), PYREXIA (101 degree of fever) and FATIGUE (extreme fatigue). At the time of the report, OROPHARYNGEAL PAIN (sore throat), BURNING SENSATION (hands and feet are like burning on fire), MECHANICAL URTICARIA (dermatographia that skin raises into welts, swells and inflames), SPUTUM DISCOLOURED (green phlegm), HEART RATE INCREASED (high heart rate of 140), RASH (rash), HYPERSENSITIVITY (allergic reaction), PYREXIA (101 degree of fever) and FATIGUE (extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101 degree of fever the first night. On an unknown date, Heart rate: 140 (High) high heart rate of 140. On an unknown date, Streptococcus test: negative (Negative) strep culture turned out negative.         No concomitant medication was reported. The treatment medication were Steroid and Antibiotic.   This case was linked to MOD-2021-435774 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The booster vaccine that was given to the mother-in-law was expired; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The booster vaccine that was given to the mother-in-law was expired) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The booster vaccine that was given to the mother-in-law was expired). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (The booster vaccine that was given to the mother-in-law was expired) had resolved.            No concomitant medications were provided. No treatment medications were reported.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received first dose on 23-Jan-2021 and second dose on 16-Mar-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose on 23-Jan-2021 and second dose on 16-Mar-2021) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose on 23-Jan-2021 and second dose on 16-Mar-2021). On 16-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose on 23-Jan-2021 and second dose on 16-Mar-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2021-435687 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Malaise, Respiration abnormal
Clinical narrative: didn't felt good; had a breath treatment; has have no energy since the first vaccine; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (didn't felt good), RESPIRATION ABNORMAL (had a breath treatment), ASTHENIA (has have no energy since the first vaccine) and FATIGUE (felt tired) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Non-smoker and Abstains from alcohol. Concomitant products included VITAMINS NOS for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MALAISE (didn't felt good), RESPIRATION ABNORMAL (had a breath treatment), ASTHENIA (has have no energy since the first vaccine) and FATIGUE (felt tired). At the time of the report, MALAISE (didn't felt good), RESPIRATION ABNORMAL (had a breath treatment), ASTHENIA (has have no energy since the first vaccine) and FATIGUE (felt tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       They patient stated that after the first dose they felt tired and didn't felt good, had a breath treatment, and had have no energy since the first vaccine, and these symptoms were ongoing.  They also reported that they don't smoke, drink, or do drugs.  It was also reported that the patient had a breath treatment.   This case was linked to MOD-2021-435962, MOD-2021-435966 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: Her lower eyelid and it was swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING OF EYELID (Her lower eyelid and it was swollen) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sleep disorder NOS. Concomitant products included ALPRAZOLAM (XANAX) for Sleep disorder.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, the patient experienced SWELLING OF EYELID (Her lower eyelid and it was swollen). On 28-Dec-2021, SWELLING OF EYELID (Her lower eyelid and it was swollen) had resolved.     When patient woke up on 23-Dec-2021, she touched her lower eyelid, and it was swollen. She did not do anything besides soak it. The next day it was worse. she went to the doctor, but the doctor did not help much. she couldn't see it anymore, so she didn't think much of it.   This case was linked to MOD-2021-435971 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Pain, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathing got labor), PAIN (The whole body hurt), DIZZINESS (Felt dizzy) and PYREXIA (A Fever) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Non-smoker and Abstains from alcohol. Concomitant products included VITAMINS NOS for an unknown indication.On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DYSPNOEA (Breathing got labor), PAIN (The whole body hurt), DIZZINESS (Felt dizzy) and PYREXIA (A Fever). At the time of the report, DYSPNOEA (Breathing got labor), PAIN (The whole body hurt), DIZZINESS (Felt dizzy) and PYREXIA (A Fever) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.It was reported that the patient do not do drugs (unspecified). Patient went to medical center and had a breath treatment. This case was linked to MOD-2021-435933, MOD-2021-435966 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: After getting the Moderna COVID-19 booster on 30Dec2021 it swelled up again.; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (After getting the Moderna COVID-19 booster on 30Dec2021 it swelled up again.) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 006B21A and 042B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALPRAZOLAM (XANAX) for Sleep disorder.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EYE SWELLING (After getting the Moderna COVID-19 booster on 30Dec2021 it swelled up again.). At the time of the report, EYE SWELLING (After getting the Moderna COVID-19 booster on 30Dec2021 it swelled up again.) outcome was unknown.            Treatment information for dose 3 event was not provided. Reporter states lot number of the Moderna COVID-19 booster vaccine: 059H21A but she says it may also be 054H21A.   This case was linked to MOD-2021-435946.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: the booster dose was expired, two weeks prior.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the booster dose was expired, two weeks prior.) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (the booster dose was expired, two weeks prior.). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (the booster dose was expired, two weeks prior.) had resolved.            No concomitant medications was reported. No treatment drug details was reported.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dry throat
