chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Illness, Loss of consciousness, Nausea
Clinical narrative: Arm kept getting more red and more swollen so she was told to go to the emergency clinic; Arm started turning red and swelling; Very sick; Bad  headache; Nausea; Fever; Passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out), ERYTHEMA (Arm kept getting more red and more swollen so she was told to go to the emergency clinic) and PERIPHERAL SWELLING (Arm started turning red and swelling) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chemotherapy.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), ERYTHEMA (Arm kept getting more red and more swollen so she was told to go to the emergency clinic) (seriousness criterion hospitalization), PERIPHERAL SWELLING (Arm started turning red and swelling) (seriousness criterion hospitalization), ILLNESS (Very sick), HEADACHE (Bad  headache), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), ERYTHEMA (Arm kept getting more red and more swollen so she was told to go to the emergency clinic), PERIPHERAL SWELLING (Arm started turning red and swelling), ILLNESS (Very sick), HEADACHE (Bad  headache), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included chemotherapy.  Treatment for the event included ice, cortisone, 4x iv antibiotics and oral antibiotics.  Based on the current available information and temporal association between the use of the product and the start date of the event,s a causal relationship cannot be excluded.   This case was linked to MODERNATX, INC.-MOD-2021-062175, MODERNATX, INC.-MOD-2021-062175 (E2B Linked Report).; 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,s a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-062175:Crosslinked case  MODERNATX, INC.-MOD-2021-062175:Crosslinked case
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, SARS-CoV-2 test
Clinical narrative: Arm kept getting more red and more swollen so she was told to go to the emergency clinic; Arm started turning red and swelling; Very sick; Bad  headache; Nausea; Fever; Passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out), ERYTHEMA (Arm kept getting more red and more swollen so she was told to go to the emergency clinic) and PERIPHERAL SWELLING (Arm started turning red and swelling) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chemotherapy.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), ERYTHEMA (Arm kept getting more red and more swollen so she was told to go to the emergency clinic) (seriousness criterion hospitalization), PERIPHERAL SWELLING (Arm started turning red and swelling) (seriousness criterion hospitalization), ILLNESS (Very sick), HEADACHE (Bad  headache), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), ERYTHEMA (Arm kept getting more red and more swollen so she was told to go to the emergency clinic), PERIPHERAL SWELLING (Arm started turning red and swelling), ILLNESS (Very sick), HEADACHE (Bad  headache), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included chemotherapy.  Treatment for the event included ice, cortisone, 4x iv antibiotics and oral antibiotics.  Based on the current available information and temporal association between the use of the product and the start date of the event,s a causal relationship cannot be excluded.   This case was linked to MODERNATX, INC.-MOD-2021-062175, MODERNATX, INC.-MOD-2021-062175 (E2B Linked Report).; 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,s a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-062175:Crosslinked case  MODERNATX, INC.-MOD-2021-062175:Crosslinked case
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood test, Electrocardiogram normal
Clinical narrative: Elevated blood pressure 15 minutes after vacine administered. 168/113 HR 75. Checked into Emergency Room for observation. Blood work results for target vitals normal EKG normal. Blood pressure normalized after 4 hours.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest pain, Chills, Fatigue
Clinical narrative: body ache and pain (chest, back and arms); joint  and hip ache; back and side of neck ache; nausea a;  chills; lethargy and tiredness; mild forehead fever.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nausea, Neck pain, Pain, Pain in extremity
Clinical narrative: body ache and pain (chest, back and arms); joint  and hip ache; back and side of neck ache; nausea a;  chills; lethargy and tiredness; mild forehead fever.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: body ache and pain (chest, back and arms); joint  and hip ache; back and side of neck ache; nausea a;  chills; lethargy and tiredness; mild forehead fever.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever and chills
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild
Sex: U
