chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot on his left leg, from his groin to his ankle/still having the blood clot; A spontaneous report was received from a consumer concerning an 80-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and had blood clot on his left leg, from his groin to his ankle.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 02 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 039KZ014) intramuscularly for prophylaxis of COVID-19 infection.   On 30 Jan 2021, approximately two weeks prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On an unknown date in Feb 2021, the patient reported having a medically significant event, blood clot on his left leg, from his groin to his ankle and is still having it. The patient taking medication for it.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  At the time of this report, the outcome of the event had blood clot on his left leg, from his groin to his ankle was not resolved.; Reporter'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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Dizziness, Fatigue
Clinical narrative: Fatigue; Dizziness; Light temperature; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), DIZZINESS (Dizziness) and BODY TEMPERATURE INCREASED (Light temperature) in an 82-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. Concomitant products included ARFORMOTEROL TARTRATE (BROVANA) and BUDESONIDE for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced FATIGUE (Fatigue), DIZZINESS (Dizziness) and BODY TEMPERATURE INCREASED (Light temperature). At the time of the report, FATIGUE (Fatigue), DIZZINESS (Dizziness) and BODY TEMPERATURE INCREASED (Light temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  This case concerns an 82-year-old female with serious unexpected events of dizziness, fatigue, and temperature increased. 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 an 82-year-old female with serious unexpected events of dizziness, fatigue, and temperature increased. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Patient did not get full dose of vaccine; The needle was not screwed in properly and the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient did not get full dose of vaccine) and DEVICE CONNECTION ISSUE (The needle was not screwed in properly and the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 207L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced UNDERDOSE (Patient did not get full dose of vaccine) and DEVICE CONNECTION ISSUE (The needle was not screwed in properly and the vaccine). On 26-Jan-2021, UNDERDOSE (Patient did not get full dose of vaccine) and DEVICE CONNECTION ISSUE (The needle was not screwed in properly and the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  This report refers to a case of vaccine underdose and syringe connection issue for mRNA-1273, lot # 207L20A with no associated AEs.; Sender's Comments: This report refers to a case of vaccine underdose and syringe connection issue for mRNA-1273, lot # 207L20A with no associated AEs.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Loss of consciousness, Movement disorder, Pyrexia
Clinical narrative: passed out; couldn't move; threw up; joint pain; headache; hives; high fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Mar-2021 and was forwarded to Moderna on 24-Mar-2021.    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 nos. 015M20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Urticaria (chronic hives for 16 years.) since an unknown date. Concomitant products included DOXEPIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced PYREXIA (high fever). On 19-Feb-2021, the patient experienced URTICARIA (hives). On 19-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), MOVEMENT DISORDER (couldn't move), VOMITING (threw up), ARTHRALGIA (joint pain) and HEADACHE (headache). On 19-Mar-2021, LOSS OF CONSCIOUSNESS (passed out) had resolved. On 24-Mar-2021, MOVEMENT DISORDER (couldn't move), VOMITING (threw up), PYREXIA (high fever), ARTHRALGIA (joint pain) and HEADACHE (headache) had resolved. At the time of the report, URTICARIA (hives) outcome was unknown.            Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: .; 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vomiting
Clinical narrative: passed out; couldn't move; threw up; joint pain; headache; hives; high fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Mar-2021 and was forwarded to Moderna on 24-Mar-2021.    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 nos. 015M20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Urticaria (chronic hives for 16 years.) since an unknown date. Concomitant products included DOXEPIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced PYREXIA (high fever). On 19-Feb-2021, the patient experienced URTICARIA (hives). On 19-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), MOVEMENT DISORDER (couldn't move), VOMITING (threw up), ARTHRALGIA (joint pain) and HEADACHE (headache). On 19-Mar-2021, LOSS OF CONSCIOUSNESS (passed out) had resolved. On 24-Mar-2021, MOVEMENT DISORDER (couldn't move), VOMITING (threw up), PYREXIA (high fever), ARTHRALGIA (joint pain) and HEADACHE (headache) had resolved. At the time of the report, URTICARIA (hives) outcome was unknown.            Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: .; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Myalgia, Pyrexia, Vomiting
