chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: He suddenly totally lost his right hearing; A spontaneous report was received from a consumer concerning  a 59 years old male patient who suddenly had a total loss of his right hearing (deafness).  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 montelukast sodium, hydrochlorothiazide, atorvastatin, losartan potassium and potassium.  On 17 Feb 2021, at 4:45 PM approximately six days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot: 030M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient suddenly totally lost his right hearing and patient went to emergency room (ER) and specialist doctors.   Treatment for the event included meclizine 25 mg, lorazepam 0.5 mg, amoxicillin 875-clavulanate 125 mg, prednisone 5 mg.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event of patient suddenly totally lost his right hearing was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dizziness, Fall, Feeling abnormal
Clinical narrative: Neck and arms tightening; Swollen glands; Pain was everywhere; Headache; Had full blown chills; Nausea; To the 100th degree, fever; body aches; Hallucinations; vertigo; Dizziness; Fell over while trying to load dish washer; chest pain; Neck and arms tightening; heart racing 120bpm; I thought I was going to die,felt really bad so she tried to sleep it off,felt like someone was pricking me with a knife; A spontaneous report was received from a consumer concerning a 54-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hallucination,COVID-19,vertigo, dizziness, fall, chest pain, heart rate increased, limb discomfort, lymphadenopathy, vaccination complication, muscle tightness, heart rate increased, pain, pyrexia, headache, chills, nausea and myalgia.  The patient's medical history was not provided as exposed to COVID-19. Concomitant medications were not reported .   On 04 MAR 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011A21A) via unknown route in an unknown location for prophylaxis of COVID-19 infection.   After receiving vaccine, patient felt like she had COVID -19 and she was going to die. On 05 Mar 2021 the events started with neck and arm tightening, swollen glands and headache. The patient had full blown chills,nausea to 100 degree, fever, body ache, hallucinations. She reported that she felt pain everywhere, heartracing 120bpm, chest pain, dizziness. She fell down while loading dishes and also she reported vertigo.  The event hallucination was considered as medically significant.  The treatment taken for the events was reported as Tylenol once in every six hours.  Action taken with mRNA-1273 in response to the events was unknown.  All the events except headache, vertigo and nausea was considered resolved 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.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, Headache, Heart rate increased, Limb discomfort, Lymphadenopathy
Clinical narrative: Neck and arms tightening; Swollen glands; Pain was everywhere; Headache; Had full blown chills; Nausea; To the 100th degree, fever; body aches; Hallucinations; vertigo; Dizziness; Fell over while trying to load dish washer; chest pain; Neck and arms tightening; heart racing 120bpm; I thought I was going to die,felt really bad so she tried to sleep it off,felt like someone was pricking me with a knife; A spontaneous report was received from a consumer concerning a 54-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hallucination,COVID-19,vertigo, dizziness, fall, chest pain, heart rate increased, limb discomfort, lymphadenopathy, vaccination complication, muscle tightness, heart rate increased, pain, pyrexia, headache, chills, nausea and myalgia.  The patient's medical history was not provided as exposed to COVID-19. Concomitant medications were not reported .   On 04 MAR 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011A21A) via unknown route in an unknown location for prophylaxis of COVID-19 infection.   After receiving vaccine, patient felt like she had COVID -19 and she was going to die. On 05 Mar 2021 the events started with neck and arm tightening, swollen glands and headache. The patient had full blown chills,nausea to 100 degree, fever, body ache, hallucinations. She reported that she felt pain everywhere, heartracing 120bpm, chest pain, dizziness. She fell down while loading dishes and also she reported vertigo.  The event hallucination was considered as medically significant.  The treatment taken for the events was reported as Tylenol once in every six hours.  Action taken with mRNA-1273 in response to the events was unknown.  All the events except headache, vertigo and nausea was considered resolved 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.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Nausea, Pain, Pyrexia, Vertigo