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: Losing their hearing after getting the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Losing their hearing after getting the vaccine) in a  patient of an unknown age and gender 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 was reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (Losing their hearing after getting the vaccine) (seriousness criterion medically significant). At the time of the report, DEAFNESS (Losing their hearing after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Very limited information regarding this event has been provided at this time.  Further information has been requested.   This case was linked to MOD21-065420, US-MODERNATX, INC.-MOD-2021-062192 (E2B Linked Report).; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested. MOD21-065420: US-MODERNATX, INC.-MOD-2021-062192:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Chills, headache, body aches;  Hard, warm, red, itchy circular rash at injection site
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Pain
Clinical narrative: Chills, headache, body aches;  Hard, warm, red, itchy circular rash at injection site
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Electrocardiogram, Feeling abnormal, Loss of consciousness, Paraesthesia oral
Clinical narrative: passed out.  felt funny before passing out.  tongue felt weird prior to  passing out
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Joint stiffness, Myalgia
Clinical narrative: Fever, muscle pain, joint stiffness, joint pain, headache, nausea, light headedness, tingling in my hands and legs.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, Pyrexia
Clinical narrative: Fever, muscle pain, joint stiffness, joint pain, headache, nausea, light headedness, tingling in my hands and legs.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling hot, Headache, Nausea
Clinical narrative: Fever (99.4), chills, aches, nausea, headache, low energy, sore arm starting 9 hours after 2nd dose. A little better 48 hours later, still have bad headache, low energy, feel hot but fever is gone. Haven't needed to go to doctor
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever (99.4), chills, aches, nausea, headache, low energy, sore arm starting 9 hours after 2nd dose. A little better 48 hours later, still have bad headache, low energy, feel hot but fever is gone. Haven't needed to go to doctor
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Cerebrovascular accident
Clinical narrative: Minor brain attack; Partial loss of speech; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (Minor brain attack) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Minor brain attack) (seriousness criterion hospitalization) and APHASIA (Partial loss of speech). The patient was hospitalized for 3 days due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Minor brain attack) and APHASIA (Partial loss of speech) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included unspecified diabetes and blood pressure medications. Treatment medications included unspecified blood pressure and blood thinner medications.  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. However, the patient's age and comorbidities may be confounding factors for causality assessment.; 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. However, the patient's age and comorbidities may be confounding factors for causality assessment.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Hypoaesthesia, Rash, Rash erythematous
Clinical narrative: numbness on forehead, progressed to painful red pustules on forehead and scalp - Shingles
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Feeling cold, Headache, Influenza like illness
Clinical narrative: FYI, Approx. 1:00 AM woke up with high fever and could hardly move. Whole body hurt very bad. Shaking from chills . Bad headache. Very thirsty. Definitely flu like symptoms, but worse. Turned electric blanket on, very cold, and just tried to sleep. Only getting out of bed to use restroom and more water. Straight back to bed. I did not vomit, nor did I have diarrhea.  Could not stand it any longer Saturday PM approx. 10:00 took two Advil. Woke up Sunday 8:00 AM felt much better. Still had slight symptoms, but I could do chores. My brother kept checking on me. Came to let my dog out. My brother wanted me to call 911 but I can not afford that.  It was holiday weekend,  I wanted to die, didn?t care.  I get the flu shot every year. I have a high pain tolerance, very rare for me to be sick.  If I needed a second dose. I would NOT get it. If I would have known it was that bad, I would not have signed up to get it. Thank you.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Movement disorder, Pain, Pyrexia, Thirst
