chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Lip swelling, Lupus-like syndrome, Pyrexia, Urticaria
Clinical narrative: the vaccine triggered lupus; hives; fever; lips were swollen; obstruction breathing; This spontaneous case was reported by a consumer and describes the occurrence of LUPUS-LIKE SYNDROME (the vaccine triggered lupus) in a 20-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.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced LUPUS-LIKE SYNDROME (the vaccine triggered lupus) (seriousness criterion medically significant and hospitalization), URTICARIA (hives) (seriousness criterion hospitalization), PYREXIA (fever) (seriousness criterion hospitalization), LIP SWELLING (lips were swollen) (seriousness criterion hospitalization) and DYSPNOEA (obstruction breathing) (seriousness criterion hospitalization). At the time of the report, LUPUS-LIKE SYNDROME (the vaccine triggered lupus), URTICARIA (hives), PYREXIA (fever), LIP SWELLING (lips were swollen) and DYSPNOEA (obstruction breathing) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Concomitant and treatment information not provided.   This case was linked to MOD-2021-050847 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Haemorrhage
Clinical narrative: started to bleed the day after the 1st Moderna shot; Doctor prescribed some antibiotics but still does not know what is happening to me/my whole body is messed up, i have to go for some tests first because they don´t know what is; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (started to bleed the day after the 1st Moderna shot) in a male patient of an unknown age 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (started to bleed the day after the 1st Moderna shot) (seriousness criterion medically significant) and FEELING ABNORMAL (Doctor prescribed some antibiotics but still does not know what is happening to me/my whole body is messed up, i have to go for some tests first because they don´t know what is). At the time of the report, HAEMORRHAGE (started to bleed the day after the 1st Moderna shot) and FEELING ABNORMAL (Doctor prescribed some antibiotics but still does not know what is happening to me/my whole body is messed up, i have to go for some tests first because they don´t know what is) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment for the event include some antibiotics but didn't specify one in particular.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Loss of consciousness, Pain in extremity
Clinical narrative: arm felt little bit achy; passed out; cold swats; felt the room was spinning; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 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 LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), COLD SWEAT (cold swats) and DIZZINESS (felt the room was spinning). On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm felt little bit achy). On 23-Mar-2021, LOSS OF CONSCIOUSNESS (passed out), COLD SWEAT (cold swats) and DIZZINESS (felt the room was spinning) had resolved. On 25-Mar-2021, PAIN IN EXTREMITY (arm felt little bit achy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   There was no concomitant medications reported. Treatment included as Ibuprofen.  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.   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 these events, a causal relationship cannot be excluded.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Eyelid ptosis, Strabismus
Clinical narrative: double vision; drooping eyelid; left eye turns inwards; This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (double vision), EYELID PTOSIS (drooping eyelid) and STRABISMUS (left eye turns inwards) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history. ). Concomitant products included LEVOTHYROXINE and TAMSULOSIN for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced DIPLOPIA (double vision) (seriousness criterion hospitalization prolonged), EYELID PTOSIS (drooping eyelid) (seriousness criterion hospitalization prolonged) and STRABISMUS (left eye turns inwards) (seriousness criterion hospitalization prolonged). At the time of the report, DIPLOPIA (double vision), EYELID PTOSIS (drooping eyelid) and STRABISMUS (left eye turns inwards) had not resolved.        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.   Treatment for the events included initially 2 aspirins.  Based on the current available 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 available 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: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pulmonary embolism, Pyrexia