Clinical narrative: she was vomiting; fever of 100.7; Felt like she had the flu; hurting all over her body; This spontaneous report was reported was received from a consumer and concerning in a 71-year-old,female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) and experienced of vomiting, high fever of 100.7, hurting all over her body and Felt like she had the flu.    The patient's past medical history included No adverse event.  Concomitant products included Acetoaminophen from 23-Mar-2021 to an unknown date, Ondansetron from 23-Mar-2021 to an unknown date, Metoclopramide and Sodium chloride 0.9% Dextrose5 % from  23-Mar-2021 to an unknown date.  Treatment included Fluids given at the ED   On 22-Mar-2021,prior to the onset of event s the patient received the second of two planned dose of mRNA-1273 Moderna COVID-19 Vaccine (Batch number:003A12A) Intramuscularly in the arm for prophylaxis of COVID-19 infection.  The patient was hospitalized on 23-Mar-2021 due to fever and Vomiting. The patient also experienced hurting all over her body, Felt like she had the flu.  Action taken with mRNA-1273 in response to the events was not Applicable.   The outcome of events vomiting, high fever of 100.7, hurting all over her body and Felt like she had the flu was unknown.; Reporter'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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Seizure
Clinical narrative: seizure; sore arm; A spontaneous report was received from a consumer, concerning a 67-years old male patient, who received Moderna's COVID-19 vaccine and experienced seizure and sore arm.  The patient's medical history included brain tumor removed. No relevant concomitant product was reported.  On 06 Ma 2021, prior to the onset of events, the patient received his first of two planned doses of mRNA-1273 (lot number 036A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On the same day patient experienced sore arm for couple of days.  On 12 Mar 2021, 6 days after the first shot, the patient experienced seizure. The patient was hospitalized for a night and laboratory tests were performed. There was no indication of stroke and everything else came back inconclusive.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event sore arm was resolved on 08 Mar 2021 and the outcome of the event seizure was unknown; 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: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Lacrimation increased, Paraesthesia
Clinical narrative: diagnosed with Bell's palsy; severe watering of left eye; tingling around mouth area; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (diagnosed with Bell's palsy) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 362A1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stent insertion NOS in 2008. Concurrent medical conditions included Lyme disease since 09-Mar-2021 and Bell's palsy since 09-Mar-2021.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced FACIAL PARALYSIS (diagnosed with Bell's palsy) (seriousness criterion medically significant), LACRIMATION INCREASED (severe watering of left eye) and PARAESTHESIA (tingling around mouth area). At the time of the report, FACIAL PARALYSIS (diagnosed with Bell's palsy), LACRIMATION INCREASED (severe watering of left eye) and PARAESTHESIA (tingling around mouth area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; 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 with the events cannot be excluded. Of note, patient has a  history of Lyme disease, Bell's palsy.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Passed away on the sleep; A spontaneous report was received from a pharmacist concerning a 73-years-old male patient who received Moderna's COVID-19 vaccine and passed way on the sleep/death.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (lot number: 024M20A) on 23 Jan 2021.  On 23 Mar 2021, patient received second of two planned doses of mRNA-1273 (lot number: 047A21A) intramuscularly for COVID-19 prophylaxis.  On an unknown date in Mar 2021, the patient passed away on the sleep.  The patient received both scheduled doses of mRNA-1273 prior to the event therefore, action taken with the drug in response to the event was not applicable.  The patient died on the sleep on an unspecified date in Mar 2021. The cause of death was unknown. Plans for an autopsy were unknown.; Reporter's Comments: This case concerns a 73-years-old, male patient, who died. The cause of death was unknown. Plans for an autopsy were unknown.  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Vaccination site pain
