chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fall, Pain in extremity, Peripheral swelling, X-ray
Clinical narrative: The patient is a 76 y.o. female who presents to the Emergency Department with three days of left ankle pain and swelling status post mechanical GLF. Patient reports that she fell onto her left side three days ago. She is not anticoagulated and denies striking her head or any LOC. Since then she has had constant dull left ankle pain which is acutely worsened with ROM and weight bearing. Patient reports a history of fracture to this ankle. Patient notes that she is able to shuffle when wearing her compression stocking, but this elicits pain. She has pain radiating up her LLE, into her buttocks, and up her back "all the way to my neck." Patient has not taken any pain medications symptomatically. Patient reports feeling chills last night.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: fatigue, brain fog, lasting two weeks after second vaccine.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Wound
Clinical narrative: rash near small wound site
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue
Clinical narrative: Patient complained of funny feeling in her stomach and tired.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old patient made an appointment and came in with her father. The consent form form was completed and signed by patients' father. Patient received the vaccine before we caught the fact that the patient was 16 years old. Patient was observed for approx. 20 minutes with no ill effects.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Pain, redness and rash on upper arm of vaccination
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dysstasia, Impaired work ability, Nausea
Clinical narrative: Got the 1st Pfizer vaccine on 4/10. Started getting dizzy with vertigo and nausea 4/14. Have missed worked. Cannot stand up for more than a minute or two before the vertigo gets debilitating.  Have been in bed, dizzy, for 7 days straight.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Got the 1st Pfizer vaccine on 4/10. Started getting dizzy with vertigo and nausea 4/14. Have missed worked. Cannot stand up for more than a minute or two before the vertigo gets debilitating.  Have been in bed, dizzy, for 7 days straight.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Clumsiness, Fatigue, Pain in extremity
Clinical narrative: Extreme fatigue/exhaustion, sore arm, clumsy for the entire day following second vaccine.  Symptoms went away on the second day following the vaccine.  Several nurse friends suggested to report this side effect.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Dizziness, Fall, Headache
Clinical narrative: Woke up around 2AM the morning after the vaccine was administered and noticed pain in hands when washing hands. Woke up officially around 9AM. Entire body hurt, most notably headache, backache, and neckache. Pain was intense, took Ibuprofen and muscle relaxer. Stayed in bed in the dark for most of the day because of pain. When standing, dizziness and weakness, fell over once. The pain finally subsided enough to function close to 7PM, disappeared completely by the following morning.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: Woke up around 2AM the morning after the vaccine was administered and noticed pain in hands when washing hands. Woke up officially around 9AM. Entire body hurt, most notably headache, backache, and neckache. Pain was intense, took Ibuprofen and muscle relaxer. Stayed in bed in the dark for most of the day because of pain. When standing, dizziness and weakness, fell over once. The pain finally subsided enough to function close to 7PM, disappeared completely by the following morning.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Dyspnoea, Fatigue, Headache
Clinical narrative: Almost 2 days after vaccination. Headache Pain upon deep breathing Increased pain at injection site so that arm could not be lifted easily.  Pain mid-back in kidney area, bilateral.  Pain in upper chest.  Fatigue
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: Almost 2 days after vaccination. Headache Pain upon deep breathing Increased pain at injection site so that arm could not be lifted easily.  Pain mid-back in kidney area, bilateral.  Pain in upper chest.  Fatigue
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Menstruation irregular
Clinical narrative: 4 days after the shot I got my periods. It lasted 4 days. That's not normal for me. It was a full, regular periods, not spotting. I haven't had my periods in a long time, as I am menauposed. My OBG doctor wants to perform a endometrial biopsy on April 26.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Discomfort, Neuralgia, Pain, Sleep deficit
Clinical narrative: body ache, tremors, never pain,  sleep deprivation, cold sweats, and general discomfort
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: body ache, tremors, never pain,  sleep deprivation, cold sweats, and general discomfort
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Feeling abnormal, Injection site pain, Injection site reaction
Clinical narrative: as soon as injection was made, it felt like liquid shooting up my neck.  I had the usual arm pain, fatigue, fever, lasting about 24 hours. For next 11 days I was sick to stomach with very mild fever that would come and go, but nothing unbearable. On about day 13 after vaccination, I had a sharp, pulsating pain in the injection site. pulsated for about 5 min, then stopped.  Over the next week, at random times, I feel pain in the injection site, not my whole arm, and feverish off and on. I have the stomach discomfort off and on as well.  I have had many injections in my life and have never felt liquid run up my neck.  Did it go into a vein?  Is the vaccination as effective?  Why am I continuing to have pain?
