chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram, Electrocardiogram, Fatigue, Neck pain
Clinical narrative: Pain in the chest; Water in lungs; Pain in the neck and left side of sternum; Soreness in arm; Fatigue; A spontaneous report was received from a consumer, concerning a 67 year old male patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced pain in the chest (chest pain), water in lungs (pleural effusion), pain in the neck that went down the left side of sternum (neck pain radiation), soreness in arm (pan in extremity) and fatigue.  The patient's medical history was not provided. Concomitant medications reported included warfarin sodium, ezetimibe, fiber, and vitamin D NOS.  On 06 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 03 Feb 2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On 03 Feb 2021, an unspecified duration after receiving the vaccine, the patient experienced soreness in the arm and fatigue.   On 08 Feb 2021, the patient experienced pain in the neck on the left side which radiated to the left side of sternum.   On 12 Feb 2021, in the morning, the patient experienced a huge pain in the chest and called 911 for an ambulance. The cardiologist and pulmonologist stated that everything was fine except that there was some water in the lungs. The patient still has pleural effusion. On the same day, the patient underwent electrocardiogram (EKG) and heart CT without significant findings and no abnormalities. The patient was recommended for a computerised tomography (CT) arteriogram.   Treatment medications included acetaminophen, codeine, fentanyl, and concomitant medications.  Action taken with second dose of mRNA-1273 in response to the events was not applicable.  The outcome of the events, pain in the chest, water in lungs, pain in the neck that went to the left side of sternum, soreness in arm, and fatigue were not reported.; 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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pleural effusion
Clinical narrative: Pain in the chest; Water in lungs; Pain in the neck and left side of sternum; Soreness in arm; Fatigue; A spontaneous report was received from a consumer, concerning a 67 year old male patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced pain in the chest (chest pain), water in lungs (pleural effusion), pain in the neck that went down the left side of sternum (neck pain radiation), soreness in arm (pan in extremity) and fatigue.  The patient's medical history was not provided. Concomitant medications reported included warfarin sodium, ezetimibe, fiber, and vitamin D NOS.  On 06 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 03 Feb 2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On 03 Feb 2021, an unspecified duration after receiving the vaccine, the patient experienced soreness in the arm and fatigue.   On 08 Feb 2021, the patient experienced pain in the neck on the left side which radiated to the left side of sternum.   On 12 Feb 2021, in the morning, the patient experienced a huge pain in the chest and called 911 for an ambulance. The cardiologist and pulmonologist stated that everything was fine except that there was some water in the lungs. The patient still has pleural effusion. On the same day, the patient underwent electrocardiogram (EKG) and heart CT without significant findings and no abnormalities. The patient was recommended for a computerised tomography (CT) arteriogram.   Treatment medications included acetaminophen, codeine, fentanyl, and concomitant medications.  Action taken with second dose of mRNA-1273 in response to the events was not applicable.  The outcome of the events, pain in the chest, water in lungs, pain in the neck that went to the left side of sternum, soreness in arm, and fatigue were not reported.; 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: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Injection site cellulitis, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Slight cellulitis at the injection site; Sore arm; Fever of about 102.4°; Nausea; A spontaneous report was received from a consumer who is a 79-year-old female patient that received Moderna's COVID-19 vaccine (mRNA-1273) vaccine and experienced cellulitis at injection site/injection site cellulitis, sore arm/pain in extremity, fever to 102.4/pyrexia, nausea.  The patient's medical history was not reported. Products known to have been used by the patient, within two weeks prior to the event were not reported.  On 05-FEB-2021, prior to the onset of events, the patient received the first dose of two planned doses of mRNA-1273 (Batch number:011M20A) intramuscularly on arm for prophylaxis of COVID-19 infection.   On an unknown date, after receiving the first dose of vaccine, patient experienced feeling a sore arm, like a slight cellulitis at injection site, fever of 102.4 and nausea. The event injection site cellulitis was considered as serious (Medically Significant).  