Clinical narrative: Neck and arms tightening; Swollen glands; Pain was everywhere; Headache; Had full blown chills; Nausea; To the 100th degree, fever; body aches; Hallucinations; vertigo; Dizziness; Fell over while trying to load dish washer; chest pain; Neck and arms tightening; heart racing 120bpm; I thought I was going to die,felt really bad so she tried to sleep it off,felt like someone was pricking me with a knife; A spontaneous report was received from a consumer concerning a 54-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hallucination,COVID-19,vertigo, dizziness, fall, chest pain, heart rate increased, limb discomfort, lymphadenopathy, vaccination complication, muscle tightness, heart rate increased, pain, pyrexia, headache, chills, nausea and myalgia.  The patient's medical history was not provided as exposed to COVID-19. Concomitant medications were not reported .   On 04 MAR 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011A21A) via unknown route in an unknown location for prophylaxis of COVID-19 infection.   After receiving vaccine, patient felt like she had COVID -19 and she was going to die. On 05 Mar 2021 the events started with neck and arm tightening, swollen glands and headache. The patient had full blown chills,nausea to 100 degree, fever, body ache, hallucinations. She reported that she felt pain everywhere, heartracing 120bpm, chest pain, dizziness. She fell down while loading dishes and also she reported vertigo.  The event hallucination was considered as medically significant.  The treatment taken for the events was reported as Tylenol once in every six hours.  Action taken with mRNA-1273 in response to the events was unknown.  All the events except headache, vertigo and nausea was considered resolved 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: Hospitalisation
Clinical narrative: Daughter had been hospitalized; A spontaneous report was received from a consumer concerning a female patient of an unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and was hospitalized.  The patient's medical history was not provided by reporter. Concomitant medications were not provided by reporter.  On an unknown date, prior to the onset of the events, the patient received the first of the two of their planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On unknown date following the vaccine administration, the patient was hospitalized. Treatment information was not provided by the reporter.   Action taken with mRNA-1273 in response to the event was not provided.    The outcome of the event, hospitalization was considered unknown.; Reporter's Comments: Very limited information regarding the event of hospitalization has been provided at this time.  Further information has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Myelodysplastic syndrome, Pancytopenia
Clinical narrative: had a blood test that showed he had pancytopenia and "his hcp gave him a preliminary diagnosis of Pre-Leukemia; preleukemia; Fatigue; A spontaneous report was received from a consumer concerning a 74 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Fatigue and the patient also reported that he had a blood test that showed he had pancytopenia and "his HCP gave him a preliminary diagnosis of Pre-Leukemia". The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030l20a) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 22 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 032h20a) in the left arm for prophylaxis of COVID-19 infection.  On 23 Feb 2021, one day after the 2nd vaccine, patient experienced fatigue. On 04 Mar 2021, the patient had a blood test that showed he had pancytopenia and "his HCP  gave him a preliminary diagnosis of Pre-Leukemia".  Patient stated that last year he had normal results and he was going to see a doctor in two weeks.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event Fatigue was reported as resolved on 23 Feb 2021.  The outcome of the events, pancytopenia and preliminary diagnosis of Pre-Leukemia, was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Enterococcal infection, Pyrexia, Urinary tract infection
Clinical narrative: Had a type of E-coli; Fever; UTI; A spontaneous report was received from a consumer who was also a 79-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who fever/ pyrexia, UTI/ urinary tract infection, and had a type of E-coli/ enterococcal infection.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 27 Feb 2021, prior to the onset of the symptoms, the patient received a dose of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date the patient developed a type of E-coli infection, Urinary tract infection and fever.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was not reported.; Reporter's Comments: This case concerns a 79-year-old female who had a medically significant and serious unexpected event of Enterococcal infection along with NS events of unexpected urinary tract infection and expected pyrexia.  Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Vaccination complication
Clinical narrative: cannot currently walk without assistance; no sensation from the waist; severe reaction to vaccine; A spontaneous report was received from an unknown (age and race) female consumer who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced severe vaccination adverse reaction, no sensation from the waist down   and cannot currently walk without assistance.  The consumer's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date the consumer received their first dose of mRNA-1273 (lot# unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the consumer experienced severe vaccination adverse reaction,no sensation from the waist  down and cannot currently walk without assistance. She was hospitalized for three days since the event started. No information on discharge from the hospital.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events were unknown.  The assessment for the events was not provided.; Reporter's Comments: Very limited information regarding these  events has been provided at this time.  Further information has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pruritus, Feeling hot, Flushing, Rash, Urticaria