Clinical narrative: FYI, Approx. 1:00 AM woke up with high fever and could hardly move. Whole body hurt very bad. Shaking from chills . Bad headache. Very thirsty. Definitely flu like symptoms, but worse. Turned electric blanket on, very cold, and just tried to sleep. Only getting out of bed to use restroom and more water. Straight back to bed. I did not vomit, nor did I have diarrhea.  Could not stand it any longer Saturday PM approx. 10:00 took two Advil. Woke up Sunday 8:00 AM felt much better. Still had slight symptoms, but I could do chores. My brother kept checking on me. Came to let my dog out. My brother wanted me to call 911 but I can not afford that.  It was holiday weekend,  I wanted to die, didn?t care.  I get the flu shot every year. I have a high pain tolerance, very rare for me to be sick.  If I needed a second dose. I would NOT get it. If I would have known it was that bad, I would not have signed up to get it. Thank you.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: FYI, Approx. 1:00 AM woke up with high fever and could hardly move. Whole body hurt very bad. Shaking from chills . Bad headache. Very thirsty. Definitely flu like symptoms, but worse. Turned electric blanket on, very cold, and just tried to sleep. Only getting out of bed to use restroom and more water. Straight back to bed. I did not vomit, nor did I have diarrhea.  Could not stand it any longer Saturday PM approx. 10:00 took two Advil. Woke up Sunday 8:00 AM felt much better. Still had slight symptoms, but I could do chores. My brother kept checking on me. Came to let my dog out. My brother wanted me to call 911 but I can not afford that.  It was holiday weekend,  I wanted to die, didn?t care.  I get the flu shot every year. I have a high pain tolerance, very rare for me to be sick.  If I needed a second dose. I would NOT get it. If I would have known it was that bad, I would not have signed up to get it. Thank you.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis
Clinical narrative: Diagnosed with diverticulitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIVERTICULITIS (Diagnosed with diverticulitis) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced DIVERTICULITIS (Diagnosed with diverticulitis) (seriousness criterion medically significant). At the time of the report, DIVERTICULITIS (Diagnosed with diverticulitis) 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.  Treatment for the events, included paracetamol, metronidazole and levofloxacin
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pruritus, Throat tightness
Clinical narrative: throat tightness, itching dyspnea onset 12 min after injection 0.3 mg EpiPen 25 mg DPH IM
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: In the last 24 hours and still continuing: Muscle aches Fatigue
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Palpitations
Clinical narrative: Joint pain, shoulder pain, racing heart
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: was in menopause.  last period Jan 2019.  period started again on 4/6/2021
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: was in menopause.  last period Jan 2019.  period started again on 4/6/2021
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: left arm and leg where numb and patient states unable to move finger-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Feeling cold, Headache, Tremor
Clinical narrative: Janssen COVID-19 Vaccine EUA.  Headache started 30 minutes after receiving shot and lasted 28 hours.  Brain fog started 1 hour after receiving shot and lasted about 5 hours.  Chills and shakes started 6 hours (6:30 pm) after receiving shot and lasted through the evening until about 1 am, then were gone.  Temperature at 7:30 pm, 7 hours after receiving shot, was 99.7.  Temperature at 7:50 pm was 101.  Temperature at 8:30 pm was 101.3.  Took 2 IBUPROFEN at 8 pm.  Still had fever 99.9 at 7 am on 4/9/21.  Took 2 IBUPROFEN at 7 am.  Fever dissipated over the next few hours.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Fatigue, Helicobacter test positive, Immune thrombocytopenia, Platelet count decreased
Clinical narrative: Patient presented to hospital 4/6/21 with rectal bleeding and subacute dysnpea on exertion/fatigue over the preceding several weeks and was found to have immune thrombocytopenic purpura (ITP) w/ platelet count of 1000.  Anticoagulation was reversed (on warfarin at home for history of PE). Platelet count  responded to steroids and TPO-agonists per typical ITP treatment. Incidentally, the patient was found to have H. pylori stool antigen + and commenced with quadruple therapy for this. Platelet counts continue to improve slowly w/ treatment.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Rectal haemorrhage
Clinical narrative: Patient presented to hospital 4/6/21 with rectal bleeding and subacute dysnpea on exertion/fatigue over the preceding several weeks and was found to have immune thrombocytopenic purpura (ITP) w/ platelet count of 1000.  Anticoagulation was reversed (on warfarin at home for history of PE). Platelet count  responded to steroids and TPO-agonists per typical ITP treatment. Incidentally, the patient was found to have H. pylori stool antigen + and commenced with quadruple therapy for this. Platelet counts continue to improve slowly w/ treatment.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain in extremity
Clinical narrative: The day after my arm was just very sore, now it?s two days after and I have nausea, fatigue, and the chills.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Amnesia, Dissociation, Hallucination, Headache
Clinical narrative: Night one- mild headache. Next morning- uncontrollable dreams which resulted in waking with hallucinations, amnesia, and mild dissociation.  Sweaty, fever, jaw locking.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pyrexia, Trismus
