chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Chest discomfort, Dyspnoea, Vaccination site erythema, Vaccination site irritation
Clinical narrative: a potential for cellulitis; Tightness in chest; hard to breathe; Has egg size lump in shoulder that is hot, red and swollen; Injeciton site is itchy, hot, irritable, painful and extremely swollen; Has egg size lump in shoulder that is hot, red and swollen; Has egg size lump in shoulder that is hot, red and swollen; Injeciton site is itchy, hot, irritable, painful and extremely swollen; Injeciton site is itchy, hot, irritable, painful and extremely swollen; A spontaneous report was received from an unknown age, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, chest discomfort, dyspnea, injection site swelling,  injection site pruritus , injection site erythema, injection site pain, and injection site irritation.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26-FEB-2021, before the events onset, the patient received the second of two planned doses of mRNA-1273 (lot/batch: Unknown) for prophylaxis of COVID-19 infection.   On 02-MAR-2021, the patient experienced tightness in chest, hard to breathe. He also manifested injection site swelling; a potential for cellulitis. He reporting having egg size lump in shoulder that is hot, red, swollen. It is not decreasing in size, has been the same size over the last couple of days. The injection site is itchy, hot, irritable, painful, and extremely swollen. No treatment details or laboratory results were provided for the reported events.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, cellulitis, chest discomfort, dyspnea, injection site swelling,  injection site pruritus , injection site erythema, injection site pain, and injection site irritation 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.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: a potential for cellulitis; Tightness in chest; hard to breathe; Has egg size lump in shoulder that is hot, red and swollen; Injeciton site is itchy, hot, irritable, painful and extremely swollen; Has egg size lump in shoulder that is hot, red and swollen; Has egg size lump in shoulder that is hot, red and swollen; Injeciton site is itchy, hot, irritable, painful and extremely swollen; Injeciton site is itchy, hot, irritable, painful and extremely swollen; A spontaneous report was received from an unknown age, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, chest discomfort, dyspnea, injection site swelling,  injection site pruritus , injection site erythema, injection site pain, and injection site irritation.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26-FEB-2021, before the events onset, the patient received the second of two planned doses of mRNA-1273 (lot/batch: Unknown) for prophylaxis of COVID-19 infection.   On 02-MAR-2021, the patient experienced tightness in chest, hard to breathe. He also manifested injection site swelling; a potential for cellulitis. He reporting having egg size lump in shoulder that is hot, red, swollen. It is not decreasing in size, has been the same size over the last couple of days. The injection site is itchy, hot, irritable, painful, and extremely swollen. No treatment details or laboratory results were provided for the reported events.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, cellulitis, chest discomfort, dyspnea, injection site swelling,  injection site pruritus , injection site erythema, injection site pain, and injection site irritation 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: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Some hearing loss; Tinnitus; A spontaneous report was received from Consumer concerning himself, a 71 years old male patient who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced some hearing loss/deafness and tinnitus/tinnitus.  The patient's medical history was not provided. Concomitant product included Warfarin.  On 1 Feb 2021, prior to onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 007m20a) by intramuscular route for prophylaxis of COVID-19 infection.   On 01 Feb 2021 he had some hearing loss and tinnitus. Patient stated he canceled second Moderna vaccine until he receives more information on his side effect. Patient was concerned about scheduling second Moderna vaccine.   Treatment was not reported.  Action taken with mRNA-1273 in response to the event was withdrawn.  The outcome of the event some hearing loss and tinnitus was unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Sensation of foreign body
Clinical narrative: Globus; A spontaneous report was received from a Physician concerning a 60 years old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced globus/Sensation of foreign body.  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 (Batch number: 006M20A) on 17 Feb 2021, approximately one day prior to the onset of the symptoms intramuscularly for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced an instance of globus.  On 18 Feb 2021, the patient was taken to the emergency room and treated with dexamethasone via intramuscular route and was discharged from the emergency room. No relevant laboratory details were included.  Action taken with the drug in response to the events were not reported.  The outcome of the event,  globus was recovered on 18 Feb 2021.; Reporter's Comments: Very limited information regarding the symptoms has been provided at this time. Further information has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Myalgia, Vaccination site pain
