chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Inflammation, Pain, Palpitations
Clinical narrative: Headaches; Mild dull achy tenderness; Irregular heartbeat; Tingling of their extremities (wrists, hands, feets, chest); Heat on theirhttps://ilssafety1f.quintiles.com/img/tabs/tab_left_move.gif extremities; Inflammation on the extremities; Normal swelling; redness; Pain; A spontaneous report was received from a consumer concerning a female patient of 69-years-old, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events normal swelling, redness, pain, mild dull achy tenderness, tingling of their extremities (wrists, hands, feets, chest)/Paraesthesia, irregular heartbeat/palpitations, heat on their extremities/burning sensation of skin, inflammation on the extremities, headaches.  The patient's medical history was not provided. Concomitant medications reported were Depakote for PTSD, acid reflux medicine, blood pressure medication,used for unknown indication.  On 26 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 025A21A)vaccine via unknown route for prophylaxis of COVID-19 infection.  On 26 Feb 2021,evening of the vaccination day, the patient had normal swelling and redness and pain for 2 and a half days,   On 27 Feb 2021,Within the first 24 hrs patient had tingling of the extremities (wrists, hands, feets, chest) along with an irregular heartbeat and it took a day to go away. Had heat and inflammation along with the pain on the extremities. This heat and inflammation lasted longer than the pain. Had the injection on the left side but all of this happened also in their right side. Had headaches too.  On 01 Mar 2021, the patient had a mild dull achy tenderness. The patient had it on a Friday afternoon and by Monday morning it was just mild.  Before getting the vaccine they tested borderline negative for rheumatoid factor (because their mother has it).the event irregular heart beat was also considered to be medically significant.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The events tingling of their extremities (wrists, hands, feets, chest) and irregular heart beat were considered resolved on 28 Feb 2021.  The events normal swelling,redness,pain were considered resolved on 01 Mar 2021.  The outcome of the events mild dull achy tenderness, heat on their extremities, inflammation on the extremities and headache 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 event, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rheumatoid factor, Skin burning sensation, Swelling, Tenderness
Clinical narrative: Headaches; Mild dull achy tenderness; Irregular heartbeat; Tingling of their extremities (wrists, hands, feets, chest); Heat on theirhttps://ilssafety1f.quintiles.com/img/tabs/tab_left_move.gif extremities; Inflammation on the extremities; Normal swelling; redness; Pain; A spontaneous report was received from a consumer concerning a female patient of 69-years-old, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events normal swelling, redness, pain, mild dull achy tenderness, tingling of their extremities (wrists, hands, feets, chest)/Paraesthesia, irregular heartbeat/palpitations, heat on their extremities/burning sensation of skin, inflammation on the extremities, headaches.  The patient's medical history was not provided. Concomitant medications reported were Depakote for PTSD, acid reflux medicine, blood pressure medication,used for unknown indication.  On 26 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 025A21A)vaccine via unknown route for prophylaxis of COVID-19 infection.  On 26 Feb 2021,evening of the vaccination day, the patient had normal swelling and redness and pain for 2 and a half days,   On 27 Feb 2021,Within the first 24 hrs patient had tingling of the extremities (wrists, hands, feets, chest) along with an irregular heartbeat and it took a day to go away. Had heat and inflammation along with the pain on the extremities. This heat and inflammation lasted longer than the pain. Had the injection on the left side but all of this happened also in their right side. Had headaches too.  On 01 Mar 2021, the patient had a mild dull achy tenderness. The patient had it on a Friday afternoon and by Monday morning it was just mild.  Before getting the vaccine they tested borderline negative for rheumatoid factor (because their mother has it).the event irregular heart beat was also considered to be medically significant.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The events tingling of their extremities (wrists, hands, feets, chest) and irregular heart beat were considered resolved on 28 Feb 2021.  The events normal swelling,redness,pain were considered resolved on 01 Mar 2021.  The outcome of the events mild dull achy tenderness, heat on their extremities, inflammation on the extremities and headache 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 event, a causal relationship cannot be excluded.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Gait disturbance, Immobile, Myalgia, Pre-existing condition improved