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: as soon as injection was made, it felt like liquid shooting up my neck.  I had the usual arm pain, fatigue, fever, lasting about 24 hours. For next 11 days I was sick to stomach with very mild fever that would come and go, but nothing unbearable. On about day 13 after vaccination, I had a sharp, pulsating pain in the injection site. pulsated for about 5 min, then stopped.  Over the next week, at random times, I feel pain in the injection site, not my whole arm, and feverish off and on. I have the stomach discomfort off and on as well.  I have had many injections in my life and have never felt liquid run up my neck.  Did it go into a vein?  Is the vaccination as effective?  Why am I continuing to have pain?
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass
Clinical narrative: Large lump developed at injection site
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 year old minor received Pfizer vaccine
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Epigastric discomfort, Laryngospasm, Livedo reticularis, Night sweats
Clinical narrative: Laryngiospasm severe Mottled skin 3 days later most severe abdominal pain epigastric Night sweats. Pain or days then distended sore abdomen.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Myalgia
Clinical narrative: Fever, chills, muscle/head/body aches, difficulty breathing, fatigue lasted for 3 1/2 to 4 days.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever, chills, muscle/head/body aches, difficulty breathing, fatigue lasted for 3 1/2 to 4 days.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Conduction disorder, Heart rate, Heart rate irregular, Myocarditis
Clinical narrative: heart conduction abnormality; inflammation in heart; heart beats at a lower rate after exercising/ there are periods where her heart rate is over 100 bpm/heart is not relaxing/ causing both parts of the heart to beat at the same time; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONDUCTION DISORDER (heart conduction abnormality), MYOCARDITIS (inflammation in heart) and HEART RATE IRREGULAR (heart beats at a lower rate after exercising/ there are periods where her heart rate is over 100 bpm/heart is not relaxing/ causing both parts of the heart to beat at the same time) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history 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 CONDUCTION DISORDER (heart conduction abnormality) (seriousness criterion medically significant), MYOCARDITIS (inflammation in heart) (seriousness criterion medically significant) and HEART RATE IRREGULAR (heart beats at a lower rate after exercising/ there are periods where her heart rate is over 100 bpm/heart is not relaxing/ causing both parts of the heart to beat at the same time) (seriousness criterion medically significant). At the time of the report, CONDUCTION DISORDER (heart conduction abnormality), MYOCARDITIS (inflammation in heart) and HEART RATE IRREGULAR (heart beats at a lower rate after exercising/ there are periods where her heart rate is over 100 bpm/heart is not relaxing/ causing both parts of the heart to beat at the same time) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 100 (abnormal) 100 bpm.         Concomitant products included hormone replacement therapy and OTC medication for an unknown indication. Treatment included 800 mg of Ibuprofen twice a day for reduction of inflammation.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Swelling face
Clinical narrative: Swelling on her forehead; Bruising on her forehead; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Swelling on her forehead) and CONTUSION (Bruising on her forehead) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history 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, the patient experienced SWELLING FACE (Swelling on her forehead) (seriousness criterion medically significant) and CONTUSION (Bruising on her forehead) (seriousness criterion medically significant). At the time of the report, SWELLING FACE (Swelling on her forehead) and CONTUSION (Bruising on her forehead) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided. Treatment information was not available.  Very limited information regarding these event/s have been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-066254 (Patient Link).; Sender's Comments: Very limited information regarding these event/s have been provided at this time.  Further information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Sudden hearing loss, Tinnitus
