chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Hypothermia, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced oxygen level of 86, temperature of 91 degrees, cough, and runny nose. The patient's medical history was not provided. Concomitant product use was not provided. The patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) on 17 Feb 2021 for prophylaxis of COVID-19 infection. On 24 Feb 2021, 8 days after the patient experienced oxygen level of 86, temperature of 91 degrees, cough, and runny nose. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the reported events was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: MOD-2021-024256:same reporter, different patient and event.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced oxygen level of 86, temperature of 91 degrees, cough, and runny nose. The patient's medical history was not provided. Concomitant product use was not provided. The patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) on 17 Feb 2021 for prophylaxis of COVID-19 infection. On 24 Feb 2021, 8 days after the patient experienced oxygen level of 86, temperature of 91 degrees, cough, and runny nose. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the reported events was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: MOD-2021-024256:same reporter, different patient and event.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia, Haematuria, Haemorrhage urinary tract, Vaccination site erythema, Vaccination site pain
Clinical narrative: dark blood clot coming out of his penis; Gross Hematuria; dark urine; Redness arm; Sore Arm; Swelling arm; A spontaneous report was received from a healthcare professional who was also a 72-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness arm/ vaccination site erythema, sore arm/ vaccination site pain, swelling arm/ vaccination site swelling, gross hematuria/ hematuria, dark blood clot coming out of his penis/ hemorrhage urinary tract, and dark urine/ chromaturia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Jan 2021, the patient experienced the events redness, sore arm and  swelling. On 20 Jan 2021, the patient experienced the events gross hematuria, with dark blood clot coming out of his penis. The patient had urine analysis (no results provided), and was still urinating dark urine. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcomes of the events, vaccination site erythema, vaccination site pain, and vaccination site swelling, were considered recovered on an unspecified date. The outcomes of the events, hematuria, hemorrhage urinary tract, and chromaturia, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: dark blood clot coming out of his penis; Gross Hematuria; dark urine; Redness arm; Sore Arm; Swelling arm; A spontaneous report was received from a healthcare professional who was also a 72-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness arm/ vaccination site erythema, sore arm/ vaccination site pain, swelling arm/ vaccination site swelling, gross hematuria/ hematuria, dark blood clot coming out of his penis/ hemorrhage urinary tract, and dark urine/ chromaturia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Jan 2021, the patient experienced the events redness, sore arm and  swelling. On 20 Jan 2021, the patient experienced the events gross hematuria, with dark blood clot coming out of his penis. The patient had urine analysis (no results provided), and was still urinating dark urine. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcomes of the events, vaccination site erythema, vaccination site pain, and vaccination site swelling, were considered recovered on an unspecified date. The outcomes of the events, hematuria, hemorrhage urinary tract, and chromaturia, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 test positive
Clinical narrative: she was supposed to get the second dose but HCP didn't administered it yet; Tested positive for COVID-19; A spontaneous report  was received from a healthcare professional concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tested positive for covid-19/ SARS-CoV-2 test positive, she was supposed to get the second dose but HCP didn't administered it yet/ missed dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the events tested positive for covid-19, she was supposed to get the second dose but HCP didn't administered it yet.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, tested positive for covid-19 was unknown, The outcome of event, she was supposed to get the second dose but HCP didn't administered it yet was considered 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: Dizziness, Syncope
Clinical narrative: Faint; Dizzy; A spontaneous report was received from a consumer regarding a female patient (demographics not provided) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizzy and faint (medically significant).  The patient's medical history and concomitant product use were not provided.  On 25 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On an unknown date, post vaccination, the patient felt very dizzy/faint. Treatment details for the events were not provided.   Action taken with mRNA-1273 in response to the events was not reported.   The events dizzy and faint were considered not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bradykinesia, Chest discomfort, Chills, Fatigue