Clinical narrative: Night one- mild headache. Next morning- uncontrollable dreams which resulted in waking with hallucinations, amnesia, and mild dissociation.  Sweaty, fever, jaw locking.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Sleep disorder
Clinical narrative: Severe body aches, severe chills and headaches. Unable to sleep due to pain. Lasted all night and all the following day. 3rd day less severe
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: ERYTHEMA-Mild
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Incontinence, Nail discolouration, Peripheral coldness, Pyrexia
Clinical narrative: Around 4:30 pm April 6 I became very cold and my fingertips went numb and fingernails turned purple-ish. This lasted for 2 hours until I could soak in a warm bath  April 6 5:00pm- April 7 8:00 pm Slight loss of urinary control; leaking urine on the way to use toilet and very frequent trips to toilet  April 7. 12:30 am 103.8 fever. Reduced when I took 2 extra strength Tylenol
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Vaginal haemorrhage
Clinical narrative: Vaginal bleeding and cramping similar to menstruation the same night as second dose was administered. Last menstrual cycle was on 11/06/2020. No period since then (due to birth control). On 03/27/2021 I started bleeding and thought how weird after all this time of not having it. The flow is light throughout the day but when go urinate there are little blood clots almost every time. The cramps are sporadic and the bleeding is going on 2nd full week without no break in between as of this date.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: pt fainted but regained his consiousness shortly after, he was observed for 1 hour after the incident, I called the parent on 4/9/21 and father said that he is doing well and back to normal
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nasopharyngitis, Nausea, Palpitations, Presyncope
Clinical narrative: felt like he was about to pass out; felt dizzy; felt like his heart was racing; felt like he had a cold; felt like he wanted to sleep; felt nauseous; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRESYNCOPE (felt like he was about to pass out) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) 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 29-Mar-2021 at 8:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PRESYNCOPE (felt like he was about to pass out) (seriousness criterion medically significant), DIZZINESS (felt dizzy), PALPITATIONS (felt like his heart was racing), NASOPHARYNGITIS (felt like he had a cold), SOMNOLENCE (felt like he wanted to sleep) and NAUSEA (felt nauseous). On 29-Mar-2021, PRESYNCOPE (felt like he was about to pass out), DIZZINESS (felt dizzy), PALPITATIONS (felt like his heart was racing), NASOPHARYNGITIS (felt like he had a cold), SOMNOLENCE (felt like he wanted to sleep) and NAUSEA (felt nauseous) 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.   No concomitant drugs were reported.  On 29 Mar 2021, the patient went to emergency room and was monitored for a couple hours, not medical treatment was provided for side effect relief.; Sender's Comments: This case concerns a 34-year-old male with a serious unexpected event of presyncope, palpitations, and nonserious unexpected dizziness, somnolence, palpitations, nasopharyngitis and expected nausea. Event onset Day1 after first dose. Events resolved. 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.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: felt like he was about to pass out; felt dizzy; felt like his heart was racing; felt like he had a cold; felt like he wanted to sleep; felt nauseous; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRESYNCOPE (felt like he was about to pass out) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) 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 29-Mar-2021 at 8:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PRESYNCOPE (felt like he was about to pass out) (seriousness criterion medically significant), DIZZINESS (felt dizzy), PALPITATIONS (felt like his heart was racing), NASOPHARYNGITIS (felt like he had a cold), SOMNOLENCE (felt like he wanted to sleep) and NAUSEA (felt nauseous). On 29-Mar-2021, PRESYNCOPE (felt like he was about to pass out), DIZZINESS (felt dizzy), PALPITATIONS (felt like his heart was racing), NASOPHARYNGITIS (felt like he had a cold), SOMNOLENCE (felt like he wanted to sleep) and NAUSEA (felt nauseous) 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.   No concomitant drugs were reported.  On 29 Mar 2021, the patient went to emergency room and was monitored for a couple hours, not medical treatment was provided for side effect relief.; Sender's Comments: This case concerns a 34-year-old male with a serious unexpected event of presyncope, palpitations, and nonserious unexpected dizziness, somnolence, palpitations, nasopharyngitis and expected nausea. Event onset Day1 after first dose. Events resolved. 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.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fall, Feeling abnormal, Feeling cold