Clinical narrative: Blood clot in lung; fever; Difficult breathing; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Blood clot in lung) and DYSPNOEA (Difficult breathing) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 007M20A) 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). Concurrent medical conditions included Hypertension.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced DYSPNOEA (Difficult breathing) (seriousness criterion medically significant). On 27-Feb-2021, the patient experienced PULMONARY EMBOLISM (Blood clot in lung) (seriousness criteria hospitalization and medically significant) and PYREXIA (fever). At the time of the report, PULMONARY EMBOLISM (Blood clot in lung), DYSPNOEA (Difficult breathing) and PYREXIA (fever) outcome was unknown.            Treatment details included Heparin, Xarelto.  Based on the current available information a temporal association between the use of the product and the onset date of the events, and with reoccurrence of blood clot with second vaccine use, causal relationship with the events cannot be excluded. Fever is consistent with the known safety profile of the vaccine.; Sender's Comments: Based on the current available information a temporal association between the use of the product and the onset date of the events, and with reoccurrence of blood clot with second vaccine use, causal relationship with the events cannot be excluded. Fever is consistent with the known safety profile of the vaccine
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Thrombosis
Clinical narrative: Blood clots; Felt extremely ill; 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 THROMBOSIS (Blood clots) in a patient of an unknown age and gender 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 Cancer and Autoimmune disorder.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant) and MALAISE (Felt extremely ill). At the time of the report, THROMBOSIS (Blood clots) and MALAISE (Felt extremely ill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Ulcer haemorrhage
Clinical narrative: bleeding ulcer; Unable to receive the second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ULCER HAEMORRHAGE (bleeding ulcer) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K2VZA) 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 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ULCER HAEMORRHAGE (bleeding ulcer) (seriousness criterion hospitalization) and INCOMPLETE COURSE OF VACCINATION (Unable to receive the second dose). At the time of the report, ULCER HAEMORRHAGE (bleeding ulcer) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (Unable to receive the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided. Treatment information included blood transfusion.  Very limited information regarding this event has been provided at this time.  Additionally, this report refers to a case of incomplete course of vaccination for mRNA-1273, lot not applicable. Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.  Additionally, this report refers to a case of incomplete course of vaccination for mRNA-1273, lot not applicable. Further information has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Atrioventricular block, Blood glucose, Dizziness, Electrocardiogram, Gait inability
Clinical narrative: EKG showed minor heart Block; Dizzy; Cannot walk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIOVENTRICULAR BLOCK (EKG showed minor heart Block) in an 80-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 Hip replacement. Concurrent medical conditions included Diabetes. Concomitant products included CALCIUM CARBONATE (FORTIFY) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced ATRIOVENTRICULAR BLOCK (EKG showed minor heart Block) (seriousness criterion medically significant), DIZZINESS (Dizzy) and GAIT INABILITY (Cannot walk). At the time of the report, ATRIOVENTRICULAR BLOCK (EKG showed minor heart Block) had not resolved and DIZZINESS (Dizzy) and GAIT INABILITY (Cannot walk) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Blood glucose: 140 140. On 06-Mar-2021, Electrocardiogram: abnormal showed minor Heart block.. On 06-Mar-2021, Heart rate: 42 42.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Based on the current available information and temporal association between the use of the product and 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 events a causal relationship cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate
Clinical narrative: EKG showed minor heart Block; Dizzy; Cannot walk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIOVENTRICULAR BLOCK (EKG showed minor heart Block) in an 80-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 Hip replacement. Concurrent medical conditions included Diabetes. Concomitant products included CALCIUM CARBONATE (FORTIFY) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced ATRIOVENTRICULAR BLOCK (EKG showed minor heart Block) (seriousness criterion medically significant), DIZZINESS (Dizzy) and GAIT INABILITY (Cannot walk). At the time of the report, ATRIOVENTRICULAR BLOCK (EKG showed minor heart Block) had not resolved and DIZZINESS (Dizzy) and GAIT INABILITY (Cannot walk) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Blood glucose: 140 140. On 06-Mar-2021, Electrocardiogram: abnormal showed minor Heart block.. On 06-Mar-2021, Heart rate: 42 42.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Based on the current available information and temporal association between the use of the product and 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 events a causal relationship cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Pneumonia, Pyrexia
