chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: itching on her back, hands and wrists (severe), and behind her ear by her hairline; delayed types of reactions; dizzy whenever she lays down; rash going up her arm.; exhausted, fatigue, and couldn't get out of bed.; pulmonary fibrosis was also exacerbated.; A spontaneous report was received from a consumer, concerning a 78 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pulmonary fibrosis was also exacerbated(Pulmonary Fibrosis), exhausted, fatigue, and couldn't get out of bed( Fatigue), itching on her back, hands and wrists (severe), and behind her ear by her hairline(Pruritus), rash going up her arm(vaccination site rash),dizzy whenever she lays down(Dizziness), delayed types of reactions(Skin Reactions).  The patient's medical history had pulmonary fibrosis.No relevant concomitant medications were reported.   On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) intramuscularly in the Left arm for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient experience exhausted, fatigue, and couldn't get out of bed, pulmonary fibrosis was also exacerbated and On 03 Feb 2021 ,the patient experience itching on her back, hands and wrists (severe), and behind her ear by her hairline,rash going up her arm, dizzy whenever she lays down,delayed types of reactions.  The patient was treated with lidocaine for itchiness on her hands and wrists.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, pulmonary fibrosis was also exacerbated(Pulmonary Fibrosis), exhausted, fatigue, and couldn't get out of bed( Fatigue), itching on her back, hands and wrists (severe), and behind her ear by her hairline(Pruritus), rash going up her arm(vaccination site rash),dizzy whenever she lays down(Dizziness), delayed types of reactions(Skin Reactions) were considered as unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. The pulmonary fibrosis and dizziness events are probably related to the patient's comorbidities. Based on the current available information and temporal association between the use of the product and the start date of the events vaccination site rashes and fatigue, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymphadenopathy, Peripheral swelling
Clinical narrative: Swelling at the left arm , neck and lymph nodes; Redness at the left arm , neck and lymph nodes; lymphadenopathy; A spontaneous report was received from a consumer concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swelling at the left arm , neck and lymph nodes, redness at the left arm , neck and lymph nodes.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 31 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced the event(s) swelling and redness at the left arm , neck and lymph nodes.  No treatment information was provided.  The seriousness criterion for the events was reported as other.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), swelling at the left arm , neck and lymph nodes, redness at the left arm , neck and lymph nodes was unknown.; Reporter's Comments: This case concerns a 71 Y/O F with serious unexpected events of peripheral swelling and erythema. Event onset 26 days after first dose mRNA-1273. Events outcomes not reported. 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.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Deafness, Decreased appetite, Diarrhoea
Clinical narrative: they found yellowish fluid which they thought was an infection, ear pain in his right ear, slight dizziness; overall had manageable energy level to work and appetite; flu-like symptoms; stomach problems; slight diarrhea; sweating; spent more of the day sleeping; had no appetite just drinking fluids; nausea; chills; experienced hearing loss in his right ear; soreness; A Spontaneous report from was received from a Healthcare professional, concerning a 65-year-old male patient, who received Moderna's COVID-19 vaccine experienced multiple symptoms.  Patient had a history of cholesterol and high blood pressure. It was reported that patient used Lipitor, Fish oil, cholesterol medications and high blood pressure medications as concomitant product.  On 01Feb2021, prior to the onset of events, the patient received his first of two planned doses of mRNA-1273 (unknown lot number) via unspecified route on left arm for COVID-19 infection prophylaxis.  On 02Feb2021, within 24 hours, he had right ear pain and following day, he developed hearing loss, slight dizziness but overall had manageable energy level to work and appetite. On the 04 FEB 2021, he had flu-like symptoms, light headed, G.I discomfort, nausea, slight diarrhea, sweating, chills, with continuous hearing impairment, spent most of time sleeping, had no appetite and was just drinking fluids. Next few days slowly gained energy and appetite back.  On the 08 FEB 2021, felt really uncomfortable in his ear, still feeling nausea. At urgent care to yellowish discharge from the  ear was assumed as infection and treated with Amoxil and Flonase. He recovered the flu-like symptoms except his hearing loss. He was referred to an ear specialist by primary to evaluate the hearing loss.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events was considered to be unknown at the time of this report.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Ear infection, Hyperhidrosis, Influenza like illness, Nausea, Pain