Clinical narrative: the pain level it was a 6 and now it's up to 9; Everything is sore; The arm was sore but that it's hard to tell as everything is sore; A spontaneous report was received from a consumer concerning, a 66 years old, male patient, who received MODERNA'S COVID-19 vaccine (mRNA-1273) and experienced the arm was sore but that it's hard to tell as everything is sore/pain in extremity and everything is sore/myalgia, and the pain level it was a 6 and now it's up to 9/condition aggravated.  The patient's medical history was provided as rare autoimmune disease and extreme pain. Concomitant medications reported were prednisone, naproxen, paracetamol, oxycodone for drug use for unknown indication.  On 09 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number:004M20A/004M204) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced the arm was sore but that it's hard to tell as everything is sore, the pain level it was a 6 and now it's up to 9. The patient stopped taking the medication in order to receive the vaccine to avoid the diminishing of the efficacy and wanted to know when can start taking the prednisone again. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, the arm was sore but that it's hard to tell as everything is sore/pain in extremity and everything is sore/myalgia, and the pain level it was a 6 and now it's up to 9, were 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 event (Vaccination site pain and myalgia) a causal relationship cannot be excluded. Very limited information regarding the event (condition aggravated) has been provided at this time. Noting underlying autoimmune disease may remain as risk factor. Further information has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Hot flush, Loss of consciousness
Clinical narrative: Passing out sometimes; Very dizzy for two days; Feeling very bad; Hot flashes; Fever; chills; felt like she would fall; A spontaneous report was received from a consumer concerning a 52-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt passing out sometimes/Loss of consciousness, very dizzy for two days/dizziness, felt like she would fall/presyncope, hot flashes/hot flush, feeling very bad/feeling abnormal, chills and fever/pyrexia.  Medical history of the patient was not reported. Her concomitant product included rosuvastatin calcium.   On 03 Feb 2021, the patient received her first of the two planned doses of mRNA-1273 (batch number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection. On the same day, she developed fever and hot flashes. She took treatment with paracetamol.  On an unknown date, she became very dizzy for two days and was feeling very bad. She was passing out sometimes and felt like she would fall. She became dizzy again after two weeks for a couple minutes.  The event passing out sometimes was considered to be medically significant.  The action taken with mRNA-1273 in response to the events was not known.  The outcome of the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Pyrexia
Clinical narrative: Passing out sometimes; Very dizzy for two days; Feeling very bad; Hot flashes; Fever; chills; felt like she would fall; A spontaneous report was received from a consumer concerning a 52-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt passing out sometimes/Loss of consciousness, very dizzy for two days/dizziness, felt like she would fall/presyncope, hot flashes/hot flush, feeling very bad/feeling abnormal, chills and fever/pyrexia.  Medical history of the patient was not reported. Her concomitant product included rosuvastatin calcium.   On 03 Feb 2021, the patient received her first of the two planned doses of mRNA-1273 (batch number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection. On the same day, she developed fever and hot flashes. She took treatment with paracetamol.  On an unknown date, she became very dizzy for two days and was feeling very bad. She was passing out sometimes and felt like she would fall. She became dizzy again after two weeks for a couple minutes.  The event passing out sometimes was considered to be medically significant.  The action taken with mRNA-1273 in response to the events was not known.  The outcome of the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Pain in extremity, Paralysis, Vaccination complication
Clinical narrative: Became paralyzed; Every single muscle became tensed; Sore arm; severe reaction/ vaccination adverse reaction; Nauseous; A spontaneous report  was received from a consumer concerning herself, a 22-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced every single muscle became tensed, became paralyzed ,sore arm, nauseous and a severe reaction.  The patient's medical history was not provided. Concomitant medication use was not provided by reporter.   On 02 Mar 2021,prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number 023A21A) intramuscularly for COVID-19 infection prophylaxis.   On 02 Mar 2021, after first dose of the Moderna vaccine, the patient experienced every single muscle became tensed, became paralyzed ,sore arm, nauseous.  Treatment details included acetaminophen.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, every single muscle became tensed, became paralyzed ,sore arm, nauseous, and a severe reaction was considered unknown at the time of this report.; 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: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature decreased, Chills, Diarrhoea, Fatigue