Clinical narrative: Covid-19; Bad Cough; Pneaumonia; Headache; Fever; A spontaneous report was received from a  consumer concerning an  70 -year old,  male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and    experienced  headache, Fever, Tested positive for covid-19, admitted to hospital, had pneumonia and covid-19, Bad cough, Received only first dose of moderna covid-19 vaccine.  The patient's medical history, was not provided by the reporter, included no known allergies,  Concomitant medications reported were Blood pressure medication, Cholesterol medication, Blood thinner medication.  On  07 Jan  2021prior to the onset of the symptoms, the patient received their first  of two planned doses of mRNA-1273 (Batch number 012L20A) unknown route  for prophylaxis of COVID-19 infection.   On 08 Jan  2021, patient experienced headache and fever. On 16-Jan-2021 he tested positive for covid-19 on same date he was admitted to a hospital where he spent 7 days in ICU, had a bad cough, Pneumonia and covid and spent one month in hospital and he discharged from hospital on 15-feb-2021. The serious events Tested positive for covid-19, pneumonia, are hospitalized and medically significant.  Treatment information  provided was 10 doses of Remdesivir, oxygen, Breathing treatment, Dexamethasone injections a couple of times a day.  Action taken with mRNA-1273 in response to the events  was not provided.   The outcome of the events  headache and fever were resolved on 15 Jan 2021, covid-19, pneumonia, admitted to hospital were resolved on 15-feb-2021.; Reporter'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: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Breast pain, Chromaturia, Decreased appetite, Dyspnoea
Clinical narrative: Pain coming from around the liver area but it radiated under my right and left breasts; Pain coming from around the liver area but it radiated under my right and left breasts; Lost my appetite; Urine was gold; Lost 10 lbs; Could not get a deep breath; Temperature reached 101F; vomiting; Nauseous; A spontaneous report was received from a consumer who is 76 year female who experienced a reaction to the vaccine, experienced pain coming from around the liver area radiating under right and left breast,  loss of appetite, difficulty breathing, vomiting and nausea.  The patient's medical history included fibromyalgia, ulcerative colitis, and obesity. Concomitant product use included:levothyroxine 150 mg, verapamil 120 mg (blood pressure), losartan 100 mg (blood pressure), Asacol 800 mg three  times a day, Eliquis 5 mg, alprazolam (Xanax) 0.5 mg up to three a day, Centrum silver once a day, iron pill once a day, B12 500 mcg once a day, GNC probiotic 50 billion CFU, vitamin D 1000 mg, Citracal max Plus D3 once a day, magnesium glycinate, diphenydrinate.   On 15-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number015M20A.).  On 16Mar2021,approximately 1 day prior to the onset of the symptoms, the patient received their first/second of two planned doses of mRNA-1273 (Batch number: 001B21A.) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 17Mar2021 about 10 am, the patient woke up screaming with pain coming from around the liver area radiating under the right and left breasts. The patient states that taking deep breaths lead to excessive vomiting resulting in the ultimate loss of 10lbs. After the initial episode of vomiting, there was only nausea. An ambulance transported her to the hospital, as she continued to scream, resulting in being medicated to calm her down. The medication used is unknown. In the hospital, received morphine for three days In the hospital, she was told her temperature reached 101F. Upon returning home on 19Mar2021 afternoon, her temperature ranged from 99.4 to 99.8, one day peaking 101F. Today (29Mar2021) it is back to a more normal temperature: 98F.  In the hospital, ultrasounds, CAT scan, and blood and urine tests was performed, results were not provided. Patient reports currently she is still in pain, that has reduced from a 10 to a 2.   The outcome of the events, pain coming from around the liver area radiating under right and left breast,  loss of appetite, difficulty breathing, vomiting and nausea is unknown.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting, Weight decreased
Clinical narrative: Pain coming from around the liver area but it radiated under my right and left breasts; Pain coming from around the liver area but it radiated under my right and left breasts; Lost my appetite; Urine was gold; Lost 10 lbs; Could not get a deep breath; Temperature reached 101F; vomiting; Nauseous; A spontaneous report was received from a consumer who is 76 year female who experienced a reaction to the vaccine, experienced pain coming from around the liver area radiating under right and left breast,  loss of appetite, difficulty breathing, vomiting and nausea.  The patient's medical history included fibromyalgia, ulcerative colitis, and obesity. Concomitant product use included:levothyroxine 150 mg, verapamil 120 mg (blood pressure), losartan 100 mg (blood pressure), Asacol 800 mg three  times a day, Eliquis 5 mg, alprazolam (Xanax) 0.5 mg up to three a day, Centrum silver once a day, iron pill once a day, B12 500 mcg once a day, GNC probiotic 50 billion CFU, vitamin D 1000 mg, Citracal max Plus D3 once a day, magnesium glycinate, diphenydrinate.   On 15-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number015M20A.).  