Clinical narrative: soreness on the upper left area of her chest; soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (soreness on the upper left area of her chest) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Smoker.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness in her arm). On 24-Mar-2021, the patient experienced CHEST PAIN (soreness on the upper left area of her chest) (seriousness criterion medically significant). On 23-Mar-2021, VACCINATION SITE PAIN (soreness in her arm) had resolved. On 26-Mar-2021, CHEST PAIN (soreness on the upper left area of her chest) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  This case concerns a 55-year-old female with a serious unexpected event of chest pain, and nonserious expected vaccination site pain. 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 55-year-old female with a serious unexpected event of chest pain, and nonserious expected vaccination site pain. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Confusional state, Disorientation, Dizziness
Clinical narrative: I fainted; today she is feeling kind of drunk; having trouble keeping in balance; Few nights before the vaccine my I was having trouble sleeping, now I'm sleepy all the time; Today I started feeling miserable,; I had general weakness; malaise; dizziness; disoriented; confusion; I threw up; I had severe nausea,; I had muscle aches and body aches; My arm was hurting the next day; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (I fainted) in a 24-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.     The patient's past medical history included No adverse event. Concomitant products included TRAMADOL and GABAPENTIN for Fibromyalgia.    On 24-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 VACCINATION SITE PAIN (My arm was hurting the next day). On 27-Mar-2021, the patient experienced SYNCOPE (I fainted) (seriousness criterion medically significant), FEELING DRUNK (today she is feeling kind of drunk), BALANCE DISORDER (having trouble keeping in balance), SOMNOLENCE (Few nights before the vaccine my I was having trouble sleeping, now I'm sleepy all the time), FEELING ABNORMAL (Today I started feeling miserable,), PAIN (I had muscle aches and body aches), ASTHENIA (I had general weakness), MALAISE (malaise), DIZZINESS (dizziness), DISORIENTATION (disoriented), CONFUSIONAL STATE (confusion), VOMITING (I threw up), NAUSEA (I had severe nausea,) and MYALGIA (I had muscle aches and body aches). At the time of the report, SYNCOPE (I fainted), FEELING DRUNK (today she is feeling kind of drunk), BALANCE DISORDER (having trouble keeping in balance), SOMNOLENCE (Few nights before the vaccine my I was having trouble sleeping, now I'm sleepy all the time), FEELING ABNORMAL (Today I started feeling miserable,), PAIN (I had muscle aches and body aches), ASTHENIA (I had general weakness), MALAISE (malaise), DIZZINESS (dizziness), DISORIENTATION (disoriented), CONFUSIONAL STATE (confusion), VOMITING (I threw up), VACCINATION SITE PAIN (My arm was hurting the next day), NAUSEA (I had severe nausea,) and MYALGIA (I had muscle aches and body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The Treatment information included Ondansetron, Ibuprofen.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling drunk, Malaise, Myalgia, Nausea
Clinical narrative: I fainted; today she is feeling kind of drunk; having trouble keeping in balance; Few nights before the vaccine my I was having trouble sleeping, now I'm sleepy all the time; Today I started feeling miserable,; I had general weakness; malaise; dizziness; disoriented; confusion; I threw up; I had severe nausea,; I had muscle aches and body aches; My arm was hurting the next day; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (I fainted) in a 24-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.     The patient's past medical history included No adverse event. Concomitant products included TRAMADOL and GABAPENTIN for Fibromyalgia.    On 24-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 VACCINATION SITE PAIN (My arm was hurting the next day). On 27-Mar-2021, the patient experienced SYNCOPE (I fainted) (seriousness criterion medically significant), FEELING DRUNK (today she is feeling kind of drunk), BALANCE DISORDER (having trouble keeping in balance), SOMNOLENCE (Few nights before the vaccine my I was having trouble sleeping, now I'm sleepy all the time), FEELING ABNORMAL (Today I started feeling miserable,), PAIN (I had muscle aches and body aches), ASTHENIA (I had general weakness), MALAISE (malaise), DIZZINESS (dizziness), DISORIENTATION (disoriented), CONFUSIONAL STATE (confusion), VOMITING (I threw up), NAUSEA (I had severe nausea,) and MYALGIA (I had muscle aches and body aches). At the time of the report, SYNCOPE (I fainted), FEELING DRUNK (today she is feeling kind of drunk), BALANCE DISORDER (having trouble keeping in balance), SOMNOLENCE (Few nights before the vaccine my I was having trouble sleeping, now I'm sleepy all the time), FEELING ABNORMAL (Today I started feeling miserable,), PAIN (I had muscle aches and body aches), ASTHENIA (I had general weakness), MALAISE (malaise), DIZZINESS (dizziness), DISORIENTATION (disoriented), CONFUSIONAL STATE (confusion), VOMITING (I threw up), VACCINATION SITE PAIN (My arm was hurting the next day), NAUSEA (I had severe nausea,) and MYALGIA (I had muscle aches and body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The Treatment information included Ondansetron, Ibuprofen.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Syncope, Vaccination site pain, Vomiting
Clinical narrative: I fainted; today she is feeling kind of drunk; having trouble keeping in balance; Few nights before the vaccine my I was having trouble sleeping, now I'm sleepy all the time; Today I started feeling miserable,; I had general weakness; malaise; dizziness; disoriented; confusion; I threw up; I had severe nausea,; I had muscle aches and body aches; My arm was hurting the next day; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (I fainted) in a 24-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.     The patient's past medical history included No adverse event. Concomitant products included TRAMADOL and GABAPENTIN for Fibromyalgia.    On 24-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 VACCINATION SITE PAIN (My arm was hurting the next day). On 27-Mar-2021, the patient experienced SYNCOPE (I fainted) (seriousness criterion medically significant), FEELING DRUNK (today she is feeling kind of drunk), BALANCE DISORDER (having trouble keeping in balance), SOMNOLENCE (Few nights before the vaccine my I was having trouble sleeping, now I'm sleepy all the time), FEELING ABNORMAL (Today I started feeling miserable,), PAIN (I had muscle aches and body aches), ASTHENIA (I had general weakness), MALAISE (malaise), DIZZINESS (dizziness), DISORIENTATION (disoriented), CONFUSIONAL STATE (confusion), VOMITING (I threw up), NAUSEA (I had severe nausea,) and MYALGIA (I had muscle aches and body aches). At the time of the report, SYNCOPE (I fainted), FEELING DRUNK (today she is feeling kind of drunk), BALANCE DISORDER (having trouble keeping in balance), SOMNOLENCE (Few nights before the vaccine my I was having trouble sleeping, now I'm sleepy all the time), FEELING ABNORMAL (Today I started feeling miserable,), PAIN (I had muscle aches and body aches), ASTHENIA (I had general weakness), MALAISE (malaise), DIZZINESS (dizziness), DISORIENTATION (disoriented), CONFUSIONAL STATE (confusion), VOMITING (I threw up), VACCINATION SITE PAIN (My arm was hurting the next day), NAUSEA (I had severe nausea,) and MYALGIA (I had muscle aches and body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The Treatment information included Ondansetron, Ibuprofen.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling abnormal, Muscular weakness
Clinical narrative: tunnel vision; wobbly legs; dizziness (had to sit down then lie down); sore arm; Foggy; burning on injection; fatigue; some chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of TUNNEL VISION (tunnel vision) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) 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). Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 26-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 TUNNEL VISION (tunnel vision) (seriousness criterion medically significant), RESTLESS LEGS SYNDROME (wobbly legs), DIZZINESS (dizziness (had to sit down then lie down)), PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (Foggy), VACCINATION SITE PAIN (burning on injection), FATIGUE (fatigue), CHILLS (some chills) and NAUSEA (nausea). On 26-Mar-2021, TUNNEL VISION (tunnel vision), RESTLESS LEGS SYNDROME (wobbly legs), FEELING ABNORMAL (Foggy), CHILLS (some chills) and NAUSEA (nausea) had resolved, DIZZINESS (dizziness (had to sit down then lie down)) and VACCINATION SITE PAIN (burning on injection) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included paracetamol.; 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: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Tunnel vision, Vaccination site pain
Clinical narrative: tunnel vision; wobbly legs; dizziness (had to sit down then lie down); sore arm; Foggy; burning on injection; fatigue; some chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of TUNNEL VISION (tunnel vision) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) 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). Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 26-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 TUNNEL VISION (tunnel vision) (seriousness criterion medically significant), RESTLESS LEGS SYNDROME (wobbly legs), DIZZINESS (dizziness (had to sit down then lie down)), PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (Foggy), VACCINATION SITE PAIN (burning on injection), FATIGUE (fatigue), CHILLS (some chills) and NAUSEA (nausea). On 26-Mar-2021, TUNNEL VISION (tunnel vision), RESTLESS LEGS SYNDROME (wobbly legs), FEELING ABNORMAL (Foggy), CHILLS (some chills) and NAUSEA (nausea) had resolved, DIZZINESS (dizziness (had to sit down then lie down)) and VACCINATION SITE PAIN (burning on injection) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included paracetamol.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Ear infection, Sudden hearing loss
Clinical narrative: there was no fluid in ear; suspected an ear infection.; he woke up with his ear blocked and he couldn't hear; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SUDDEN HEARING LOSS (he woke up with his ear blocked and he couldn't hear) 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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced SUDDEN HEARING LOSS (he woke up with his ear blocked and he couldn't hear) (seriousness criterion medically significant). On 05-Mar-2021, the patient experienced EAR DISCOMFORT (there was no fluid in ear) and EAR INFECTION (suspected an ear infection.). At the time of the report, SUDDEN HEARING LOSS (he woke up with his ear blocked and he couldn't hear), EAR DISCOMFORT (there was no fluid in ear) and EAR INFECTION (suspected an ear infection.) 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.   Reporter did not allow further contact
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Inappropriate schedule of vaccine administered; Tachycardia on exertion; shortness of breath; This spontaneous pregnancy case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (Tachycardia on exertion) and DYSPNOEA (shortness of breath) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 027A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pregnancy and Tachycardia (History of tachycardia with previous pregnancy treated with beta blocker.) on 29-Dec-2020.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On 29-Dec-2020, the patient experienced TACHYCARDIA (Tachycardia on exertion) (seriousness criterion medically significant) and DYSPNOEA (shortness of breath) (seriousness criterion medically significant). On 06-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 29-Dec-2020, TACHYCARDIA (Tachycardia on exertion) and DYSPNOEA (shortness of breath) had resolved. On 06-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, Blood test: inconclusive (Inconclusive) CBC, TSH, and CMP. On 29-Dec-2020, Cardiac monitoring: inconclusive (Inconclusive) Inconclusive. On 29-Dec-2020, Chest X-ray: inconclusive (Inconclusive) Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment reported was not reported/ unknown.  This is a case of product exposure during pregnancy associated  with tachycardia on exertion and dyspnea for this 25-year-old female. Patient has a history of tachycardia with previous pregnancy treated with beta blocker. 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.   The causality of the event of inappropriate schedule of vaccine administered is assessed as Not applicable.   Reporter did not allow further contact; Sender's Comments: This is a case of product exposure during pregnancy associated  with tachycardia on exertion and dyspnea for this 25-year-old female. Patient has a history of tachycardia with previous pregnancy treated with beta blocker. 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.   The causality of the event of inappropriate schedule of vaccine administered is assessed as Not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Drug interaction, Emotional distress, Serotonin syndrome
Clinical narrative: exhibited all of the symptoms of serotonin toxicity; emotional ride on the weekend; possible drug interaction/patient on Prozac and Trazodone; This spontaneous case was reported by a physician and describes the occurrence of SEROTONIN SYNDROME (exhibited all of the symptoms of serotonin toxicity) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination and experienced exhibited all of the symptoms of serotonin toxicity, emotional ride on the weekend and possible drug interaction/patient on Prozac and Trazodone    The patient's past medical history included Blood pressure high (On blood pressure medication (stable)).  Concomitant products included TRAZODONE for Sleep disorder NOS, FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEROTONIN SYNDROME (exhibited all of the symptoms of serotonin toxicity) (seriousness criterion medically significant), EMOTIONAL DISTRESS (emotional ride on the weekend) and DRUG INTERACTION (possible drug interaction/patient on Prozac and Trazodone). At the time of the report, SEROTONIN SYNDROME (exhibited all of the symptoms of serotonin toxicity) and DRUG INTERACTION (possible drug interaction/patient on Prozac and Trazodone) was resolving and EMOTIONAL DISTRESS (emotional ride on the weekend) had resolved.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient took vaccine and then exhibited all of the symptoms of serotonin toxicity. Patient went to urgent care and "they had no clue." Patient hopes the message can be used to add to the research as serotonin syndrome is very serious.; Sender's Comments: There is not enough information to assess this case as treatment date and onset date of the events were not provided.  Description of symptoms for all reported events to enable adequate assessment is also lacking.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: cardiac arrest; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (cardiac arrest) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 011A21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack in September 2020. Concomitant products included LEVOTHYROXINE, ATORVASTATIN, CLOPIDOGREL BISULFATE (PLAVIX), CARVEDILOL, ACETYLSALICYLIC ACID (ASPIRIN 81), VITAMIN D3, ALENDRONATE SODIUM (ALENDRONATE), LISINOPRIL and FAMOTIDINE for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced CARDIAC ARREST (cardiac arrest) (seriousness criterion hospitalization). The patient was hospitalized on 27-Mar-2021 due to CARDIAC ARREST. At the time of the report, CARDIAC ARREST (cardiac arrest) outcome was unknown.            Cardiac catheterization to be performed on the patient on 31-MAR-2021.  Based on the current available information and temporal association between the use of the product and the onset date of the reported event of cardiac arrest, a causal relationship cannot be excluded. However, patient's recent myocardial infarction may have been contributory.; 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 cardiac arrest, a causal relationship cannot be excluded. However, patient's recent myocardial infarction may have been contributory.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dehydration, Diarrhoea, Dyspnoea
Clinical narrative: Massive extreme diarrhea; Dehydrated; Low blood pressure; Fever; Chills; Shortness of breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Massive extreme diarrhea), DEHYDRATION (Dehydrated), HYPOTENSION (Low blood pressure), PYREXIA (Fever) and CHILLS (Chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) 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 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DYSPNOEA (Shortness of breath). On 25-Mar-2021, the patient experienced PYREXIA (Fever) (seriousness criterion hospitalization) and CHILLS (Chills) (seriousness criterion hospitalization). On 26-Mar-2021, the patient experienced DIARRHOEA (Massive extreme diarrhea) (seriousness criterion hospitalization), DEHYDRATION (Dehydrated) (seriousness criterion hospitalization) and HYPOTENSION (Low blood pressure) (seriousness criterion hospitalization). The patient was hospitalized from 26-Mar-2021 to 27-Mar-2021 due to CHILLS, DEHYDRATION, DIARRHOEA, HYPOTENSION and PYREXIA. On 27-Mar-2021, DIARRHOEA (Massive extreme diarrhea), DEHYDRATION (Dehydrated), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, HYPOTENSION (Low blood pressure) and DYSPNOEA (Shortness of breath) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Body temperature: 102 (High) fever.         Treatment drugs were not reported.  Based on the current available information and temporal association between the use of the product and the start dates 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 dates of the event, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Pyrexia
Clinical narrative: Massive extreme diarrhea; Dehydrated; Low blood pressure; Fever; Chills; Shortness of breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Massive extreme diarrhea), DEHYDRATION (Dehydrated), HYPOTENSION (Low blood pressure), PYREXIA (Fever) and CHILLS (Chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) 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 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DYSPNOEA (Shortness of breath). On 25-Mar-2021, the patient experienced PYREXIA (Fever) (seriousness criterion hospitalization) and CHILLS (Chills) (seriousness criterion hospitalization). On 26-Mar-2021, the patient experienced DIARRHOEA (Massive extreme diarrhea) (seriousness criterion hospitalization), DEHYDRATION (Dehydrated) (seriousness criterion hospitalization) and HYPOTENSION (Low blood pressure) (seriousness criterion hospitalization). The patient was hospitalized from 26-Mar-2021 to 27-Mar-2021 due to CHILLS, DEHYDRATION, DIARRHOEA, HYPOTENSION and PYREXIA. On 27-Mar-2021, DIARRHOEA (Massive extreme diarrhea), DEHYDRATION (Dehydrated), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, HYPOTENSION (Low blood pressure) and DYSPNOEA (Shortness of breath) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Body temperature: 102 (High) fever.         Treatment drugs were not reported.  Based on the current available information and temporal association between the use of the product and the start dates 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 dates of the event, a causal relationship cannot be excluded.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea haemorrhagic, Haemoglobin, Presyncope
Clinical narrative: Diarrhea mixed with blood; Almost passed out; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA HAEMORRHAGIC (Diarrhea mixed with blood) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020 and Diverticulitis since an unknown date. Concomitant products included LOPERAMIDE HYDROCHLORIDE (IMODIUM) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced DIARRHOEA HAEMORRHAGIC (Diarrhea mixed with blood) (seriousness criterion medically significant) and PRESYNCOPE (Almost passed out). On 02-Mar-2021, PRESYNCOPE (Almost passed out) had resolved. At the time of the report, DIARRHOEA HAEMORRHAGIC (Diarrhea mixed with blood) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Blood test: normal (normal) Blood test-Normal. On 02-Mar-2021, Haemoglobin: normal (normal) Hemoglobin-Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient went to the ER for observation and blood tests which came back normal (including hemoglobin). For several days it cleared up, then it has come back sporadically but not to the same degree.   This case was linked to (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, Further information is requested.
Sex: M
Vaccine: COVID19
Symptoms: Colonoscopy, Hospitalisation
Clinical narrative: Admitted to emergency room; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HOSPITALISATION (Admitted to emergency room) 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.    On 25-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced HOSPITALISATION (Admitted to emergency room) (seriousness criterion hospitalization). The patient was hospitalized on 26-Mar-2021 due to HOSPITALISATION. At the time of the report, HOSPITALISATION (Admitted to emergency room) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: unknown (Inconclusive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Very limited information regarding this event has been provided at this time.  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.  Further information has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Myalgia
Clinical narrative: Severe muscle aches, exhaustion and extreme dizziness for about 36 hours  Took Tylenol and slept a lot
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Haematemesis, Nausea, Vomiting
Clinical narrative: Patient became nauseated 5 minutes after vaccine administration. She ended up vomiting in pharmacy lobby.  There was blood in vomit so emergency was called.  Patient was transported to hospital. At this time no information on outcome.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Loss of consciousness
Clinical narrative: Patient was asked to stay seated for 15 min after getting her shot. But less than 5 minutes after receiving her shot she walked to the pharmacy counter, we asked her if she is feeling OK, she gazed at the staff and fell on the floor.  We kept her head elevated and made sure she was responsive (OB managed to remember her name and asked to call her mother). We called 911, measured her blood pressure 115/80 mmHg her HR:117 bpm. EMT took her to the hospital when she was still not feeling well.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cheilitis, Fatigue, Headache, Myalgia
Clinical narrative: After 48 hours, mouth irritation on palate and lip corners, after 72 hours fever blisters, 2 on lips and 1 on hard palate.  I get them with sunburn, stress, etc. ( I had had the typical arm pain, headache, fatigue, muscle and joint pain and fever on day two).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pain in extremity, Pyrexia, Stomatitis
Clinical narrative: After 48 hours, mouth irritation on palate and lip corners, after 72 hours fever blisters, 2 on lips and 1 on hard palate.  I get them with sunburn, stress, etc. ( I had had the typical arm pain, headache, fatigue, muscle and joint pain and fever on day two).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Peripheral swelling, Pruritus, Rash
Clinical narrative: I didn't have any issues until 10 days later. My arm was red, bumpy, hard, swollen and it itched. I talked to a friend of mine that was a nurse and she told me I should go to the ER. I called the clinic and they set up a appt. He said that he thinks it's a case of cellulitis, so he put me on doxycycline in case that's what it was. I took the medication and was fine from there.