Clinical narrative: Around five hours after shot I felt what I would describe as brain fog and light headache, by the evening I was aching, chilling and had 101 fever. Aches in my muscles and joints as if I had Rocky mountain spotted fever again. That is what the side effects reminded me of. This went on for over 48 hours. I have never been so sick. Very nauseous by next day. Also fell to the floor from nearly passing out the following morning. Took a minute for the light headed To pass. Arm pain still today. It was very scary and seemed to be a very serious reaction. Friday after noon finally started feeling better. The other strange part of this is that my daughter and best friend and I received the shot together in the same lot number and every one of us was deathly ill with the same symptoms. I am the only one with the fainting spells. Still feel fatigued today. And shoulders and left arm injection site still sore and achy.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Injection site pain, Myalgia, Nausea
Clinical narrative: Around five hours after shot I felt what I would describe as brain fog and light headache, by the evening I was aching, chilling and had 101 fever. Aches in my muscles and joints as if I had Rocky mountain spotted fever again. That is what the side effects reminded me of. This went on for over 48 hours. I have never been so sick. Very nauseous by next day. Also fell to the floor from nearly passing out the following morning. Took a minute for the light headed To pass. Arm pain still today. It was very scary and seemed to be a very serious reaction. Friday after noon finally started feeling better. The other strange part of this is that my daughter and best friend and I received the shot together in the same lot number and every one of us was deathly ill with the same symptoms. I am the only one with the fainting spells. Still feel fatigued today. And shoulders and left arm injection site still sore and achy.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Syncope
Clinical narrative: Around five hours after shot I felt what I would describe as brain fog and light headache, by the evening I was aching, chilling and had 101 fever. Aches in my muscles and joints as if I had Rocky mountain spotted fever again. That is what the side effects reminded me of. This went on for over 48 hours. I have never been so sick. Very nauseous by next day. Also fell to the floor from nearly passing out the following morning. Took a minute for the light headed To pass. Arm pain still today. It was very scary and seemed to be a very serious reaction. Friday after noon finally started feeling better. The other strange part of this is that my daughter and best friend and I received the shot together in the same lot number and every one of us was deathly ill with the same symptoms. I am the only one with the fainting spells. Still feel fatigued today. And shoulders and left arm injection site still sore and achy.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactoid reaction, Pharyngeal paraesthesia, Pharyngeal swelling
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Menstrual disorder
Clinical narrative: After the first dose, I had an unusually long menstrual cycle. After the second dose, I had bleeding mid way through my cycle (had just finished my period a few days prior to the vaccine). The bleeding/spotting went on for 3 days. I also had sharp pains in the side of my breast on the same side that I received the vaccine on.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Began with extreme fatigue on Wednesday, on Thursday became nauseous with multiple incidents,  Friday a fever developed going into the evening,  fever and sweats through the night, fever seemed to break about 3:30am Saturday morning
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: fainting but responsive-Medium, Systemic: Weakness-Medium
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: 2am woke up with nausea, severe headache, chills and sweats. Vertigo upon standing. Drank water and slept little till 8 am. Took 1 Tylenol at 8, and noon. Had a morning nap and afternoon nap over an hour and normally cannot nap. Took 2 Ibuprofen at 4pm. Aches in joints along with previous symptoms mentioned all day and subsided significantly by 8pm. Was unable to function normally and slept or laid down all day. Felt normal the next morning. Had no arm pain at injection sight at all this time.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Nausea, Vertigo
Clinical narrative: 2am woke up with nausea, severe headache, chills and sweats. Vertigo upon standing. Drank water and slept little till 8 am. Took 1 Tylenol at 8, and noon. Had a morning nap and afternoon nap over an hour and normally cannot nap. Took 2 Ibuprofen at 4pm. Aches in joints along with previous symptoms mentioned all day and subsided significantly by 8pm. Was unable to function normally and slept or laid down all day. Felt normal the next morning. Had no arm pain at injection sight at all this time.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Fatigue, General physical condition abnormal, Hyperhidrosis