Clinical narrative: Not to receive second dose in series until she recovers; "couldn't get out of bed"; doing a little better now; Practically immobile; could barely walk; achiness became worse and worse; "achy"; sore left arm; A spontaneous report was received from a consumer, concerning  herself a female patient of age 81years, who had received her first dose on (17-feb-2021) Moderna's COVID-19 experienced sore left arm , achy , achiness became worse , Difficulty in walking , immobile , Bedridden.  The patient's medical history include hypertension, COPD, hypothyroidism, and Fibromyalgia with pain, concomitant medication includes Levothroid, hydralazine, Bystolic, Savella, lisinopril, Ventolin Inhaler, Advair Inhaler and Oxygen at night was provided by reporter.  On 17-feb-2021 patient received her first dose of two planned doses of mRNA-1273 (lot number:028L20A) via intramuscular route for COVID-19 infection prophylaxis.  On same day she experienced soreness of left arm, 20Feb2021 she developed "achy" and stated that the achiness became worse and worse on 17Mar2021, she was "practically immobile" and "couldn't get out Of bed".  On 18 mar 2021 Patient consulted HCP and took ibuprofen (every 6th hourly) as treatment and her HCP advised her not to take second dose which was scheduled on 21 mar 2021.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event was resolving at the time of this reporting.; Reporter's Comments: This case concerns an 81 Y/O F with a serious unexpected event of immobile along with nonserious unexpected bedridden, gait disturbance, pre-existing condition improved, treatment noncompliance and expected vaccination site pain, myalgia.  Event onset on Day 4 after first dose mRNA-1273. Treated with ibuprofen. Events resolving. 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: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Treatment noncompliance, Vaccination site pain
Clinical narrative: Not to receive second dose in series until she recovers; "couldn't get out of bed"; doing a little better now; Practically immobile; could barely walk; achiness became worse and worse; "achy"; sore left arm; A spontaneous report was received from a consumer, concerning  herself a female patient of age 81years, who had received her first dose on (17-feb-2021) Moderna's COVID-19 experienced sore left arm , achy , achiness became worse , Difficulty in walking , immobile , Bedridden.  The patient's medical history include hypertension, COPD, hypothyroidism, and Fibromyalgia with pain, concomitant medication includes Levothroid, hydralazine, Bystolic, Savella, lisinopril, Ventolin Inhaler, Advair Inhaler and Oxygen at night was provided by reporter.  On 17-feb-2021 patient received her first dose of two planned doses of mRNA-1273 (lot number:028L20A) via intramuscular route for COVID-19 infection prophylaxis.  On same day she experienced soreness of left arm, 20Feb2021 she developed "achy" and stated that the achiness became worse and worse on 17Mar2021, she was "practically immobile" and "couldn't get out Of bed".  On 18 mar 2021 Patient consulted HCP and took ibuprofen (every 6th hourly) as treatment and her HCP advised her not to take second dose which was scheduled on 21 mar 2021.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event was resolving at the time of this reporting.; Reporter's Comments: This case concerns an 81 Y/O F with a serious unexpected event of immobile along with nonserious unexpected bedridden, gait disturbance, pre-existing condition improved, treatment noncompliance and expected vaccination site pain, myalgia.  Event onset on Day 4 after first dose mRNA-1273. Treated with ibuprofen. Events resolving. 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blindness, Fall, Illness, Product physical issue
Clinical narrative: They are half blind from how bad they feel; Have been very sick; Lost their balance; Fallen twice hitting their face and head; Have lost 15 pounds; Second dose they received must have been damaged.; Very high fever; A spontaneous report was received from a consumer concerning a 66-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, very sick, fallen twice, lost 15 pounds and they were half blind.    The patient's medical history included blood pressure and diabetes. Products known to have been used by the patient, within two weeks prior to the event, included metformin.     The patient received their first of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection on 05 Feb 2021. On the same day, after vaccination, the left arm inflamed and was red and itchy for 3 weeks.  On 05 Mar 2021, on the same day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: CA21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 05 Mar 2021, same day after vaccination, the patient experienced high grade fever, sickness, lost balance, fell twice hitting their face and head. The patient went to emergency room thrice and was given unknown antibiotics. It was reported that the patient lost 15 pounds and half blind (medically significant) from how bad they felt. The patient stated that the second dose it might have been damaged.  Treatment details included unknown antibiotics and other treatments for the event.    Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events high grade fever, sickness, lost balance, fell twice hitting their face and head were considered as recovering. The outcome of the events fell twice hitting their face and head and product damaged were considered as recovered. The outcome of the events lost 15 pounds and half blind were considered as unknown.; Reporter's Comments: Based on the current available information which shows a strong temporal association between the use of the mRNA-1273 and the reported events and excluding all other etiology, a causal relationship cannot be excluded. Fever is consistent with the safety profile of the product; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-049386:Crosslinked for Dose 1