Clinical narrative: they found yellowish fluid which they thought was an infection, ear pain in his right ear, slight dizziness; overall had manageable energy level to work and appetite; flu-like symptoms; stomach problems; slight diarrhea; sweating; spent more of the day sleeping; had no appetite just drinking fluids; nausea; chills; experienced hearing loss in his right ear; soreness; A Spontaneous report from was received from a Healthcare professional, concerning a 65-year-old male patient, who received Moderna's COVID-19 vaccine experienced multiple symptoms.  Patient had a history of cholesterol and high blood pressure. It was reported that patient used Lipitor, Fish oil, cholesterol medications and high blood pressure medications as concomitant product.  On 01Feb2021, prior to the onset of events, the patient received his first of two planned doses of mRNA-1273 (unknown lot number) via unspecified route on left arm for COVID-19 infection prophylaxis.  On 02Feb2021, within 24 hours, he had right ear pain and following day, he developed hearing loss, slight dizziness but overall had manageable energy level to work and appetite. On the 04 FEB 2021, he had flu-like symptoms, light headed, G.I discomfort, nausea, slight diarrhea, sweating, chills, with continuous hearing impairment, spent most of time sleeping, had no appetite and was just drinking fluids. Next few days slowly gained energy and appetite back.  On the 08 FEB 2021, felt really uncomfortable in his ear, still feeling nausea. At urgent care to yellowish discharge from the  ear was assumed as infection and treated with Amoxil and Flonase. He recovered the flu-like symptoms except his hearing loss. He was referred to an ear specialist by primary to evaluate the hearing loss.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events was considered to be unknown at the time of this report.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: they found yellowish fluid which they thought was an infection, ear pain in his right ear, slight dizziness; overall had manageable energy level to work and appetite; flu-like symptoms; stomach problems; slight diarrhea; sweating; spent more of the day sleeping; had no appetite just drinking fluids; nausea; chills; experienced hearing loss in his right ear; soreness; A Spontaneous report from was received from a Healthcare professional, concerning a 65-year-old male patient, who received Moderna's COVID-19 vaccine experienced multiple symptoms.  Patient had a history of cholesterol and high blood pressure. It was reported that patient used Lipitor, Fish oil, cholesterol medications and high blood pressure medications as concomitant product.  On 01Feb2021, prior to the onset of events, the patient received his first of two planned doses of mRNA-1273 (unknown lot number) via unspecified route on left arm for COVID-19 infection prophylaxis.  On 02Feb2021, within 24 hours, he had right ear pain and following day, he developed hearing loss, slight dizziness but overall had manageable energy level to work and appetite. On the 04 FEB 2021, he had flu-like symptoms, light headed, G.I discomfort, nausea, slight diarrhea, sweating, chills, with continuous hearing impairment, spent most of time sleeping, had no appetite and was just drinking fluids. Next few days slowly gained energy and appetite back.  On the 08 FEB 2021, felt really uncomfortable in his ear, still feeling nausea. At urgent care to yellowish discharge from the  ear was assumed as infection and treated with Amoxil and Flonase. He recovered the flu-like symptoms except his hearing loss. He was referred to an ear specialist by primary to evaluate the hearing loss.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events was considered to be unknown at the time of this report.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Malaise, Melaena
Clinical narrative: Black diarrhea; Lethargic - didn't feel like doing anything; Not feeling good  like when you are coming down with something; A spontaneous report was received from a Healthcare Professional concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events black diarrhea/melaena, lethargic - didnt feel like doing anything/lethargy, not feeling good like when you are coming down with something/malaise.  The patient's medical history included constipation. Concomitant medications reported were Fluoxetine, Rosuvastatin, Zonisamide, Pregabalin, Alendronic acid, Prednisone, Multivitamin, Aspirin, Calcium for drug use for unknown indication.  On 30 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient experienced the events black diarrhea, lethargic - didnt feel like doing anything and not feeling good like when you are coming down with something.  