Treatment medication included alcohol which was used at the injection site. Laboratory tests were not reported.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events experienced cellulitis at injection site/injection site cellulitis, sore arm/pain in extremity, fever to 102.4/pyrexia and nausea were considered as unknown.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: I am experiencing Bells' palsy and don't knowwhat to do about it.; A spontaneous report  was received from a consumer concerning a unknown age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy/facial paralysis.   The patient's medical history was not  provided by the reporter. Concomitant medications were not reported .   On unspecified date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through unknown route for prophylaxis of COVID-19 infection.   On unspecified date, after vaccination patient experienced Bell's palsy. Treatment for the event was not provided. Lab details were not provided. The event was medically significant.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of Bell's palsy was considered unknown.; Reporter's Comments: This case concerns a female of unknown age who had a serious unexpected event of Bell's palsy (facial paralysis). Event onset occurred with unknown latency after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Ageusia, Anosmia, Electrocardiogram, Fall
Clinical narrative: Fell; Felt like he was dying; couldn't taste, and had a terrible taste in his mouth; Could not smell; Stomach hurt; A spontaneous report was received from a consumer concerning a 92-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced could not taste and had terrible taste in his mouth (ageusia), could not smell (anosmia), his stomach hurt (abdominal pain upper), felt like he was dying (feeling abnormal) and he fell (fall).  The patient's medical history included hospitalization due to COVID-19. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) an unspecified date.   On 22 Feb 2021, two hours prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. Two hours after the vaccination, the patient could not taste, and had a terrible taste in his mouth The patient could not smell and his stomach hurt. The patient felt like he was dying.   On 23 Feb 2021, the patient fell.  911 was called and the patient was hospitalized. Treatment for the event included electrolytes. The patient had an abnormal electrocardiogram (EKG  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, could not taste and had a terrible taste in his mouth (ageusia), could not smell (anosmia), his stomach hurt (abdominal pain upper), felt like he was dying (feeling abnormal) and he fell (fall), were unknown.; Reporter's Comments: Very limited information regarding the event has been provided at this time. Noting advance age is a risk factor. Noting the history of advance age and previous COVID infection may remain as risk factors. Further information has been requested.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, SARS-CoV-2 test
Clinical narrative: Fell; Felt like he was dying; couldn't taste, and had a terrible taste in his mouth; Could not smell; Stomach hurt; A spontaneous report was received from a consumer concerning a 92-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced could not taste and had terrible taste in his mouth (ageusia), could not smell (anosmia), his stomach hurt (abdominal pain upper), felt like he was dying (feeling abnormal) and he fell (fall).  The patient's medical history included hospitalization due to COVID-19. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) an unspecified date.   On 22 Feb 2021, two hours prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. Two hours after the vaccination, the patient could not taste, and had a terrible taste in his mouth The patient could not smell and his stomach hurt. The patient felt like he was dying.   On 23 Feb 2021, the patient fell.  911 was called and the patient was hospitalized. Treatment for the event included electrolytes. The patient had an abnormal electrocardiogram (EKG  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, could not taste and had a terrible taste in his mouth (ageusia), could not smell (anosmia), his stomach hurt (abdominal pain upper), felt like he was dying (feeling abnormal) and he fell (fall), were unknown.; Reporter's Comments: Very limited information regarding the event has been provided at this time. Noting advance age is a risk factor. Noting the history of advance age and previous COVID infection may remain as risk factors. Further information has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypoxia, Pain, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: COVID arm bullseye; Arm was red and swollen; Arm was red and swollen; His arm started itching; Oxygen level dropped; Little aching and fatigued; A rash on the same arm as his injection; Little aching and fatigued; A spontaneous report was received from a consumer concerning a 76-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following: little aching and fatigued (fatigue/pain), drop in oxygen levels(hypoxia), his arm started itching (pruritis),arm was red and swollen (erythema/peripheral swelling), rash on the same arm as injection (rash), and COVID arm bullseye (vaccination site reaction).  