chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: patient was one of several waiting for vaccine. nurse who went to get next patient asked for patient to come to vaccine area. teenager stood up and came to nurse. teenager was not who the nurse called but another pt (Pt 2). Pt 2 was given the original pt's Moderna vaccine. Pharmacist noticed the original pt was still waiting for vaccine. Asked Nurse why the original pt was waiting- and nurse said no that is pt 2 there- and I told nurse no that is pt 1. So pt 2 got MOderna not pfizer. we will follow up with pt in few days. SHe received 0.25 ml of moderna
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Magnetic resonance imaging, Nausea, Palpitations
Clinical narrative: Felt dizzy and my vision was out of focus, nausea, palpitations, felt like I was going to fell out
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Venogram, Visual impairment
Clinical narrative: Felt dizzy and my vision was out of focus, nausea, palpitations, felt like I was going to fell out
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Hyperhidrosis
Clinical narrative: Cheast pain, shortness of breath, sweating. Rest. No medications perscribed.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature increased, Dermatitis, Injected limb mobility decreased, Injection site erythema
Clinical narrative: On 10/30/21 at 3:26pm my temperature was 100.0F.  On 10/30/21 at 9:33pm my left arm area around the injection site was swollen, warm, firm, and pink. It felt too swollen to lay on that side. My temperature was 99.8F.  On 10/30/21 at 10:17pm my skin felt inflamed and warm on my cheeks, head, neck, torso and arms. I used ice bags and a cool compress. My left underarm was swollen, warm and painful. On 10/31/21 at 2:29am my deltoid area still hurt. On 10/31/21 at 5:54am my temperature was 98.3F.  On 10/31/21 at 11:25am I had additional pink areas of skin on my left arm that were oval shaped, dark pink and warm.  On 10/31/21 10:19pm my temperature was 97.0F.  Through the day the left underarm swelling continued. On 11/1/21 12:53pm my left arm was still red, warm, swollen, firm.  On 11/1/21 2:10pm it was difficult to raise my arm, where range of motion had previously been normal.  On 11/02/21 2:26am I could not raise my left arm. The upper arm area was raised, dark pink, and swollen.   On 11/02/21 2:45am my arm was still warm at the injection site, swollen under the arm, and I could not raise my left arm.  On 11/03/21 1:33pm the upper arm was still pink, swollen and firm.  On 11/03/21 10:53pm left arm was still pink and sore and I could not raise my arm. On 11/30/21 10:55am my arm was still hurting and felt like a burning feeling and I still had no improvement in mobility. On 12/03/21 at 9:30am I saw an orthopedist.  The adverse event I want to report is the prolonged arm swelling, firmness and inability to raise my arm.  An ample amount of time and rest has passed, but I cannot raise my arm.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Oedema peripheral, Skin warm
Clinical narrative: On 10/30/21 at 3:26pm my temperature was 100.0F.  On 10/30/21 at 9:33pm my left arm area around the injection site was swollen, warm, firm, and pink. It felt too swollen to lay on that side. My temperature was 99.8F.  On 10/30/21 at 10:17pm my skin felt inflamed and warm on my cheeks, head, neck, torso and arms. I used ice bags and a cool compress. My left underarm was swollen, warm and painful. On 10/31/21 at 2:29am my deltoid area still hurt. On 10/31/21 at 5:54am my temperature was 98.3F.  On 10/31/21 at 11:25am I had additional pink areas of skin on my left arm that were oval shaped, dark pink and warm.  On 10/31/21 10:19pm my temperature was 97.0F.  Through the day the left underarm swelling continued. On 11/1/21 12:53pm my left arm was still red, warm, swollen, firm.  On 11/1/21 2:10pm it was difficult to raise my arm, where range of motion had previously been normal.  On 11/02/21 2:26am I could not raise my left arm. The upper arm area was raised, dark pink, and swollen.   On 11/02/21 2:45am my arm was still warm at the injection site, swollen under the arm, and I could not raise my left arm.  On 11/03/21 1:33pm the upper arm was still pink, swollen and firm.  On 11/03/21 10:53pm left arm was still pink and sore and I could not raise my arm. On 11/30/21 10:55am my arm was still hurting and felt like a burning feeling and I still had no improvement in mobility. On 12/03/21 at 9:30am I saw an orthopedist.  The adverse event I want to report is the prolonged arm swelling, firmness and inability to raise my arm.  An ample amount of time and rest has passed, but I cannot raise my arm.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Headache, Hypopnoea, Painful respiration
