chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Neck pain, Pain in extremity
Clinical narrative: Patient stated she felt the vaccine go into her arm and she continues to have pain in her neck and arm 4 days later. She also mentioned pain in her feet after having them elevated for a period of time. She has also complained of having diarrhea since getting her shot. I told her to take Tylenol for the pain and use the form to report concerns along with talking to her doctor.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dysstasia, Pain
Clinical narrative: Severe body aches, bad headache, bad chills, lack of energy. I woke up at 4:30am the morning after receiving the vaccine needing to use the restroom, but I could barely get out of bed because of my severe body aches and lack of energy. When I did manage to get out of bed, I struggled to even stand up. I took 800mg of ibuprofen at that time (around 4:30am) for the pain, which helped. I spent more than the first half of my day in bed under layers of blankets until about 3:00pm, where I finally felt good enough to get out of bed. I didn?t feel the body aches completely go away until the morning of the 8th, 3 days after receiving the vaccine.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: CG recieved vaccine on 3/19. CG called 4/13 to report the follow: On the evening of 3/19, CG experienced nausea, body aches, and chills. Next day on 3/20--  CG describes feeling lousy and experienced body aches. On 3/21, CG states feelings of a bad hangover (nausea, headache, chills, fatigue). After 3/23,  CG experienced moderate to severe headaches every other day. Severe headache continues to persist. Today (4/13), CG called to report severe headaches. History of migraines. CG will visit PCP tomorrow
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: CG recieved vaccine on 3/19. CG called 4/13 to report the follow: On the evening of 3/19, CG experienced nausea, body aches, and chills. Next day on 3/20--  CG describes feeling lousy and experienced body aches. On 3/21, CG states feelings of a bad hangover (nausea, headache, chills, fatigue). After 3/23,  CG experienced moderate to severe headaches every other day. Severe headache continues to persist. Today (4/13), CG called to report severe headaches. History of migraines. CG will visit PCP tomorrow
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Coagulopathy, Menstrual disorder
Clinical narrative: onset of extended and unusual menstrual bleeding continuing for 2 weeks with excessive clotting
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Malaise, Nausea
Clinical narrative: Began with chills, had severe chills and slight fever all night long, body in pain, couldn't sleep.  The next day I was fatigued and nauseous.  I received vaccine Thursday 4/8/21. It is now Tuesday 4/13/21 and I am still a bit fatigued and sick to my stomach.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Began with chills, had severe chills and slight fever all night long, body in pain, couldn't sleep.  The next day I was fatigued and nauseous.  I received vaccine Thursday 4/8/21. It is now Tuesday 4/13/21 and I am still a bit fatigued and sick to my stomach.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pruritus
Clinical narrative: Left arm started itching a few minutes after injection,  slight redness appeared although only where patient had scratched.  Back also started itching no rash. Complained of burning sensation in legs.  Denies shortness of breath, difficulty swallowing, no swelling in tongue or throat.  BP- 124/79, p-93, O2sat-97% Given SL Zyrtec 10 mg at 5:30 pm.   Did notice slight decrease in symptoms within 10 minutes however symptoms persisting.  Given 50  mg IM Benadryl (RFA) at 5:40 pm .   5:44 pm- BP-112/73, p-85, O2sat- 98%  Discharged home with mother at 5:50 pm, given ER precautions- seek immediate care if shortness of breath, trouble swallowing, swelling or worsening in any way
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: WE WERE MISINFORMED BY THE HEALTH DEPARTMENT REP THAT WE CAN ADMINISTER THE MODERNA VACCINE TO ANYONE YOUNGER THAN 18 YEARS AND WE GAVE THIS 16YR OLD PATIENT THE MODERNA VACCINE.  SHE WILL NEED HER SECOND DOSAGE, BUT WE WANTED TO KNOW WHAT SHOULD BE DONE? THE PATIENT HAS HAD NO REACTION TO THE VACCINE.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Lymph node pain, Nausea
Clinical narrative: Fever, peaking at 101.5 F, starting at approx 2 am 4/12 lasting until approx 4 pm. Severe nausea from 2 am 4/12, lessening but continuing through following day (the day this report is written). Mild vomiting and diarrhea at 7 am 4/12 not continuing. Severe jaw pain starting 48 hours after vaccination (approx 12 pm 4/13) on right side of jaw, constant and intense, not limiting ability to move but preventing focus on tasks. Mild pain in some lymph nodes, mild headache, moderate fatigue not inconsistent with having been recently ill. All symptoms dealt with by patient without seeking medical intervention. OTC anti-nausea was taken without relief.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Pyrexia, Vomiting
Clinical narrative: Fever, peaking at 101.5 F, starting at approx 2 am 4/12 lasting until approx 4 pm. Severe nausea from 2 am 4/12, lessening but continuing through following day (the day this report is written). Mild vomiting and diarrhea at 7 am 4/12 not continuing. Severe jaw pain starting 48 hours after vaccination (approx 12 pm 4/13) on right side of jaw, constant and intense, not limiting ability to move but preventing focus on tasks. Mild pain in some lymph nodes, mild headache, moderate fatigue not inconsistent with having been recently ill. All symptoms dealt with by patient without seeking medical intervention. OTC anti-nausea was taken without relief.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, Chest X-ray, Dyspnoea, Electrocardiogram, Fibrin D dimer
Clinical narrative: Increasing shortness of breath that gets worse when laying down. Pt came by ambulance to the ER.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Metabolic function test, Troponin
Clinical narrative: Increasing shortness of breath that gets worse when laying down. Pt came by ambulance to the ER.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hot flush
Clinical narrative: Having the chills and hot flashes. Feeling dizzy
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: Lemon sized lump under left armpit - soft.  No treatment.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Goitre
Clinical narrative: Swelling thyroid, started one day after received my first shot of the Pfizer vaccine
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine given - No reaction
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature fluctuation, Chills, Dizziness, Headache
Clinical narrative: At 2:30am on April 13, I woke up with a 101-degree fever. Throughout the rest of the day I have felt chills, a headache, soreness all over my body, dizziness and overall weak. My temperature had fluctuated around 99.5-100 degrees all day.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: At 2:30am on April 13, I woke up with a 101-degree fever. Throughout the rest of the day I have felt chills, a headache, soreness all over my body, dizziness and overall weak. My temperature had fluctuated around 99.5-100 degrees all day.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: Woke with: Blood Clots in my left arm at injection pt and lower arm, wrist, hand. Blood Clots in my left leg, mainly calf, lower leg, ankle, some in thigh. Larger, more numerically present than in past from antihistamines. None present before Vax, allergen-free diet prevents usually.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Eye swelling, Headache, Hypertension
Clinical narrative: high blood pressure; Arm bothered her; Congested; Right arm started tingling; Not feel well; Eyes are puffy/cannot see out of her eyes; headache/headache got worse; Chills/felt ice cold on one side; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (high blood pressure) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Kidney disorder and Blood pressure increased (High Blood Pressure).    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced HYPERTENSION (high blood pressure) (seriousness criterion hospitalization), LIMB DISCOMFORT (Arm bothered her), NASAL CONGESTION (Congested), PARAESTHESIA (Right arm started tingling), MALAISE (Not feel well), EYE SWELLING (Eyes are puffy/cannot see out of her eyes), HEADACHE (headache/headache got worse) and CHILLS (Chills/felt ice cold on one side). At the time of the report, HYPERTENSION (high blood pressure), LIMB DISCOMFORT (Arm bothered her), NASAL CONGESTION (Congested), PARAESTHESIA (Right arm started tingling), MALAISE (Not feel well), EYE SWELLING (Eyes are puffy/cannot see out of her eyes), HEADACHE (headache/headache got worse) and CHILLS (Chills/felt ice cold on one side) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Blood pressure measurement: high (High) it was 175/80 after 10 minutes of receiving the vaccine. and high (High) It was 195/90 after 15 minutes of first measurement..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was hospitalized for 3 days. Treatment given was IV medication to lower blood pressure and Valium.; Sender's Comments: This case concerns a 69-year-old female with a serious unexpected event of hypertension, and nonserious unexpected eye swelling, nasal congestion, paraesthesia, malaise, limb discomfort, and expected headache, chills. 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Malaise, Nasal congestion, Paraesthesia
Clinical narrative: high blood pressure; Arm bothered her; Congested; Right arm started tingling; Not feel well; Eyes are puffy/cannot see out of her eyes; headache/headache got worse; Chills/felt ice cold on one side; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (high blood pressure) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes, Kidney disorder and Blood pressure increased (High Blood Pressure).    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced HYPERTENSION (high blood pressure) (seriousness criterion hospitalization), LIMB DISCOMFORT (Arm bothered her), NASAL CONGESTION (Congested), PARAESTHESIA (Right arm started tingling), MALAISE (Not feel well), EYE SWELLING (Eyes are puffy/cannot see out of her eyes), HEADACHE (headache/headache got worse) and CHILLS (Chills/felt ice cold on one side). At the time of the report, HYPERTENSION (high blood pressure), LIMB DISCOMFORT (Arm bothered her), NASAL CONGESTION (Congested), PARAESTHESIA (Right arm started tingling), MALAISE (Not feel well), EYE SWELLING (Eyes are puffy/cannot see out of her eyes), HEADACHE (headache/headache got worse) and CHILLS (Chills/felt ice cold on one side) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Blood pressure measurement: high (High) it was 175/80 after 10 minutes of receiving the vaccine. and high (High) It was 195/90 after 15 minutes of first measurement..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was hospitalized for 3 days. Treatment given was IV medication to lower blood pressure and Valium.; Sender's Comments: This case concerns a 69-year-old female with a serious unexpected event of hypertension, and nonserious unexpected eye swelling, nasal congestion, paraesthesia, malaise, limb discomfort, and expected headache, chills. 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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea at rest, Hypoxia, Oxygen saturation
Clinical narrative: Blood oxygen level dropped down to 79%; Extreme shortness of breath at rest; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA AT REST (Extreme shortness of breath at rest) and HYPOXIA (Blood oxygen level dropped down to 79%) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic obstructive pulmonary disease. Concomitant products included OXYGEN for COPD.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced DYSPNOEA AT REST (Extreme shortness of breath at rest) (seriousness criteria disability and medically significant). In March 2021, the patient experienced HYPOXIA (Blood oxygen level dropped down to 79%) (seriousness criteria disability and medically significant). At the time of the report, DYSPNOEA AT REST (Extreme shortness of breath at rest) and HYPOXIA (Blood oxygen level dropped down to 79%) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Oxygen saturation: 79 (Low) 79.         No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Epilepsy, Fatigue, Headache, Nausea
Clinical narrative: pain and swelling in arms and leg; nausea; fatigue; EPILEPTIC SEIZURES; chills; pain and swelling in arms and leg; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of EPILEPSY (EPILEPTIC SEIZURES) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Mental disability and Epilepsy. Concomitant products included CARBAMAZEPINE (CARBAMAZEPIN) and PHENOBARBITAL (FENABBOTT) for Convulsion.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced EPILEPSY (EPILEPTIC SEIZURES) (seriousness criterion medically significant), CHILLS (chills), PERIPHERAL SWELLING (pain and swelling in arms and leg), PYREXIA (fever), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain and swelling in arms and leg). On 28-Mar-2021, EPILEPSY (EPILEPTIC SEIZURES) outcome was unknown. At the time of the report, CHILLS (chills), PERIPHERAL SWELLING (pain and swelling in arms and leg), PYREXIA (fever), HEADACHE (headache), PAIN IN EXTREMITY (pain and swelling in arms and leg), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company comment:Based on the current information and the temporal association between the use of the product and the event start date a causal relationship cannot be excluded.; Sender's Comments: Based on the current information and the temporal association between the use of the product and the event start date a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: pain and swelling in arms and leg; nausea; fatigue; EPILEPTIC SEIZURES; chills; pain and swelling in arms and leg; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of EPILEPSY (EPILEPTIC SEIZURES) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Mental disability and Epilepsy. Concomitant products included CARBAMAZEPINE (CARBAMAZEPIN) and PHENOBARBITAL (FENABBOTT) for Convulsion.