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Weight decreased
Clinical narrative: They are half blind from how bad they feel; Have been very sick; Lost their balance; Fallen twice hitting their face and head; Have lost 15 pounds; Second dose they received must have been damaged.; Very high fever; A spontaneous report was received from a consumer concerning a 66-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, very sick, fallen twice, lost 15 pounds and they were half blind.    The patient's medical history included blood pressure and diabetes. Products known to have been used by the patient, within two weeks prior to the event, included metformin.     The patient received their first of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection on 05 Feb 2021. On the same day, after vaccination, the left arm inflamed and was red and itchy for 3 weeks.  On 05 Mar 2021, on the same day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: CA21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 05 Mar 2021, same day after vaccination, the patient experienced high grade fever, sickness, lost balance, fell twice hitting their face and head. The patient went to emergency room thrice and was given unknown antibiotics. It was reported that the patient lost 15 pounds and half blind (medically significant) from how bad they felt. The patient stated that the second dose it might have been damaged.  Treatment details included unknown antibiotics and other treatments for the event.    Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events high grade fever, sickness, lost balance, fell twice hitting their face and head were considered as recovering. The outcome of the events fell twice hitting their face and head and product damaged were considered as recovered. The outcome of the events lost 15 pounds and half blind were considered as unknown.; Reporter's Comments: Based on the current available information which shows a strong temporal association between the use of the mRNA-1273 and the reported events and excluding all other etiology, a causal relationship cannot be excluded. Fever is consistent with the safety profile of the product; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-049386:Crosslinked for Dose 1
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: eye condition broken blood vessel in the eye; A spontaneous report was received from a consumer concerning herself, a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced eye condition broken blood vessel in the eye/ Eye haemorrhage,  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 27Feb2021, prior to the onset of the event the patient received the first of two planned doses of mRNA-1273 (lot/batch: Unknown) via Intramuscular route for prophylaxis of COVID-19 infection.  On an unknown date, patient experienced eye condition broken blood vessel in the eye and was considered as medically significant.  Action taken with mRNA-1273 in response to the event was Unknown.   The outcome of event eye condition broken blood vessel in the eye was unknown, at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Headache, Hypoaesthesia, Myalgia, Taste disorder
Clinical narrative: Bell's Palsy, left side began drooping/complete drooping of left side, unable to close eye; taste as being off; numbness; soreness, achiness; bad headache; A spontaneous report was received from a Health Care  Professional, concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed bell's palsy, bad headache, taste as being off, soreness, achiness, numbness.  The patient had no history of bell's palsy. Concomitant product use was not provided by the reporter.     On 10 Mar 2021, patient received her  second of two planned doses of mRNA-1273 vaccine. (Batch number:027A21A) intramuscularly for prophylaxis of COVID-19 infection.   On Saturday 13 Mar 2021, patient had  bad headache and on 16 Mar 2021, patient reported taste being off, soreness, achiness, numbness and left side began drooping.  On 17 Mar 2021, patient went to emergency room  due to complete drooping of left side and unable to close eye.   Treatment for the event included IV methylprednisolone sodium succinate and patient was sent home with prednisone pack and valacyclovir (1g/5 days).  The patient received both scheduled doses of mRNA-1273 prior to the events; the action taken with respect to the drug in response to the events is not applicable.    The outcome of the events, bell's palsy, bad headache, taste as being off, soreness, achiness/pain, left side began drooping/complete drooping of left side, numbness and unable to close eye 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: Dyspnoea, Fear, Pain in extremity