The patient's medical history was not provided. Concomitant medications reported were metoprolol.  On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient felt fatigued and a little aching after receiving the vaccine. The patient's oxygen levels were being monitored and had dropped from an average of 95 to 90-91. On 2 Feb 2021, the patient's arm started itching. By 3 Feb 2021, the patient's arm was red and swollen. On 4 Feb 2021, the patient developed the "COVID arm bullseye" that appeared to be swollen, hot and spreading down towards the elbow. On 9 Feb 2021, the COVID arm bullseye was bigger than a baseball, was starting to fade in color , but had spread further almost to the elbow.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, little aching and fatigued, drop in oxygen levels, arm started itching, arm was red and swollen, rash on the same arm as injection, and COVID arm bullseye, 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 the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site reaction, Vaccination site swelling
Clinical narrative: COVID arm bullseye; Arm was red and swollen; Arm was red and swollen; His arm started itching; Oxygen level dropped; Little aching and fatigued; A rash on the same arm as his injection; Little aching and fatigued; A spontaneous report was received from a consumer concerning a 76-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following: little aching and fatigued (fatigue/pain), drop in oxygen levels(hypoxia), his arm started itching (pruritis),arm was red and swollen (erythema/peripheral swelling), rash on the same arm as injection (rash), and COVID arm bullseye (vaccination site reaction).  The patient's medical history was not provided. Concomitant medications reported were metoprolol.  On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient felt fatigued and a little aching after receiving the vaccine. The patient's oxygen levels were being monitored and had dropped from an average of 95 to 90-91. On 2 Feb 2021, the patient's arm started itching. By 3 Feb 2021, the patient's arm was red and swollen. On 4 Feb 2021, the patient developed the "COVID arm bullseye" that appeared to be swollen, hot and spreading down towards the elbow. On 9 Feb 2021, the COVID arm bullseye was bigger than a baseball, was starting to fade in color , but had spread further almost to the elbow.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, little aching and fatigued, drop in oxygen levels, arm started itching, arm was red and swollen, rash on the same arm as injection, and COVID arm bullseye, 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 the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Pain in extremity, Vaccination site pain
Clinical narrative: I sat down on floor passed out for 5 mins; light headedness, dizzy; Sweaty; arm soreness; legs felt achy; A spontaneous report was received from a consumer who was also a 65-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sat down on floor passed out for 5 mins/ loss of consciousness, legs felt achy/ pain in extremity, light headedness, dizzy/ dizziness, sweaty/hyperhidrosis, and arm soreness/ vaccination site pain.  The patient's medical history was not provided. Concomitant medications included fluticasone propionate and salmeterol xinafoate and salbutamol.  On 27 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 28 Feb 2021, the patient had arm soreness and in night her legs felt achy. On 01 Mar 2021, the patient suddenly had light headedness, dizzy, and sweaty. The patient sat down on floor passed out for five minutes. The patient reported feeling better.  Treatment for the events included Ibuprofen and paracetamol.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, the patient sat down on floor passed out for five minutes was considered as resolved on 1 Mar 2021.  The outcome of the events, the patient suddenly had light headedness, dizzy, and sweaty was considered recovering.; Reporter's Comments: This case concerns a 65-year-old female with serious unexpected events of loss of consciousness along with nonserious unexpected dizziness, hyperhidrosis, pain in extremity and expected vaccination site pain. Event onset occurred 2 days after the first dose of mRNA-1273. Treatment included Motrin and Tylenol. Events resolving. 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: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash, Rash macular