Clinical narrative: weakness; noodle legs; excruciating headache; vomit; extremely nauseous; freezing cold with chills; passed out; weak tingling feeling; loose bowels; low grade temp of 96; sore arm; total, severe exhaustion; A Spontaneous report was received from a consumer concerning herself a 67-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced passed out/loss of consciousness, severe exhaustion/fatigue, sore arm/ pain in extremity, extremely nauseous, weak tingling feeling/Paresthesia , vomiting, freezing cold with chills, loose bowels/diarrhea, low grade temp of 96/body temperature decreased, excruciating headache, weakness/asthenia, noodle legs/muscular weakness.      The patient's medical history was not included. Concomitant medications were not listed.   On 23 Feb 2021 prior to the onset of events the patients received first dose of their two planned doses of mRNA-1273 (Batch N0:023M7) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 23 Feb 2021, She felt total, severe exhaustion until Saturday 27 Feb 2021. She woke up with a sore arm on 24 Feb 2021.   On Sunday 28 Feb 2021, she felt extremely nauseous. She had a weak tingling feeling; she started seeing spots and passed out. When she came to, she started to vomit, was freezing cold with chills, then had loose bowels. She had a low-grade temp of 96. She had excruciating headaches. She had weakness; she has noodle legs  The event passed out/loss of consciousness was medically significant and serious.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, severe exhaustion was resolved on 27 Feb 2021, and outcome of event passed out resolved on unknown date. The outcome of the events sore arm, extremely nauseous, weak tingling feeling, vomiting, freezing cold with chills, loose bowels, low grade temp of 96, excruciating headache, weakness, noodle legs were 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.; Sender's Comments:  MOD-2021-035997:Same Reporter, Different Patient
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Muscular weakness, Nausea, Pain in extremity
Clinical narrative: weakness; noodle legs; excruciating headache; vomit; extremely nauseous; freezing cold with chills; passed out; weak tingling feeling; loose bowels; low grade temp of 96; sore arm; total, severe exhaustion; A Spontaneous report was received from a consumer concerning herself a 67-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced passed out/loss of consciousness, severe exhaustion/fatigue, sore arm/ pain in extremity, extremely nauseous, weak tingling feeling/Paresthesia , vomiting, freezing cold with chills, loose bowels/diarrhea, low grade temp of 96/body temperature decreased, excruciating headache, weakness/asthenia, noodle legs/muscular weakness.      The patient's medical history was not included. Concomitant medications were not listed.   On 23 Feb 2021 prior to the onset of events the patients received first dose of their two planned doses of mRNA-1273 (Batch N0:023M7) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 23 Feb 2021, She felt total, severe exhaustion until Saturday 27 Feb 2021. She woke up with a sore arm on 24 Feb 2021.   On Sunday 28 Feb 2021, she felt extremely nauseous. She had a weak tingling feeling; she started seeing spots and passed out. When she came to, she started to vomit, was freezing cold with chills, then had loose bowels. She had a low-grade temp of 96. She had excruciating headaches. She had weakness; she has noodle legs  The event passed out/loss of consciousness was medically significant and serious.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, severe exhaustion was resolved on 27 Feb 2021, and outcome of event passed out resolved on unknown date. The outcome of the events sore arm, extremely nauseous, weak tingling feeling, vomiting, freezing cold with chills, loose bowels, low grade temp of 96, excruciating headache, weakness, noodle legs were 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.; Sender's Comments:  MOD-2021-035997:Same Reporter, Different Patient
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vomiting
Clinical narrative: weakness; noodle legs; excruciating headache; vomit; extremely nauseous; freezing cold with chills; passed out; weak tingling feeling; loose bowels; low grade temp of 96; sore arm; total, severe exhaustion; A Spontaneous report was received from a consumer concerning herself a 67-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced passed out/loss of consciousness, severe exhaustion/fatigue, sore arm/ pain in extremity, extremely nauseous, weak tingling feeling/Paresthesia , vomiting, freezing cold with chills, loose bowels/diarrhea, low grade temp of 96/body temperature decreased, excruciating headache, weakness/asthenia, noodle legs/muscular weakness.      The patient's medical history was not included. Concomitant medications were not listed.   On 23 Feb 2021 prior to the onset of events the patients received first dose of their two planned doses of mRNA-1273 (Batch N0:023M7) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 23 Feb 2021, She felt total, severe exhaustion until Saturday 27 Feb 2021. She woke up with a sore arm on 24 Feb 2021.   On Sunday 28 Feb 2021, she felt extremely nauseous. She had a weak tingling feeling; she started seeing spots and passed out. When she came to, she started to vomit, was freezing cold with chills, then had loose bowels. She had a low-grade temp of 96. She had excruciating headaches. She had weakness; she has noodle legs  The event passed out/loss of consciousness was medically significant and serious.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, severe exhaustion was resolved on 27 Feb 2021, and outcome of event passed out resolved on unknown date. The outcome of the events sore arm, extremely nauseous, weak tingling feeling, vomiting, freezing cold with chills, loose bowels, low grade temp of 96, excruciating headache, weakness, noodle legs were 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.; Sender's Comments:  MOD-2021-035997:Same Reporter, Different Patient
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Cold sweat, Decreased appetite, Dizziness
Clinical narrative: Hypothermia; Cold sweats; No appetite; Some dizziness; Temperature 94.2; Dull headache; A spontaneous report was received from a consumer concerning a 72-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypothermia, cold sweat, appetite lost/decreased appetite, dizziness, temperature body decreased/body temperature decreased and headache   The patient's medical history was not provided by the reporter. No concomitant medications were reported.   On 12 Feb 2021, about two weeks prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 015M20A) via unknown route in an unknown location for prophylaxis of COVID-19 infection.   On 12 Mar 2021, the patient received the second of two planned doses of mRNA-1273 (Lot number: 015M20A) via unknown route in an unknown location for prophylaxis of COVID-19 infection.   After two weeks on 26 Feb 2021, the patient developed hypothermia in the morning. Then patient experienced a drop in body temperature to 94.2 F. The patient had to change clothes frequently due to cold sweats. The patient also reported that she had headache, dizziness and no appetite.  The treatment medication was reported as acetylsalicylic acid for headache.  The event hypothermia was considered medically significant.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events, hypothermia, dropping body temperature, cold sweats, headache, dizziness and no appetite 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 event, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypothermia
Clinical narrative: Hypothermia; Cold sweats; No appetite; Some dizziness; Temperature 94.2; Dull headache; A spontaneous report was received from a consumer concerning a 72-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypothermia, cold sweat, appetite lost/decreased appetite, dizziness, temperature body decreased/body temperature decreased and headache   The patient's medical history was not provided by the reporter. No concomitant medications were reported.   On 12 Feb 2021, about two weeks prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 015M20A) via unknown route in an unknown location for prophylaxis of COVID-19 infection.   On 12 Mar 2021, the patient received the second of two planned doses of mRNA-1273 (Lot number: 015M20A) via unknown route in an unknown location for prophylaxis of COVID-19 infection.   After two weeks on 26 Feb 2021, the patient developed hypothermia in the morning. Then patient experienced a drop in body temperature to 94.2 F. The patient had to change clothes frequently due to cold sweats. The patient also reported that she had headache, dizziness and no appetite.  The treatment medication was reported as acetylsalicylic acid for headache.  The event hypothermia was considered medically significant.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events, hypothermia, dropping body temperature, cold sweats, headache, dizziness and no appetite 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 event, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Memory impairment
Clinical narrative: Diagnosed with Mild Stroke; Forgetfulness; A spontaneous report was received from a consumer concerning a 48-year-old, female patient, who experienced  no movement in her eft arm, all the way to her hand and felt no movement in lip or chin. She experienced numbness on the side of her face and was forgetful and Forgetfulness.   The patient's medical history was not provided. Products known to have been used by patient, within two weeks prior to the event, included atorvastatin calcium, acetylsalicylic acid, sodium alginate, sodium bicarbonate, vitamin d and antidepressants.  On 12-FEB-2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12-MAR-2021, prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: 003A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 14-MAR-2021, approximately two days after receiving her vaccine, the patient began experiencing no movement in her left arm, all the way to her hand and felt no movement in lip or chin. She experienced numbness on the side of her face and was forgetful. The patient went to the hospital and was diagnosed with a stroke and felt forgetfulness.  On 16-MAR-2021, the patient was discharged from hospital. She was able to use her arm, although her hand was still stiff, and her fingers could move.  Treatments for the events was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, cerebrovascular accident and forgetfulness 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Fatigue
Clinical narrative: extreme fatigue to a point last night she could not go to bed; diarrhea; tested positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extreme fatigue to a point last night she could not go to bed), DIARRHOEA (diarrhea) and COVID-19 (tested positive for covid-19) 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 (No reported medical history).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (extreme fatigue to a point last night she could not go to bed) (seriousness criterion hospitalization), DIARRHOEA (diarrhea) (seriousness criterion hospitalization) and COVID-19 (tested positive for covid-19) (seriousness criterion hospitalization). At the time of the report, FATIGUE (extreme fatigue to a point last night she could not go to bed), DIARRHOEA (diarrhea) and COVID-19 (tested positive for covid-19) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case concerns an 82 Y/O F hospitalized with serious unexpected events of diarrhea, fatigue, and SARS-CoV-2 test positive. Event onset with unknown latency after first dose mRNA-1273. Treated with bamlanivimab. Events ongoing. 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 Y/O F hospitalized with serious unexpected events of diarrhea, fatigue, and SARS-CoV-2 test positive. Event onset with unknown latency after first dose mRNA-1273. Treated with bamlanivimab. Events ongoing. 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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pulmonary congestion, Pyrexia
Clinical narrative: Chest congestion; Sore arm; Body aches; Fever of 101-102°F; Fatigue; Headache; A spontaneous report was received from consumer, concerning himself, a 68-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever of 101 to 102 F, chest congestion, body aches, fatigue, headache and sore arm.  The patient's medical history was not reported. Products known to have been used by the patient, within two weeks prior to the events, included atorvastatin, enalapril and travoprost. Patient took paracetamol for the symptoms.  On 13 Feb 2021, prior to onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 038K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 13 Mar 2021, prior to onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 030A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the same day post vaccination, the patient started having a fever of 101 to 102F, chest congestion, body aches, fatigue, headache and sore arm.  Action taken with mRNA-1273 in response to events were not applicable.  All events were resolved over a week.; 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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Chest congestion; Sore arm; Body aches; Fever of 101-102°F; Fatigue; Headache; A spontaneous report was received from consumer, concerning himself, a 68-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever of 101 to 102 F, chest congestion, body aches, fatigue, headache and sore arm.  The patient's medical history was not reported. Products known to have been used by the patient, within two weeks prior to the events, included atorvastatin, enalapril and travoprost. Patient took paracetamol for the symptoms.  On 13 Feb 2021, prior to onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 038K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 13 Mar 2021, prior to onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 030A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the same day post vaccination, the patient started having a fever of 101 to 102F, chest congestion, body aches, fatigue, headache and sore arm.  Action taken with mRNA-1273 in response to events were not applicable.  All events were resolved over a week.; 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: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hyperpyrexia, Tremor
Clinical narrative: 106°F fever; severe shakes; very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of HYPERPYREXIA (106°F fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced HYPERPYREXIA (106°F fever) (seriousness criterion medically significant), TREMOR (severe shakes) and FATIGUE (very fatigued). At the time of the report, HYPERPYREXIA (106°F fever), TREMOR (severe shakes) and FATIGUE (very fatigued) outcome was unknown.            Based on the current available information and temporal association between the use of the product and the onset date of the reported 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 onset date of the reported events, a causal relationship cannot be excluded.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cardiac flutter, Discomfort, Fatigue, Pyrexia
Clinical narrative: Heart fluttering; more extreme exhaustion; Discomfort; sore arm; Heart fluttering; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021 and was forwarded to Moderna on 18-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of the first episode of CARDIAC FLUTTER (Heart fluttering) and the second episode of CARDIAC FLUTTER (Heart fluttering) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 015M20A) 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).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2020, the patient experienced PYREXIA (Fever). On 12-Feb-2021, the patient experienced the first episode of CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant), FATIGUE (more extreme exhaustion), DISCOMFORT (Discomfort) and VACCINATION SITE PAIN (sore arm). On 13-Mar-2021, the patient experienced the second episode of CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant). At the time of the report, last episode of CARDIAC FLUTTER (Heart fluttering) outcome was unknown, FATIGUE (more extreme exhaustion) had resolved, DISCOMFORT (Discomfort) and VACCINATION SITE PAIN (sore arm) was resolving and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 103.3 (High) Fever for 103.3 degree.         This case concerns a 43 Y/O M with a serious unexpected event of cardiac flutter and non-serious expected pyrexia.  Event onset on Day 2 after second dose mRNA-1273. Events ongoing. 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.  Treatment medications included ibuprofen and acetaminophen.; Sender's Comments: This case concerns a 43 Y/O M with a serious unexpected event of cardiac flutter and nonserious expected pyrexia.  Event onset on Day 2 after second dose mRNA-1273. Events ongoing. 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: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Heart fluttering; more extreme exhaustion; Discomfort; sore arm; Heart fluttering; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021 and was forwarded to Moderna on 18-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of the first episode of CARDIAC FLUTTER (Heart fluttering) and the second episode of CARDIAC FLUTTER (Heart fluttering) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 015M20A) 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).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2020, the patient experienced PYREXIA (Fever). On 12-Feb-2021, the patient experienced the first episode of CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant), FATIGUE (more extreme exhaustion), DISCOMFORT (Discomfort) and VACCINATION SITE PAIN (sore arm). On 13-Mar-2021, the patient experienced the second episode of CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant). At the time of the report, last episode of CARDIAC FLUTTER (Heart fluttering) outcome was unknown, FATIGUE (more extreme exhaustion) had resolved, DISCOMFORT (Discomfort) and VACCINATION SITE PAIN (sore arm) was resolving and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 103.3 (High) Fever for 103.3 degree.         This case concerns a 43 Y/O M with a serious unexpected event of cardiac flutter and non-serious expected pyrexia.  Event onset on Day 2 after second dose mRNA-1273. Events ongoing. 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.  Treatment medications included ibuprofen and acetaminophen.; Sender's Comments: This case concerns a 43 Y/O M with a serious unexpected event of cardiac flutter and nonserious expected pyrexia.  Event onset on Day 2 after second dose mRNA-1273. Events ongoing. 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ulcerative keratitis
Clinical narrative: corneal ulcer outbreak/two ulcers on her eye; A spontaneous report was received from a consumer concerning a 73-year-old female patient of who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced corneal ulcer outbreak/two ulcers on her eye.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included aciclovir sodium, atenolol, and lisinopril.  The patient received the first of two planned doses of mRNA-1273 (batch number: 030L20A) on 25 Jan 2021. On 22 Feb 2021, 3 hours prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (batch number: 030L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 22 Feb 2021, 3 hours after administration of the second dose, the patient had a corneal ulcer outbreak which she explained as two ulcers on her eye. The event corneal ulcer outbreak/two ulcers on her eye was assessed as medically significant.  Treatment for the event included, acyclovir, 5 times a day and ganciclovir (zirgan) ointment.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of event, corneal ulcer outbreak/two ulcers on her eye was 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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pulmonary embolism
Clinical narrative: pulmonary embolism; shortness of breath; A Spontaneous report was received from physician concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had pulmonary embolism and shortness of breath.  The patient's medical history was not reported, and concomitant medication included Albuterol, Lipitor, Flonase, Synthroid, loratadine, metoprolol and Torsemide.  On 24 Feb 2021, 1 day prior to the onset of the event, the patient received their first dose mRNA-1273 (Lot number: unknown, Expiration date: not provided) via intramuscular route for prophylaxis of COVID-19 infection.   On 27 Feb 2021, after administration of vaccine patient experienced shortness of breath.  On an unknown date patient experienced pulmonary embolism and was admitted for three days.   She was given Heparin and Coumadin. She was admitted for three days and was sent home with a prescription for Lovenox and Warfarin.  Action taken with the mRNA-1273 in response to the events was not provided.   The outcome were recovered for events.; 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: Neuropathy peripheral
Clinical narrative: Peripheral neuropathy extended to whole body; A spontaneous report was received from a consumer concerning a 67-years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event peripheral neuropathy extended to whole body/neuropathy peripheral.   The patient's medical history included peripheral neuropathy. Concomitant medications included acetylsalicylic acid, losartan and metoprolol.  On 02 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029A21A) intramuscularly for prophylaxis of COVID-19 infection.    The patient is having peripheral neuropathy from last 15 years and it was limited to hands and feet. On an unknown date, after receiving the vaccine it extended to whole body. The patient reported that the condition has been worsened from level 1 to level 3.  No treatment details were provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event peripheral neuropathy extended to whole body was not recovered/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: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Extrasystoles, Headache
Clinical narrative: A spontaneous report was received from a consumer concerning an 81 years old, female patient who experienced headache, heart flutter and skip a beat/extra systoles.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 02 Mar 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025A21A) intramuscularly for prophylaxis of COVID-19 infection.   On 02 Mar 2021, the patient experienced headache, heart flutter and skip a beat. Treatment for the event included acetaminophen.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events headache, heart flutter and skip a beat were 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.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Skin laceration
Clinical narrative: Mechanical fall; Cut her wrist pretty bad and had to get stitches; A spontaneous report was received from a consumer concerning a 94-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mechanical fall/ fall and very bad cut on the wrist /skin lacerations.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 23 Feb 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 20 Mar 2021, the patient experienced a life threatening and medically significant event of mechanical fall and cut on her wrist which was pretty bad and had to get stitches. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the events, mechanical fall and cut her wrist pretty bad and had to get stitches was not reported.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, SARS-CoV-2 test positive
Clinical narrative: A Spontaneous report was received from a Consumer concerning a female patient of 77 years who received a dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced positive for COVID-19, diarrhea, decreased appetite.  The patient's medical history included heart transplant and was on dialysis prior to the vaccination.  No relevant concomitant medications were reported.  On 10 Mar 2021, the patient received her first of two planned doses of mRNA-1273 (lot/batch: unknown) on right arm , intramuscularly for prophylaxis of COVID-19 infection.   On 11 Mar 2021, the patient reports she was tested positive for COVID-19 and was hospitalized with symptoms of diarrhea, loss of appetite. The patient was discharged from the hospital on 19 March 2021 and was still in quarantine at the time of this report.   Laboratory details were not provided.  Treatment details included Remdesivir.  Action taken with mRNA-1273 in response to the events was not reported.  On date of this report, the outcome of the events of patient, positive for COVID-19, decreased appetite, diarrhea was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Epistaxis, SARS-CoV-2 test
Clinical narrative: COVID positive with mild infection; Difficulty breathing; Nose bleed; A spontaneous report was received from an 82-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nosebleed, difficulty breathing and COVID positive with mild infection.  The patient's medical history included Pulmonary arterial hypertension and Concomitant medication include TREPROSTINIL SODIUM and TADALAFIL. Lab tests provided for COVID-19 tests positive.  On 26 Jan 2021, patient received first of two planned dose  and on 16 Feb 2021, received second of two planned dose.  On 13 Mar 2021, the patient was hospitalized with nosebleed, difficulty breathing and COVID positive with mild infection and the treatment provided was unknown.  Action taken with mRNA-1273 in response to the event was not applicable as the patient received both the planned doses prior to the event  The outcome of events, nosebleed, difficulty breathing and COVID positive with mild infection was reported unknown; Reporter's Comments: Very limited information regarding these events has been provided at this time. Based on the known causative agent of COVID-19 infection, the event is assessed as unlikely related to mRNA-1273. It is likely that the patient was already infected with the virus but asymptomatic before being administered with the mRNA-1273 vaccine