Clinical narrative: Short of breath and had to go to the hospital for oxygen; pain in her arms; scared out of her wits; A spontaneous report was received from a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced short of breath and had to go to the hospital for oxygen, pain in her arms, scared out of her wits.  The patient's medical history included history of lung disease and previous pattern of experiencing shortness of breath and had COVID-19 in December. No concomitant medications were reported.  On 11 Mar 2021 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 12 Mar 2021 date, the patient experienced shortness of breath and had to go to the hospital for oxygen, pain in her arms, scared out of her wits. The patient was hospitalized. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcomes of events short of breath and had to go to the hospital for oxygen, pain in her arms, scared out of her wits 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: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate, Ventricular tachycardia
Clinical narrative: Heart arrhythmia on EKG which is ventricular tachycardia; A spontaneous report was received from a healthcare professional concerning a 22 years old, female patient who experienced Heart arrhythmia on EKG which is ventricular tachycardia(ventricular tachycardia).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 13 Feb 2021, the patient received their first of the two planned vaccine doses of mRNA-1273 (Batch number not provided) in her left arm with no associated symptoms.  On 13 Mar 2021, prior to the onset of the symptoms, the patient received their second of the two planned vaccine doses of mRNA-1273 (Batch number not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 14 Mar 2021, the patient's heart rate got up to 206bpm and was seen in the emergency room and stayed overnight. On the same day the EKG(Electrocardiogram) was performed for the patient which revealed heart arrhythmia, which is ventricular tachycardia and was advised that she might need a surgery like defibrillator placement for lifetime or ablation. She was reported to be home from work for a week while on cardiac monitor and appropriate surgery will be decided after results are received after a week of monitoring.  cardioversion was reportedly performed, which was able to bring back her heartbeat back to normal.  The event ventricular tachycardia was considered as medically significant.  Treatment for the event included cardioversion.   The patient received both scheduled vaccine doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, Heart arrhythmia on EKG which is ventricular tachycardia, 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 event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Dose dribbled down the arm; Top was not tight; A spontaneous report  was received from a pharmacist for a patient (unspecified age and sex) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dose dribbled down the arm and top was not right (syringe connection issue).  The patient's medical history was not provided. No concomitant product use was reported.  On an unspecified date, the patient received their one of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. While pharmacist giving the shot to the patient the dose dripped down the arm. The pharmacist believe top was not right.  Treatment information was not provided.  Action taken with mRNA-1273 was unknown.  The outcome of the events, dose dribbled down the arm and top was not right (syringe connection issue) was  resolved on an unknown date.; Reporter's Comments: This report refers to a case of Device connection issue for mRNA-1273  with possible underdose.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional dose omission, Paralysis, Pruritus, Vaccination complication
Clinical narrative: Told her not get the second dose of the vaccine; Doctor told her she had a bad reaction to the first dose; Partially paralyzed for about 4/5 hours on her bottom half; Little bit itchy  hair, ears, and eyes; A spontaneous report was received from a consumer concerning a 78-year-old, female patient, who experienced partial paralysis on her bottom half/paralysis, bad reaction to the first dose/vaccine complication, not to take second dose/ intentional dose omission, itchy- hair, ears, and eyes/pruritus.  The patient's medical history included COVID-19 in Dec 2020 and high blood pressure.  Products known to have been used by the patient, within two weeks prior to the event included high blood pressure pills.  On 09 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 036A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 10 Mar 2021, the patient was partially paralyzed for 4-5hrs on her bottom half. The patient had same symptoms when prior exposed to COVID-19 in Dec 2020 and experienced little itchy- hair, ears and eyes. Brain scan, lungs, heart, blood tests and neurological functions were tested when patient consulted a health care provider (HCP) hence was advised not to take second dose.   Treatment for the event included Benadryl.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, partial Paralysis on her bottom half/Paralysis was recovered.  The outcome of the events,bad reaction to the first dose/vaccine complication, not to take second dose/ intentional dose omission, itchy- hair, ears, and eyes/pruritus 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 events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Depressed level of consciousness, Fatigue, Feeling abnormal, Haemorrhage