Clinical narrative: rash from the elbows to the wrists in both arms; Moderna arm; a very red splotch that was 4x3inches for the first 3 days but know it has been spreading reaching; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Feb-2021 and was forwarded to Moderna on 18-Feb-2021.    This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of RASH (rash from the elbows to the wrists in both arms) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported. ). Concomitant products included SIMVASTATIN (ZOCOR) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced RASH (rash from the elbows to the wrists in both arms) (seriousness criterion medically significant), PERIPHERAL SWELLING (Moderna arm) and RASH MACULAR (a very red splotch that was 4x3inches for the first 3 days but know it has been spreading reaching). At the time of the report, RASH (rash from the elbows to the wrists in both arms), PERIPHERAL SWELLING (Moderna arm) and RASH MACULAR (a very red splotch that was 4x3inches for the first 3 days but know it has been spreading reaching) 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.   This case concerns a 79 Y/O M with a serious unexpected event of rash, and nonserious unexpected rash macular and peripheral swelling.  Event onset 11 days after first 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 79 Y/O M with a serious unexpected event of rash, and nonserious unexpected rash macular and peripheral swelling.  Event onset 11 days after first 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Chills, Diarrhoea haemorrhagic, Nausea
Clinical narrative: mild pain at the injection site of vaccine; after diarrhea, she had blood dripping in the toilet; pain in kidney area; pains in abdomen/soreness in lower abdomen; nausea; throwing up; chills; A spontaneous report was received from a consumer, concerning a female patient of 58 age , who received Moderna's COVID-19 vaccine and experienced after diarrhea, she had blood dripping in the toilet (diarrhea haemorrhagic), pain in kidney area (back pain), pains in abdomen/soreness in lower abdomen (abdominal pain), nausea, throwing up (vomiting), chills, and mild pain at the injection site of vaccine (vaccination site pain).  History of the patient was not provided. Concomitant product use was not provided by the reporter.  On 26Feb2021, prior to the onset of events, the patient received his first of two planned doses of mRNA-1273 (lot number 025A21A) via intramuscular route in her right arm for COVID-19 infection prophylaxis.  On 26Feb2021, after first dose of vaccine, the patient  had intense  lower abdominal pain, cramping, nausea, vomiting and diarrhea. Patient reported chills with a temperature of 98.9. Patient noticed blood dripping after diarrhea, until 2 days after vaccination (Sunday). Patient states she has less cramps today, but pain in the loin (kidney area). she also had mild pain at the injection site of the vaccine.   Action taken with mRNA-1273 in response to the event Abdominal pain, Muscle spasms, Nausea, Vomiting, Diarrhoea, Chills, Tremor, Haemorrhage, Renal pain, and Vaccination site pain was reported as unknown.  The outcome of the event Abdominal pain, Nausea, Vomiting, Chills, Haemorrhage was considered to be unknown. Renal pain and Vaccination site pain was considered to be recovered/ resolved at the time of this report.  Haemorrhage was considered to be medically significant.  No treatment medication was reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: mild pain at the injection site of vaccine; after diarrhea, she had blood dripping in the toilet; pain in kidney area; pains in abdomen/soreness in lower abdomen; nausea; throwing up; chills; A spontaneous report was received from a consumer, concerning a female patient of 58 age , who received Moderna's COVID-19 vaccine and experienced after diarrhea, she had blood dripping in the toilet (diarrhea haemorrhagic), pain in kidney area (back pain), pains in abdomen/soreness in lower abdomen (abdominal pain), nausea, throwing up (vomiting), chills, and mild pain at the injection site of vaccine (vaccination site pain).  History of the patient was not provided. Concomitant product use was not provided by the reporter.  On 26Feb2021, prior to the onset of events, the patient received his first of two planned doses of mRNA-1273 (lot number 025A21A) via intramuscular route in her right arm for COVID-19 infection prophylaxis.  On 26Feb2021, after first dose of vaccine, the patient  had intense  lower abdominal pain, cramping, nausea, vomiting and diarrhea. Patient reported chills with a temperature of 98.9. Patient noticed blood dripping after diarrhea, until 2 days after vaccination (Sunday). Patient states she has less cramps today, but pain in the loin (kidney area). she also had mild pain at the injection site of the vaccine.   