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced EPILEPSY (EPILEPTIC SEIZURES) (seriousness criterion medically significant), CHILLS (chills), PERIPHERAL SWELLING (pain and swelling in arms and leg), PYREXIA (fever), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain and swelling in arms and leg). On 28-Mar-2021, EPILEPSY (EPILEPTIC SEIZURES) outcome was unknown. At the time of the report, CHILLS (chills), PERIPHERAL SWELLING (pain and swelling in arms and leg), PYREXIA (fever), HEADACHE (headache), PAIN IN EXTREMITY (pain and swelling in arms and leg), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company comment:Based on the current information and the temporal association between the use of the product and the event start date a causal relationship cannot be excluded.; Sender's Comments: Based on the current information and the temporal association between the use of the product and the event start date a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Hypoaesthesia, Muscle spasms, Respiratory disorder, Vaccination site pain
Clinical narrative: Respiratory attack; Left arm was numb; Had muscle restrictions and spasms; Pain in the back; Pain in the arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RESPIRATORY DISORDER (Respiratory attack), HYPOAESTHESIA (Left arm was numb), MUSCLE SPASMS (Had muscle restrictions and spasms) and BACK PAIN (Pain in the back) in a 60-year-old female 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 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced RESPIRATORY DISORDER (Respiratory attack) (seriousness criterion medically significant), HYPOAESTHESIA (Left arm was numb) (seriousness criterion intervention required), MUSCLE SPASMS (Had muscle restrictions and spasms) (seriousness criterion intervention required), BACK PAIN (Pain in the back) (seriousness criterion intervention required) and VACCINATION SITE PAIN (Pain in the arm). At the time of the report, RESPIRATORY DISORDER (Respiratory attack), HYPOAESTHESIA (Left arm was numb), MUSCLE SPASMS (Had muscle restrictions and spasms), BACK PAIN (Pain in the back) and VACCINATION SITE PAIN (Pain in the arm) outcome was unknown.            Treatment provided include morphine, tramadol 50 mg and meloxicam 50 mg.  Action taken with mRNA-1273 in response to the events was not applicable.   Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature increased, Nausea, Nephrolithiasis, Vomiting
Clinical narrative: passed a kidney stone in his urine.; elevated temperature at night.; back pain in his left side.; throw up every hour from waves of pain/vomit every time his pain increased; nausea and vomiting that correlated to the dull burning pain; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (passed a kidney stone in his urine.) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced BODY TEMPERATURE INCREASED (elevated temperature at night.), BACK PAIN (back pain in his left side.), VOMITING (throw up every hour from waves of pain/vomit every time his pain increased) and NAUSEA (nausea and vomiting that correlated to the dull burning pain). On 24-Mar-2021, the patient experienced NEPHROLITHIASIS (passed a kidney stone in his urine.) (seriousness criterion medically significant). At the time of the report, NEPHROLITHIASIS (passed a kidney stone in his urine.), BODY TEMPERATURE INCREASED (elevated temperature at night.), BACK PAIN (back pain in his left side.), VOMITING (throw up every hour from waves of pain/vomit every time his pain increased) and NAUSEA (nausea and vomiting that correlated to the dull burning pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was included One extra strength Tylenol, three naproxens, water and Pedialyte  Based on the current information available and the temporal association between the product use and the onset of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current information available and the temporal association between the product use and the onset of the events a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Rash, White blood cell count decreased
Clinical narrative: Full body rash; WBC drastically dropped to almost zero; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of RASH (Full body rash) and WHITE BLOOD CELL COUNT DECREASED (WBC drastically dropped to almost zero) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Full body rash) (seriousness criterion hospitalization) and WHITE BLOOD CELL COUNT DECREASED (WBC drastically dropped to almost zero) (seriousness criteria hospitalization and medically significant). At the time of the report, RASH (Full body rash) and WHITE BLOOD CELL COUNT DECREASED (WBC drastically dropped to almost zero) 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 were not provided.  Physician called to report adverse reaction for her husband's co-worker who received the vaccine ten days back and developed full body rash and was hospitalized. Patient's WBC count drastically dropped(Almost zero). They were not sure if the vaccine was Moderna.  Treatment details were not provided.  Very limited information regarding these events has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram, Feeling abnormal, Loss of consciousness, Vaccination complication
Clinical narrative: Diagnosed with an A-Fib; She went to pick up a glass of water, and she does not remember dropping the glass but it crashed to the floor and it broke. She does not remember anything about that; A very strange thing happened; Had a very violent reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Diagnosed with an A-Fib) and LOSS OF CONSCIOUSNESS (She went to pick up a glass of water, and she does not remember dropping the glass but it crashed to the floor and it broke. She does not remember anything about that) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Allergy NOS (morphin).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced ATRIAL FIBRILLATION (Diagnosed with an A-Fib) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (She went to pick up a glass of water, and she does not remember dropping the glass but it crashed to the floor and it broke. She does not remember anything about that) (seriousness criterion medically significant), FEELING ABNORMAL (A very strange thing happened) and VACCINATION COMPLICATION (Had a very violent reaction). At the time of the report, ATRIAL FIBRILLATION (Diagnosed with an A-Fib), LOSS OF CONSCIOUSNESS (She went to pick up a glass of water, and she does not remember dropping the glass but it crashed to the floor and it broke. She does not remember anything about that), FEELING ABNORMAL (A very strange thing happened) and VACCINATION COMPLICATION (Had a very violent reaction) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: atrial fibrillation (abnormal) Atrial fibrillation.         Concomitant medications include natural fibroid 60 mg, Biestrogen  (Hormone regulator). Treatment medication include unknown intravenous medication.  Based on the current information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Fluid retention, Syncope, Vaccination complication
Clinical narrative: put on 30 pounds of water weight; Fainted; blood pressure dropped so low that she fainted; Moderna COVID-19 Vaccine reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Moderna COVID-19 Vaccine reaction) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included MACITENTAN for Primary pulmonary hypertension, WARFARIN, TADALAFIL and DILTIAZEM for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (Moderna COVID-19 Vaccine reaction). The patient was hospitalized on sometime in February 2021 due to SYNCOPE. At the time of the report, VACCINATION COMPLICATION (Moderna COVID-19 Vaccine reaction) 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.   On an unspecified date in Feb-2021, the patient reported that she became very ill and hospitalized for 12 days after receiving the Moderna vaccination. She reported that her blood pressure dropped so low that she fainted.  She also had had put on 30 pounds of water weight, which she is trying to get off.  She reported that her doctor was aware of the hospitalization.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Cellulitis on his elbow; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis on his elbow) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced CELLULITIS (Cellulitis on his elbow) (seriousness criterion medically significant). At the time of the report, CELLULITIS (Cellulitis on his elbow) 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 event included antibiotics.  Based on the current information and the temporal association between the use of the product and the start date of the event a causal relationship cannot be excluded.; Sender's Comments: Based on the current information and the temporal association between the use of the product and the start date of the event a causal relationship cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dysentery, Dyspnoea
Clinical narrative: could hardly breathe/hurts me to breath; Right side of chest hurt/pain on right side of the chest like muscle pulled; two weeks ago had dysentery; This spontaneous case was reported by a consumer and describes the occurrence of DYSENTERY (two weeks ago had dysentery) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes mellitus and Blood pressure high.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced DYSENTERY (two weeks ago had dysentery) (seriousness criterion medically significant). On 31-Mar-2021, the patient experienced DYSPNOEA (could hardly breathe/hurts me to breath) and CHEST PAIN (Right side of chest hurt/pain on right side of the chest like muscle pulled). At the time of the report, DYSENTERY (two weeks ago had dysentery), DYSPNOEA (could hardly breathe/hurts me to breath) and CHEST PAIN (Right side of chest hurt/pain on right side of the chest like muscle pulled) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       At first she didn't feel bad but last night 31Mar2021, she could hardly breathe, right side of chest hurt, hurts me to breathe, pain on right side of chest like I pulled a muscle, two weeks ago had dysentery. Treatment included ointment. Patient didn't want to call doctor as her doctor would just tell her to go to the hospital. Doctor told her to get tested for COVID.  Based on the known etiology of dysentery as being if infective origin, causality with mRNA-1273 is assessed as unlikely.  Although a temporal association exist, it is not enough to assess the other reported events as related to the administration of mRNA-1273.  Additional information has been requested as causality is cofounded by the patient's concurrent history of diabetes.; Sender's Comments: Based on the known etiology of dysentery as being if infective origin, causality with mRNA-1273 is assessed as unlikely.  Although a temporal association exist, it is not enough to assess the other reported events as related to the administration of mRNA-1273.  Additional information has been requested as causality is cofounded by the patient's concurrent history of diabetes.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Chromaturia, Fatigue, Hallucination, Pyrexia
Clinical narrative: Hallucinations; Skin turned "yellow"; body smelled like "old Urine"; her urine was the color of "coffee"; Fever; Chills; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of HALLUCINATION (Hallucinations) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 03-Dec-2020. Concurrent medical conditions included Scleroderma.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HALLUCINATION (Hallucinations) (seriousness criterion medically significant), YELLOW SKIN (Skin turned "yellow"), SKIN ODOUR ABNORMAL (body smelled like "old Urine"), CHROMATURIA (her urine was the color of "coffee"), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). On 13-Mar-2021, HALLUCINATION (Hallucinations), YELLOW SKIN (Skin turned "yellow"), SKIN ODOUR ABNORMAL (body smelled like "old Urine"), CHROMATURIA (her urine was the color of "coffee") and PYREXIA (Fever) had resolved. At the time of the report, CHILLS (Chills) and FATIGUE (Fatigue) had not 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 medications were reported.  The treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Skin odour abnormal, Yellow skin
Clinical narrative: Hallucinations; Skin turned "yellow"; body smelled like "old Urine"; her urine was the color of "coffee"; Fever; Chills; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of HALLUCINATION (Hallucinations) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 03-Dec-2020. Concurrent medical conditions included Scleroderma.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HALLUCINATION (Hallucinations) (seriousness criterion medically significant), YELLOW SKIN (Skin turned "yellow"), SKIN ODOUR ABNORMAL (body smelled like "old Urine"), CHROMATURIA (her urine was the color of "coffee"), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). On 13-Mar-2021, HALLUCINATION (Hallucinations), YELLOW SKIN (Skin turned "yellow"), SKIN ODOUR ABNORMAL (body smelled like "old Urine"), CHROMATURIA (her urine was the color of "coffee") and PYREXIA (Fever) had resolved. At the time of the report, CHILLS (Chills) and FATIGUE (Fatigue) had not 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 medications were reported.  The treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chest pain, Dysphagia, Dyspnoea, Fatigue
Clinical narrative: fatigue; difficulty swallowing.; allergic reaction; chest pain; shortness of breath; not feeling good; Weakness in Lower half of body; Difficulty breathing, brain is foggy, swelling in throat, excessive sweating, puffy face,having difficulty talking and her face became puffy; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Difficulty breathing, brain is foggy, swelling in throat, excessive sweating, puffy face,having difficulty talking and her face became puffy), CHEST PAIN (chest pain), DYSPNOEA (shortness of breath) and FEELING ABNORMAL (not feeling good) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ISOTRETINOIN (ACCUTANE) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced ANAPHYLACTIC REACTION (Difficulty breathing, brain is foggy, swelling in throat, excessive sweating, puffy face,having difficulty talking and her face became puffy) (seriousness criteria medically significant and life threatening), MUSCULAR WEAKNESS (Weakness in Lower half of body) and PYREXIA (Feverish). On 21-Jan-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion medically significant), DYSPNOEA (shortness of breath) (seriousness criterion medically significant), FEELING ABNORMAL (not feeling good) (seriousness criterion medically significant) and HYPERSENSITIVITY (allergic reaction). On 22-Jan-2021, the patient experienced DYSPHAGIA (difficulty swallowing.). On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, ANAPHYLACTIC REACTION (Difficulty breathing, brain is foggy, swelling in throat, excessive sweating, puffy face,having difficulty talking and her face became puffy), CHEST PAIN (chest pain), DYSPNOEA (shortness of breath), FEELING ABNORMAL (not feeling good), MUSCULAR WEAKNESS (Weakness in Lower half of body), HYPERSENSITIVITY (allergic reaction), DYSPHAGIA (difficulty swallowing.), FATIGUE (fatigue) and PYREXIA (Feverish) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product included birth control. Treatment information included anti nausea pills, aspirin, epiPen, benadryl, tylenol, injection for breathing and surmonside.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypersensitivity, Muscular weakness, Pyrexia
Clinical narrative: fatigue; difficulty swallowing.; allergic reaction; chest pain; shortness of breath; not feeling good; Weakness in Lower half of body; Difficulty breathing, brain is foggy, swelling in throat, excessive sweating, puffy face,having difficulty talking and her face became puffy; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Difficulty breathing, brain is foggy, swelling in throat, excessive sweating, puffy face,having difficulty talking and her face became puffy), CHEST PAIN (chest pain), DYSPNOEA (shortness of breath) and FEELING ABNORMAL (not feeling good) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ISOTRETINOIN (ACCUTANE) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced ANAPHYLACTIC REACTION (Difficulty breathing, brain is foggy, swelling in throat, excessive sweating, puffy face,having difficulty talking and her face became puffy) (seriousness criteria medically significant and life threatening), MUSCULAR WEAKNESS (Weakness in Lower half of body) and PYREXIA (Feverish). On 21-Jan-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion medically significant), DYSPNOEA (shortness of breath) (seriousness criterion medically significant), FEELING ABNORMAL (not feeling good) (seriousness criterion medically significant) and HYPERSENSITIVITY (allergic reaction). On 22-Jan-2021, the patient experienced DYSPHAGIA (difficulty swallowing.). On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, ANAPHYLACTIC REACTION (Difficulty breathing, brain is foggy, swelling in throat, excessive sweating, puffy face,having difficulty talking and her face became puffy), CHEST PAIN (chest pain), DYSPNOEA (shortness of breath), FEELING ABNORMAL (not feeling good), MUSCULAR WEAKNESS (Weakness in Lower half of body), HYPERSENSITIVITY (allergic reaction), DYSPHAGIA (difficulty swallowing.), FATIGUE (fatigue) and PYREXIA (Feverish) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product included birth control. Treatment information included anti nausea pills, aspirin, epiPen, benadryl, tylenol, injection for breathing and surmonside.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells palsy; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Bells palsy) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included OXYBATE SODIUM (XYREM), PIMOZIDE (ORAP), METFORMIN and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced FACIAL PARALYSIS (Bells palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bells palsy) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment for the event included Amantadine and Methylprednisolone. She was on treatment for that and will be still on treatment during her 2nd dose.  Company comment:Based on the current available information and temporal association between the use of the product and the onset date of the reported event of facial paralysis, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of facial paralysis, a causal relationship cannot be excluded.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Malaise, Nasopharyngitis, Treatment noncompliance
Clinical narrative: really sick; chest pains; will not take the second shot; pretty bad cold; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (really sick) and CHEST PAIN (chest pains) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced NASOPHARYNGITIS (pretty bad cold). On an unknown date, the patient experienced MALAISE (really sick) (seriousness criterion hospitalization), CHEST PAIN (chest pains) (seriousness criterion hospitalization) and TREATMENT NONCOMPLIANCE (will not take the second shot). At the time of the report, MALAISE (really sick), CHEST PAIN (chest pains), TREATMENT NONCOMPLIANCE (will not take the second shot) and NASOPHARYNGITIS (pretty bad cold) outcome was unknown. Not provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's weight is 170 (units not reported). Whilst hospitalized, all laboratory tests (unspecified) were normal. Concomitant medication included unspecified medication for asthma.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.