Clinical narrative: A spontaneous report was received from a consumer, concerning a 72 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) where I passed out, hit my head and skull was bleeding, lost control of my body functions, sever chills, I could hardly move, threw up, extremely tired, don't feel good and  totally incoherent.  The patient's medical history was not provided by the reporter, concomitant medications are losartan, baby aspirin, pill for cholesterol included by the reporter.   On 05 Feb 2021, the patient received the first planned doses of mRNA-1273 on right arm and Lot number reported for the first dose was (010M20A) for prophylaxis of COVID-19 vaccination.  On 05 Mar 2021, the patient received the second  planned doses of mRNA-1273 on left arm and Lot number reported for the first dose was (014M20A) for prophylaxis of COVID-19 vaccination.   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of I passed out, hit my head and skull was bleeding and lost control of my body functions were resolved and other events like sever chills, I could hardly move, threw up, extremely tired, don't feel good and  totally incoherent 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Incoherent, Loss of consciousness, Vomiting
Clinical narrative: A spontaneous report was received from a consumer, concerning a 72 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) where I passed out, hit my head and skull was bleeding, lost control of my body functions, sever chills, I could hardly move, threw up, extremely tired, don't feel good and  totally incoherent.  The patient's medical history was not provided by the reporter, concomitant medications are losartan, baby aspirin, pill for cholesterol included by the reporter.   On 05 Feb 2021, the patient received the first planned doses of mRNA-1273 on right arm and Lot number reported for the first dose was (010M20A) for prophylaxis of COVID-19 vaccination.  On 05 Mar 2021, the patient received the second  planned doses of mRNA-1273 on left arm and Lot number reported for the first dose was (014M20A) for prophylaxis of COVID-19 vaccination.   Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of I passed out, hit my head and skull was bleeding and lost control of my body functions were resolved and other events like sever chills, I could hardly move, threw up, extremely tired, don't feel good and  totally incoherent 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.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Myocarditis, SARS-CoV-2 test
Clinical narrative: Acute myocarditis; Chest pain; A spontaneous report was received from a physician concerning (patient age: unknown) male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chest pain, acute myocarditis (myocarditis).  The patient's medical history included COVID-19 in Mar 2020 and was exposed and may have had it a second time in Nov 2020. Concomitant medications were not provided.  On 12 Mar 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 038A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 15 Mar 2021, the patient developed chest pain and was admitted to the hospital. The patient underwent cardiac catheterization, echocardiogram and cardiac MRI (magnetic resonance imaging). Results of the echocardiogram and cardiac MRI were not provided. The final diagnosis of the patient  was acute myocarditis. COVID antibodies were positive, about 561 for the patient. The events chest pain and acute myocarditis lead to hospitalization. Treatment activities for the events were unknown.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, experienced chest pain and acute myocarditis, 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: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Psoriatic arthropathy, Vaccination site pain
Clinical narrative: Psoriatic arthritis; Vaccination site pain; This case was received from another manufacturer (reference number: 21K-163-379008-00) via physician and was forwarded to Moderna on 18 Mar 2021, concerning a 74-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Psoriatic arthritis/ Psoriatic arthropathic and vaccination site pain with Humira. Medical history of the patient included kidney issues. Her concomitant product use was not reported. Additional suspect product included adalimumab. On an unknown date, the patient received her first of the two planned doses of mRNA-1273 (batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 19 Feb 2021, the patient received her second of the two planned doses of mRNA-1273 (batch number: unknown) intramuscularly. On an unknown date, the patient also received a subcutaneous injection of adalimumab for moderate to severe chronic plaque psoriasis. On an unknown date, the patient developed psoriatic arthritis and slight soreness around the injection site. Treatment was taken with ibuprofen. The event Psoriatic arthritis was considered to be medically significant. The action was taken with mRNA-1273 and adalimumab in response to the events was unknown. The outcome of the event, Psoriatic arthritis, was not resolved while that of vaccination site pain was 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: Ischaemic stroke