Action taken with mRNA-1273 in response to the event Abdominal pain, Muscle spasms, Nausea, Vomiting, Diarrhoea, Chills, Tremor, Haemorrhage, Renal pain, and Vaccination site pain was reported as unknown.  The outcome of the event Abdominal pain, Nausea, Vomiting, Chills, Haemorrhage was considered to be unknown. Renal pain and Vaccination site pain was considered to be recovered/ resolved at the time of this report.  Haemorrhage was considered to be medically significant.  No treatment medication was reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Gait disturbance, Nausea, Vertigo
Clinical narrative: Blood pressure was 200/100; Very dizzy; Could not lie down without things spinning around; Felt unsteady; Nauseous; A spontaneous report was received from a consumer concerning a 65-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood pressure raise (200/100) with dizziness, nausea, vertigo and gait disturbance.  The patient's medical history was not provided. Concomitant medications were not reported.  On 27 Feb 2021, 16 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 010A21A) intramuscularly for the prophylaxis of COVID-19 infection.  On 28 Feb 2021, the patient woke up to turn over and was very dizzy. The dizziness continue most of the following day, and the patient was also nauseous and could not lie down without things spinning around. The patient stayed upright and felt unsteady so they had to hold on to the walls to move around. The patient was taken to urgent care where her blood pressure was 200/100.  She was taken to the hospital where she remained for two days and tests were taken.  Treatment medications included nitroglycerin and acetylsalicylic acid.  The patient was released from the hospital on 02 Mar 2021.  She had an appointment with her PCP (primary care physician) on Friday 05 Mar 2021 for follow-up.    Action taken with mRNA-1273 in response to the events was unknown.  The outcomes of the events were reported as unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Blood pressure decreased, Blood pressure measurement, Body temperature, Feeling cold
Clinical narrative: Blood pressure dropped down to 85; Patient could not get out of bed; Slept on and off; Temperature of 100.4 °F; More than a shivering, like having convulsions; cold; Shaking; Left arm was a little bit tender; A spontaneous case was reported by a consumer concerning an 83-year-old female patient who experienced More than a shivering, like having convulsions, feeling cold/chilliness, shaking, Left arm was a little bit tender, blood pressure dropped down to 85, patient could not get out of bed, slept on and off) and temperature of 100.4 °F.   The patient's past medical history was not provided. Concomitant medications included blood thinners (unspecified).    On 26-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26-Feb-2021, the patient experienced SEIZURE (More than a shivering, like having convulsions), NASOPHARYNGITIS (Cold), TREMOR (Shaking) and TENDERNESS (Left arm was a little bit tender). On an unknown date, the patient experienced BLOOD PRESSURE DECREASED (Blood pressure dropped down to 85), BEDRIDDEN (Patient could not get out of bed), SLEEP DISORDER (Slept on and off) and PYREXIA (Temperature of 100.4 °F). Treatment information was not provided for these events.   The action taken with mRNA-1273 in response to these events was unknown.  On 26-Feb-2021, SEIZURE (More than a shivering, like having convulsions), NASOPHARYNGITIS (Cold) and TREMOR (Shaking) outcome was unknown. On 28-Feb-2021, TENDERNESS (Left arm was a little bit tender) outcome was unknown. At the time of the report, BLOOD PRESSURE DECREASED (Blood pressure dropped down to 85), BEDRIDDEN (Patient could not get out of bed), SLEEP DISORDER (Slept on and off) and PYREXIA (Temperature of 100.4 °F) outcome was unknown.   The patient consented for safety follow-up.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported event, and excluding any other etiology, a causal relationship with the event cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Seizure, Sleep disorder, Tenderness, Tremor
Clinical narrative: Blood pressure dropped down to 85; Patient could not get out of bed; Slept on and off; Temperature of 100.4 °F; More than a shivering, like having convulsions; cold; Shaking; Left arm was a little bit tender; A spontaneous case was reported by a consumer concerning an 83-year-old female patient who experienced More than a shivering, like having convulsions, feeling cold/chilliness, shaking, Left arm was a little bit tender, blood pressure dropped down to 85, patient could not get out of bed, slept on and off) and temperature of 100.4 °F.   The patient's past medical history was not provided. Concomitant medications included blood thinners (unspecified).    On 26-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26-Feb-2021, the patient experienced SEIZURE (More than a shivering, like having convulsions), NASOPHARYNGITIS (Cold), TREMOR (Shaking) and TENDERNESS (Left arm was a little bit tender). On an unknown date, the patient experienced BLOOD PRESSURE DECREASED (Blood pressure dropped down to 85), BEDRIDDEN (Patient could not get out of bed), SLEEP DISORDER (Slept on and off) and PYREXIA (Temperature of 100.4 °F). Treatment information was not provided for these events.   The action taken with mRNA-1273 in response to these events was unknown.  On 26-Feb-2021, SEIZURE (More than a shivering, like having convulsions), NASOPHARYNGITIS (Cold) and TREMOR (Shaking) outcome was unknown. On 28-Feb-2021, TENDERNESS (Left arm was a little bit tender) outcome was unknown. At the time of the report, BLOOD PRESSURE DECREASED (Blood pressure dropped down to 85), BEDRIDDEN (Patient could not get out of bed), SLEEP DISORDER (Slept on and off) and PYREXIA (Temperature of 100.4 °F) outcome was unknown.   The patient consented for safety follow-up.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported event, and excluding any other etiology, a causal relationship with the event cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Urticaria
Clinical narrative: significant amount, huge hives were probably 2 inches in diameter all over her body; hives on her trunk breast little on legs, arms, and hair; A spontaneous report was received from a family member concerning an 80-year old, female  patient who developed hives on her trunk, breast, hair, a little on legs and arms, hives were huge and a significant amount(Angioedema, Urticaria).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On 18 Feb 2021, approximately four days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (batch number 023M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Feb. 2021, the patient experienced hives on her trunk, breast, hair, a little on legs and arms. The hives were huge and a significant amount. They were probably 2 inches in diameter all over her body. The patient took  a 7 days course of prednisone as advised by her HCP. The symptoms went away after finishing a 7 days course of prednisone but returned 2 days after finishing the medication. The patient is currently taking over-the-counter claritin and pepsid as advised by her HCP to help alleviate the symptoms. Treatment for the event included a 7 days course of prednisone, over-the-counter claritin and pepsid.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of events were considered not recovered.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Disorganised speech, Disorientation
Clinical narrative: disorientation; couldn't properly respond/was speaking gibberish; weakness; cough; now she's dealing with fluctuating fever/running a slight temperature; Chills; was physically shaking, like a convulsion; doesn't feel she's completely okay; A spontaneous report was received from a consumer, who was the husband of a 72-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced extreme chills, was physically shaking, like a convulsion (seizure), disorientation, couldn't properly respond/was speaking gibberish (disorganized speech), weakness (asthenia), fluctuating fever/running a slight temperature (pyrexia), cough, and doesn't feel she's completely okay (malaise).   The patient's medical history was not provided by the reporter.  Concomitant medications included acyclovir.  On 12 MAR  2021, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On the same day, the patient had extreme chills and was physically shaking, like a convulsion where her husband had to hold her up.  On 12 Mar 2021, she experienced disorientation, she couldn't properly respond/was speaking gibberish, and had weakness.  The husband called 911 and a stroke was ruled out.  At the time of the report, the patient was dealing with a fluctuating fever/was running a slight temperature and a cough.  The husband didn't feel she was completely ok.  Treatment for the events included Gatorade and paracetamol.   The reporter considered the events of disorientation and couldn't properly respond/was speaking gibberish to be disabling.    Action taken with mRNA-1273 in response to the events was unknown except for stroke it was resolved.   The outcome of the events of chills, was physically shaking, like a convulsion, disorientation, couldn't properly respond/was speaking gibberish, and weakness were unknown.   The events of fluctuating fever/running a slight temperature, cough, and doesn't feel she's completely okay were considered not resolved at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Seizure
Clinical narrative: disorientation; couldn't properly respond/was speaking gibberish; weakness; cough; now she's dealing with fluctuating fever/running a slight temperature; Chills; was physically shaking, like a convulsion; doesn't feel she's completely okay; A spontaneous report was received from a consumer, who was the husband of a 72-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced extreme chills, was physically shaking, like a convulsion (seizure), disorientation, couldn't properly respond/was speaking gibberish (disorganized speech), weakness (asthenia), fluctuating fever/running a slight temperature (pyrexia), cough, and doesn't feel she's completely okay (malaise).   The patient's medical history was not provided by the reporter.  Concomitant medications included acyclovir.  On 12 MAR  2021, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On the same day, the patient had extreme chills and was physically shaking, like a convulsion where her husband had to hold her up.  On 12 Mar 2021, she experienced disorientation, she couldn't properly respond/was speaking gibberish, and had weakness.  The husband called 911 and a stroke was ruled out.  At the time of the report, the patient was dealing with a fluctuating fever/was running a slight temperature and a cough.  The husband didn't feel she was completely ok.  Treatment for the events included Gatorade and paracetamol.   The reporter considered the events of disorientation and couldn't properly respond/was speaking gibberish to be disabling.    Action taken with mRNA-1273 in response to the events was unknown except for stroke it was resolved.   The outcome of the events of chills, was physically shaking, like a convulsion, disorientation, couldn't properly respond/was speaking gibberish, and weakness were unknown.   The events of fluctuating fever/running a slight temperature, cough, and doesn't feel she's completely okay were considered not resolved at the time of this report.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Gait inability
Clinical narrative: Unable to walk; Diarrhea; A spontaneous report was received from a consumer concerning a 75-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events diarrhea, unable to walk/gait inability.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Mar 2021, after the vaccination, he walked 3 miles back to his house. On the 3 Mar 2021, he was unable to walk and he started having diarrhea.  On 18 Mar 2021, he was admitted to the hospital because he still could not walk. The relevant lab tests included MRI, EKG, blood test and CT scan with the result all negative. On 20 Mar 2021 the patient is reported to being still admitted to the hospital and his physician stated considering recharging him to a rehab facility.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event unable to walk was not resolved. The outcome of events diarrhea 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 event, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ichthyosis, Keratosis pilaris, Lichenification, Rash erythematous, Rash pruritic
Clinical narrative: Snake-like skin; Red bumps/rashes spread all over the body; Burning rashes; Itching rashes; Sandy-like skin; Leathery skin; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Mar-2021 and was forwarded to Moderna on 19-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ICHTHYOSIS (Snake-like skin), RASH ERYTHEMATOUS (Red bumps/rashes spread all over the body), SKIN BURNING SENSATION (Burning rashes) and RASH PRURITIC (Itching rashes) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) 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 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced ICHTHYOSIS (Snake-like skin) (seriousness criterion medically significant), RASH ERYTHEMATOUS (Red bumps/rashes spread all over the body) (seriousness criterion disability), SKIN BURNING SENSATION (Burning rashes) (seriousness criterion disability), RASH PRURITIC (Itching rashes) (seriousness criterion disability), KERATOSIS PILARIS (Sandy-like skin) and LICHENIFICATION (Leathery skin). At the time of the report, ICHTHYOSIS (Snake-like skin), RASH ERYTHEMATOUS (Red bumps/rashes spread all over the body), SKIN BURNING SENSATION (Burning rashes), RASH PRURITIC (Itching rashes), KERATOSIS PILARIS (Sandy-like skin) and LICHENIFICATION (Leathery skin) had not resolved.            No concomitant medications reported. Treatment medications included diphenhydramine and 6-day pack prednisone.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: Snake-like skin; Red bumps/rashes spread all over the body; Burning rashes; Itching rashes; Sandy-like skin; Leathery skin; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Mar-2021 and was forwarded to Moderna on 19-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ICHTHYOSIS (Snake-like skin), RASH ERYTHEMATOUS (Red bumps/rashes spread all over the body), SKIN BURNING SENSATION (Burning rashes) and RASH PRURITIC (Itching rashes) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) 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 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced ICHTHYOSIS (Snake-like skin) (seriousness criterion medically significant), RASH ERYTHEMATOUS (Red bumps/rashes spread all over the body) (seriousness criterion disability), SKIN BURNING SENSATION (Burning rashes) (seriousness criterion disability), RASH PRURITIC (Itching rashes) (seriousness criterion disability), KERATOSIS PILARIS (Sandy-like skin) and LICHENIFICATION (Leathery skin). At the time of the report, ICHTHYOSIS (Snake-like skin), RASH ERYTHEMATOUS (Red bumps/rashes spread all over the body), SKIN BURNING SENSATION (Burning rashes), RASH PRURITIC (Itching rashes), KERATOSIS PILARIS (Sandy-like skin) and LICHENIFICATION (Leathery skin) had not resolved.            No concomitant medications reported. Treatment medications included diphenhydramine and 6-day pack prednisone.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Epistaxis
Clinical narrative: another gushing nose bleed; minor nose bleed; fourth nose bleed; third severe nose bleed; second severe nose bleed; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (second severe nose bleed), EPISTAXIS (third severe nose bleed), EPISTAXIS (fourth nose bleed) and EPISTAXIS (another gushing nose bleed) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer. Concurrent medical conditions included Von Willebrand's disease.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced EPISTAXIS (second severe nose bleed) (seriousness criterion disability). On 25-Feb-2021, the patient experienced EPISTAXIS (third severe nose bleed) (seriousness criterion disability). On 09-Mar-2021, the patient experienced EPISTAXIS (fourth nose bleed) (seriousness criterion disability). On 13-Mar-2021, the patient experienced EPISTAXIS (minor nose bleed). On 18-Mar-2021, the patient experienced EPISTAXIS (another gushing nose bleed) (seriousness criterion disability). On 13-Mar-2021, EPISTAXIS (minor nose bleed) had resolved. In March 2021, EPISTAXIS (fourth nose bleed) had resolved. On 18-Mar-2021, EPISTAXIS (another gushing nose bleed) had resolved. At the time of the report, EPISTAXIS (second severe nose bleed) and EPISTAXIS (third severe nose bleed) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Computerised tomogram head: normal (normal) Normal frontal sinuses, nose, and frontal lobe of brain.         Concomitant product use was not reported. Treatment for the nose bleeds included intravenous desmopressin, aminocapriotic acid, cauterization, and packing.; Sender's Comments: This case concerns a 69 Y/O F with multiple serious unexpected events of severe epistaxis.  Event onset 8 days after first dose mRNA-1273. Treated with desmopressin, aminocapriotic acid, cauterization. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: serious medical condition; A spontaneous report was received from a consumer female patient, concerning herself, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced serious medical condition/vaccination adverse event.  The patient's medical history was not provided. Concomitant medication was not reported.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route for prophylaxis of COVID-19 infection.   On an unknown date, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route for prophylaxis of COVID-19 infection.   On an unknown date, after the first dose of the two planned doses of mRNA-1273, the patient was said to have experienced a serious medical condition. Post second dose of the planned two doses of mRNA-1273, the event became severe. Treatment given was not provided.  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.  The event serious medical condition was reported as resolved on an unknown date.; Sender's Comments: Very limited information regarding the reported event has been provided at this time.  Further information has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Mouth swelling, Oral pruritus, Pharyngeal swelling
Clinical narrative: Difficulty breathing, swelling and itchiness in mouth and throat, and dizziness all within 5-10 minutes of taking shot.   Used inhaler, took Benadryl. Symptoms subsided within two hours.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Difficulty breathing, swelling and itchiness in mouth and throat, and dizziness all within 5-10 minutes of taking shot.   Used inhaler, took Benadryl. Symptoms subsided within two hours.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neuralgia, Pain, Paraesthesia
Clinical narrative: Shooting nerve pain down left arm.  Numbness and tingling to left arm