Clinical narrative: Tingling in hands and fingers; Alternating sweats and cold; Sweating; Hypothermic 93 F; Functioning slow; Chest felt heavy; Flu-like symptoms; Weakness; felt like i couldnt move; Chills; Arm pain; Fever; Nauseous; Fatigue; A spontaneous report was received from consumer concerning a 63-year old, female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm pain, nausea, fever, fatigue, chills, weakness, chest felt heavy, couldn't go to work, felt like i couldn't move, flu-like symptoms, hypothermic, alternating sweats and cold, tingling in hands and fingers, functioning slow.  The consumer's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first dose of mRNA-1273 (batch number: 025J20A) on an unknown date. On 2 Feb 2021, prior to the onset of the events the consumer received second of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly in right arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the consumer experienced the events arm pain, nauseous, fever, fatigue, chills, weakness, chest felt heavy, couldn't go to work, felt like i couldn't move, flu-like symptoms. On 4 Feb 2021, the patient experienced the events hypothermic 93 f, alternating sweats and cold, tingling in hands and fingers, functioning slow. The event hypothermic 93 F was considered medically significant.  Treatment details included paracetamol and ibuprofen to relieve symptoms.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   The outcome of the events, fever and alternating sweating and cold, was considered recovered/ resolved on 04 Feb 2021.  The outcome of the events, arm pain, nausea, fatigue, chills, weakness, chest felt heavy, couldn't go to work, felt like i couldn't move, flu-like symptoms, tingling in hands and fingers, functioning slow, were unknown/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. Further information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hyperhidrosis, Hypothermia, Influenza like illness, Nausea
Clinical narrative: Tingling in hands and fingers; Alternating sweats and cold; Sweating; Hypothermic 93 F; Functioning slow; Chest felt heavy; Flu-like symptoms; Weakness; felt like i couldnt move; Chills; Arm pain; Fever; Nauseous; Fatigue; A spontaneous report was received from consumer concerning a 63-year old, female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm pain, nausea, fever, fatigue, chills, weakness, chest felt heavy, couldn't go to work, felt like i couldn't move, flu-like symptoms, hypothermic, alternating sweats and cold, tingling in hands and fingers, functioning slow.  The consumer's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first dose of mRNA-1273 (batch number: 025J20A) on an unknown date. On 2 Feb 2021, prior to the onset of the events the consumer received second of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly in right arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the consumer experienced the events arm pain, nauseous, fever, fatigue, chills, weakness, chest felt heavy, couldn't go to work, felt like i couldn't move, flu-like symptoms. On 4 Feb 2021, the patient experienced the events hypothermic 93 f, alternating sweats and cold, tingling in hands and fingers, functioning slow. The event hypothermic 93 F was considered medically significant.  Treatment details included paracetamol and ibuprofen to relieve symptoms.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   The outcome of the events, fever and alternating sweating and cold, was considered recovered/ resolved on 04 Feb 2021.  The outcome of the events, arm pain, nausea, fatigue, chills, weakness, chest felt heavy, couldn't go to work, felt like i couldn't move, flu-like symptoms, tingling in hands and fingers, functioning slow, were unknown/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. Further information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Vaccination site pain
Clinical narrative: Tingling in hands and fingers; Alternating sweats and cold; Sweating; Hypothermic 93 F; Functioning slow; Chest felt heavy; Flu-like symptoms; Weakness; felt like i couldnt move; Chills; Arm pain; Fever; Nauseous; Fatigue; A spontaneous report was received from consumer concerning a 63-year old, female who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm pain, nausea, fever, fatigue, chills, weakness, chest felt heavy, couldn't go to work, felt like i couldn't move, flu-like symptoms, hypothermic, alternating sweats and cold, tingling in hands and fingers, functioning slow.  The consumer's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first dose of mRNA-1273 (batch number: 025J20A) on an unknown date. On 2 Feb 2021, prior to the onset of the events the consumer received second of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly in right arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the consumer experienced the events arm pain, nauseous, fever, fatigue, chills, weakness, chest felt heavy, couldn't go to work, felt like i couldn't move, flu-like symptoms. On 4 Feb 2021, the patient experienced the events hypothermic 93 f, alternating sweats and cold, tingling in hands and fingers, functioning slow. The event hypothermic 93 F was considered medically significant.  Treatment details included paracetamol and ibuprofen to relieve symptoms.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   The outcome of the events, fever and alternating sweating and cold, was considered recovered/ resolved on 04 Feb 2021.  The outcome of the events, arm pain, nausea, fatigue, chills, weakness, chest felt heavy, couldn't go to work, felt like i couldn't move, flu-like symptoms, tingling in hands and fingers, functioning slow, were unknown/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. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bell's palsy, Headache, Pyrexia, Vision blurred