Clinical narrative: ischaemic stroke; A spontaneous report was received from a  other health care professional  concerning a female patient of an unknown age who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced ischemic stroke.  The patient's medical history, was not provided by the reporter, included no known allergies,  Concomitant medications were not reported.  On unknown date , the patient received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscular for prophylaxis of COVID-19 infection.  Additional information was requested.  On Unknown date the patient experienced events ischemic stroke.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events ischemic stroke was unknown.  Causality was not provided by the reporter.; Reporter's Comments: This case concerns a female of unknown age with a serious unexpected event of ischaemic stroke.  Event onset with unknown latency after first dose mRNA-1273. Event outcomes not reported. 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: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Product dose omission issue, Pyrexia, Respiratory tract infection
Clinical narrative: respiratory type thing; dizziness; postpone second shot; fever; chills; A spontaneous report was received from a consumer concerning a 84-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, dizziness, fever, respiratory infection and had to postpone second shot schedule.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date after first dose vaccination, the patient experienced  chills, dizziness, fever and respiratoryinfection for which she received antibiotics from ER visit. She had to postpone second  shot schedule.  Treatment information included as antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of all events was not recovered and for missed dose recovered.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood culture, Illness, Influenza like illness, Influenza virus test, Malaise
Clinical narrative: Pneumonia; Sick for 19 days after the Moderna shot; Flu like symptoms; She is not feeling well at all; 102 degree F fever since 19 days every day/ running fever all day; This spontaneous case was reported by a consumer concerning a 45-year-old female patient who experienced pneumonia, illness (sick for 19 days after the Moderna shot), pyrexia (102degF) fever since 19 days every day/ running fever all day),Influenza-like illness and malaise (She is not feeling well at all).   The patient's past medical history was not reported. Concomitant product use was not provided by the reporter.    On an unknown date, the patient received the first of two planned doses of mRNA-1273 (Batch number not reported) intramuscularly (injection site not reported) for the prophylaxis of COVID-19 infection.   On 28-Feb-2021, the patient received the second of two planned doses of mRNA-1273 (Lot number:012M20A ) intramuscularly (injection site not reported) for the prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced Pneumonia, Sick for 19 days after the Moderna shot, 102degF fever since 19 days every day/ running fever all day, flu like symptoms and not feeling well at all. Treatment for the events included antibiotics, steroids, IV fluids, levofloxacin, antibody shots, ibuprofen and was on home health.   The action taken with mRNA-1273 in response to these events was not applicable.   The outcome for the events PNEUMONIA (Pneumonia), ILLNESS (Sick for 19 days after the Moderna shot), PYREXIA (102degF fever since 19 days every day/ running fever all day), INFLUENZA LIKE ILLNESS (flu like symptoms) and MALAISE (She is not feeling well at all)  were considered not recovered/not resolved.; Reporter's Comments: Based on the information provided, a causal association between the administration of and the event of pneumonia is assessed as not related as pneumonia is of an infective etiology. However, although the other events are consistent with symptoms of pneumonia, based on temporality with product use, causal association cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Pneumonia; Sick for 19 days after the Moderna shot; Flu like symptoms; She is not feeling well at all; 102 degree F fever since 19 days every day/ running fever all day; This spontaneous case was reported by a consumer concerning a 45-year-old female patient who experienced pneumonia, illness (sick for 19 days after the Moderna shot), pyrexia (102degF) fever since 19 days every day/ running fever all day),Influenza-like illness and malaise (She is not feeling well at all).   The patient's past medical history was not reported. Concomitant product use was not provided by the reporter.    On an unknown date, the patient received the first of two planned doses of mRNA-1273 (Batch number not reported) intramuscularly (injection site not reported) for the prophylaxis of COVID-19 infection.   On 28-Feb-2021, the patient received the second of two planned doses of mRNA-1273 (Lot number:012M20A ) intramuscularly (injection site not reported) for the prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced Pneumonia, Sick for 19 days after the Moderna shot, 102degF fever since 19 days every day/ running fever all day, flu like symptoms and not feeling well at all. Treatment for the events included antibiotics, steroids, IV fluids, levofloxacin, antibody shots, ibuprofen and was on home health.   The action taken with mRNA-1273 in response to these events was not applicable.   The outcome for the events PNEUMONIA (Pneumonia), ILLNESS (Sick for 19 days after the Moderna shot), PYREXIA (102degF fever since 19 days every day/ running fever all day), INFLUENZA LIKE ILLNESS (flu like symptoms) and MALAISE (She is not feeling well at all)  were considered not recovered/not resolved.; Reporter's Comments: Based on the information provided, a causal association between the administration of and the event of pneumonia is assessed as not related as pneumonia is of an infective etiology. However, although the other events are consistent with symptoms of pneumonia, based on temporality with product use, causal association cannot be excluded.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dyspnoea, Fall, Glassy eyes, Hyperhidrosis
Clinical narrative: ended up passing out, seemed to black out; couldn't respond/ not responding to his name; falling; achy; very shaky; eyes were glassed over; couldn't hold his head up straight; breathing was labored; soaking with sweat; slight temperature of 99.5-100.9F; A spontaneous report was received from a spouse concerning a 65-year old, male patient who received Moderna's COVID-19 vaccine(mRNA1273) experienced ended up passing out, seemed to black out/ loss of consciousness, couldn't respond, not responding to his name/ unresponsive to stimuli, fall, achy/ pain, shaky/ tremor, eyes were glassed over/ glassy eyes, couldn't hold his head up straight/ balance disorder, labored breathing/ dyspnea, soaking with sweat/ hyperhidrosis, and slight temperature of 99.5-100.9f/ pyrexia.  The patient's medical history was not provided. Concomitant medications included medicine for chlolestrol and blood pressure.  On 18 Mar 2021, prior to the onset of the events, the patient received second of two planned doses of mRNA-1273 (lot/batch:047A21A) intramuscularly on left arm  for prophylaxis of COVID-19 infection.  19 Mar 2021, the patient complained of being achy and had a slight temperature of 99.5 F that went up to 100.9 F. The patient was very shaky, and ending up passing out, and falling. The patient seemed to black out, his eyes were open and glassed over, but he couldn't respond or hold his head up straight. He did not respond to his name and his breathing was labored. The patient was also sweating. Treatment for the events included aspirin and rest.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events was unknown.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported event, and excluding any other etiology, a causal relationship with the event cannot be excluded.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Pain, Pyrexia, Tremor, Unresponsive to stimuli
Clinical narrative: ended up passing out, seemed to black out; couldn't respond/ not responding to his name; falling; achy; very shaky; eyes were glassed over; couldn't hold his head up straight; breathing was labored; soaking with sweat; slight temperature of 99.5-100.9F; A spontaneous report was received from a spouse concerning a 65-year old, male patient who received Moderna's COVID-19 vaccine(mRNA1273) experienced ended up passing out, seemed to black out/ loss of consciousness, couldn't respond, not responding to his name/ unresponsive to stimuli, fall, achy/ pain, shaky/ tremor, eyes were glassed over/ glassy eyes, couldn't hold his head up straight/ balance disorder, labored breathing/ dyspnea, soaking with sweat/ hyperhidrosis, and slight temperature of 99.5-100.9f/ pyrexia.  The patient's medical history was not provided. Concomitant medications included medicine for chlolestrol and blood pressure.  On 18 Mar 2021, prior to the onset of the events, the patient received second of two planned doses of mRNA-1273 (lot/batch:047A21A) intramuscularly on left arm  for prophylaxis of COVID-19 infection.  19 Mar 2021, the patient complained of being achy and had a slight temperature of 99.5 F that went up to 100.9 F. The patient was very shaky, and ending up passing out, and falling. The patient seemed to black out, his eyes were open and glassed over, but he couldn't respond or hold his head up straight. He did not respond to his name and his breathing was labored. The patient was also sweating. Treatment for the events included aspirin and rest.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events was unknown.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported event, and excluding any other etiology, a causal relationship with the event cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Diarrhoea, Fatigue, Gait disturbance
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (Felt her legs start to wobble and needed her cane to walk.), DIARRHOEA (Diarrhea), COUGH (Cough), FATIGUE (Tired), PAIN (Body aches), HEADACHE (Headache), DECREASED APPETITE (Wasn't hungry), OROPHARYNGEAL PAIN (Sore throat from vomiting often) and VOMITING (Vomiting) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On an unknown date, the patient experienced GAIT DISTURBANCE (Felt her legs start to wobble and needed her cane to walk.) (seriousness criterion hospitalization), DIARRHOEA (Diarrhea) (seriousness criterion hospitalization), COUGH (Cough) (seriousness criterion hospitalization), FATIGUE (Tired) (seriousness criterion hospitalization), PAIN (Body aches) (seriousness criterion hospitalization), HEADACHE (Headache) (seriousness criterion hospitalization), DECREASED APPETITE (Wasn't hungry) (seriousness criterion hospitalization), OROPHARYNGEAL PAIN (Sore throat from vomiting often) (seriousness criterion hospitalization) and VOMITING (Vomiting) (seriousness criterion hospitalization). The patient was hospitalized for 2 days due to COUGH, DECREASED APPETITE, DIARRHOEA, FATIGUE, GAIT DISTURBANCE, HEADACHE, OROPHARYNGEAL PAIN, PAIN and VOMITING. At the time of the report, GAIT DISTURBANCE (Felt her legs start to wobble and needed her cane to walk.), DIARRHOEA (Diarrhea), COUGH (Cough), FATIGUE (Tired), PAIN (Body aches), HEADACHE (Headache), DECREASED APPETITE (Wasn't hungry) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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. Noting the history of COVID infection (Nov 2020) may remain as risk factor. Further information has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pain, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (Felt her legs start to wobble and needed her cane to walk.), DIARRHOEA (Diarrhea), COUGH (Cough), FATIGUE (Tired), PAIN (Body aches), HEADACHE (Headache), DECREASED APPETITE (Wasn't hungry), OROPHARYNGEAL PAIN (Sore throat from vomiting often) and VOMITING (Vomiting) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On an unknown date, the patient experienced GAIT DISTURBANCE (Felt her legs start to wobble and needed her cane to walk.) (seriousness criterion hospitalization), DIARRHOEA (Diarrhea) (seriousness criterion hospitalization), COUGH (Cough) (seriousness criterion hospitalization), FATIGUE (Tired) (seriousness criterion hospitalization), PAIN (Body aches) (seriousness criterion hospitalization), HEADACHE (Headache) (seriousness criterion hospitalization), DECREASED APPETITE (Wasn't hungry) (seriousness criterion hospitalization), OROPHARYNGEAL PAIN (Sore throat from vomiting often) (seriousness criterion hospitalization) and VOMITING (Vomiting) (seriousness criterion hospitalization). The patient was hospitalized for 2 days due to COUGH, DECREASED APPETITE, DIARRHOEA, FATIGUE, GAIT DISTURBANCE, HEADACHE, OROPHARYNGEAL PAIN, PAIN and VOMITING. At the time of the report, GAIT DISTURBANCE (Felt her legs start to wobble and needed her cane to walk.), DIARRHOEA (Diarrhea), COUGH (Cough), FATIGUE (Tired), PAIN (Body aches), HEADACHE (Headache), DECREASED APPETITE (Wasn't hungry) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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. Noting the history of COVID infection (Nov 2020) may remain as risk factor. Further information has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Contusion, Multiple organ dysfunction syndrome, Platelet count, Platelet count decreased
Clinical narrative: Brain bleed; Platelet count droppped to 40; Bruises all over the body; Organs shut down; A spontaneous report  was received from a consumer concerning a 64-year-old female patient, who experienced bruises all over the body (contusion) , brain bleed (cerebral haemorrhage), platelet count dropped below 40 (platelet count decreased) and organs shutdown (multi organ failure).   The patient's medical history included bacterial infection 2 days prior to receiving vaccine dose. Product known to have been used by the patient, within two weeks prior to the event, included antibiotics (not specified).  On 02 Mar 2021, the patient received her first of the two planned vaccine doses of mRNA-1237 (Lot # unknown) for prophylaxis of Covid-19 infection.  On 03-Mar-2021, the patient developed severe bruises all over her body.  On 04 Mar 2021, within 2 days after receiving the vaccination, the patient was rushed to the hospital where it was determined that she had sustained a brain bleed. She had all her organs shutdown and her platelet count had dropped below 40.  On 04 Mar 2021, it was reported that the patient died.  The cause of death was reported as organ failure. Plans for autopsy were not provided.   Action taken with the mRNA-1273 in response to the events was not applicable.  The outcome of the events, bruises all over the body(contusion), brain bleed(cerebral haemorrhage), platelet count dropped below 40(platelet count decreased) 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.  However, the patient's underlying history of bacterial infection could be a contributory factor.  Awaiting further clarification.; Reported Cause(s) of Death: Organ Failure