Clinical narrative: having bad pains in the middle of her chest; has a sore throat; she is dizzy all the time; sweaty; foot doctor who told her she did not look good; fatigue, she spent a whole week in bed; her blood pressure elevated to 220/120 mmHg; heart started racing; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (her blood pressure elevated to 220/120 mmHg) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030MZ0A) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced HYPERTENSION (her blood pressure elevated to 220/120 mmHg) (seriousness criterion medically significant) and PALPITATIONS (heart started racing). On an unknown date, the patient experienced CHEST PAIN (having bad pains in the middle of her chest), OROPHARYNGEAL PAIN (has a sore throat), DIZZINESS (she is dizzy all the time), HYPERHIDROSIS (sweaty), GENERAL PHYSICAL CONDITION ABNORMAL (foot doctor who told her she did not look good) and FATIGUE (fatigue, she spent a whole week in bed). At the time of the report, HYPERTENSION (her blood pressure elevated to 220/120 mmHg), PALPITATIONS (heart started racing), CHEST PAIN (having bad pains in the middle of her chest), OROPHARYNGEAL PAIN (has a sore throat), DIZZINESS (she is dizzy all the time), HYPERHIDROSIS (sweaty), GENERAL PHYSICAL CONDITION ABNORMAL (foot doctor who told her she did not look good) and FATIGUE (fatigue, she spent a whole week in bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case concerns a 67-year-old female with a serious unexpected event of hypertension, and nonserious unexpected general physical condition abnormal, dizziness, hyperhidrosis, chest pain, palpitations, oropharyngeal pain, and expected fatigue. 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 67-year-old female with a serious unexpected event of hypertension, and nonserious unexpected general physical condition abnormal, dizziness, hyperhidrosis, chest pain, palpitations, oropharyngeal pain, and expected fatigue. 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.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Oropharyngeal pain, Palpitations
Clinical narrative: having bad pains in the middle of her chest; has a sore throat; she is dizzy all the time; sweaty; foot doctor who told her she did not look good; fatigue, she spent a whole week in bed; her blood pressure elevated to 220/120 mmHg; heart started racing; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (her blood pressure elevated to 220/120 mmHg) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030MZ0A) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced HYPERTENSION (her blood pressure elevated to 220/120 mmHg) (seriousness criterion medically significant) and PALPITATIONS (heart started racing). On an unknown date, the patient experienced CHEST PAIN (having bad pains in the middle of her chest), OROPHARYNGEAL PAIN (has a sore throat), DIZZINESS (she is dizzy all the time), HYPERHIDROSIS (sweaty), GENERAL PHYSICAL CONDITION ABNORMAL (foot doctor who told her she did not look good) and FATIGUE (fatigue, she spent a whole week in bed). At the time of the report, HYPERTENSION (her blood pressure elevated to 220/120 mmHg), PALPITATIONS (heart started racing), CHEST PAIN (having bad pains in the middle of her chest), OROPHARYNGEAL PAIN (has a sore throat), DIZZINESS (she is dizzy all the time), HYPERHIDROSIS (sweaty), GENERAL PHYSICAL CONDITION ABNORMAL (foot doctor who told her she did not look good) and FATIGUE (fatigue, she spent a whole week in bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case concerns a 67-year-old female with a serious unexpected event of hypertension, and nonserious unexpected general physical condition abnormal, dizziness, hyperhidrosis, chest pain, palpitations, oropharyngeal pain, and expected fatigue. 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 67-year-old female with a serious unexpected event of hypertension, and nonserious unexpected general physical condition abnormal, dizziness, hyperhidrosis, chest pain, palpitations, oropharyngeal pain, and expected fatigue. 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.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Haemoglobinuria, Headache, Nausea
Clinical narrative: Hemoglobinuria brownish; pain at injection site left arm; body ache; chills; Fever; headache; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HAEMOGLOBINURIA (Hemoglobinuria brownish) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 014M20A) 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 was provided.).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site left arm), PAIN (body ache), CHILLS (chills), PYREXIA (Fever), HEADACHE (headache), NAUSEA (Nausea) and FATIGUE (Fatigue). On 31-Mar-2021, the patient experienced HAEMOGLOBINURIA (Hemoglobinuria brownish) (seriousness criterion medically significant). On 31-Mar-2021, PAIN (body ache) and CHILLS (chills) had resolved, FATIGUE (Fatigue) outcome was unknown. At the time of the report, HAEMOGLOBINURIA (Hemoglobinuria brownish), VACCINATION SITE PAIN (pain at injection site left arm), PYREXIA (Fever), HEADACHE (headache) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications reported. Treatment medications included paracetamol 5 doses on 30 Mar 2021 and 1 dose on 31 Mar 2021.  