Clinical narrative: Patient still feels her ears hot and itchiness; COVID arm; immediate flushing of the face following vaccination; Hives on her foot; temperature on her ears; Rash on hands; A spontaneous report was received from a consumer concerning a 47-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced immediate flushing of the face following vaccination/ flushing, hives on her foot/ urticaria, temperature on her ears/ feeling hot, rash on her hands/ rash with seriousness criteria as medically important, covid arm/ pain in extremity, feels her ears hot and itchiness/ ear pruritus.  The patient's medical history was not provided by the reporter. No relevant concomitant medications were reported.   On 26 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 022m20a) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Feb 2021, the patient experienced immediate flushing of the face following vaccination and seven hours later hives on her foot, temperature on her ears and rash on her hands with seriousness criteria as medically important.  On 05 Mar 2021, after seven days of mRNA-1273 the patient experienced covid arm.  On 11 Mar 2021, the patient experienced feels her ears hot and itchiness.  Lab details were not provided by the reporter. Patient reported that PEG allergy test was scheduled on an unspecified date.   Treatment for the events included Benadryl tablets and allegra.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, immediate flushing of the face following vaccination, hives on her foot, temperature on her ears, rash on her hands were recovered on 26 Feb 2021.  The outcome of the events, covid arm, feels her ears hot and itchiness were unknown.; Reporter's Comments: This is a report 47-year-old female who experienced medically significant and unexpected serious events of rash, urticaria, flushing, feeling hot, along with nonserious unexpected pain in extremity and ear pruritus.  Event onset the same day as first dose mRNA-1273, with "COVID arm" at Day 7. Treated with Benadryl and Allegra. 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Patient still feels her ears hot and itchiness; COVID arm; immediate flushing of the face following vaccination; Hives on her foot; temperature on her ears; Rash on hands; A spontaneous report was received from a consumer concerning a 47-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced immediate flushing of the face following vaccination/ flushing, hives on her foot/ urticaria, temperature on her ears/ feeling hot, rash on her hands/ rash with seriousness criteria as medically important, covid arm/ pain in extremity, feels her ears hot and itchiness/ ear pruritus.  The patient's medical history was not provided by the reporter. No relevant concomitant medications were reported.   On 26 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 022m20a) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Feb 2021, the patient experienced immediate flushing of the face following vaccination and seven hours later hives on her foot, temperature on her ears and rash on her hands with seriousness criteria as medically important.  On 05 Mar 2021, after seven days of mRNA-1273 the patient experienced covid arm.  On 11 Mar 2021, the patient experienced feels her ears hot and itchiness.  Lab details were not provided by the reporter. Patient reported that PEG allergy test was scheduled on an unspecified date.   Treatment for the events included Benadryl tablets and allegra.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, immediate flushing of the face following vaccination, hives on her foot, temperature on her ears, rash on her hands were recovered on 26 Feb 2021.  The outcome of the events, covid arm, feels her ears hot and itchiness were unknown.; Reporter's Comments: This is a report 47-year-old female who experienced medically significant and unexpected serious events of rash, urticaria, flushing, feeling hot, along with nonserious unexpected pain in extremity and ear pruritus.  Event onset the same day as first dose mRNA-1273, with "COVID arm" at Day 7. Treated with Benadryl and Allegra. 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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Heart rate
Clinical narrative: Atrial fibrillation; A spontaneous report was received from a consumer concerning a 70 years old female patient who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced Atrial fibrillation.  The patient's medical history was not provided. Concomitant medications reported included LEVOTHYROXINE(75mcg daily), HYDROCHLOROTHIAZIDE(25mg daily), CO Q10(200mg daily), VITAMIN D (2000iu daily), VITAMIN, RESTORE VITAMIN, BIOTIN (5000mcg daily), NEXIUM(daily), ATIVAN(0.5mg as needed for sleep), METFORMIN (500mg three times daily), METOPROLOL ER (25mg daily), ELIQUIS( 5mg twice daily), POTASSIUM CHLORIDE ER (10meq twice daily).  On 05 Feb 2021, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273(Lot number: 010MZ0A ) vaccine intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 05 Feb 2021, patient reported that 3-4 hrs later she had Atrial fibrillation where her heart rate reached 170. She went to the ER and they were able to convert within a couple of hours.  Patient reported that she had no prior history.  The event was considered to be medically significant.  Treatment for the event included Metoprolol ER 25mg daily.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event Atrial fibrillation is 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: Neuropathy peripheral