Clinical narrative: teeny weeny buzzing sound in right ear , different sound in ear; woke up during a night, and could not hear/could not hear for a week; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SUDDEN HEARING LOSS (woke up during a night, and could not hear/could not hear for a week) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 19B21A and 30A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history not provided).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced TINNITUS (teeny weeny buzzing sound in right ear , different sound in ear). In March 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SUDDEN HEARING LOSS (woke up during a night, and could not hear/could not hear for a week) (seriousness criterion medically significant). In March 2021, SUDDEN HEARING LOSS (woke up during a night, and could not hear/could not hear for a week) had resolved. At the time of the report, TINNITUS (teeny weeny buzzing sound in right ear , different sound in ear) outcome was unknown.            Concomitant product use was not provided.  Treatment included a visit to the patient's Primary Care Physician (PCP) who checked her ear and said her ear looks good, there was no wax. An appointment was scheduled for an Ear Specialist Doctor. The patient stated there are still different sounds in her right ear. Over a period of time it is getting better but still not there.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Gait disturbance, Immune system disorder, Nausea, Pruritus
Clinical narrative: systematic immune shock; red bump on chest, legs, arms, looks like chicken pox; hard for him to walk; Itchy; not hungry; nauseous; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of IMMUNE SYSTEM DISORDER (systematic immune shock) and RASH ERYTHEMATOUS (red bump on chest, legs, arms, looks like chicken pox) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).  Concomitant products included INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (HUMULIN 70/30), CHLORTHALIDONE, POTASSIUM CHLORIDE, AMLODIPINE, CLOPIDOGREL, ATORVASTATIN and LOSARTAN for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 08-APR-2021, the patient's wife reported that on an unknown date after the first dose of  mRNA-1273, the patient experienced systematic immune shock, red bump on his chest, legs, arms, and which looked like chicken pox. The patient experienced nauseas, was itchy, not hungry, and hard to walk. The patient was taken to urgent care where he was prescribed antibiotics and advised to take go to hospital. The patient made an appointment with primary care physician where patient was seen. The patient was prescribed a cream and Zyrtec.  The patient experienced IMMUNE SYSTEM DISORDER (systematic immune shock) (seriousness criterion medically significant), RASH ERYTHEMATOUS (red bump on chest, legs, arms, looks like chicken pox) (seriousness criterion medically significant), GAIT DISTURBANCE (hard for him to walk), PRURITUS (Itchy), DECREASED APPETITE (not hungry) and NAUSEA (nauseous). At the time of the report, IMMUNE SYSTEM DISORDER (systematic immune shock), RASH ERYTHEMATOUS (red bump on chest, legs, arms, looks like chicken pox), GAIT DISTURBANCE (hard for him to walk), PRURITUS (Itchy), DECREASED APPETITE (not hungry) and NAUSEA (nauseous) outcome was unknown. Not Provided     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded. Nausea is consistent to the known safety profile of mRNA-1273.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: systematic immune shock; red bump on chest, legs, arms, looks like chicken pox; hard for him to walk; Itchy; not hungry; nauseous; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of IMMUNE SYSTEM DISORDER (systematic immune shock) and RASH ERYTHEMATOUS (red bump on chest, legs, arms, looks like chicken pox) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).  Concomitant products included INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (HUMULIN 70/30), CHLORTHALIDONE, POTASSIUM CHLORIDE, AMLODIPINE, CLOPIDOGREL, ATORVASTATIN and LOSARTAN for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 08-APR-2021, the patient's wife reported that on an unknown date after the first dose of  mRNA-1273, the patient experienced systematic immune shock, red bump on his chest, legs, arms, and which looked like chicken pox. The patient experienced nauseas, was itchy, not hungry, and hard to walk. The patient was taken to urgent care where he was prescribed antibiotics and advised to take go to hospital. The patient made an appointment with primary care physician where patient was seen. The patient was prescribed a cream and Zyrtec.  