The event of black diarrhea was considered to be serious with criteria of important medical event.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events black diarrhea, lethargic - didnt feel like doing anything and not feeling good like when you are coming down with something was resolved on 31 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events (Lethargy, and malaise) a causal relationship cannot be excluded. Very limited information regarding the events (Melaena) has been provided at this time. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: hearing is gone, cotton in his ear; A spontaneous report  was received from a consumer, concerning a male patient of unspecified age, who received Moderna COVID-19 vaccine (mRNA-1273) and experienced hearing loss.  The patient's medical history was not provided but it was reported he sees a dialysis doctor. concomitant product use was not provided by the reporter.  On 24-FEB-2021, prior to the onset of the symptoms, the patient received his first vaccination of mRNA-1273 (lot/ batch number unknown) via intramuscular route for COVID-19 infection prophylaxis.  On 25-FEB-2021, the patient's wife reported his hearing was gone, seems like the patient had cotton in his ear. No treatment medication was reported.  Action taken with mRNA-1273 in response to event was unknown.  The outcome of the event was considered to be unknown at the time of this report.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chest wall abscess
Clinical narrative: Abscess on her chest; A spontaneous report was received from a consumer, who was also a 80-years old, female patient, who developed chest wall abscess (abscess on her chest).   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 not provided) intramuscularly for prophylaxis of COVID-19 infection on unknown date.  On 16 Feb 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Batch number: 006M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unknown date, prior to receiving the second dose of mRNA-1273, the patient developed abscess on her chest. On 17 Feb 2021, the dermatologist drained the abscess. Further treatment included sulfa antibiotic. Reportedly, the patient did not have any side effects from the vaccine (second dose) and was feeling fine.   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 the event, chest wall abscess, was unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. The event was consistent with infectious process confounded by elderly age of patient. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Hemiparaesthesia, Pain
Clinical narrative: Numbness on the Left Side of Body; left side of head from eye to temple  to jaw hurting; A Spontaneous report was received from a 63-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced numbness on the left side of body and left side of head from eye to temple  to jaw hurting.  The patient medical history was not provided. The patient's current conditions included blood pressure abnormal and reaction non-specific. Concomitant product use included blood pressure medications and reaction medications.  On 25 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly in right upper arm for prophylaxis of COVID-19 infection.   On 25 Feb 2021, the patient experienced numbness on the left side of the body, left eye, left side roof of mouth and head. The patient also stated that left side of her head from eye to temple to jaw hurt for 2 and half days. The seriousness criteria for the event numbness on the left side of body was medically significant.  No treatment details were reported.  Action taken with mRNA-1273 in response to events was unknown.  The outcome of the event numbness on the left side of body was unknown and the outcome for the event left side of head from eye to temple  to jaw hurting was 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 events a causal relationship cannot be excluded. Further information has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Imaging procedure, Joint swelling, Oedema peripheral
Clinical narrative: Patient's left ankle starting swelling; Patient's left leg starting swelling; A spontaneous report  was received from a physician concerning a 38 years old male patient who experienced patient's left ankle starting swelling (joint swelling) and patient's left leg starting swelling (peripheral oedema).  The patient's medical history was not reported by the reporter. Concomitant medications were not provided.  On 11 Jan 2021, seven days prior to the onset of the event, the patient received first of their two planned doses of mRNA-1273 in the left arm for prophylaxis of Covid-19 infection.  On 18 Jan 2021, the patient's left ankle and leg started swelling. Healthcare professional performed an X ray and other analysis on the patient but didn't find anything. The patient  was treated with prednisone and the symptoms went away but when they stopped treating with prednisone the symptoms came back. Patient's symptoms were ongoing.  Healthcare professional showed his concern as he doesn't know what was happening to the patient. The patient was advised by his physician not to received the second dose.  Treatment for the events inluded predisone and Ibuprofen.  The second dose of mRNA-1273 was discontinued in response to the events.   The events, patient's left ankle and leg starting swelling, were considered not recovered.; 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nephrolithiasis, Pyrexia, Vaccination site erythema, Vaccination site mass