Clinical narrative: Neuropathy in hands and feet; A spontaneous report was received from a Consumer concerning a 62- years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed neuropathy in hands and feet (neuropathy peripheral).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 13 Feb 2021, approximately eight days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot: 007M2A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Feb 2021, the patient experienced neuropathy in hands and feet. The event was medically significant. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event developed neuropathy in hands and feet was unknown.; Reporter's Comments: Based on the information provided which includes a temporal association between the reported event and the administration of mRNA-1273 vaccine, a causal association cannot be excluded. However, critical details such as the patient's medical history, list of concomitant medication are lacking.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Cerebrovascular accident, Dyspnoea, Magnetic resonance imaging, Pericardial effusion
Clinical narrative: Congestive Heart Failure; fluid on lungs; He was found to have fluid on the heart; Shortness of breath; Stroke; A spontaneous report was received from a family member concerning reporter's husband who was also a 86-years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced stroke/cerebrovascular accident, congestive heart failure/cardiac failure congestive, he was found to have fluid on lungs and hear /pulmonary oedema and pericardial effusion and shortness of breath/dyspnoea.  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: 027L20A) on 23 Jan 2021. On 20 Feb 2021, approximately one day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Feb 2021, the patient had a stroke. The patient consulted with general practitioner on 22 Feb 2021 who ordered a magnetic resonance imaging (MRI). Patient started to develop shortness of breath on 22 Feb 2021. The MRI on 24 Feb 2021 confirmed that the patient had suffered a stroke. On 05 Mar 2021 the patient went to the emergency room with shortness of breath. The patient was diagnosed to have fluid on the heart and lungs and with congestive heart failure. Treatment for the events included Clopidogrel and aspirin.  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 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 event, a causal relationship cannot be excluded.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary oedema
Clinical narrative: Congestive Heart Failure; fluid on lungs; He was found to have fluid on the heart; Shortness of breath; Stroke; A spontaneous report was received from a family member concerning reporter's husband who was also a 86-years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced stroke/cerebrovascular accident, congestive heart failure/cardiac failure congestive, he was found to have fluid on lungs and hear /pulmonary oedema and pericardial effusion and shortness of breath/dyspnoea.  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: 027L20A) on 23 Jan 2021. On 20 Feb 2021, approximately one day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Feb 2021, the patient had a stroke. The patient consulted with general practitioner on 22 Feb 2021 who ordered a magnetic resonance imaging (MRI). Patient started to develop shortness of breath on 22 Feb 2021. The MRI on 24 Feb 2021 confirmed that the patient had suffered a stroke. On 05 Mar 2021 the patient went to the emergency room with shortness of breath. The patient was diagnosed to have fluid on the heart and lungs and with congestive heart failure. Treatment for the events included Clopidogrel and aspirin.  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 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 event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Deep vein thrombosis, Muscle spasms, Pulmonary embolism, Ultrasound scan
Clinical narrative: a blood clot in his leg behind his knee; blood clots on both of his lungs; leg pain and cramps that got worst as time went by; A spontaneous report was received from a consumer concerning a 65 year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced leg pain and cramps that worsen as time progressed, a blood clot in his leg behind his knee, and blood clots in both lungs.  The patient's medical history include high blood pressure.   The relevant concomitant medications are Lisinopril, Paroxetine, and Multivitamins.  On 31 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 026l20a) intramuscularly for prophylaxis of COVID-19 infection.   On 28 Jan 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (lot/batch: 004m20a) via unknown route in left arm for prophylaxis of COVID-19 infection.   On 01 Mar 2021, the patient experienced leg pain and cramps that worsen with time.  03 Mar 2021, the patient developed a blood clot in his leg behind his knee and blood clots on both lungs. The seriousness criteria for the events, blood clot in the leg behind the knee and blood clots in both lungs was were life threatening and medically significant.   The Laboratory findings include an ultrasound showing a blood clot in the leg behind the knee on 03 Mar 2021.  On unknown day of Mar 2021, chest CT showed blood clots in both lungs.   Treatment medication included rivaroxaban prescribed earlier by his physician.  Action taken with mRNA-1273 in response to the events was not applicable.   At the time of this report, the outcome of the events, leg pain and cramps that got worst as time went by and a blood clot in his leg behind his knee was unknown. The event, blood clots on both of his lungs was considered recovering 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 events, a causal relationship cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Dyspnoea, Dysstasia, Fatigue