Clinical narrative: Approximately 30 minutes after my 2nd covid-19 vaccination dose, I started to experience sharp strong pain in my chest on my left side. I had to keep my breath shallow in order to keep the pain tolerable. A headache and fatigue accompanied the pain around the same time.  It lasted several hours and I did not seek medical attention. It eventually alleviated itself within 6 hours.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nasal polyps, Neuroblastoma, Pathology test, Polypectomy
Clinical narrative: Polyp growth within the left nostril, which was surgically removed, and was diagnosed as olfactory neuroblastoma.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Peripheral swelling, Swelling face
Clinical narrative: booster shot 0.25ml post pfizer primary series Red swollen arm began around noon of the same day, redness and pain continued for 5 days, began to reduce on 1/11 but then face began to swell slightly and had redness beginning. Patient was advised to seek treatment if possible due to facial swelling but was not interested, advised to continue antihistamine that had reduced swelling in arm but to seek medical attention as soon as any worsening occurred. Patient familiar with anaphylactic reactions due to macrobid allergy and will monitor self closely.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dental discomfort, Mouth ulceration, Noninfective gingivitis, Oral pain
Clinical narrative: Approximately 30 minutes after receiving my 3rd vaccination (booster dose), I began to experience strong pain in my two upper rear molars on the left side of my mouth. Inflammation of my gums was slightly noticeable. A few days later, I developed mouth ulcers across the roof of my mouth for no reason.  The ulcers lasted about 10 days and were very painful. Salt rinses were done daily to keep them from becoming infected. The tooth pain has continued daily since my booster. I am currently taking Advil's and Tylenol daily to manage the discomfort. The pain varies and the gums do not seem infected. Teeth are not loose. I am seeking medical attention from my dentist this week.  Within an hour of my 3rd vaccination (booster dose) I experienced the same strong, sharp chest pain as I noticed in my 2nd dose. It only lasted about an hour at the time, but since that event I have experienced the chest pain several times a week with no warning or discernible reason. I will be reaching out to a doctor for assistance this week. I am no longer with this facility for health care.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: Approximately 30 minutes after receiving my 3rd vaccination (booster dose), I began to experience strong pain in my two upper rear molars on the left side of my mouth. Inflammation of my gums was slightly noticeable. A few days later, I developed mouth ulcers across the roof of my mouth for no reason.  The ulcers lasted about 10 days and were very painful. Salt rinses were done daily to keep them from becoming infected. The tooth pain has continued daily since my booster. I am currently taking Advil's and Tylenol daily to manage the discomfort. The pain varies and the gums do not seem infected. Teeth are not loose. I am seeking medical attention from my dentist this week.  Within an hour of my 3rd vaccination (booster dose) I experienced the same strong, sharp chest pain as I noticed in my 2nd dose. It only lasted about an hour at the time, but since that event I have experienced the chest pain several times a week with no warning or discernible reason. I will be reaching out to a doctor for assistance this week. I am no longer with this facility for health care.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Feeling hot, Malaise, SARS-CoV-2 test negative
Clinical narrative: BP: 151/100 Pulse 125 Resp:20 Temp 98.6 Weight 203 Height 5' 10.5" BMI: 28.751 02SAT 98% Tightness in chest and overall unwell feeling, presented myself to urgent care and was told to go to nearest hospital. Arrived at Hospital where multiple vials of blood were taken for tests, I was put on some sort of liquid iv and a few hrs later I was released. Since that time, I am always running hot, is the only way I can describe it. I can have the AC on in the house and it be 68 degrees and Im not cold but wife is freezing.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Cardiac failure congestive, Condition aggravated, Pain
Clinical narrative: Patient received Moderna COVID vaccine on 3/1/21 (lot # 001A21A), 3/29/21 (lot # 008B21A), and 11/11/21 (lot # 032F21A).  On 1/9/22, patient tested positive for COVID and admitted to our inpatient facilit with acute hypoxic/hypercapnic respiratory failure (unclear how much of this is COVID vs possible new CHF vs chronic OSA vs OHS) and worsening pain for chronic cutaneous venous stasis. As of today (1/11/22), patient is still admitted in our med/surg unit.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral venous disease, Pickwickian syndrome, Respiratory failure, SARS-CoV-2 test positive, Sleep apnoea syndrome
Clinical narrative: Patient received Moderna COVID vaccine on 3/1/21 (lot # 001A21A), 3/29/21 (lot # 008B21A), and 11/11/21 (lot # 032F21A).  On 1/9/22, patient tested positive for COVID and admitted to our inpatient facilit with acute hypoxic/hypercapnic respiratory failure (unclear how much of this is COVID vs possible new CHF vs chronic OSA vs OHS) and worsening pain for chronic cutaneous venous stasis. As of today (1/11/22), patient is still admitted in our med/surg unit.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Eczema
Clinical narrative: Dry cough (persistent since April 2021 till date) and eczema.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Anticoagulant therapy, COVID-19, COVID-19 pneumonia, Electrocardiogram ST-T segment abnormal
Clinical narrative: Patient received Pfizer COVID vaccine on 12/31/20 and 1/21/21. On 12/28/21, patient tested positive for COVID at home. On 1/7/22, patient admitted to our inpatient facility with acute respiratory failure with hypoxia likely due to both COVID-19 pneumonia and acute pulmonary emboli bilaterally with mild right heart strain. COVID PCR status upon admission on 1/7/22 was negative, but given recent positive test and progression of illness strongly suspect this is residual inflammation/pneumonia from COVID-19. Patient discharged home with oxygen and anticoagulation on 1/11/22.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: Patient received Pfizer COVID vaccine on 12/31/20 and 1/21/21. On 12/28/21, patient tested positive for COVID at home. On 1/7/22, patient admitted to our inpatient facility with acute respiratory failure with hypoxia likely due to both COVID-19 pneumonia and acute pulmonary emboli bilaterally with mild right heart strain. COVID PCR status upon admission on 1/7/22 was negative, but given recent positive test and progression of illness strongly suspect this is residual inflammation/pneumonia from COVID-19. Patient discharged home with oxygen and anticoagulation on 1/11/22.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Intensive care, SARS-CoV-2 test positive
Clinical narrative: Patient received Janssen COVID vaccine on 4/6/21. On 12/30/21, patient tested positive for COVID. On 1/5/22, patient admitted to our facility with acute hypoxic respiratory failure secondary to COVID-19 pneumonia on high flow. Patient transferred out of facility to med/surg unit today (1/11/22) and currently still hospitalized.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest X-ray, Chest pain, Echocardiogram, Gait inability
Clinical narrative: Weakness, Loss of limb on the area of vaccine given, stiffness, Unable to walk or sit up, Pain, Chest pain, Started the next  day in the morning around 500 AM.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Laboratory test, Magnetic resonance imaging head, Musculoskeletal stiffness, Pain
Clinical narrative: Weakness, Loss of limb on the area of vaccine given, stiffness, Unable to walk or sit up, Pain, Chest pain, Started the next  day in the morning around 500 AM.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Sitting disability
Clinical narrative: Weakness, Loss of limb on the area of vaccine given, stiffness, Unable to walk or sit up, Pain, Chest pain, Started the next  day in the morning around 500 AM.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Embolic stroke, Hemiparaesthesia
Clinical narrative: Patient received Moderna COVID vaccine on 4/8/21 and 5/6/21. On 1/10/22, patient presented with awake L side hemiparesthesia and hemiparesis and admitted to our inpatient CCU with embolic stroke potentially related to Depo-Provera (if paradoxical) +/- COVID infection. Patient was found to be COVID positive upon admission with cough, sore throat, fever, and chills. Patient underwent mechanical thrombectomy on 1/10/22. As of today (1/11/22), patient was transferred to our med/surg unit and still admitted.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hemiparesis, Injectable contraception, Intensive care, Oropharyngeal pain, Pyrexia
Clinical narrative: Patient received Moderna COVID vaccine on 4/8/21 and 5/6/21. On 1/10/22, patient presented with awake L side hemiparesthesia and hemiparesis and admitted to our inpatient CCU with embolic stroke potentially related to Depo-Provera (if paradoxical) +/- COVID infection. Patient was found to be COVID positive upon admission with cough, sore throat, fever, and chills. Patient underwent mechanical thrombectomy on 1/10/22. As of today (1/11/22), patient was transferred to our med/surg unit and still admitted.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Thrombectomy
Clinical narrative: Patient received Moderna COVID vaccine on 4/8/21 and 5/6/21. On 1/10/22, patient presented with awake L side hemiparesthesia and hemiparesis and admitted to our inpatient CCU with embolic stroke potentially related to Depo-Provera (if paradoxical) +/- COVID infection. Patient was found to be COVID positive upon admission with cough, sore throat, fever, and chills. Patient underwent mechanical thrombectomy on 1/10/22. As of today (1/11/22), patient was transferred to our med/surg unit and still admitted.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient received her booster- and right after she received her vaccines about 2-3 minutes she reports feeling lightheaded and dizzziness-  passed out for about 3-5 secwe lower her down the floor and elevated her legs to keep her pressure to vital organ- Checked her BP was within range- Heart rate 53, BP 113/66- alert and oriented-
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Rash erythematous, Rash papular, Swelling, Urticaria
Clinical narrative: I have hives that could pop up anywhere on my body, last anywhere from minutes to hours, on multiple locations on the body at the same time, a single area could be as small as the size of a coin to as big as my entire back. Sometimes the hives are not raised. Most of the time they're pink, but sometimes flesh-colored (I am a light-skinned female). Scratching causes more raised, pink bumps. There's no other trigger whatsoever that could have caused this. I take Zyrtec twice a day to manage it. If I go more than 24 hours without medication, the hives return in full force again and I wouldn't be able to sleep.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Cystitis haemorrhagic, SARS-CoV-2 test positive
Clinical narrative: Patient received Pfizer COVID vaccine on 1/21/21 and 2/8/21. Patient was diagnosed with COVID on 1/5/22 in her nursing home. On 1/9/22, patient admitted to our inpatient facility with acute hypoxic respiratory failure, COVID-19 pneumonia (? bacterial pneumonia), and acute hemorrhagic cystitis. As of today (1/11/22), patient is still admitted in our med/surg unit.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Aphasia, Dyspnoea, Feeling hot, Hyperhidrosis
Clinical narrative: 11 mins into having the 2nd shot my daughter Was saying her stomach hurt she couldn?t breathe her heart was pounding she turned white as a ghost she was sliding out of her chair, then wasn?t able to really speak much, be came hot in touch sweaty. Call the pharmacist over he offered us an ice pack then put it on her head it was rotating it to her side of her neck and back  then her color started coming back.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Palpitations, Posture abnormal
Clinical narrative: 11 mins into having the 2nd shot my daughter Was saying her stomach hurt she couldn?t breathe her heart was pounding she turned white as a ghost she was sliding out of her chair, then wasn?t able to really speak much, be came hot in touch sweaty. Call the pharmacist over he offered us an ice pack then put it on her head it was rotating it to her side of her neck and back  then her color started coming back.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Hip arthroplasty, Joint dislocation, Osteoarthritis, SARS-CoV-2 test positive
Clinical narrative: Patient received Pfizer COVID vaccine on 3/26/21 and 4/23/21. On 1/10/22, patient admitted to our inpatient facility with NSTEMI type II and COVID-19 pneumonia (status positive upon admission). As of today (1/11/22), patient is still admitted in our med/surg unit.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test normal, Dizziness, Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased
Clinical narrative: Myocarditis-fast heart rate , shortness of breath and dizziness.  Was prescribed coreg for 6 months after my echo came back a little reduced.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Myocarditis
Clinical narrative: Myocarditis-fast heart rate , shortness of breath and dizziness.  Was prescribed coreg for 6 months after my echo came back a little reduced.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Myalgia, Oedema peripheral, Pyrexia
Clinical narrative: Swelling under left armpit, fever, chills, muscle aches, stomach pain and cramping.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chest pain, Dyspnoea, Injection site pain, Pruritus
Clinical narrative: Days 1-4: very sore arm at injection sight but especially sore in the armpit to the pectoral area only on injection side..  Day 9: started developing hives and itching around neck, face and scalp. Began taking antihistamines. Day 10: covered in rash, raised welts/Hives on chest, back, arms, heads, legs and feet.  Day 12: rashes and intense itching continue and now get bouts of asthmatic symptoms wheezing and shortness of breath. Usually bouts last about an hour then resolve naturally(while still on oral antihistamines). Day 16: Today. Still having all the same symptoms and found many similar cases by searching the internet with people having similar reactions to the booster shot and realized that my symptoms are in line with many others. I can?t skip a dose of antihistamine without suffering.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash papular, Urticaria, Wheezing
Clinical narrative: Days 1-4: very sore arm at injection sight but especially sore in the armpit to the pectoral area only on injection side..  Day 9: started developing hives and itching around neck, face and scalp. Began taking antihistamines. Day 10: covered in rash, raised welts/Hives on chest, back, arms, heads, legs and feet.  Day 12: rashes and intense itching continue and now get bouts of asthmatic symptoms wheezing and shortness of breath. Usually bouts last about an hour then resolve naturally(while still on oral antihistamines). Day 16: Today. Still having all the same symptoms and found many similar cases by searching the internet with people having similar reactions to the booster shot and realized that my symptoms are in line with many others. I can?t skip a dose of antihistamine without suffering.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Foot fracture, Ultrasound scan
Clinical narrative: DEEP VEIN THROMBOSIS; FRACTURE IN RIGHT FOOT; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic, postural orthostatic tachycardia syndrome form dysautonomia, myasthenia gravis, latex allergy, morphine drug allergy, iodine allergy, ibuprofen drug allergy, sulfa drug allergy and drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 23-AUG-2021) dose was not reported, 1 total administered on 11-MAR-2021 to Left deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-NOV-2021, the patient experienced fracture in right foot. On 21-NOV-2021, the patient experienced pain in the calf and went in to ER (emergency room) and was diagnosed with DVT (Deep vein thrombosis) in the right calf using an ultrasound and was discharged on the same day. Patient stated that she do not think that this had any thing to do with the vaccine but it was provoked by the fracture and stated her doctors do not know why exactly but said it was likely due to fracture (fairly common). Patient never had DVT (Deep vein thrombosis) before though and had fractured same foot before. She said DVT (Deep vein thrombosis) has not resolved and she saw her vascular dr. Laboratory data included: Diagnostic ultrasound (NR: not provided) DVT (Deep vein thrombosis) in the right calf. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deep vein thrombosis, and the outcome of fracture in right foot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220116203-covid-19 vaccine ad26.cov2.s- deep vein thrombosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Gait disturbance, Hyperhidrosis, Hypersomnia
Clinical narrative: Dizzy; Slept for 3 days/sleeping a lot; Waking up in sweats; Could not walk or stand up; Could not walk or stand up; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), HYPERSOMNIA (Slept for 3 days/sleeping a lot), HYPERHIDROSIS (Waking up in sweats), GAIT DISTURBANCE (Could not walk or stand up) and DYSSTASIA (Could not walk or stand up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced DYSSTASIA (Could not walk or stand up). On an unknown date, the patient experienced DIZZINESS (Dizzy), HYPERSOMNIA (Slept for 3 days/sleeping a lot), HYPERHIDROSIS (Waking up in sweats) and GAIT DISTURBANCE (Could not walk or stand up). At the time of the report, DIZZINESS (Dizzy), HYPERSOMNIA (Slept for 3 days/sleeping a lot), HYPERHIDROSIS (Waking up in sweats), GAIT DISTURBANCE (Could not walk or stand up) and DYSSTASIA (Could not walk or stand up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided. Patient reported not taking any medications for side effects or for any other health conditions.  Company Comment: This is a case concerning a female patient of unknown age, with unknown medical history, who experienced the unexpected events of Hypersomnia, Hyperhidrosis, Gait disturbance, and Dysstasia, and expected event of Dizziness. The events occurred unknown number of days after the first dose of mRNA-1273 vaccine. There is no available information regarding clinical course or treatment medication. The rechallenge was not applicable as events happened after the first dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2021: Follow up received contains No new information.; Sender's Comments: This is a case concerning a female patient of unknown age, with unknown medical history, who experienced the unexpected events of Hypersomnia, Hyperhidrosis, Gait disturbance, and Dysstasia, and expected event of Dizziness. The events occurred unknown number of days after the first dose of mRNA-1273 vaccine. There is no available information regarding clinical course or treatment medication. The rechallenge was not applicable as events happened after the first dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Had COVID after primary series; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Had COVID after primary series) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had COVID after primary series). At the time of the report, COVID-19 (Had COVID after primary series) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. Company comment:This spontaneous case is concerning a patient of unknown age and gender with no medical history reported, who received mRNA-1273 vaccine on an unknown date, experienced the unexpected, AESI of COVID-19. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The outcome was reported unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.     Reporter did not allow further contact; Sender's Comments: This spontaneous case is concerning a patient of unknown age and gender with no medical history reported, who received mRNA-1273 vaccine on an unknown date, experienced the unexpected, AESI of COVID-19. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The outcome was reported unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 1st dose in Feb2021 and 2nd dose Mar2021and then was positive for COVID-19 in Sep2021; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (1st dose in Feb2021 and 2nd dose Mar2021and then was positive for COVID-19 in Sep2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced COVID-19 (1st dose in Feb2021 and 2nd dose Mar2021and then was positive for COVID-19 in Sep2021). At the time of the report, COVID-19 (1st dose in Feb2021 and 2nd dose Mar2021and then was positive for COVID-19 in Sep2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications reported by reporter No treatment medications provided by the reporter.   She had Regeneron antibodies when she had COVID. Company comment:This spontaneous case is concerning a female patient of unknown age with no medical history reported, who received mRNA-1273 vaccine on an unknown date, experienced the unexpected, AESI of COVID-199 (with SARS-CoV-2 test positive). The event occurred approximately 6 months after the second dose of mRNA-1273 vaccine. The outcome was reported unknown. Patient was reported to be fully vaccinated before the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case is concerning a female patient of unknown age with no medical history reported, who received mRNA-1273 vaccine on an unknown date, experienced the unexpected, AESI of COVID-199 (with SARS-CoV-2 test positive). The event occurred approximately 6 months after the second dose of mRNA-1273 vaccine. The outcome was reported unknown. Patient was reported to be fully vaccinated before the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive test for COVID-19 Disease; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Positive test for COVID-19 Disease) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive test for COVID-19 Disease). At the time of the report, COVID-19 (Positive test for COVID-19 Disease) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive test for COVID-19 disease..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided.  No treatment medication was provided. Company comment:This spontaneous case is concerning a patient of unknown age and gender with no medical history reported, who received mRNA-1273 vaccine on an unknown date, experienced the unexpected, AESI of COVID-19 (with SARS-CoV-2 test positive). The event occurred on unknown date after the unknown dose of mRNA-1273 vaccine. The outcome was reported unknown. Patient was reported to be fully vaccinated before the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.     Reporter did not allow further contact; Sender's Comments: This spontaneous case is concerning a patient of unknown age and gender with no medical history reported, who received mRNA-1273 vaccine on an unknown date, experienced the unexpected, AESI of COVID-19 (with SARS-CoV-2 test positive). The event occurred on unknown date after the unknown dose of mRNA-1273 vaccine. The outcome was reported unknown. Patient was reported to be fully vaccinated before the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Cough, Drug ineffective, Illness
Clinical narrative: cough; phlegm; don't have the energy as before; Lack of drug effect; sick/pretty sick; Tested positive for covid; Didn't feel well at all; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (cough), ILLNESS (sick/pretty sick), COVID-19 (Tested positive for covid), MALAISE (Didn't feel well at all) and PRODUCTIVE COUGH (phlegm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 1015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced ILLNESS (sick/pretty sick), COVID-19 (Tested positive for covid), MALAISE (Didn't feel well at all) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced COUGH (cough), PRODUCTIVE COUGH (phlegm) and ASTHENIA (don't have the energy as before). On 02-Sep-2021, DRUG INEFFECTIVE (Lack of drug effect) had resolved. At the time of the report, COUGH (cough) had not resolved and ILLNESS (sick/pretty sick), COVID-19 (Tested positive for covid), MALAISE (Didn't feel well at all), PRODUCTIVE COUGH (phlegm) and ASTHENIA (don't have the energy as before) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Her daughter took her to urgent care and they decided she needed the infusion to keep her out of the hospital. She still has a cough and is slowly getting her energy back.   On the 3-SEP  infusion treatment was given.  No concomitant product information was provided. No treatment information was provided. Company comment This case concerns an 84-year-old female patient, with no reported medical history, who experienced the unexpected non-serious event of COVID-19 (AESI). The events occurred approximately 6 months after the administration of the second dose of mRNA-1273 vaccine. Drug ineffective was considered as an additional event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 30-Dec-2021: Follow up received contains significant information new event added.; Sender's Comments: This case concerns an 84-year-old female patient, with no reported medical history, who experienced the unexpected non-serious event of COVID-19 (AESI). The events occurred approximately 6 months after the administration of the second dose of mRNA-1273 vaccine. Drug ineffective was considered as an additional event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Productive cough
Clinical narrative: cough; phlegm; don't have the energy as before; Lack of drug effect; sick/pretty sick; Tested positive for covid; Didn't feel well at all; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (cough), ILLNESS (sick/pretty sick), COVID-19 (Tested positive for covid), MALAISE (Didn't feel well at all) and PRODUCTIVE COUGH (phlegm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 1015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced ILLNESS (sick/pretty sick), COVID-19 (Tested positive for covid), MALAISE (Didn't feel well at all) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced COUGH (cough), PRODUCTIVE COUGH (phlegm) and ASTHENIA (don't have the energy as before). On 02-Sep-2021, DRUG INEFFECTIVE (Lack of drug effect) had resolved. At the time of the report, COUGH (cough) had not resolved and ILLNESS (sick/pretty sick), COVID-19 (Tested positive for covid), MALAISE (Didn't feel well at all), PRODUCTIVE COUGH (phlegm) and ASTHENIA (don't have the energy as before) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Her daughter took her to urgent care and they decided she needed the infusion to keep her out of the hospital. She still has a cough and is slowly getting her energy back.   On the 3-SEP  infusion treatment was given.  No concomitant product information was provided. No treatment information was provided. Company comment This case concerns an 84-year-old female patient, with no reported medical history, who experienced the unexpected non-serious event of COVID-19 (AESI). The events occurred approximately 6 months after the administration of the second dose of mRNA-1273 vaccine. Drug ineffective was considered as an additional event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 30-Dec-2021: Follow up received contains significant information new event added.; Sender's Comments: This case concerns an 84-year-old female patient, with no reported medical history, who experienced the unexpected non-serious event of COVID-19 (AESI). The events occurred approximately 6 months after the administration of the second dose of mRNA-1273 vaccine. Drug ineffective was considered as an additional event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain under arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain under arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2022 at 7:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain under arm). At the time of the report, PAIN IN EXTREMITY (Pain under arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient was currently having pain under arm was on the side of the vaccination received. Patient reported as she knows lymph nodes was there and was reported before. The caller had no other symptoms to report.  Concomitant medication information was not reported Treatment information was not reported
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: still have a rash on my shoulder; still have soreness on my shoulder; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (still have a rash on my shoulder) and VACCINATION SITE PAIN (still have soreness on my shoulder) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (still have a rash on my shoulder) and VACCINATION SITE PAIN (still have soreness on my shoulder). At the time of the report, VACCINATION SITE RASH (still have a rash on my shoulder) and VACCINATION SITE PAIN (still have soreness on my shoulder) had not 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.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin discolouration, Vaccination site mass, Vaccination site swelling
Clinical narrative: big bump on it.; Black and blue 3x9In that does not hurt.; Sore arm later in the afternoon; arm is very swollen, Swollen below the injection site; This spontaneous case was reported by a non-health professional and describes the occurrence of SKIN DISCOLOURATION, PAIN IN EXTREMITY, VACCINATION SITE SWELLING, and VACCINATION SITE in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE SWELLING. On 07-Jan-2022, the patient experienced PAIN IN EXTREMITY. On 09-Jan-2022, the patient experienced SKIN DISCOLOURATION. On an unknown date, the patient experienced VACCINATION SITE MASS. At the time of the report, SKIN DISCOLOURATION, PAIN IN EXTREMITY and VACCINATION SITE MASS outcome was unknown and VACCINATION SITE SWELLING had resolved with sequelae.            No concomitant medication was provided by the reporter.  Treatment medications which includes She used ice to alleviate the inflammation, after that she applied heath.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination site movement impairment
Clinical narrative: Missed dose; not being able to move his arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (not being able to move his arm) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (not being able to move his arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). In August 2021, VACCINATION SITE MOVEMENT IMPAIRMENT (not being able to move his arm) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Patient reported that he never got a chance to get second dose and it's been since 5 months he got the first one.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jan-2022: Non-significant follow up received. On 10-Jan-2022: Significant follow up received added new event missed dose from SD.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Erythema, Fatigue, Feeling abnormal, Illness
Clinical narrative: Arm Red; felt not like herself; Arm Swollen; stay in bed for day and a half; feel tired; sick for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm Red), FEELING ABNORMAL (felt not like herself), PERIPHERAL SWELLING (Arm Swollen), ILLNESS (sick for 2 days) and BEDRIDDEN (stay in bed for day and a half) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 046B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Arm Red), FEELING ABNORMAL (felt not like herself), PERIPHERAL SWELLING (Arm Swollen), ILLNESS (sick for 2 days), BEDRIDDEN (stay in bed for day and a half) and FATIGUE (feel tired). At the time of the report, ERYTHEMA (Arm Red), FEELING ABNORMAL (felt not like herself), PERIPHERAL SWELLING (Arm Swollen) and FATIGUE (feel tired) outcome was unknown and ILLNESS (sick for 2 days) and BEDRIDDEN (stay in bed for day and a half) had resolved.            Concomitant medications were not provided. Treatment information was not provided.  Symptoms onset date for all events was on JAN 2022 and stop date for Illness and bedridden on JAN 2022.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Arm Red; felt not like herself; Arm Swollen; stay in bed for day and a half; feel tired; sick for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm Red), FEELING ABNORMAL (felt not like herself), PERIPHERAL SWELLING (Arm Swollen), ILLNESS (sick for 2 days) and BEDRIDDEN (stay in bed for day and a half) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 046B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Arm Red), FEELING ABNORMAL (felt not like herself), PERIPHERAL SWELLING (Arm Swollen), ILLNESS (sick for 2 days), BEDRIDDEN (stay in bed for day and a half) and FATIGUE (feel tired). At the time of the report, ERYTHEMA (Arm Red), FEELING ABNORMAL (felt not like herself), PERIPHERAL SWELLING (Arm Swollen) and FATIGUE (feel tired) outcome was unknown and ILLNESS (sick for 2 days) and BEDRIDDEN (stay in bed for day and a half) had resolved.            Concomitant medications were not provided. Treatment information was not provided.  Symptoms onset date for all events was on JAN 2022 and stop date for Illness and bedridden on JAN 2022.