Clinical narrative: Lump; Itchy; Red mark on the injection site; Fever close to 101.4 degrees F; Kidney stone; Has also been coughing since she got the injection; A spontaneous report was received from a consumer concerning a 58-year-old female patient, who developed kidney stone/nephrolithiasis, fever close to 101.4 degrees F/Pyrexia, a red mark on the injection site/vaccination site erythema,  an itchy/vaccination site pruritis, lump/vaccination site mass and coughing/cough.  The patient's medical history was included night sweats. Products known to have been used by the patient included alprazolam, atorvastatin calcium, biotin, macrogol 3350, black cohosh, calcium carbonate/colecalciferol, minerals/vitamins NOS (not otherwise specified), celecoxib, eszopiclone, fluticasone, HCTZ, levothyroxine, pregabalin, montelukast, oxycodone, paroxetine, fluticasone proprionate/salmeterol xinafoate, potassium, risedronate sodium, and topiramate.  On 22-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: 012A21A) intramuscularly in the left deltoid muscle for prophylaxis of COVID-19 infection.  On 26-Feb-2021 the patient got a kidney stone and the doctor gave her medications. On 27-Feb-2021 she got a fever close to 101.4 degrees F for two days. Aspirin was taken which helped. A red mark was noticed on the injection site on 1-Mar-2021 which was described as an itchy lump. The patient also experienced coughing since receiving the injection. Treatment medications for the events included aspirin, ciprofloxacin and tamsulosin. The event kidney stone/nephrolithiasis was medically significant.  The action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, fever close to 101.4 degrees F, was considered recovered/resolved on 1-Mar-2021. The outcome of the events, kidney stone, a red mark on the injection site, an itchy lump, and coughing, was unknown.; Reporter's Comments: This case concerns a 58 Y/O F with a serious unexpected event of nephrolithiasis and nonserious unexpected cough, vaccination site mass, and expected fever, vaccination site erythema, vaccination site pruritus.  Event onset on Day 1 after first dose mRNA-1273. Treated with aspirin, ciprofloxacin and tamsulosin. Fever 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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Lump; Itchy; Red mark on the injection site; Fever close to 101.4 degrees F; Kidney stone; Has also been coughing since she got the injection; A spontaneous report was received from a consumer concerning a 58-year-old female patient, who developed kidney stone/nephrolithiasis, fever close to 101.4 degrees F/Pyrexia, a red mark on the injection site/vaccination site erythema,  an itchy/vaccination site pruritis, lump/vaccination site mass and coughing/cough.  The patient's medical history was included night sweats. Products known to have been used by the patient included alprazolam, atorvastatin calcium, biotin, macrogol 3350, black cohosh, calcium carbonate/colecalciferol, minerals/vitamins NOS (not otherwise specified), celecoxib, eszopiclone, fluticasone, HCTZ, levothyroxine, pregabalin, montelukast, oxycodone, paroxetine, fluticasone proprionate/salmeterol xinafoate, potassium, risedronate sodium, and topiramate.  On 22-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: 012A21A) intramuscularly in the left deltoid muscle for prophylaxis of COVID-19 infection.  On 26-Feb-2021 the patient got a kidney stone and the doctor gave her medications. On 27-Feb-2021 she got a fever close to 101.4 degrees F for two days. Aspirin was taken which helped. A red mark was noticed on the injection site on 1-Mar-2021 which was described as an itchy lump. The patient also experienced coughing since receiving the injection. Treatment medications for the events included aspirin, ciprofloxacin and tamsulosin. The event kidney stone/nephrolithiasis was medically significant.  The action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, fever close to 101.4 degrees F, was considered recovered/resolved on 1-Mar-2021. The outcome of the events, kidney stone, a red mark on the injection site, an itchy lump, and coughing, was unknown.; Reporter's Comments: This case concerns a 58 Y/O F with a serious unexpected event of nephrolithiasis and nonserious unexpected cough, vaccination site mass, and expected fever, vaccination site erythema, vaccination site pruritus.  Event onset on Day 1 after first dose mRNA-1273. Treated with aspirin, ciprofloxacin and tamsulosin. Fever 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: Bell's palsy, Ear pain
Clinical narrative: Droopy face bells palsy; An ear ache; A spontaneous report was received from a consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events droopy face bells palsy/facial paralysis and an ear ache/ear pain.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 16 Jan 2021, approximately 22 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 097k701A) for prophylaxis of COVID-19 infection.  On 08 Feb 2021, the patient had an ear ache, and on 09 Feb 2021 the patient had droopy face bells palsy. At the time of this report she still had Bell's palsy and was being treated by her doctor with prednisone and an anti viral. She was scheduled to receive her second shot on 13 Feb 2021. The event droopy face bells palsy was considered as medically significant. Treatment for the event included prednisone and an anti viral.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event droopy face bells palsy was considered as not recovered. The outcome of the event an ear ache 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.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Erythema, Hypersensitivity, Hypoaesthesia, Paraesthesia
Clinical narrative: blood pressure high; swelling right hand; severe numbness on right hand,severe numbness on left hand; delayed hypersensitivity reaction; Hypersensitivity reaction; Body rash,rash over arms,rash over foots; rash progressed into large red patches; rash large and red patches over wrists; tingle right hand/like electric shooting on hands; A spontaneous report was received from a Healthcare Professional who is also a Consumer and a 65-years-old male patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced elevated blood pressure,  hypoesthesia , peripheral swelling , paresthesia, erythema, rash erythematous, rash, and delayed hypersensitivity .  The patient's medical history was not provided but she reported she does not suffer of chronic hypertension. Concomitant medications reported were cholesterol medicine (Lipitor), levothyroxine, calcium, vitamin D, multivitamin, magnesium for drug use for unknown indication.  On 24-JAN-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 02-FEB-2021, the patient experienced a delayed hypersensitivity reaction with body rash, rash over arms, rash over foots, rash over hips, rash over chest, rash very itchy, rash progressed into large red patches, large and red rash patches over wrists, tingling right hand, swelling right hand, severe numbness on right hand, severe numbness on left hand, like electric shooting on hands. On 04-FEB-2021, the patient experienced the blood pressure high without being hypertensive before.  From 04-FEB-2021 to 05-FEB-2021, treatment included Benadryl and Oral Prednisone, which solved the rash.   Additiona treatment was reported to start on 11-FEB-2021 and included Oral Prednisone and Gabapentin..  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events elevated blood pressure,  hypoesthesia , peripheral swelling , paresthesia, erythema, rash erythematous, rash, and delayed hypersensitivity 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.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash, Rash erythematous
Clinical narrative: blood pressure high; swelling right hand; severe numbness on right hand,severe numbness on left hand; delayed hypersensitivity reaction; Hypersensitivity reaction; Body rash,rash over arms,rash over foots; rash progressed into large red patches; rash large and red patches over wrists; tingle right hand/like electric shooting on hands; A spontaneous report was received from a Healthcare Professional who is also a Consumer and a 65-years-old male patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced elevated blood pressure,  hypoesthesia , peripheral swelling , paresthesia, erythema, rash erythematous, rash, and delayed hypersensitivity .  The patient's medical history was not provided but she reported she does not suffer of chronic hypertension. Concomitant medications reported were cholesterol medicine (Lipitor), levothyroxine, calcium, vitamin D, multivitamin, magnesium for drug use for unknown indication.  On 24-JAN-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 02-FEB-2021, the patient experienced a delayed hypersensitivity reaction with body rash, rash over arms, rash over foots, rash over hips, rash over chest, rash very itchy, rash progressed into large red patches, large and red rash patches over wrists, tingling right hand, swelling right hand, severe numbness on right hand, severe numbness on left hand, like electric shooting on hands. On 04-FEB-2021, the patient experienced the blood pressure high without being hypertensive before.  From 04-FEB-2021 to 05-FEB-2021, treatment included Benadryl and Oral Prednisone, which solved the rash.   Additiona treatment was reported to start on 11-FEB-2021 and included Oral Prednisone and Gabapentin..  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events elevated blood pressure,  hypoesthesia , peripheral swelling , paresthesia, erythema, rash erythematous, rash, and delayed hypersensitivity 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.
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Hospitalisation, Product dose omission issue
Clinical narrative: Prolonged hospitalization over 7 weeks; Missed second dose; A spontaneous report was received from a nurse, concerning an 80 years-old patient of unknown gender, was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced prolonged hospitalization over 7 weeks (hospitalization), and missed second dose (product dose omission issue).  The patient's medical history was not reported. Concomitant medications were not reported.  On 16 Jan 2021, prior to the onset of events, the patient received their first of the two planned doses of mRNA-1273 (batch number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient was hospitalized for an unspecified reason. It was past seven weeks since the first vaccine was given, and patient could not get the second dose of vaccine because of prolonged hospitalization. Treatment information was not provided.  Action taken with second dose of mRNA-1273 in response to the events was unknown.  The outcomes of the event, prolonged hospitalization over 7 weeks was unknow and that of missed second dose was considered as resolved on an unknown date.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Chills, Heart rate, Nausea, Pyrexia
Clinical narrative: fast heart beat; Chills; pain at injection site (left); fever; nausea; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site pain, fast heart beat (atrial fibrillation ), fever, nausea, chills and was hospitalized with a diagnosis with atrial fibrillation.  The patient's medical history was not provided. Concomitant medications reported were Eliquis(apixaban) pill for drug use for unknown indication.  On 04-FEB-2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011M20A) Intramuscularly for prophylaxis of COVID-19 infection.   On 08-MAR-2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 003A21A) Intramuscularly for prophylaxis of COVID-19 infection.  On 08-MAR-2021, the patient experienced pain at injection site (left), fast heart beat, fever, nausea. On 09-MAR-2021, the patient experienced chills, The patient was diagnosed with atrial fibrillation and the patient was hospitalized on 09-MAR-2021 and discharged on 10-MAR-2021.   Treatment details not given but the patient was prescribed a Holter(14 days monitor).  Action taken with mRNA-1273 in response to the events was not applicable  The outcome of event(s), pain at injection site (left), fast heart beat, fever, nausea, chills, and atrial fibrillation was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  It is unclear if the patient had AFib before as she did not report prior medical history but is taking a medication usually prescribed for AFib. Further information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: fast heart beat; Chills; pain at injection site (left); fever; nausea; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site pain, fast heart beat (atrial fibrillation ), fever, nausea, chills and was hospitalized with a diagnosis with atrial fibrillation.  The patient's medical history was not provided. Concomitant medications reported were Eliquis(apixaban) pill for drug use for unknown indication.  On 04-FEB-2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011M20A) Intramuscularly for prophylaxis of COVID-19 infection.   On 08-MAR-2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 003A21A) Intramuscularly for prophylaxis of COVID-19 infection.  On 08-MAR-2021, the patient experienced pain at injection site (left), fast heart beat, fever, nausea. On 09-MAR-2021, the patient experienced chills, The patient was diagnosed with atrial fibrillation and the patient was hospitalized on 09-MAR-2021 and discharged on 10-MAR-2021.   Treatment details not given but the patient was prescribed a Holter(14 days monitor).  Action taken with mRNA-1273 in response to the events was not applicable  The outcome of event(s), pain at injection site (left), fast heart beat, fever, nausea, chills, and atrial fibrillation was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  It is unclear if the patient had AFib before as she did not report prior medical history but is taking a medication usually prescribed for AFib. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, Post procedural haemorrhage, Vaccination site pain
Clinical narrative: Bleeding from stiches; Pressure behind eyes along stiches; Soreness in arm; A spontaneous report was received from a consumer who was a 63-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced post procedural hemorrhage, vaccination site pain, and ocular discomfort.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16-FEB-2021 or 17-FEB-2021, prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the arm for prophylaxis of COVID-19 infection.   The patient had eye surgery 1 week before the 2nd dose of vaccine. She experienced pressure behind where stitches were done and a little bleeding from stitches. The patient also experienced soreness in her arm. Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The outcomes of the events 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, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Myocarditis, Vaccination complication
Clinical narrative: Myocarditis; Started having symptoms and typical symptoms; A spontaneous report was reported from a nurse (patient), concerning herself, a 62 years-old female patient, unknown race and ethnicity, was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced myocarditis, and started having symptoms and typical symptoms (vaccination complication).     The patient's current condition included blood donor. Concomitant medications reported included acetylsalicylic acid, atorvastatin, and escitalopram.   On 23 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (batch number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 20 Jan 2021, prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (batch number: 027L20A) intramuscularly for prophylaxis of COVID-19 infection.  The patient had nothing after the first dose and typical symptoms after the second dose. She started having symptoms on 07 Mar 2021. The patient was healthy and doesn't have any coronary disease. This was a red herring and stated that she was a blood donor and gave blood on Sunday, 07 Mar 2021. That's, the same day, the symptoms started. Also, the patient was a blood donor all last year. All the antibody tests were negative for last year and including the recent 07 Mar 2021 donation. This was outside the window of expected reactions, but she's been diagnosed with myocarditis, effective last week on 11 Mar 2021. The patient reported that the doctor started her on metoprolol tartrate 25 mg twice daily, which was started on 14 Mar 2021.  Action taken with second dose of mRNA-1273 in response to the event was not applicable.  The outcome of the events, myocarditis, and started having symptoms and typical symptoms were considered as unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information is requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Cardiac discomfort, Fungal infection, Vulvovaginal burning sensation, Vulvovaginal discomfort
Clinical narrative: sharp heart pain; tingling in her arm and leg; pressure in her heart; horrible feeling in vagina; like a severe yeast infection; vagina burned like fire; A spontaneous report was received from a consumer, concerning a female patient of 56 years, who received Moderna's COVID-19 vaccine and experienced tingling in her arm and leg/paraesthesia , sharp heart pain/angina pectoris, pressure in her heart/cardiac discomfort, horrible feeling in vagina/vulvovaginal discomfort, like a severe yeast infection/fungal infection, vagina burned like fire/ vulvovaginal burning sensation.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 15 Mar 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) via intramuscular route on left arm for COVID-19 infection prophylaxis.  On an unknown date, after receiving mRNA-1273, patient reported during receiving the vaccine she had tingling in her arm and leg, sharp heart pain and pressure in her heart. The patient stated a few minutes later she had horrible feeling in vagina, like a severe yeast infection and it burned like fire which lasted a couple minutes and went away. The event angina pectoris was assessed as serious as per IME. Treatment was not reported.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events, tingling in her arm and leg, sharp heart pain and pressure in her heart was not reported whereas events had horrible feeling in vagina, like a severe yeast infection and it burned like fire were recovered on an unknown date.; 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: Abdominal pain upper, Chills, Dizziness, Nausea, Syncope
Clinical narrative: Fainted; Bad stomach pain; Feeling Light headed; Chills; Nausea; A spontaneous report was received from a Consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea, chills, bad stomach pain/abdominal pain, feeling lightheaded/dizziness and fainted/syncope.  The patient's medical history was not provided. Concomitant products used by the reporter were lansoprazole, simvastatin and famotidine.  The patient received the first dose of two planned doses of mRNA-1273 (batch no: 023M20A) for prophylaxis of COVID-19 infection on an unknown date.  On 16-Mar-2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (batch no: 006B21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16 Mar 2021, same day of vaccination, the patient experienced nausea, chills, bad stomach pain, felt lightheadedness and fainted (medically significant).  Laboratory details were not provided.  The treatment medication included acetaminophen for the events  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events fainted, nausea, chills, stomach pain, feeling lightheaded were considered as 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Pregnancy, Product dose omission issue