Clinical narrative: short of breath; felt like she was fainting; dizziness; loss of straight; fatigue; muscle pain/body aches; headaches; joint pain; A spontaneous report was received from a consumer concerning a female patient of 52 year old, who experienced events loss of straight, headaches, muscle pain, body aches, fatigue, dizziness, joint pain,short of breath and syncope.  The patients medical history,as provided by the reporter, included she had covid-19 three months ago and prediabetes.  Concomitant medications were reported included 2 unknown medications for prediabetes  On 25 Feb 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 012a21a ) vaccine intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 25 Feb 2021, The first day of vaccination patient experienced loss of straight, headaches, muscle pain, body aches, fatigue, dizziness and joint pain for 3 days. On an unknown date, patient experienced short of breath and syncope. The event syncope was also considered to be medically significant.  Treatment for the event included Ibuprofen 800mg.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event loss of straight, headaches, muscle pain, body aches, fatigue, dizziness and joint pain were considered resolved on 28 Feb 2021. The outcome of the event short of breath and syncope 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Syncope
Clinical narrative: short of breath; felt like she was fainting; dizziness; loss of straight; fatigue; muscle pain/body aches; headaches; joint pain; A spontaneous report was received from a consumer concerning a female patient of 52 year old, who experienced events loss of straight, headaches, muscle pain, body aches, fatigue, dizziness, joint pain,short of breath and syncope.  The patients medical history,as provided by the reporter, included she had covid-19 three months ago and prediabetes.  Concomitant medications were reported included 2 unknown medications for prediabetes  On 25 Feb 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 012a21a ) vaccine intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 25 Feb 2021, The first day of vaccination patient experienced loss of straight, headaches, muscle pain, body aches, fatigue, dizziness and joint pain for 3 days. On an unknown date, patient experienced short of breath and syncope. The event syncope was also considered to be medically significant.  Treatment for the event included Ibuprofen 800mg.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event loss of straight, headaches, muscle pain, body aches, fatigue, dizziness and joint pain were considered resolved on 28 Feb 2021. The outcome of the event short of breath and syncope 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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Joint injury
Clinical narrative: passed out; hurt her knee and ankle; tired; headache; chills; flu-like symptoms; A spontaneous report (United States) was received from a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced passing out, tired, headache, chills  flu-like symptoms and hurt her knee and ankle.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10-MAR-2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 10- Mar-2021, after receiving the vaccine, the patient experienced tired, headache, chills like flu symptoms and passed out and hurt her knee and ankle. The patient felt better at the time of this report.  The seriousness criteria for the event passed out was considered as medically significant.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event(s) experienced passed out, tired, headache, chills like flu symptoms and hurt her knee and ankle was recovering/ resolving.  The reporter did not provide the assessment for the event's, passed out, tired, headache, chills like flu symptoms and hurt her knee and ankle.; 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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: passed out; hurt her knee and ankle; tired; headache; chills; flu-like symptoms; A spontaneous report (United States) was received from a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced passing out, tired, headache, chills  flu-like symptoms and hurt her knee and ankle.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10-MAR-2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 10- Mar-2021, after receiving the vaccine, the patient experienced tired, headache, chills like flu symptoms and passed out and hurt her knee and ankle. The patient felt better at the time of this report.  The seriousness criteria for the event passed out was considered as medically significant.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event(s) experienced passed out, tired, headache, chills like flu symptoms and hurt her knee and ankle was recovering/ resolving.  The reporter did not provide the assessment for the event's, passed out, tired, headache, chills like flu symptoms and hurt her knee and ankle.; 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: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Carbon dioxide, Chills, Dyspnoea, Pyrexia