The patient experienced IMMUNE SYSTEM DISORDER (systematic immune shock) (seriousness criterion medically significant), RASH ERYTHEMATOUS (red bump on chest, legs, arms, looks like chicken pox) (seriousness criterion medically significant), GAIT DISTURBANCE (hard for him to walk), PRURITUS (Itchy), DECREASED APPETITE (not hungry) and NAUSEA (nauseous). At the time of the report, IMMUNE SYSTEM DISORDER (systematic immune shock), RASH ERYTHEMATOUS (red bump on chest, legs, arms, looks like chicken pox), GAIT DISTURBANCE (hard for him to walk), PRURITUS (Itchy), DECREASED APPETITE (not hungry) and NAUSEA (nauseous) outcome was unknown. Not Provided     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded. Nausea is consistent to the known safety profile of mRNA-1273.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness unilateral, Tinnitus
Clinical narrative: could not hear with my left ear at all; hearing lots of noise in left ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (could not hear with my left ear at all) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced DEAFNESS UNILATERAL (could not hear with my left ear at all) (seriousness criterion medically significant) and TINNITUS (hearing lots of noise in left ear). On 04-Apr-2021, DEAFNESS UNILATERAL (could not hear with my left ear at all) was resolving and TINNITUS (hearing lots of noise in left ear) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Acoustic stimulation tests: abnormal (abnormal) she has 90% of hearing lost.         According to the patient, 3 hours after receiving vaccine, she started hearing lots of noise in her left ear. She plugged her right ear and found that she could not hear with left hear at all. She went to emergency room where she was given a low dose steroid. She was prescribed a high dose steroid.  No relevant concomitant medications were reported.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Blepharospasm, Transient ischaemic attack, Vertigo
Clinical narrative: Mini-stroke transient ischemic attack; Room spinning; Winking eyelids involuntarily; Felt like he was falling to his right side; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Mini-stroke transient ischemic attack), VERTIGO (Room spinning) and BLEPHAROSPASM (Winking eyelids involuntarily) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery. Concomitant products included POTASSIUM, FUROSEMIDE (LASIX [FUROSEMIDE]), WARFARIN, METOPROLOL SUCCINATE (TOPROL XL), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Mini-stroke transient ischemic attack) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required), VERTIGO (Room spinning) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required) and BLEPHAROSPASM (Winking eyelids involuntarily) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required). The patient was hospitalized from 19-Mar-2021 to 21-Mar-2021 due to TRANSIENT ISCHAEMIC ATTACK. On 21-Mar-2021, TRANSIENT ISCHAEMIC ATTACK (Mini-stroke transient ischemic attack), VERTIGO (Room spinning) and BLEPHAROSPASM (Winking eyelids involuntarily) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received vaccine in right non-dominate deltoid muscle to prevent COVID-19. Patient was admitted to hospital from 19Mar2021 to 21Mar2021 for a magnetic resonance imaging (MRI) and computerized tomography (CT) scan, with observation and Low-Dose Aspirin. Patient was feeling much better and his cardiologist recommended that he receives his second Moderna vaccine as soon as required and to take an extra Vitamin D supplement as a precaution. Scheduled second dose was due on 08Apr2021. Treatment included was low dose aspirin.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Contusion, Vaccination site erythema, Vaccination site pain
Clinical narrative: it was an infection, it was celulitis; felt bruised; it was red; it was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (it was an infection, it was celulitis) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced CONTUSION (felt bruised), VACCINATION SITE ERYTHEMA (it was red) and VACCINATION SITE PAIN (it was sore). On 02-Apr-2021, the patient experienced CELLULITIS (it was an infection, it was celulitis) (seriousness criterion medically significant). On 25-Mar-2021, CONTUSION (felt bruised), VACCINATION SITE ERYTHEMA (it was red) and VACCINATION SITE PAIN (it was sore) had resolved. At the time of the report, CELLULITIS (it was an infection, it was celulitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Description: The patient in the first couple of days felt bruised, like a normal shot, it was sore and red. Then it was red and had a red area, probably it happened during the first week and second week it got worse, got swollen, it was hot. On 02 Apr 2021, the patient  went to the urgent care and they said it was an infection, it was cellulitis (medically significant) and she stayed there for a couple of hours.  The patient was treated with two intravenous (IVs): antibiotic (piperacillin/tazobactam) intravenous and a steroid (dexamethasone) intravenous. They gave her three pills to take: clindamycin, methylprednisolone pack and ibuprofen, both oral (did not take the latter).   Subsuming events swelling, skin warm and erythema under cellulitis.  Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Epistaxis, Fear, Immune thrombocytopenia
Clinical narrative: Immune thrombocytopenic purpura; petechia/ blood spots in his legs went from his feet up to his mid thigh; nose bleeding, heavy bleeding, more than 20 minutes to make it stop; blood pressure fluctuation; Fear; pain; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenic purpura), PETECHIAE (petechia/ blood spots in his legs went from his feet up to his mid thigh) and EPISTAXIS (nose bleeding, heavy bleeding, more than 20 minutes to make it stop) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0181321H) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bleeding nose (No reported medical history).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced EPISTAXIS (nose bleeding, heavy bleeding, more than 20 minutes to make it stop) (seriousness criterion hospitalization). On 04-Apr-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenic purpura) (seriousness criterion hospitalization) and PETECHIAE (petechia/ blood spots in his legs went from his feet up to his mid thigh) (seriousness criterion hospitalization). On an unknown date, the patient experienced FEAR (Fear), PAIN (pain) and BLOOD PRESSURE FLUCTUATION (blood pressure fluctuation). The patient was hospitalized on 08-Apr-2021 due to IMMUNE THROMBOCYTOPENIA and PETECHIAE. On 09-Apr-2021, EPISTAXIS (nose bleeding, heavy bleeding, more than 20 minutes to make it stop) had resolved. At the time of the report, IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenic purpura), PETECHIAE (petechia/ blood spots in his legs went from his feet up to his mid thigh), FEAR (Fear), PAIN (pain) and BLOOD PRESSURE FLUCTUATION (blood pressure fluctuation) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Platelet count: 130 (Inconclusive) raised to 130. On an unknown date, Blood pressure measurement: 150/90 (High) high and 90/50 (Low) low. On an unknown date, Platelet count: 0-2 (Low) down to  0-2 and 50 (Inconclusive) raised to 50.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       His treatment were steroids and ivIG. In the hospital, they told him that given the treatment they had to apply he no longer has a functioning immune system and that he will have to seek for constant medical care, all that will interfere with his life and work plans.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Petechiae, Platelet count
Clinical narrative: Immune thrombocytopenic purpura; petechia/ blood spots in his legs went from his feet up to his mid thigh; nose bleeding, heavy bleeding, more than 20 minutes to make it stop; blood pressure fluctuation; Fear; pain; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenic purpura), PETECHIAE (petechia/ blood spots in his legs went from his feet up to his mid thigh) and EPISTAXIS (nose bleeding, heavy bleeding, more than 20 minutes to make it stop) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0181321H) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bleeding nose (No reported medical history).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced EPISTAXIS (nose bleeding, heavy bleeding, more than 20 minutes to make it stop) (seriousness criterion hospitalization). On 04-Apr-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenic purpura) (seriousness criterion hospitalization) and PETECHIAE (petechia/ blood spots in his legs went from his feet up to his mid thigh) (seriousness criterion hospitalization). On an unknown date, the patient experienced FEAR (Fear), PAIN (pain) and BLOOD PRESSURE FLUCTUATION (blood pressure fluctuation). The patient was hospitalized on 08-Apr-2021 due to IMMUNE THROMBOCYTOPENIA and PETECHIAE. On 09-Apr-2021, EPISTAXIS (nose bleeding, heavy bleeding, more than 20 minutes to make it stop) had resolved. At the time of the report, IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenic purpura), PETECHIAE (petechia/ blood spots in his legs went from his feet up to his mid thigh), FEAR (Fear), PAIN (pain) and BLOOD PRESSURE FLUCTUATION (blood pressure fluctuation) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Platelet count: 130 (Inconclusive) raised to 130. On an unknown date, Blood pressure measurement: 150/90 (High) high and 90/50 (Low) low. On an unknown date, Platelet count: 0-2 (Low) down to  0-2 and 50 (Inconclusive) raised to 50.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       His treatment were steroids and ivIG. In the hospital, they told him that given the treatment they had to apply he no longer has a functioning immune system and that he will have to seek for constant medical care, all that will interfere with his life and work plans.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Helicobacter gastritis, Nausea, Pyrexia
Clinical narrative: H. Pylori; chills; nausea; headache.; fever; This spontaneous case was reported by a consumer and describes the occurrence of HELICOBACTER GASTRITIS (H. Pylori) in a 65-year-old female patient who received mRNA-1273 for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Helicobacter pylori infection.    On 11-Apr-2021, the patient received second dose of mRNA-1273 (Intramuscular) 2 dosage form. On 11-Apr-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced HELICOBACTER GASTRITIS (H. Pylori) (seriousness criterion medically significant), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache.). At the time of the report, HELICOBACTER GASTRITIS (H. Pylori), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache.) outcome was unknown.            Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Mental disorder, Paraesthesia oral, Suicidal ideation
Clinical narrative: Suicidal idealization; felt bad; tongue swollen; Mental health issues; bad tingling in mouth; Face is red; mind is spinning; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SUICIDAL IDEATION (Suicidal idealization) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Generalized anxiety disorder and Gastric bypass in June 2020. Concomitant products included DIAZEPAM, DULOXETINE HYDROCHLORIDE (CYMBALTA) and ALPRAZOLAM (XANAX) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced SUICIDAL IDEATION (Suicidal idealization) (seriousness criterion medically significant), FEELING ABNORMAL (felt bad), SWOLLEN TONGUE (tongue swollen), MENTAL DISORDER (Mental health issues), PARAESTHESIA ORAL (bad tingling in mouth), ERYTHEMA (Face is red) and VERTIGO (mind is spinning). At the time of the report, SUICIDAL IDEATION (Suicidal idealization), FEELING ABNORMAL (felt bad), SWOLLEN TONGUE (tongue swollen), MENTAL DISORDER (Mental health issues), PARAESTHESIA ORAL (bad tingling in mouth), ERYTHEMA (Face is red) and VERTIGO (mind is spinning) had not resolved.            Treatment included benadryl.  Patient mentioned he went to urgent care, his covid test was negative, psych evaluation recommended help for side effects only.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-073680 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Swollen tongue, Vertigo
Clinical narrative: Suicidal idealization; felt bad; tongue swollen; Mental health issues; bad tingling in mouth; Face is red; mind is spinning; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SUICIDAL IDEATION (Suicidal idealization) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Generalized anxiety disorder and Gastric bypass in June 2020. Concomitant products included DIAZEPAM, DULOXETINE HYDROCHLORIDE (CYMBALTA) and ALPRAZOLAM (XANAX) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced SUICIDAL IDEATION (Suicidal idealization) (seriousness criterion medically significant), FEELING ABNORMAL (felt bad), SWOLLEN TONGUE (tongue swollen), MENTAL DISORDER (Mental health issues), PARAESTHESIA ORAL (bad tingling in mouth), ERYTHEMA (Face is red) and VERTIGO (mind is spinning). At the time of the report, SUICIDAL IDEATION (Suicidal idealization), FEELING ABNORMAL (felt bad), SWOLLEN TONGUE (tongue swollen), MENTAL DISORDER (Mental health issues), PARAESTHESIA ORAL (bad tingling in mouth), ERYTHEMA (Face is red) and VERTIGO (mind is spinning) had not resolved.            Treatment included benadryl.  Patient mentioned he went to urgent care, his covid test was negative, psych evaluation recommended help for side effects only.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-073680 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pneumonia
Clinical narrative: Pneumonia; Cough; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant) and COUGH (Cough). The patient was hospitalized from 06-Apr-2021 to 09-Apr-2021 due to PNEUMONIA. At the time of the report, PNEUMONIA (Pneumonia) had resolved and COUGH (Cough) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She was hospitalized on 6Apr 2021 for pneumonia and discharged on 9Apr2021. She has cough at present and she is on antibiotics.  Company comment:Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded, although the presentation of the pneumonia more than 2 weeks after receiving first dose of mRNA-1273 (Moderna COVID-19 Vaccine) suggests an alternative cause is possible.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded, although the presentation of the pneumonia more than 2 weeks after receiving first dose of mRNA-1273 (Moderna COVID-19 Vaccine) suggests an alternative cause is possible.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Muscle contractions involuntary, Pyrexia, Seizure, Urinary incontinence
Clinical narrative: Loss of control of bladder; Patient got her second dose after 35 days of first dose; fever; Convulsions; terrible contractions of muscles; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of SEIZURE (Convulsions) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced SEIZURE (Convulsions) (seriousness criterion medically significant), MUSCLE CONTRACTIONS INVOLUNTARY (terrible contractions of muscles), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got her second dose after 35 days of first dose) and PYREXIA (fever). On 09-Apr-2021, the patient experienced URINARY INCONTINENCE (Loss of control of bladder). On 08-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got her second dose after 35 days of first dose) had resolved. At the time of the report, SEIZURE (Convulsions), MUSCLE CONTRACTIONS INVOLUNTARY (terrible contractions of muscles), URINARY INCONTINENCE (Loss of control of bladder) and PYREXIA (fever) had resolved.            No relevant concomitant medications were provided. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Delirium, Disturbance in attention, Dizziness, Headache, Miosis
Clinical narrative: delerious; Fever; Rash; horrible body aches; Skin on fire; severe headache; pounding a rod into brain; dizzy; lack of concentration; eyes not dilating; ringing in ears; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (delerious) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced DELIRIUM (delerious) (seriousness criterion medically significant), PYREXIA (Fever), VACCINATION SITE RASH (Rash), PAIN (horrible body aches), SKIN BURNING SENSATION (Skin on fire), HEADACHE (severe headache), HEADACHE (pounding a rod into brain), DIZZINESS (dizzy), DISTURBANCE IN ATTENTION (lack of concentration), MIOSIS (eyes not dilating) and TINNITUS (ringing in ears). At the time of the report, DELIRIUM (delerious), PYREXIA (Fever), VACCINATION SITE RASH (Rash), PAIN (horrible body aches), SKIN BURNING SENSATION (Skin on fire), HEADACHE (severe headache), HEADACHE (pounding a rod into brain), DIZZINESS (dizzy), DISTURBANCE IN ATTENTION (lack of concentration) and MIOSIS (eyes not dilating) outcome was unknown and TINNITUS (ringing in ears) had not resolved.            This case concerns a 62-year-old female with a serious unexpected event of delirium, and nonserious unexpected dizziness, pain, skin burning sensation, disturbance in attention, miosis, tinnitus, and expected fever, headache, vaccination site rash. Event onset 2 days after second dose mRNA-1273. Event outcomes ongoing or unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 62-year-old female with a serious unexpected event of delirium, and nonserious unexpected dizziness, pain, skin burning sensation, disturbance in attention, miosis, tinnitus, and expected fever, headache, vaccination site rash. Event onset 2 days after second dose mRNA-1273. Event outcomes ongoing or unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.