Clinical narrative: Miscarriage; Pregnancy; well past the 42 day mark; A Spontaneous report was received from a Healthcare Professional concerning a  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient subsequently found out that she was pregnant . Patient had a miscarriage and now wants to receive the second dose of her vaccine. Well past the 42 day mark Patient now wants to receive the second dose of the Moderna Covid-19 vaccine.  The patients medical history was not provided.No concomitant medication information was provided.  On an unknown date in JAN 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273  intramuscularly  for prophylaxis of COVID-19 infection.  On an unknown date, The patient The patient subsequently found out that she was pregnant . Patient had a miscarriage and now wants to receive the second dose of her vaccine. Well past the 42 day mark Patient now wants to receive the second dose of the Moderna Covid-19 vaccine.  Laboratory details was not provided.No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events Pregnancy and Miscarriage was resolved.  The outcome of the event  well past 42 days was unknown.; Reporter's Comments: This is a case of product exposure during pregnancy with spontaneous abortion for this female (age unknown).  Patient missed her second dose. She will continue to be contacted for further monitoring of AEs post abortion. .
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dysuria, Gait disturbance, Movement disorder, Myelitis
Clinical narrative: not able to walk without a cane; lower body pains; cannot bend over; vaccine might have aggravated the myelitis she had in 2009; vaccine might have aggravated the myelitis she had in 2009; had difficulty urinating; A spontaneous report was received from a consumer who was a 59-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced not able to walk without a cane/gait disturbance, cannot bend over/movement disorder, difficulty urinating/dysuria, lower body pains/pain, and vaccine might have aggravated the myelitis that she had in 2009/myelitis and condition aggravated.  The patient's medical history included myelitis. Concomitant product use was not provided by the reporter.  On 16 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 027A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 16 Mar 2021, two hours after the vaccination, the patient experienced lower body pains, had difficulty urinating, was not able to walk without a cane and could not bend over.  She felt the vaccine may have aggravated the myelitis that she had in 2009.  Treatment information was not provided.  The reporter felt the events of cannot bend over, lower body pains, not able to walk without a cane, and vaccine might have aggravated the myelitis that she had in 2009 were disabling.      Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event of not able to walk without a cane, cannot bend over, difficulty urinating, lower body pains, and vaccine might have aggravated the myelitis that she had in 2009 was unknown at the time of this report.; Reporter's Comments: Very limited information regarding the rest of the event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the rest of the event has been provided at this time. Further information has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: not able to walk without a cane; lower body pains; cannot bend over; vaccine might have aggravated the myelitis she had in 2009; vaccine might have aggravated the myelitis she had in 2009; had difficulty urinating; A spontaneous report was received from a consumer who was a 59-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced not able to walk without a cane/gait disturbance, cannot bend over/movement disorder, difficulty urinating/dysuria, lower body pains/pain, and vaccine might have aggravated the myelitis that she had in 2009/myelitis and condition aggravated.  The patient's medical history included myelitis. Concomitant product use was not provided by the reporter.  On 16 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 027A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 16 Mar 2021, two hours after the vaccination, the patient experienced lower body pains, had difficulty urinating, was not able to walk without a cane and could not bend over.  She felt the vaccine may have aggravated the myelitis that she had in 2009.  Treatment information was not provided.  The reporter felt the events of cannot bend over, lower body pains, not able to walk without a cane, and vaccine might have aggravated the myelitis that she had in 2009 were disabling.      Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event of not able to walk without a cane, cannot bend over, difficulty urinating, lower body pains, and vaccine might have aggravated the myelitis that she had in 2009 was unknown at the time of this report.; Reporter's Comments: Very limited information regarding the rest of the event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the rest of the event has been provided at this time. Further information has been requested.