This case concerns a 60-year-old female with a serious unexpected event of Hemoglobinuria and expected vaccination site pain, pain, pyrexia, chills, headache, fatigue, nausea. Event onset Day 2 after second dose mRNA-1273. 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.   This case was linked to (E2B Linked Report).; Sender's Comments: This case concerns a 60-year-old female with a serious unexpected event of Hemoglobinuria and expected vaccination site pain, pain, pyrexia, chills, headache, fatigue, nausea. Event onset Day 2 after second dose mRNA-1273. 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.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: Hemoglobinuria brownish; pain at injection site left arm; body ache; chills; Fever; headache; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HAEMOGLOBINURIA (Hemoglobinuria brownish) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 014M20A) 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 was provided.).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site left arm), PAIN (body ache), CHILLS (chills), PYREXIA (Fever), HEADACHE (headache), NAUSEA (Nausea) and FATIGUE (Fatigue). On 31-Mar-2021, the patient experienced HAEMOGLOBINURIA (Hemoglobinuria brownish) (seriousness criterion medically significant). On 31-Mar-2021, PAIN (body ache) and CHILLS (chills) had resolved, FATIGUE (Fatigue) outcome was unknown. At the time of the report, HAEMOGLOBINURIA (Hemoglobinuria brownish), VACCINATION SITE PAIN (pain at injection site left arm), PYREXIA (Fever), HEADACHE (headache) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications reported. Treatment medications included paracetamol 5 doses on 30 Mar 2021 and 1 dose on 31 Mar 2021.  This case concerns a 60-year-old female with a serious unexpected event of Hemoglobinuria and expected vaccination site pain, pain, pyrexia, chills, headache, fatigue, nausea. Event onset Day 2 after second dose mRNA-1273. 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.   This case was linked to (E2B Linked Report).; Sender's Comments: This case concerns a 60-year-old female with a serious unexpected event of Hemoglobinuria and expected vaccination site pain, pain, pyrexia, chills, headache, fatigue, nausea. Event onset Day 2 after second dose mRNA-1273. 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.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Incomplete course of vaccination, SARS-CoV-2 antibody test, Vaccination complication
Clinical narrative: COVID; Didn't got the vaccine before the 37 day mark; Got a negative reaction to the vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) 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 relevant medical history provided).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION COMPLICATION (Got a negative reaction to the vaccine). On 31-Mar-2021, the patient experienced INCOMPLETE COURSE OF VACCINATION (Didn't got the vaccine before the 37 day mark). On an unknown date, the patient experienced COVID-19 (COVID) (seriousness criterion hospitalization). The patient was hospitalized on 19-Jan-2021 due to COVID-19. On 31-Mar-2021, INCOMPLETE COURSE OF VACCINATION (Didn't got the vaccine before the 37 day mark) had resolved. At the time of the report, COVID-19 (COVID) and VACCINATION COMPLICATION (Got a negative reaction to the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       18-Jan-2021, the patient had a negative reaction to the mRNA-1273 (Moderna COVID-19 Vaccine). The next day, she had to go to the hospital and was there for about a week. She had a bad cough/a terrible cough and all the symptoms that "are expected".  She then tested positive for COVID a few days after vaccination.   This case was linked; 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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Haemoglobinuria, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Hemoglobinuria Reddish; body ache; chills; Fever; Pain at injection arm; This spontaneous case was reported by a consumer and describes the occurrence of HAEMOGLOBINURIA (Hemoglobinuria Reddish) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) 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), Cyst and Cyst removal.    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection arm). On 30-Mar-2021, the patient experienced HAEMOGLOBINURIA (Hemoglobinuria Reddish) (seriousness criterion medically significant), PAIN (body ache), CHILLS (chills) and PYREXIA (Fever). At the time of the report, HAEMOGLOBINURIA (Hemoglobinuria Reddish), PAIN (body ache), CHILLS (chills), PYREXIA (Fever) and VACCINATION SITE PAIN (Pain at injection arm) outcome was unknown.        Anesthesia for surgery on index finger cyst on 02 Mar 2021.  Company comment: 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-063819 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-063819: