chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence, Vaccination complication
Clinical narrative: third dose had an impact on her hormones; sick with all three doses; had the period start and it is still coming; breasts were terribly sore (one week ago)/breasts hurt so bad/hurt to put on a bra; fever not above a 100°F after dose 3; extremely lethargic after dose 3; Too much sleep after dose 3; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (had the period start and it is still coming), VACCINATION COMPLICATION (third dose had an impact on her hormones), ILLNESS (sick with all three doses), LETHARGY (extremely lethargic after dose 3) and SOMNOLENCE (Too much sleep after dose 3) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced LETHARGY (extremely lethargic after dose 3), SOMNOLENCE (Too much sleep after dose 3) and PYREXIA (fever not above a 100°F after dose 3). On 22-Sep-2021, the patient experienced BREAST PAIN (breasts were terribly sore (one week ago)/breasts hurt so bad/hurt to put on a bra). On 28-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MENSTRUAL DISORDER (had the period start and it is still coming). On an unknown date, the patient experienced VACCINATION COMPLICATION (third dose had an impact on her hormones) and ILLNESS (sick with all three doses). The patient was treated with IBUPROFEN on 29-Aug-2021 for Adverse event, at an unspecified dose and frequency. On 29-Aug-2021, LETHARGY (extremely lethargic after dose 3), SOMNOLENCE (Too much sleep after dose 3) and PYREXIA (fever not above a 100°F after dose 3) had resolved. At the time of the report, MENSTRUAL DISORDER (had the period start and it is still coming) had not resolved, VACCINATION COMPLICATION (third dose had an impact on her hormones) and ILLNESS (sick with all three doses) outcome was unknown and BREAST PAIN (breasts were terribly sore (one week ago)/breasts hurt so bad/hurt to put on a bra) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2021, Body temperature: 100 (High) fever not above 100°F.         No relevant concomitant medications were reported. PAPs smear was completely normal.   This case was linked to MOD-2021-335764, MOD-2021-335745 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Illness
Clinical narrative: sick; mouth is numb; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) and HYPOAESTHESIA ORAL (mouth is numb) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick) and HYPOAESTHESIA ORAL (mouth is numb). At the time of the report, ILLNESS (sick) and HYPOAESTHESIA ORAL (mouth is numb) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Insomnia
Clinical narrative: sweating; couldn't sleep one night; headaches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), INSOMNIA (couldn't sleep one night) and HEADACHE (headaches) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     The patient's past medical history included Heart murmur, Skin cancer, Brain neoplasm benign and Depression. Concomitant products included ALPRAZOLAM (XANAX) and ZOLPIDEM for an unknown indication.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating), INSOMNIA (couldn't sleep one night) and HEADACHE (headaches). At the time of the report, HYPERHIDROSIS (sweating), INSOMNIA (couldn't sleep one night) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was reported by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Decreased appetite, Feeling abnormal, Headache
Clinical narrative: has a sore arm with some itching as of today 29Sep2021only her arm is still affected; The following day everything hurt but her hair, she could stay up a half hour then; fever of 99.2; joint pain; bad headache; Her 3rd injection was on 26Sep2021 at 11:30AM that day she had a sore arm; she started feeling bad; she hardly ate or drank all day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she started feeling bad), DECREASED APPETITE (she hardly ate or drank all day), VACCINATION SITE PRURITUS (has a sore arm with some itching as of today 29Sep2021only her arm is still affected), MYALGIA (The following day everything hurt but her hair, she could stay up a half hour then) and PYREXIA (fever of 99.2) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021 at 11:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient experienced FEELING ABNORMAL (she started feeling bad), DECREASED APPETITE (she hardly ate or drank all day), MYALGIA (The following day everything hurt but her hair, she could stay up a half hour then), PYREXIA (fever of 99.2), ARTHRALGIA (joint pain), HEADACHE (bad headache) and VACCINATION SITE PAIN (Her 3rd injection was on 26Sep2021 at 11:30AM that day she had a sore arm). On 29-Sep-2021, the patient experienced VACCINATION SITE PRURITUS (has a sore arm with some itching as of today 29Sep2021only her arm is still affected). On 28-Sep-2021, FEELING ABNORMAL (she started feeling bad), DECREASED APPETITE (she hardly ate or drank all day), MYALGIA (The following day everything hurt but her hair, she could stay up a half hour then), PYREXIA (fever of 99.2), ARTHRALGIA (joint pain), HEADACHE (bad headache) and VACCINATION SITE PAIN (Her 3rd injection was on 26Sep2021 at 11:30AM that day she had a sore arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (has a sore arm with some itching as of today 29Sep2021only her arm is still affected) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.2 (High) fever of 99.2..         No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2021-335962, MOD-2021-335979, MOD-2021-335962 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain, Vaccination site pruritus
Clinical narrative: has a sore arm with some itching as of today 29Sep2021only her arm is still affected; The following day everything hurt but her hair, she could stay up a half hour then; fever of 99.2; joint pain; bad headache; Her 3rd injection was on 26Sep2021 at 11:30AM that day she had a sore arm; she started feeling bad; she hardly ate or drank all day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she started feeling bad), DECREASED APPETITE (she hardly ate or drank all day), VACCINATION SITE PRURITUS (has a sore arm with some itching as of today 29Sep2021only her arm is still affected), MYALGIA (The following day everything hurt but her hair, she could stay up a half hour then) and PYREXIA (fever of 99.2) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021 at 11:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient experienced FEELING ABNORMAL (she started feeling bad), DECREASED APPETITE (she hardly ate or drank all day), MYALGIA (The following day everything hurt but her hair, she could stay up a half hour then), PYREXIA (fever of 99.2), ARTHRALGIA (joint pain), HEADACHE (bad headache) and VACCINATION SITE PAIN (Her 3rd injection was on 26Sep2021 at 11:30AM that day she had a sore arm). On 29-Sep-2021, the patient experienced VACCINATION SITE PRURITUS (has a sore arm with some itching as of today 29Sep2021only her arm is still affected). On 28-Sep-2021, FEELING ABNORMAL (she started feeling bad), DECREASED APPETITE (she hardly ate or drank all day), MYALGIA (The following day everything hurt but her hair, she could stay up a half hour then), PYREXIA (fever of 99.2), ARTHRALGIA (joint pain), HEADACHE (bad headache) and VACCINATION SITE PAIN (Her 3rd injection was on 26Sep2021 at 11:30AM that day she had a sore arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (has a sore arm with some itching as of today 29Sep2021only her arm is still affected) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.2 (High) fever of 99.2..         No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2021-335962, MOD-2021-335979, MOD-2021-335962 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: has been felling sick since the night of his second dose of the Moderna covid19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (has been felling sick since the night of his second dose of the Moderna covid19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (has been felling sick since the night of his second dose of the Moderna covid19 vaccine). At the time of the report, MALAISE (has been felling sick since the night of his second dose of the Moderna covid19 vaccine) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Ocular discomfort, Visual impairment
Clinical narrative: a little numbness ( Right eye); My vision has been wonky (Right eye)/right eye twitching (like a tremor); my vision has been wonky (Right eye); This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (a little numbness ( Right eye)), OCULAR DISCOMFORT (My vision has been wonky (Right eye)/right eye twitching (like a tremor)) and VISUAL IMPAIRMENT (my vision has been wonky (Right eye)) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.    Concurrent medical conditions included Diabetes and Hypertension.   On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Sep-2021, the patient experienced HYPOAESTHESIA (a little numbness ( Right eye)), OCULAR DISCOMFORT (My vision has been wonky (Right eye)/right eye twitching (like a tremor)) and VISUAL IMPAIRMENT (my vision has been wonky (Right eye)). At the time of the report, HYPOAESTHESIA (a little numbness ( Right eye)), OCULAR DISCOMFORT (My vision has been wonky (Right eye)/right eye twitching (like a tremor)) and VISUAL IMPAIRMENT (my vision has been wonky (Right eye)) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medications were not reported. treatment medications were not reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: diagnosed with covid after first dose of the vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021.    This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (diagnosed with covid after first dose of the vaccine) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No medical history was provided.     On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (diagnosed with covid after first dose of the vaccine). At the time of the report, COVID-19 (diagnosed with covid after first dose of the vaccine) 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.   Concomitant medications was not provided by the reporter Treatment information was not provided; Sender's Comments: This case concerns a 40-year-old female with a non-serious unexpected event of COVID-19. Event onset with unknown latency after first dose mRNA-1273. Event outcome unknown. No information reported on second dose and rechallenge. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of vaccine past 30 days in the fridge; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of vaccine past 30 days in the fridge) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of vaccine past 30 days in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of vaccine past 30 days in the fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   HCP vaccinated patients with vials that were past 30 days in the fridge. No concomitant drug details were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Updated dose 1 and dose 2 details.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I just felt real tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I just felt real tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023H20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, the patient experienced FATIGUE (I just felt real tired). At the time of the report, FATIGUE (I just felt real tired) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Itchy chickenpox like rash that is continuing to pop up. Had chickenpox badly 23 years ago but had to have vaccine for college.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Condition aggravated, Dermatomyositis, Rash, Swelling of eyelid
Clinical narrative: Acute exacerbation of amyopatis dermatomyositis.  Prominen heliotrope rash and swelling of eyelids, "shawl" sign eruption, scalp dermatomyositis flare
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Dyspnoea, Echocardiogram abnormal, Exposure during pregnancy, Hepatic enzyme increased
Clinical narrative: Woke up the morning of 9/25  with trouble breathing. This was ~19 hours after 2nd dose. Held off for a day and checked myself into ER. Cardiologist at ER diagnosed me with acute pericarditis and sent me home without meds since the meds typically used to treat acute pericarditis are not used for pregnant women. On Monday 9/27 I had a 34 week OB-GYN checkup. Doctor saw me and urged me to go to the hospital where she delivers as soon as possible. My husband and I drove to Hospital. Was checked into ER and sent to the Telemetry department. Dr's there did blood work and an echocardiogram and confirm that I have acute pericarditis.   Was advised to deliver baby ASAP so that the appropriate meds can be used to help my symptoms. Was induced and gave birth on 10/1 to a baby 34 weeks and 5 days old.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Induced labour, Inflammatory marker increased, Pericarditis, Premature delivery
Clinical narrative: Woke up the morning of 9/25  with trouble breathing. This was ~19 hours after 2nd dose. Held off for a day and checked myself into ER. Cardiologist at ER diagnosed me with acute pericarditis and sent me home without meds since the meds typically used to treat acute pericarditis are not used for pregnant women. On Monday 9/27 I had a 34 week OB-GYN checkup. Doctor saw me and urged me to go to the hospital where she delivers as soon as possible. My husband and I drove to Hospital. Was checked into ER and sent to the Telemetry department. Dr's there did blood work and an echocardiogram and confirm that I have acute pericarditis.   Was advised to deliver baby ASAP so that the appropriate meds can be used to help my symptoms. Was induced and gave birth on 10/1 to a baby 34 weeks and 5 days old.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Magnetic resonance imaging abnormal, Nipple pain, Peripheral swelling, Swelling
Clinical narrative: Reactive lymphadenopathy/diagnosed 10/5/2021 10/1/2021-Swelling in neck/ Underarm wasn't notice until doctors visit on 10/5/2021 10/4/2021- swelling of feet that went away the next day 10/8/2021-nipples hurting9Not diagnose or treated
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Bilirubin conjugated increased, Blood lactate dehydrogenase increased, Coombs positive haemolytic anaemia, Coombs test positive
Clinical narrative: Warm autoimmune hemolytic anemia
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Leukocytosis, Red blood cell count decreased, Reticulocyte count increased, Serum ferritin increased, Warm type haemolytic anaemia
Clinical narrative: Warm autoimmune hemolytic anemia
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: Warm autoimmune hemolytic anemia
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Pain, Swelling of eyelid
Clinical narrative: Swelling and pain in right eye occurred within 10 minutes of getting shot. Eye swelled nearly shut overnight and over 24 hours later is still swollen with a burning pain.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm  Headache  Fever  Body aches  Tired
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives developed over entire body at 6 hours post vaccine and lasted for 12 days. Treated with prednisone.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, Vaccination site pain
Clinical narrative: Pain in the injection site/Pain is severe; Patient received 3rd dose; 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 VACCINATION SITE PAIN (Pain in the injection site/Pain is severe) and EXTRA DOSE ADMINISTERED (Patient received 3rd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain in the injection site/Pain is severe) and EXTRA DOSE ADMINISTERED (Patient received 3rd dose). At the time of the report, VACCINATION SITE PAIN (Pain in the injection site/Pain is severe) outcome was unknown and EXTRA DOSE ADMINISTERED (Patient received 3rd dose) had resolved.            No concomitant medications were provided. No treatment medications were reported.    Reporter did not allow further contact
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling face
Clinical narrative: On Friday October 8th, 2021, three days after receiving my first dose My left side of my face began to swell and form a rash. As a couple of hours went by the rash spread to the right side of the face. Jaw line and neck as well as hands and arms. I contacted the local clinic to inform them of my symptoms and they suggested to go to the hospital. I went to the hospital and received medication to help the swelling and slow down the spread of the rash.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Nausea, Pyrexia
Clinical narrative: At approximately 2 PM which was four hours after vaccination patient began to become ill.  He developed headache, fever, chills, nausea and vomiting.  He continued to have persistent vomiting throughout the night. He was seen in ER. He reports that he was given 2, IV's of Ondansetron (4 mg each) at which time it brought his non stop vomiting under control.  He was also given a shot of Toradol for his headache.  He was given a prescription of Ondansetron  and told to take Tylenol or Advil for his headache.  His symptoms required that he take these medications for 3 days.  Patient was home sick for 24 hours after ER visit and then was able to go to work again in the ER using his medications.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: At approximately 2 PM which was four hours after vaccination patient began to become ill.  He developed headache, fever, chills, nausea and vomiting.  He continued to have persistent vomiting throughout the night. He was seen in ER. He reports that he was given 2, IV's of Ondansetron (4 mg each) at which time it brought his non stop vomiting under control.  He was also given a shot of Toradol for his headache.  He was given a prescription of Ondansetron  and told to take Tylenol or Advil for his headache.  His symptoms required that he take these medications for 3 days.  Patient was home sick for 24 hours after ER visit and then was able to go to work again in the ER using his medications.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium decreased, Blood pressure increased, Condition aggravated, Feeling abnormal, Headache
Clinical narrative: Blood pressure to 185/109 within 10 minutes.  Potassium level (serum) drop.  Pulse at 51 bpm.  Typical BP is 110 / 75.   Followed over course of 48 hours with extreme muscle weakness and near flaccid paralysis, irregular heartbeat and gripping headache (not a common occurrence for me) with "brain fog"; slept approximately 16 hours over the next 36.  Second reaction better than first dose because we prepared better based on first reaction.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Muscular weakness, Paralysis, Somnolence
Clinical narrative: Blood pressure to 185/109 within 10 minutes.  Potassium level (serum) drop.  Pulse at 51 bpm.  Typical BP is 110 / 75.   Followed over course of 48 hours with extreme muscle weakness and near flaccid paralysis, irregular heartbeat and gripping headache (not a common occurrence for me) with "brain fog"; slept approximately 16 hours over the next 36.  Second reaction better than first dose because we prepared better based on first reaction.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: reported blurry vision, intermittent x 1 month starting day of vaccination. Currently monitoring, awaiting further workup
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Nausea, Parosmia, Retching, Taste disorder
Clinical narrative: I was unable to eat or drink because everything smelled and tasted rotten. The sight and smell of food or drink besides water made me gag or vomit. It took me more than three days to transition to liquids besides water, and five for solid foods. I still cannot eat or drink foods with strong smell without feeling nauseous, is had been at least eight days.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: I was unable to eat or drink because everything smelled and tasted rotten. The sight and smell of food or drink besides water made me gag or vomit. It took me more than three days to transition to liquids besides water, and five for solid foods. I still cannot eat or drink foods with strong smell without feeling nauseous, is had been at least eight days.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypogeusia, Parosmia
Clinical narrative: My first 2 doses were Moderna 8 months prior.  About 6 or so hours later I smelled burnt chemicals when apple pies were cooking. I had diminished taste with peppermint candy. It went away with in about 3 hours
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Heavy menstrual bleeding, Iron deficiency, Loss of personal independence in daily activities, Menstruation irregular
Clinical narrative: My periods have been very irregular since I?ve received my vaccination. Not only do they last significantly longer (10+ days when they would originally go 5 or 6 days), I?ve had heavy mensural bleeding and blood clots. I?ve been filling one super+ tampon every 2 hours for at least 5 days of my period. I wear pads every day because I have continuous bleeding throughout the month.  This has impacted my quality of life.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Erythema, Fatigue, Injection site rash
Clinical narrative: ?Covid arm.? Large, red, swollen, rash at injection site, 5.5 inches in diameter. Joint pain, weakness, tiredness.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: ?Covid arm.? Large, red, swollen, rash at injection site, 5.5 inches in diameter. Joint pain, weakness, tiredness.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chills, Pain in extremity, Pyrexia
Clinical narrative: Stomach cramps, achy joints, mild fever and chills, very sore arm that received the injection.  Symptoms lasted approx. 1 day.  Note:  This was the third dose (booster).  Dose one produced no symptoms.  Dose two produced moderate joint pain.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Pain, Pain in jaw
Clinical narrative: Lightheadedness within 15 minutes that remained intermittent and low. Nausea within 15 minutes that was transient.  9 hours after injection  body aches hear through pelvis. Excessive yawning and stretching. Headaches.  Right side worse than left.  Jaw pain especially right side
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pelvic pain, Yawning
Clinical narrative: Lightheadedness within 15 minutes that remained intermittent and low. Nausea within 15 minutes that was transient.  9 hours after injection  body aches hear through pelvis. Excessive yawning and stretching. Headaches.  Right side worse than left.  Jaw pain especially right side
Age: 55.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Paraesthesia, Rash erythematous, Rash papular
Clinical narrative: Shingles on R forehead, w painful tingling, erythematous patch w papular lesions.  Seen in Urgent Care 28 Sep, ER 10/4/21.
Age: 55.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injury corneal
Clinical narrative: Shingles on R forehead, w painful tingling, erythematous patch w papular lesions.  Seen in Urgent Care 28 Sep, ER 10/4/21.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pruritus
Clinical narrative: 24 hours after COVID booster shot felt itchy, and tired.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Skin irritation, Vaccination site rash
Clinical narrative: Itches; more patient scratches it, the more it sores; Irritation; rash in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itches), PAIN (more patient scratches it, the more it sores), SKIN IRRITATION (Irritation) and VACCINATION SITE RASH (rash in the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced PRURITUS (Itches), PAIN (more patient scratches it, the more it sores), SKIN IRRITATION (Irritation) and VACCINATION SITE RASH (rash in the injection site). At the time of the report, PRURITUS (Itches), PAIN (more patient scratches it, the more it sores), SKIN IRRITATION (Irritation) and VACCINATION SITE RASH (rash in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  The patient applied creams and ointments give by dermatologist to treat symptoms.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot
Age: 37.0
Sex: F
Vaccine: FLUA4
Symptoms: Biopsy stomach abnormal, Blood test abnormal, Coeliac disease, Cold sweat, Diarrhoea
Clinical narrative: The reactions I have to the Flu vaccine are always the same but the adverse reaction time was become more rapid. This one was instantaneous. On Nov. 5, 2020, I went to Employee Heath to receive my free vaccine, this is the first time I had received this free vaccine. The moment that the fluid hit my muscle, I immediately experience vertigo with the entire room spinning, I went cold and clammy, and experience immediate nausea. I was told the color drained from my face with the gentleman coming out of the room next door because he saw my reaction and the monitor. I always have someone drive me to and from my vaccinations due to my previous adverse reactions. Before I even made it to the car, I went down in the parking lot because the lot started to spin and I became quite light headed. I live about 6 minutes from the hospital and before I even got home I was throwing up. I then experienced extreme nausea, vomiting, and diarrhea for the next three months. Following the vaccination, I missed meetings for work and even had to call off of a few shifts because I was unable to due my job.
Age: 37.0
Sex: F
Vaccine: FLUA4
Symptoms: Dizziness, Endoscopy, Epigastric discomfort, Gastritis, Immediate post-injection reaction
Clinical narrative: The reactions I have to the Flu vaccine are always the same but the adverse reaction time was become more rapid. This one was instantaneous. On Nov. 5, 2020, I went to Employee Heath to receive my free vaccine, this is the first time I had received this free vaccine. The moment that the fluid hit my muscle, I immediately experience vertigo with the entire room spinning, I went cold and clammy, and experience immediate nausea. I was told the color drained from my face with the gentleman coming out of the room next door because he saw my reaction and the monitor. I always have someone drive me to and from my vaccinations due to my previous adverse reactions. Before I even made it to the car, I went down in the parking lot because the lot started to spin and I became quite light headed. I live about 6 minutes from the hospital and before I even got home I was throwing up. I then experienced extreme nausea, vomiting, and diarrhea for the next three months. Following the vaccination, I missed meetings for work and even had to call off of a few shifts because I was unable to due my job.
Age: 37.0
Sex: F
Vaccine: FLUA4
Symptoms: Impaired work ability, Nausea, Pallor, Vertigo, Vomiting
Clinical narrative: The reactions I have to the Flu vaccine are always the same but the adverse reaction time was become more rapid. This one was instantaneous. On Nov. 5, 2020, I went to Employee Heath to receive my free vaccine, this is the first time I had received this free vaccine. The moment that the fluid hit my muscle, I immediately experience vertigo with the entire room spinning, I went cold and clammy, and experience immediate nausea. I was told the color drained from my face with the gentleman coming out of the room next door because he saw my reaction and the monitor. I always have someone drive me to and from my vaccinations due to my previous adverse reactions. Before I even made it to the car, I went down in the parking lot because the lot started to spin and I became quite light headed. I live about 6 minutes from the hospital and before I even got home I was throwing up. I then experienced extreme nausea, vomiting, and diarrhea for the next three months. Following the vaccination, I missed meetings for work and even had to call off of a few shifts because I was unable to due my job.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: My ears are ringing. Like a high frequency test tone. It?s constant in both ears. I have never experienced tinnitus before nor diagnosed with it.  What I?m experiencing is not of an orthostatic nature. It?s constant laying down or standing/walking.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives developed two weeks after vaccination.  Hives are daily and have not dissipated.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Ear pain, Herpes zoster, Impaired work ability, Lipoma
Clinical narrative: I got shingles within 2 weeks after my 2nd shot. No hx health problems. I believe it to be a severe case on my face. I spent time in the ER due to this and despite treatment,  still in severe pain 1.5 weeks after the initial onset of sxs. I am unable to work due to the pain.  This was 2 weeks after my 2nd Moderna shot.   I also had a lipoma grow on my forearm within 2 weeks after my first shot. No hx of lipomas, and no family hx of them either. I now have to have it removed by a general surgeon.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Rash
Clinical narrative: I got shingles within 2 weeks after my 2nd shot. No hx health problems. I believe it to be a severe case on my face. I spent time in the ER due to this and despite treatment,  still in severe pain 1.5 weeks after the initial onset of sxs. I am unable to work due to the pain.  This was 2 weeks after my 2nd Moderna shot.   I also had a lipoma grow on my forearm within 2 weeks after my first shot. No hx of lipomas, and no family hx of them either. I now have to have it removed by a general surgeon.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Pruritus, Rash
Clinical narrative: Since getting the vaccine I have had a rash and itching that I have been seen twice for and none of the prescribed medications have cured it.  Additionally my mental cycle is sometimes twice monthly and the clotting is large and abnormal for my usual period. I experience heavy bleeding that last for several days.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Fibrin D dimer increased, Pulmonary embolism
Clinical narrative: I was diagnosed to two "unprovoked" Pulmonary Embolisms in my right lung.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Auditory disorder, Cardiac disorder, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Almost had to be admitted into Emergency room, but I left the hospital because they wouldn't let my husband inside.  I had severe heart issue! Not sure exactly what was wrong but I came close to having heart attack! This lasted for a few days. I had the worst dizziness that lasted more than 23 minutes! Chest pain, restricted  breathing, and static sound in my head between the ears. The vaccine  also left a taste in my throat even though I got the shot in my arm. My heart has not felt right since the vaccine! I felt wonderful just prior to getting the injection!
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Hyperhidrosis, Inflammation, Insomnia
Clinical narrative: second dose made it worse; Redness; very inflamed; not been able to sleep; massive sweats; intense dreams; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (not been able to sleep), HYPERHIDROSIS (massive sweats), ABNORMAL DREAMS (intense dreams), CONDITION AGGRAVATED (second dose made it worse) and ERYTHEMA (Redness) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included COVID-19 in June 2020, Neurological symptoms NOS (amplified neurological effects) on 04-Jul-2020, Bug bite and Rash (had sever rashes all over leg and arm left marks due to bug). Concurrent medical conditions included Type 1 diabetes mellitus (type 1 diabetic with major neuropathic reaction). Concomitant products included INSULIN for an unknown indication.   On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jul-2021, the patient experienced INSOMNIA (not been able to sleep), HYPERHIDROSIS (massive sweats), ABNORMAL DREAMS (intense dreams), ERYTHEMA (Redness) and INFLAMMATION (very inflamed). On an unknown date, the patient experienced CONDITION AGGRAVATED (second dose made it worse). At the time of the report, INSOMNIA (not been able to sleep), HYPERHIDROSIS (massive sweats), ABNORMAL DREAMS (intense dreams), CONDITION AGGRAVATED (second dose made it worse), ERYTHEMA (Redness) and INFLAMMATION (very inflamed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-337495 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Memory impairment
Clinical narrative: last 6 months a lot of brain fog/ She is now 6 months past the 2nd dose and she still has a lot of brain fog; my memory issues got worse/ just feels like my memory is going; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (last 6 months a lot of brain fog/ She is now 6 months past the 2nd dose and she still has a lot of brain fog) and MEMORY IMPAIRMENT (my memory issues got worse/ just feels like my memory is going) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 002B21A) for COVID-19 vaccination.     The patient's past medical history included Back surgery. Concurrent medical conditions included Cold sores, Urinary tract disorder, Fibromyalgia, Arthritis, Muscle pain, Sleep apnea and Lipoma. Concomitant products included AMOXICILLIN for Back surgery, VALACICLOVIR HYDROCHLORIDE (VALTREX) for Cold sores, PREGABALIN (LYRICA) for Fibromyalgia and Arthritis, ARNICA MONTANA for Muscle pain, OXYGEN for Sleep apnea, TROSPIUM CHLORIDE for Urinary tract disorder, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), CALCIUM, COLECALCIFEROL (VITAMIN D3), ASCORBIC ACID (VITAMIN C PLUS [ASCORBIC ACID]), LISINOPRIL, LORAZEPAM (ATIVAN), DONEPEZIL HYDROCHLORIDE (ARICEPT), ESCITALOPRAM OXALATE (LEXAPRO), QUETIAPINE FUMARATE (SEROQUEL), ATORVASTATIN, FISH OIL and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced FEELING ABNORMAL (last 6 months a lot of brain fog/ She is now 6 months past the 2nd dose and she still has a lot of brain fog) and MEMORY IMPAIRMENT (my memory issues got worse/ just feels like my memory is going). The patient was treated with DONEPEZIL HYDROCHLORIDE (ARICEPT) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (last 6 months a lot of brain fog/ She is now 6 months past the 2nd dose and she still has a lot of brain fog) had not resolved and MEMORY IMPAIRMENT (my memory issues got worse/ just feels like my memory is going) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication details also included centrum silver, breo and albuterol for unknown indication. Patient reported that she got her EKG and bloodwork done for the surgery. The patient took  20-30 seconds to remember where she got her EKG and bloodwork done.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Encephalitis autoimmune, Hospitalisation, Memory impairment
Clinical narrative: Admitted to hospital for three weeks; Memory issue/ it effects your memory; Diagnosed with autoimmune encephalitis; This spontaneous case was reported by a consumer and describes the occurrence of ENCEPHALITIS AUTOIMMUNE (Diagnosed with autoimmune encephalitis), HOSPITALISATION (Admitted to hospital for three weeks) and MEMORY IMPAIRMENT (Memory issue/ it effects your memory) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced ENCEPHALITIS AUTOIMMUNE (Diagnosed with autoimmune encephalitis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced HOSPITALISATION (Admitted to hospital for three weeks) (seriousness criterion hospitalization) and MEMORY IMPAIRMENT (Memory issue/ it effects your memory) (seriousness criterion hospitalization). The patient was hospitalized on sometime in March 2021 due to ENCEPHALITIS AUTOIMMUNE. At the time of the report, ENCEPHALITIS AUTOIMMUNE (Diagnosed with autoimmune encephalitis), HOSPITALISATION (Admitted to hospital for three weeks) and MEMORY IMPAIRMENT (Memory issue/ it effects your memory) outcome was unknown.            After Moderna vaccine patient ended up with auto immune disease. The patient was admitted to hospital in March for three weeks and was diagnosed with autoimmune encephalitis. The patient was diagnosed by a neurologist and reported it affected memory.  Treatment information was not provided.  Company comment: This case concerns a 61-year-old female patient with no relevant medical history, who experienced the unexpected serious events of hospitalization, autoimmune encephalitis and memory impairment. The events occurred unknown number of days after the second dose of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine. The rechallenge was not applicable, as the event was reported after the second dose and no additional dosing will be given. The benefit-risk relationship of vaccine is not affected by this report.; Sender's Comments: This case concerns a 61-year-old female patient with no relevant medical history, who experienced the unexpected serious events of hospitalization, autoimmune encephalitis and memory impairment. The events occurred unknown number of days after the second dose of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine. The rechallenge was not applicable, as the event was reported after the second dose and no additional dosing will be given. The benefit-risk relationship of vaccine is not affected by this report.