On 16Mar2021,approximately 1 day prior to the onset of the symptoms, the patient received their first/second of two planned doses of mRNA-1273 (Batch number: 001B21A.) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 17Mar2021 about 10 am, the patient woke up screaming with pain coming from around the liver area radiating under the right and left breasts. The patient states that taking deep breaths lead to excessive vomiting resulting in the ultimate loss of 10lbs. After the initial episode of vomiting, there was only nausea. An ambulance transported her to the hospital, as she continued to scream, resulting in being medicated to calm her down. The medication used is unknown. In the hospital, received morphine for three days In the hospital, she was told her temperature reached 101F. Upon returning home on 19Mar2021 afternoon, her temperature ranged from 99.4 to 99.8, one day peaking 101F. Today (29Mar2021) it is back to a more normal temperature: 98F.  In the hospital, ultrasounds, CAT scan, and blood and urine tests was performed, results were not provided. Patient reports currently she is still in pain, that has reduced from a 10 to a 2.   The outcome of the events, pain coming from around the liver area radiating under right and left breast,  loss of appetite, difficulty breathing, vomiting and nausea is unknown.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Malaise, Nausea
Clinical narrative: head hurt so bad, she thought it was a stroke; had to lay around the house/weak; dizziness; not well; nausea; little bit of soreness in the arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (head hurt so bad, she thought it was a stroke) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 039K20A) 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 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (little bit of soreness in the arm). On 09-Feb-2021, the patient experienced HEADACHE (head hurt so bad, she thought it was a stroke) (seriousness criterion medically significant), ASTHENIA (had to lay around the house/weak), DIZZINESS (dizziness), MALAISE (not well) and NAUSEA (nausea).   At the time of the report, HEADACHE (head hurt so bad, she thought it was a stroke), ASTHENIA (had to lay around the house/weak), DIZZINESS (dizziness), MALAISE (not well), VACCINATION SITE PAIN (little bit of soreness in the arm) and NAUSEA (nausea) outcome was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: head hurt so bad, she thought it was a stroke; had to lay around the house/weak; dizziness; not well; nausea; little bit of soreness in the arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (head hurt so bad, she thought it was a stroke) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 039K20A) 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 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (little bit of soreness in the arm). On 09-Feb-2021, the patient experienced HEADACHE (head hurt so bad, she thought it was a stroke) (seriousness criterion medically significant), ASTHENIA (had to lay around the house/weak), DIZZINESS (dizziness), MALAISE (not well) and NAUSEA (nausea).   At the time of the report, HEADACHE (head hurt so bad, she thought it was a stroke), ASTHENIA (had to lay around the house/weak), DIZZINESS (dizziness), MALAISE (not well), VACCINATION SITE PAIN (little bit of soreness in the arm) and NAUSEA (nausea) outcome was unknown.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039AZ1A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion medically significant). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium decreased, Diarrhoea
Clinical narrative: Severe chronic diarrhea up to 20 times a day; potassium level at 2; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Severe chronic diarrhea up to 20 times a day) and BLOOD POTASSIUM DECREASED (potassium level at 2) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Severe chronic diarrhea up to 20 times a day) (seriousness criterion hospitalization) and BLOOD POTASSIUM DECREASED (potassium level at 2) (seriousness criterion hospitalization). The patient was hospitalized from 16-Mar-2021 to 24-Mar-2021 due to BLOOD POTASSIUM DECREASED and DIARRHOEA. At the time of the report, DIARRHOEA (Severe chronic diarrhea up to 20 times a day) and BLOOD POTASSIUM DECREASED (potassium level at 2) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Deafness, Hypoaesthesia, Influenza like illness, Tinnitus
Clinical narrative: Bell's palsy on right side; Numbness of face on right side; Hearing loss in right ear; Buzzing in both ears; Flu like symptoms for 4 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS (Hearing loss in right ear) and FACIAL PARALYSIS (Bell's palsy on right side) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis, Blood pressure and Cholesterol.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms for 4 days). On 25-Mar-2021, the patient experienced DEAFNESS (Hearing loss in right ear) (seriousness criterion medically significant) and TINNITUS (Buzzing in both ears). On 27-Mar-2021, the patient experienced FACIAL PARALYSIS (Bell's palsy on right side) (seriousness criterion medically significant) and HYPOAESTHESIA (Numbness of face on right side). On 22-Mar-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms for 4 days) had resolved. At the time of the report, DEAFNESS (Hearing loss in right ear), FACIAL PARALYSIS (Bell's palsy on right side), TINNITUS (Buzzing in both ears) and HYPOAESTHESIA (Numbness of face on right side) outcome was unknown.            She was taking blood pressure and cholesterol medicine as concomitant.  Treatment included steroid infusion.; Sender's Comments: Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died; 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 DEATH (Died) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter. No treatment information was provided.  Very limited information regarding the event of death has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the event of death has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Feeling abnormal, Insomnia, Neuropathy peripheral, Vaccination site pain
Clinical narrative: neuropathy was really bad/felt worse when sitting and laying; couldn't sleep; felt sick to her stomach; felt really bad; injection arm sore; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy was really bad/felt worse when sitting and laying) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history not provided).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection arm sore). On 30-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (neuropathy was really bad/felt worse when sitting and laying) (seriousness criterion medically significant), INSOMNIA (couldn't sleep), ABDOMINAL DISCOMFORT (felt sick to her stomach) and FEELING ABNORMAL (felt really bad). On 31-Mar-2021, VACCINATION SITE PAIN (injection arm sore) had resolved. At the time of the report, NEUROPATHY PERIPHERAL (neuropathy was really bad/felt worse when sitting and laying), INSOMNIA (couldn't sleep), ABDOMINAL DISCOMFORT (felt sick to her stomach) and FEELING ABNORMAL (felt really bad) outcome was unknown.            Concomitant medication use was not provided.  Treatment information was not reported.  This case concerns a 73-year-old female with a serious unexpected event of neuropathy peripheral, and nonserious unexpected feeling abnormal, abdominal discomfort, insomnia, and expected vaccination site pain. Event onset the same day as second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 73-year-old female with a serious unexpected event of neuropathy peripheral, and nonserious unexpected feeling abnormal, abdominal discomfort, insomnia, and expected vaccination site pain. Event onset the same day as second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Diarrhoea, Dizziness, Hypotension
Clinical narrative: COVID-19; Passed out; Diarrhea; Dizziness; Weakness; Low blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history provided).    On 14-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 LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), ASTHENIA (Weakness) and HYPOTENSION (Low blood pressure). On 26-Mar-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), ASTHENIA (Weakness), HYPOTENSION (Low blood pressure) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, COVID-19 (positive-negative): positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was given intravenous bamlanivimab monoclonal antibodies therapy in the emergency room  Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of Covid-19 and the product use is assessed as unlikely. The remaining events are assessed as a symptom of the disease and also assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of Covid-19 and the product use is assessed as unlikely. The remaining events are assessed as a symptom of the disease and also assessed as unlikely related to mRNA-1273.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: COVID-19; Passed out; Diarrhea; Dizziness; Weakness; Low blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history provided).    On 14-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 LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), ASTHENIA (Weakness) and HYPOTENSION (Low blood pressure). On 26-Mar-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), ASTHENIA (Weakness), HYPOTENSION (Low blood pressure) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, COVID-19 (positive-negative): positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was given intravenous bamlanivimab monoclonal antibodies therapy in the emergency room  Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of Covid-19 and the product use is assessed as unlikely. The remaining events are assessed as a symptom of the disease and also assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of Covid-19 and the product use is assessed as unlikely. The remaining events are assessed as a symptom of the disease and also assessed as unlikely related to mRNA-1273.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Gilliam barre syndrome; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of GUILLAIN-BARRE SYNDROME (Gilliam barre syndrome) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bell's palsy.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced GUILLAIN-BARRE SYNDROME (Gilliam barre syndrome) (seriousness criterion hospitalization). The patient was hospitalized from 01-Mar-2021 to 07-Mar-2021 due to GUILLAIN-BARRE SYNDROME. At the time of the report, GUILLAIN-BARRE SYNDROME (Gilliam barre syndrome) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by patient. Treatment of this event was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Gingival bleeding, Hypersensitivity, Platelet count abnormal, Platelet count decreased
Clinical narrative: Severe allergic reaction; Redness on her face; Gum started bleeding; Platelet count was down to 1000; Platelet count went up to 3000, then suddenly went back to 1000 again.; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Severe allergic reaction), ERYTHEMA (Redness on her face), GINGIVAL BLEEDING (Gum started bleeding), PLATELET COUNT DECREASED (Platelet count was down to 1000) and PLATELET COUNT ABNORMAL (Platelet count went up to 3000, then suddenly went back to 1000 again.) in a 25-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.   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 HYPERSENSITIVITY (Severe allergic reaction) (seriousness criteria hospitalization and life threatening), ERYTHEMA (Redness on her face) (seriousness criteria hospitalization and life threatening), GINGIVAL BLEEDING (Gum started bleeding) (seriousness criteria hospitalization and life threatening), PLATELET COUNT DECREASED (Platelet count was down to 1000) (seriousness criteria hospitalization and life threatening) and PLATELET COUNT ABNORMAL (Platelet count went up to 3000, then suddenly went back to 1000 again.) (seriousness criteria hospitalization and life threatening). At the time of the report, HYPERSENSITIVITY (Severe allergic reaction), ERYTHEMA (Redness on her face), GINGIVAL BLEEDING (Gum started bleeding), PLATELET COUNT DECREASED (Platelet count was down to 1000) and PLATELET COUNT ABNORMAL (Platelet count went up to 3000, then suddenly went back to 1000 again.) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information included IV infusion (8 bags of platelets).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site induration, Nephrolithiasis
Clinical narrative: has developed a kidney stone; hardness around the injection site; redness around the injection site; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEPHROLITHIASIS (has developed a kidney stone) in a 59-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 No adverse event.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 24-Mar-2021, the patient experienced NEPHROLITHIASIS (has developed a kidney stone) (seriousness criterion medically significant), INJECTION SITE INDURATION (hardness around the injection site), INJECTION SITE ERYTHEMA (redness around the injection site) and FATIGUE (fatigue).   At the time of the report, NEPHROLITHIASIS (has developed a kidney stone) had not resolved and INJECTION SITE INDURATION (hardness around the injection site), INJECTION SITE ERYTHEMA (redness around the injection site) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Keflex for kidney stones.; Sender's Comments: Based on the known etiology and timing to diagnosis of nephrolithiasis, a causal relationship with the administration of mRNA-1273 is assessed as unlikely. The other events of hardness and redness around the injection and fatigue are temporarily associated with mRNA-1273 administration and consistent with the known safety profile of the vaccine.  Hence, causal association cannot be excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid ptosis, Facial paralysis, Headache, Hypoaesthesia, Inappropriate schedule of product administration
Clinical narrative: Patient took second dose 22 days after the first dose; felt like everything was pushing downward on her face; face felt frozen and could not move her face; Ptosis of her left eye; Dull and severe headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (felt like everything was pushing downward on her face) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 0077M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced FACIAL PARALYSIS (felt like everything was pushing downward on her face) (seriousness criterion medically significant), HYPOAESTHESIA (face felt frozen and could not move her face), EYELID PTOSIS (Ptosis of her left eye) and HEADACHE (Dull and severe headache). On 23-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took second dose 22 days after the first dose). On 23-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took second dose 22 days after the first dose) had resolved. At the time of the report, FACIAL PARALYSIS (felt like everything was pushing downward on her face), HYPOAESTHESIA (face felt frozen and could not move her face) and HEADACHE (Dull and severe headache) outcome was unknown and EYELID PTOSIS (Ptosis of her left eye) 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 product use was reported. She consulted neurologist who prescribed apraclonidine 0.5 percent.   This case was linked to MOD-2021-066385 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, this is also a case of Inappropriate schedule of product administration of mRNA-1273 lot #(001A21A) with associated AE"s of facial paralysis, hypoesthesia, headache and ptosis. Further information is requested.