Clinical narrative: Her throat is different, it's dry; She is starting to have a cough, not a heavy one, but a dry cough; This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (Her throat is different, it's dry) and COUGH (She is starting to have a cough, not a heavy one, but a dry cough) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 041C21A and 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Deaf and Autism.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced DRY THROAT (Her throat is different, it's dry) and COUGH (She is starting to have a cough, not a heavy one, but a dry cough). At the time of the report, DRY THROAT (Her throat is different, it's dry) and COUGH (She is starting to have a cough, not a heavy one, but a dry cough) outcome was unknown.            No concomitant product use was provided. No treatment medication was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Feeling abnormal, Headache, Mobility decreased
Clinical narrative: Diarrhea; She can hardly move; Side effects hit her like a ton of bricks; Headache; Body aches so bad she can hardly move; Temperature over 100F; Left arm is so sore from injection she feels like it's going to fall off.; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), MOBILITY DECREASED (She can hardly move), FEELING ABNORMAL (Side effects hit her like a ton of bricks), HEADACHE (Headache) and MYALGIA (Body aches so bad she can hardly move) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic and Cancer.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, the patient experienced DIARRHOEA (Diarrhea), MOBILITY DECREASED (She can hardly move), FEELING ABNORMAL (Side effects hit her like a ton of bricks), HEADACHE (Headache), MYALGIA (Body aches so bad she can hardly move), PYREXIA (Temperature over 100F), VACCINATION SITE PAIN (Left arm is so sore from injection she feels like it's going to fall off.) and VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhea), MOBILITY DECREASED (She can hardly move), FEELING ABNORMAL (Side effects hit her like a ton of bricks), HEADACHE (Headache), MYALGIA (Body aches so bad she can hardly move), PYREXIA (Temperature over 100F), VACCINATION SITE PAIN (Left arm is so sore from injection she feels like it's going to fall off.) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100F.         Patient stated that she felt 50 times worse after the booster than with the 2nd dose. No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-052027 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Diarrhea; She can hardly move; Side effects hit her like a ton of bricks; Headache; Body aches so bad she can hardly move; Temperature over 100F; Left arm is so sore from injection she feels like it's going to fall off.; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), MOBILITY DECREASED (She can hardly move), FEELING ABNORMAL (Side effects hit her like a ton of bricks), HEADACHE (Headache) and MYALGIA (Body aches so bad she can hardly move) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic and Cancer.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, the patient experienced DIARRHOEA (Diarrhea), MOBILITY DECREASED (She can hardly move), FEELING ABNORMAL (Side effects hit her like a ton of bricks), HEADACHE (Headache), MYALGIA (Body aches so bad she can hardly move), PYREXIA (Temperature over 100F), VACCINATION SITE PAIN (Left arm is so sore from injection she feels like it's going to fall off.) and VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhea), MOBILITY DECREASED (She can hardly move), FEELING ABNORMAL (Side effects hit her like a ton of bricks), HEADACHE (Headache), MYALGIA (Body aches so bad she can hardly move), PYREXIA (Temperature over 100F), VACCINATION SITE PAIN (Left arm is so sore from injection she feels like it's going to fall off.) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100F.         Patient stated that she felt 50 times worse after the booster than with the 2nd dose. No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-052027 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine given to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided The vial was punctured yesterday, 28DEC2021, and used for up to 17 hours post puncture. No patients have reported any side effects from this dose.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine given to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication information was given. It was reported that patients received an expired dose of the Moderna COVID-19 vaccine. The vial was punctured on 28-DEC-2021 and used for up to 17 hours post puncture. No patients have reported any side effects from this dose.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vial was punctured yesterday 28-Dec-2021 and used for up to 17 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was punctured yesterday 28-Dec-2021 and used for up to 17 hours post puncture) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was punctured yesterday 28-Dec-2021 and used for up to 17 hours post puncture). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (The vial was punctured yesterday 28-Dec-2021 and used for up to 17 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patients) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patients). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was stated that the vial was punctured on 28 Dec 2021, and was used for up to 17 hours post puncture that is till 29 Dec 2021. No patients have reported any side effects from this dose. Did the vial undergo any temperature excursions? No. No concomitant medications and treatment details were reported.   This case was linked to MOD-2021-435992 (Patient Link).