Clinical narrative: Chills and feeling freezing; Vomitting; Abdominal pain; Difficulty breathing; Fever; A spontaneous report, was received from a consumer (patient's wife), concerning her husband, a 64 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced chills and feeling freezing (chills), vomiting, abdominal pain, difficulty breathing (dyspnoea) and fever (pyrexia).  The patient's medical history included history of congestive heart failure; triple bypass surgery done in 2017. The patient received dialysis on (Mon, Wed, & Fri), and was on oxygen 24 hours a day. The patient has allergy to valsartan and morphine. No Relevant concomitant medications were reported.  On 11 Mar 2021, approximately within one hour prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 11 Mar 2021, while at home, within an hour of receiving the vaccine, the patient started to experience chills and feeling freezing. The patient was taken to the hospital. The patient also experienced vomiting, complained of chills, developed abdominal pain, and had difficulty in breathing. The patient was currently in the intensive care unit. The patient's carbon level was high, needed a pit line and under bypap. The patient also had developed fever. Treatment medications included unspecified antibiotics and bilevel positive airway pressure (BiPAP) given to the patient at the hospital.  Action taken with second dose of mRNA-1273 in response to the events was unknown.  The outcome of the events, chills and feeling freezing, vomiting, abdominal pain, difficulty breathing, fever were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Chills and feeling freezing; Vomitting; Abdominal pain; Difficulty breathing; Fever; A spontaneous report, was received from a consumer (patient's wife), concerning her husband, a 64 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced chills and feeling freezing (chills), vomiting, abdominal pain, difficulty breathing (dyspnoea) and fever (pyrexia).  The patient's medical history included history of congestive heart failure; triple bypass surgery done in 2017. The patient received dialysis on (Mon, Wed, & Fri), and was on oxygen 24 hours a day. The patient has allergy to valsartan and morphine. No Relevant concomitant medications were reported.  On 11 Mar 2021, approximately within one hour prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 11 Mar 2021, while at home, within an hour of receiving the vaccine, the patient started to experience chills and feeling freezing. The patient was taken to the hospital. The patient also experienced vomiting, complained of chills, developed abdominal pain, and had difficulty in breathing. The patient was currently in the intensive care unit. The patient's carbon level was high, needed a pit line and under bypap. The patient also had developed fever. Treatment medications included unspecified antibiotics and bilevel positive airway pressure (BiPAP) given to the patient at the hospital.  Action taken with second dose of mRNA-1273 in response to the events was unknown.  The outcome of the events, chills and feeling freezing, vomiting, abdominal pain, difficulty breathing, fever were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Pain
Clinical narrative: Admitted to hospital for pre-diagnosed cellulitis in her right foot; Felt soreness; A spontaneous report was received from a consumer concerning a 71-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced, Admitted to hospital for pre-diagnosed cellulitis in her right foot (Cellulitis), Second dose of vaccine scheduled 53 days after the first dose of vaccine (Inappropriate schedule of product administration ), and Felt soreness (Pain).  The patient's medical history included pre-diagnosed Cellulitis in her right foot. Concomitant product use was not provided by the reporter.  On 22 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 042L20A) intramuscularly for prophylaxis of COVID-19 infection.   The same day, patient felt soreness. On 24 Jan 2021, the soreness went away. On 07 Feb 2021, the patient was admitted to hospital for her pre-diagnosed Cellulitis in right foot. On 14 Feb 2021, the patient was discharged from the hospital. Due to hospitalization, the patient's second dose of vaccine was pushed to 17 Mar 2021 (53 days from first dose of vaccine).  No treatment information was provided.  The second dose of mRNA-1273 was delayed in response to the events.   The event, Admitted to hospital for pre-diagnosed cellulitis in her right foot was resolved on 14 Feb 2021.  The event, Felt soreness, was resolved on 24 Jan 2021.  The outcome of event, Second dose of vaccine scheduled 53 days after the first dose of vaccine was considered as ongoing.; 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: Body temperature, Chest pain, Chills, Hyperhidrosis, Malaise
Clinical narrative: Pneumonia in right lung; Shooting pains in her chest; Cold; Sweats; Felt unwell; Fever up to 102.4 F; Shakes; A spontaneous report was received from a pharmacist for a 67 year old female patient who experienced pneumonia in right lung (pneumonia), shakes (tremors), felt unwell (malaise), cold (nasopharyngitis), fever up to 102.4 degrees Fahrenheit (pyrexia), sweating(hyperhidrosis), and shooting pains in chest (pain).   The patient's medical history was not provided. No concomitant product use was reported.  On 08 Mar 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 048A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On 08-Mar-2021, an hour after the administration of vaccine, the patient felt unwell, was cold, had fever up to 102.4 degrees Fahrenheit, sweats, and shooting pains in chest.   On 10-Mar-2021, the patient went to emergency room and was diagnosed with pneumonia in the right lung. The symptoms were persisting at the time of the report.   Treatment information included paracetamol and doxycycline hydrochloride.  Action taken with mRNA-1273 was unknown.  The outcome of the events, pneumonia in right lung (pneumonia), shakes (tremors), felt unwell (malaise), cold (nasopharyngitis), fever up to 102.4 degrees Fahrenheit (pyrexia), sweating(hyperhidrosis) and shooting pains in chest (pain) is 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pneumonia, Pyrexia
Clinical narrative: Pneumonia in right lung; Shooting pains in her chest; Cold; Sweats; Felt unwell; Fever up to 102.4 F; Shakes; A spontaneous report was received from a pharmacist for a 67 year old female patient who experienced pneumonia in right lung (pneumonia), shakes (tremors), felt unwell (malaise), cold (nasopharyngitis), fever up to 102.4 degrees Fahrenheit (pyrexia), sweating(hyperhidrosis), and shooting pains in chest (pain).   The patient's medical history was not provided. No concomitant product use was reported.  On 08 Mar 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 048A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On 08-Mar-2021, an hour after the administration of vaccine, the patient felt unwell, was cold, had fever up to 102.4 degrees Fahrenheit, sweats, and shooting pains in chest.   On 10-Mar-2021, the patient went to emergency room and was diagnosed with pneumonia in the right lung. The symptoms were persisting at the time of the report.   Treatment information included paracetamol and doxycycline hydrochloride.  Action taken with mRNA-1273 was unknown.  The outcome of the events, pneumonia in right lung (pneumonia), shakes (tremors), felt unwell (malaise), cold (nasopharyngitis), fever up to 102.4 degrees Fahrenheit (pyrexia), sweating(hyperhidrosis) and shooting pains in chest (pain) is 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: Dizziness, Loss of consciousness, Pain in extremity
Clinical narrative: passed out; arm a little sore; feeling dizzy; A spontaneous report was received from a consumer concerning herself 70 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed passed out/loss of consciousness, arm a little sore/pain in extremity, feeling dizzy/dizziness.   The patient's medical history was not provided.  Concomitant product use was Mometasone, Anastrozole, Rosuvastatin, Vitamin D and C.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 013L20A) on 10 Feb 2021 intramuscularly at left arm for prophylaxis of COVID-19 infection. The patient received their second of two planned doses of mRNA-1273 (Batch number: 030M20A) on 10 Mar 2021 intramuscularly at left arm for prophylaxis of COVID-19 infection.   On 11 Mar 2021 on the morning the patient experienced her arm was a little sore. She used her usual nasal spray with Mometasone, started feeling dizzy and within seconds she passed out. The medically significant event was loss of consciousness. Treatment information was not provided. But the other treatment included Mometasone, Anastrozole, Rosuvastatin, Vitamin D and C   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events passed out, arm a little sore, feeling dizzy was 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: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Intense chills leading to uncontrollable shivering in the middle of the night for several hours
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Dizziness, Ear discomfort, Gait disturbance
Clinical narrative: pt stated she got nauseas and dizzy right away after taking the vax.  Her arm is sore and has bump around the injection site. She then developed a sever headache, got stiff achy muscles, muscle weakness,  legs were very wobbly and had trouble walking, ear pressure, sniffles, and coughing.  On 3/24/2021 she still has all of the symptoms except the sniffles and cough.  She is still very weak, and having sever muscle body aches and pains and severe headache.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site mass, Injection site pain, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: pt stated she got nauseas and dizzy right away after taking the vax.  Her arm is sore and has bump around the injection site. She then developed a sever headache, got stiff achy muscles, muscle weakness,  legs were very wobbly and had trouble walking, ear pressure, sniffles, and coughing.  On 3/24/2021 she still has all of the symptoms except the sniffles and cough.  She is still very weak, and having sever muscle body aches and pains and severe headache.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Rhinorrhoea
Clinical narrative: pt stated she got nauseas and dizzy right away after taking the vax.  Her arm is sore and has bump around the injection site. She then developed a sever headache, got stiff achy muscles, muscle weakness,  legs were very wobbly and had trouble walking, ear pressure, sniffles, and coughing.  On 3/24/2021 she still has all of the symptoms except the sniffles and cough.  She is still very weak, and having sever muscle body aches and pains and severe headache.