Clinical narrative: Diagnosed with Bell's Palsy; Stomach pain; Blurred vision; Severe headache; Slight fever; A spontaneous case was received from a 70 -year-old, female consumer, who experienced stomach pain, severe headache, slight fever, blurred vision and was diagnosed with bell's palsy. The patient medical history was not provided.  Concomitant medications were include metformin, gabapentin, lisinopril, celecoxib, atorvastatin,and glipizide.  On 14-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch no; 022M20A), intramuscularly in the upper right arm for prophylaxis of COVID-19 infection.  On 15-FEB-2021 , the patient experienced stomach pain, severe headache, slight fever, blurred vision.  On 23-FEB-2021 she was diagnosed with bell's palsy.  She had taken prednisolone and valacyclovir to treat bells palsy.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events were not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Disorientation, Dizziness, Fatigue, Migraine
Clinical narrative: Faint; Migraine; Dizzy; Disoriented; Joint pain; Fatigue; Muscle pain; Nausea; Slight fever; A spontaneous report  was received from a consumer concerning a 23 year old, male patient, who experienced faint (syncope), migraine, dizziness, fatigue, disoriented (disorientation), joint pain (arthralgia), muscle pain (myalgia), nausea, and slight fever (pyrexia).   The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the events, included allergy medication unspecified.  On unspecified date, the patient received their first of two planned doses of mRNA-1273  for prophylaxis of COVID-19 infection.   On 10-FEB-2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 10-FEB-2021, after vaccination, the patient experienced faint, migraine, dizzy, fatigue, disoriented, joint pain, muscle pain, nausea and slight fever. Treatment  for the event included Ibuprofen and Excedrin.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The event of faint was considered recovered. The outcome for the events of migraine, dizziness, fatigue, disoriented (disorientation), joint pain (arthralgia), muscle pain (myalgia), nausea, and slight fever (pyrexia) was considered 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: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Syncope
Clinical narrative: Faint; Migraine; Dizzy; Disoriented; Joint pain; Fatigue; Muscle pain; Nausea; Slight fever; A spontaneous report  was received from a consumer concerning a 23 year old, male patient, who experienced faint (syncope), migraine, dizziness, fatigue, disoriented (disorientation), joint pain (arthralgia), muscle pain (myalgia), nausea, and slight fever (pyrexia).   The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the events, included allergy medication unspecified.  On unspecified date, the patient received their first of two planned doses of mRNA-1273  for prophylaxis of COVID-19 infection.   On 10-FEB-2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 10-FEB-2021, after vaccination, the patient experienced faint, migraine, dizzy, fatigue, disoriented, joint pain, muscle pain, nausea and slight fever. Treatment  for the event included Ibuprofen and Excedrin.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The event of faint was considered recovered. The outcome for the events of migraine, dizziness, fatigue, disoriented (disorientation), joint pain (arthralgia), muscle pain (myalgia), nausea, and slight fever (pyrexia) was considered 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: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fall, Joint injury, Loss of consciousness
Clinical narrative: passed out; Fall; knee got banged up pretty bad; Got dizzy; weak; A spontaneous report was received from a consumer who was also an 81-year-old, female patient that received Moderna's COVID-19 Vaccine (mRNA-1273) and passed out/ loss of consciousness, fall, knee got banged up pretty bad/ joint injury, dizzy/ dizziness, and weak/ asthenia.  The patient's medical history included knee replacement, COVID-19 in Nov 2020, and pneumonia. Concomitant product use was not provided by the reporter.  On 01 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013h21a or 013E21a) intramuscularly for prophylaxis of COVID-19 infection.   On 01 Mar 2021, the patient got dizzy. The patient was weak and passed out. She was sitting on toilet cover and was getting ready for a shower but the next thing she knew was that, she found herself laying in the shower stall. The patient did not know for how long she was passed out for. Treatment for the events included 2 Tylenol.  Action taken with mRNA-1273 in response to the events was unknown.  The outcomes of events, loss of consciousness, fall, joint injury, dizziness, and asthenia, were considered as unknown.; Reporter's Comments: Very limited information regarding these even/s has been provided at this time.  Further information has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Heart rate increased, Hypoxia
Clinical narrative: Chills; Low fever of 99.3F; Soreness on injection site; Oxygen levels went down to 93%; Rapid heartbeat; Headache; A spontaneous report was received from a consumer concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rapid heartbeat, headache that won't go away, chills, low fever of 99.3f, soreness on injection site, oxygen levels went down to 93%.  The patient's medical history reported was gastritis. Current condition include immune issues. Allergies include Omnicef. No relevant concomitant medications were reported.  On 16 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 015M20A) in the right arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced the event rapid heartbeat . On 16 Feb 2021, the patient experienced the event headache that won't go away . On 16 Feb 2021, the patient experienced the event chills . On 16 Feb 2021, the patient experienced the event low fever of 99.3f . On 16 Feb 2021, the patient experienced the event soreness on injection site . On 16 Feb 2021, the patient experienced the event oxygen levels went down to 93%. The event is considered as medically significant.  No treatment details were provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of event, rapid heartbeat was unknown.The outcome of event, headache that won't go away was not resolved.The outcome of event, chills was unknown.The outcome of event, low fever of 99.3f was unknown.The outcome of event, soreness on injection site was unknown.The outcome of event, oxygen levels went down to 93% 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Pyrexia, Vaccination site pain
Clinical narrative: Chills; Low fever of 99.3F; Soreness on injection site; Oxygen levels went down to 93%; Rapid heartbeat; Headache; A spontaneous report was received from a consumer concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rapid heartbeat, headache that won't go away, chills, low fever of 99.3f, soreness on injection site, oxygen levels went down to 93%.  The patient's medical history reported was gastritis. Current condition include immune issues. Allergies include Omnicef. No relevant concomitant medications were reported.  On 16 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 015M20A) in the right arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced the event rapid heartbeat . On 16 Feb 2021, the patient experienced the event headache that won't go away . On 16 Feb 2021, the patient experienced the event chills . On 16 Feb 2021, the patient experienced the event low fever of 99.3f . On 16 Feb 2021, the patient experienced the event soreness on injection site . On 16 Feb 2021, the patient experienced the event oxygen levels went down to 93%. The event is considered as medically significant.  No treatment details were provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of event, rapid heartbeat was unknown.The outcome of event, headache that won't go away was not resolved.The outcome of event, chills was unknown.The outcome of event, low fever of 99.3f was unknown.The outcome of event, soreness on injection site was unknown.The outcome of event, oxygen levels went down to 93% was unknown..; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Disorientation, Dizziness, Fall, Myalgia
Clinical narrative: Disorientated; Falls; Could not eat or drink; Dizziness; Hot shoulder; All the body was achy; Tender shoulder; Red shoulder; A spontaneous report was received from a 76-years-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Disorientated (Disorientation), Falls (Fall), Could not eat or drink (Decreased appetite), Dizziness (Dizziness), All the body was achy (Myalgia), Tender shoulder (Vaccination site pain), Hot shoulder (Vaccination site warmth) and Red shoulder (Vaccination site erythema).  The patient's medical history included procedure for cataract surgerydone on an unknown date. No relevant concomitant medications were reported.  On 25-FEB-2021, prior to the onset of the events, the consumer received second of two planned doses of mRNA-1273 (batch number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 02-MAR-2021, the consumer experienced the events Disorientated, Falls, Could not eat or drink, Dizziness, All the body was achy, Tender shoulder, Hot shoulder and Red shoulder.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events, Disorientated, Falls, Could not eat or drink, Dizziness, All the body was achy, Tender shoulder, Hot shoulder and Red shoulder  was unknown.; Reporter's Comments: This case concerns a 76 Y/O F with serious unexpected events of disorientation, fall, decreased appetite and nonserious unexpected dizziness, feeling hot and erythema and expected arthralgia, myalgia.  Event onset 6 days after first dose mRNA-1273. 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: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Disorientated; Falls; Could not eat or drink; Dizziness; Hot shoulder; All the body was achy; Tender shoulder; Red shoulder; A spontaneous report was received from a 76-years-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Disorientated (Disorientation), Falls (Fall), Could not eat or drink (Decreased appetite), Dizziness (Dizziness), All the body was achy (Myalgia), Tender shoulder (Vaccination site pain), Hot shoulder (Vaccination site warmth) and Red shoulder (Vaccination site erythema).  The patient's medical history included procedure for cataract surgerydone on an unknown date. No relevant concomitant medications were reported.  On 25-FEB-2021, prior to the onset of the events, the consumer received second of two planned doses of mRNA-1273 (batch number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 02-MAR-2021, the consumer experienced the events Disorientated, Falls, Could not eat or drink, Dizziness, All the body was achy, Tender shoulder, Hot shoulder and Red shoulder.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events, Disorientated, Falls, Could not eat or drink, Dizziness, All the body was achy, Tender shoulder, Hot shoulder and Red shoulder  was unknown.; Reporter's Comments: This case concerns a 76 Y/O F with serious unexpected events of disorientation, fall, decreased appetite and nonserious unexpected dizziness, feeling hot and erythema and expected arthralgia, myalgia.  Event onset 6 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Seizure
Clinical narrative: Seizure; A spontaneous report was received from a consumer concerning a 72-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed light headache/headache, fever/pyrexia and seizure.  Medical history or concomitant product use were not reported.  On 17 Jan 2021, the patient received her first of the two planned doses of mRNA-1273 (batch number: 013620A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 14 Feb 2021, the patient received her second of the two planned doses of mRNA-1273 (batch number: 013M20A) intramuscularly in the right arm. Soon, she had a light headache and fever. She took treatment with paracetamol  On 16 Feb 2021, the patient was hospitalized. She had her CT scan of the brain and was reported to have seizure because of the symptoms.   On 18 Feb 2021, the patient was discharged from the hospital.   The action was taken with mRNA-1273 in response to the events was not applicable since they developed after the second dose.  The outcomes of the event headache was resolved on 15 Feb 2021 and for other 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; A spontaneous report was received from consumer (patient), concerning herself, a female patient of unknown age, unknown age and gender, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced anaphylactic reaction.  The patient's medical history was not reported. Concomitant medications were not provided.  On an unknown date in Jan 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date in Jan 2021, the patient had an anaphylactic reaction to the first dose. No treatment information was not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event, anaphylactic reaction was not reported.; Reporter's Comments: This case concerns a female of unknown age with a serious expected Anaphylactic reaction. Event onset with unknown latency after first dose mRNA-1273. Event outcome 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: Chills, Peripheral swelling, Pyrexia, Rheumatoid arthritis, Vaccination site movement impairment
Clinical narrative: relapse for Rheumatoid arthritis (that she didn't had for 20 years); chills; fever; swelling of her hands and not being able to lift her arms; swelling of her hands and not being able to lift her arms; A spontaneous report was received from consumer, concerning herself, a 79 year-old, elderly female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rheumatoid arthritis, chills, fever, swelling of her hands/peripheral swelling and not able to lift her arms/vaccination site movement impairment.  The patient's medical history, as provided by the consumer, included rheumatoid arthritis and low count of white blood cells. Concomitant medications reported included clopidogrel, unspecified high blood pressure medication, unspecified cholesterol medication and unspecified thyroid medication.   On 18 Feb 2021, the patient received the first of two planned doses of mRNA (Lot number: 031M20A) in the left arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced chills, fever, swelling of her hands and not being able to lift her arm 3 days after receiving the vaccine.   Treatment for the events included acetaminophen.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, rheumatoid arthritis, chills, fever, swelling of her hands and not being able to lift her arms, were considered 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: A spontaneous report was received from a consumer who is also the 77-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced blood clots in lung/pulmonary embolism. The patient's medical history was not provided. No concomitant product use was reported. On 10 Feb 2021, the patient received first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 23 Feb 2021, the patient was admitted to hospital with blood clots in lung. Patient was put on blood thinner. On 26-Feb-2021, the patient was discharged from hospital. Treatment medication included unspecified blood thinners. Action taken with mRNA-1273 was unknown. The outcome of the event, blood clots in lung/pulmonary embolism, was reported as resolved on 26-FEB-2021.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Malaise, Pain, Vaccination site pain
Clinical narrative: I was knocked out; I was not able to get out of bed for two days; I was sore all over; Sore in arm where I got the injection; A spontaneous report was received from a consumer concerning a 68 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced was knocked out/loss of consciousness,  was not able to get out of the bed for two days/movement disorder, sore in arm where got the injection/injection site pain and was sore all over/pain.  The patient's medical history included Covid-19 about a year ago.  Concomitant product use was not provided by the reporter.  On 01 Mar 2021, the patient received the first of two planned doses of mRNA-1273 (Batch number: 029A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unspecified date, approximately 12 hours after the vaccination patient experienced soreness all over and pain in arm where she got the vaccination. Later patient lost her consciousness and was not able to get out of bed for two days. Patient expressed these side effects are far worse than when getting the disease (Covid-19). Treated with Ibuprofen and it didn't help. No relevant laboratory details were included.  Action taken with the drug in response to the events were not reported.  The outcomes of the events, was knocked out/loss of consciousness,  was not able to get out of the bed for two days/movement disorder and was sore all over/pain were considered as unknown. The outcome of the event, sore in arm where got the injection/injection site pain was considered as not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fall, Headache, Loss of consciousness
Clinical narrative: passed out; fall; Lower back pain; fever up to 102 F; Chills; nauseous; Head hurts; A spontaneous report was received from a consumer concerning a 66-year-old, female patient, who experienced fever (pyrexia), chills, nausea and had passed out (loss of consciousness).  The patient's medical history was not provided. Concomitant medications were not provided.  On 28-FEB-2021, the patient received their first of two planned doses of mRNA-1273(Lot number- 012A21A) in the left arm for prophlaxis of Covid-19 infection.  On 01-Mar-2021, the patient experienced fever, chills, nausea and had passed out when she went to the bathroom. When she woke up, she was on her bed and reported that her lower back and head hurts after that fall. Treatment medications included acetaminophen for fever and chills.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events of fever (pyrexia), chills, nausea and passed out (loss of consciousness) resulting in fall and head and back hurts thereafter were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: passed out; fall; Lower back pain; fever up to 102 F; Chills; nauseous; Head hurts; A spontaneous report was received from a consumer concerning a 66-year-old, female patient, who experienced fever (pyrexia), chills, nausea and had passed out (loss of consciousness).  The patient's medical history was not provided. Concomitant medications were not provided.  On 28-FEB-2021, the patient received their first of two planned doses of mRNA-1273(Lot number- 012A21A) in the left arm for prophlaxis of Covid-19 infection.  On 01-Mar-2021, the patient experienced fever, chills, nausea and had passed out when she went to the bathroom. When she woke up, she was on her bed and reported that her lower back and head hurts after that fall. Treatment medications included acetaminophen for fever and chills.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events of fever (pyrexia), chills, nausea and passed out (loss of consciousness) resulting in fall and head and back hurts thereafter were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: Transverse Myelitis; A spontaneous report  was received from a consumer, concerning an 86-year-old, male patient and experienced transverse myelitis/myelitis transverse.  The patient's medical history was not reported. No relevant concomitant medications were reported.  On 05 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 05 Feb 2021, the patient experienced transverse myelitis and was hospitalized on 23 Feb 2021.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event of transverse myelitis was unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Facial paresis, Feeling abnormal, Paraesthesia, Swelling face
Clinical narrative: Suspected Bell's palsy; Facial drooping right/upper chin; Mild swelling to right eye and chin; Abnormal feelings on literal right upper ileus and the region of his chin; Tangling; A spontaneous report was received from a healthcare professional concerning a 31-years-old, male patient who developed suspected Bell's palsy/facial paralysis, facial drooping right/upper chin/facial paresis, mild swelling to right eye and chin/swelling face, abnormal feelings on literal right upper ileus and the region of his chin/feeling abnormal, tangling/paraesthesia.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 23 Feb 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (lot number 022M20A) intramuscularly for prophylaxis of COVID-19 infection.   On unknown date,  the patient developed abnormal feelings on his lateral right upper ileus, his chin bone, tangling, facial dropping right upper chin, mild welling to his right eye and chin. He can't open his right eye. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, suspected Bell's palsy/facial paralysis, facial drooping right/upper chin/facial paresis, mild swelling to right eye and chin/swelling face, abnormal feelings on literal right upper ileus and the region of his chin/feeling abnormal, tangling/paraesthesia, 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Chills, Feeling abnormal, Hyperhidrosis, Loss of consciousness
Clinical narrative: Delayed hypersensitivity COVID arm; Arm was red; Arm was swollen/wewlt on arm at the site of injection; Felt like she was going to die/everything went fuzzy; Sweat pouring over me; Shivering; Everything went black; Had words but couldnt get them out of my mouth; A spontaneous report was received from a consumer (patient), concerning herself, a 31-year-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced everything went black (loss of consciousness), had words but could not get them out of my mouth (aphasia), felt like she was going to die/everything went fuzzy (feeling abnormal), sweat pouring over me (hyperhidrosis), delayed hypersensitivity COVID arm (vaccination site reaction), arm was red (vaccination site erythema), arm was swollen / welt on arm at the site of injection (vaccination site swelling), and shivering (chills).  The patient's medical history was not provided. Concomitant medications were not reported.  On 24 Feb 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 030M20A) intramuscularly in left deltoid for prophylaxis of COVID-19 infection.   On the same day on 24 Feb 2021, within 3 minutes after receiving the vaccine, everything went blank for a minute. The patient had words but could not get them out of her mouth. The patient was observed and sent home. The patient was fine until the next day. The patient got up from bed around 07 00 AM on 25 Feb 2021, everything went black. The patient felt like she was going to die, like she was about to lose consciousness. Someone in her household, helped her put ice on her forehead and back on her neck. The patient also stated that she was shivering, sweat pouring over her. The patient was on the floor for 45 minutes; she could not get up. Twice, everything was fuzzy. The patient did not have strength to call emergency room (ER). The patient had no underlying medical conditions and not on any medications. The patient got a delayed hypersensitivity on COVID arm on 05 Mar 2021. The patient iced her arm for 2 to 3 hours because it was red and swollen. The patient thinks that it will become a ball on her underarm. There was a welt on her arm at site of injection. No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the events was not reported.  The outcome of the events, everything went black, had words but could not get them out of my mouth, felt like she was going to die/everything went fuzzy, sweat pouring over me, delayed hypersensitivity COVID arm, arm was red, arm was swollen, welt on arm at the site of injection, and shivering were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Delayed hypersensitivity COVID arm; Arm was red; Arm was swollen/wewlt on arm at the site of injection; Felt like she was going to die/everything went fuzzy; Sweat pouring over me; Shivering; Everything went black; Had words but couldnt get them out of my mouth; A spontaneous report was received from a consumer (patient), concerning herself, a 31-year-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced everything went black (loss of consciousness), had words but could not get them out of my mouth (aphasia), felt like she was going to die/everything went fuzzy (feeling abnormal), sweat pouring over me (hyperhidrosis), delayed hypersensitivity COVID arm (vaccination site reaction), arm was red (vaccination site erythema), arm was swollen / welt on arm at the site of injection (vaccination site swelling), and shivering (chills).  The patient's medical history was not provided. Concomitant medications were not reported.  On 24 Feb 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 030M20A) intramuscularly in left deltoid for prophylaxis of COVID-19 infection.   On the same day on 24 Feb 2021, within 3 minutes after receiving the vaccine, everything went blank for a minute. The patient had words but could not get them out of her mouth. The patient was observed and sent home. The patient was fine until the next day. The patient got up from bed around 07 00 AM on 25 Feb 2021, everything went black. The patient felt like she was going to die, like she was about to lose consciousness. Someone in her household, helped her put ice on her forehead and back on her neck. The patient also stated that she was shivering, sweat pouring over her. The patient was on the floor for 45 minutes; she could not get up. Twice, everything was fuzzy. The patient did not have strength to call emergency room (ER). The patient had no underlying medical conditions and not on any medications. The patient got a delayed hypersensitivity on COVID arm on 05 Mar 2021. The patient iced her arm for 2 to 3 hours because it was red and swollen. The patient thinks that it will become a ball on her underarm. There was a welt on her arm at site of injection. No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the events was not reported.  The outcome of the events, everything went black, had words but could not get them out of my mouth, felt like she was going to die/everything went fuzzy, sweat pouring over me, delayed hypersensitivity COVID arm, arm was red, arm was swollen, welt on arm at the site of injection, and shivering were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.