chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Mobility decreased, Paralysis, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Felt like she was paralyzed; Could not move or lift arm; Weak; Fever of 100.4; A spontaneous report was received from a consumer concerning a 84-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced felt like she was paralyzed, could not move or lift arm, fever of 100.4, and weak.  The patient's medical history mentions COVID-19 in Dec 2020 and blood pressure. Concomitant medications provided were blood pressure medicine NOS and vitamins.  On 09 Mar 2021, prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273 (Batch number: 030a21a) intramuscularly for prophylaxis of COVID-19 infection.   On 09 Mar 2021, patient stated she had a bad reaction. Patient stated it felt like she was paralyzed, and she could not move or lift arm. Patient stated she had a fever of 100.4 and weak . The event, felt like she was paralyzed was deemed medically significant.  Treatment information was not provided. Lab tests were not provided.  Action taken with respect to mRNA-1273 was not reported.  The outcome of the events, felt like she was paralyzed, could not move or lift arm, fever of 100.4 and weak 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: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Obstructive airways disorder, Pyrexia, Systemic lupus erythematosus, Urticaria
Clinical narrative: Lupus; Obstruction breathing; Lips were swollen; Hives on face/ huge welts all over body; Fever; A spontaneous report  was received from a consumer concerning a 20-year-old, adult female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lupus/systemic lupus erythematosus, fever/pyrexia, hives on face/huge welts all over body/urticaria, lips were swollen/lip swelling and obstruction breathing/obstructive airways disorder.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On  an unspecified date in Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch number: Unknown) for prophylaxis of COVID-19 infection. On an unspecified date in Feb 2021, Patient received the second of two planned doses of mRNA-1273 (Batch number: Unknown) for prophylaxis of COVID-19 infection.   On an unspecified date in Feb 2021, within 24 hours after receiving the second dose, patient experienced fever, hives on face/huge welts all over body, lips were swollen and obstruction breathing. The patient went to the ER and was given unspecified steriods and Diphenhydramine and the patient went to the ER (emergency room) on 19 Mar 2021 because she had another reaction and the doctor confirmed her that the vaccine triggered lupus. The event lupus was considered as medically significant.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.  The  outcome of the events, lupus, fever, hives on face/huge welts all over body, lips were swollen and obstruction breathing 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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Hypersensitivity, Paraesthesia, Pruritus
Clinical narrative: anaphylactic reaction; tingling; itching; throat tightening; problems breathing; generalized allergic reaction; 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, anaphylatic reaction/anaphylactic reaction, generalized allergic reaction/hypersensitivity, tingling/parasthesia, itching/pruritis, throat tightening/throat tightness, problems breathing/dyspnoea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch:unknown) for prophylaxis of COVID-19 infection. After that she had numbness, tingling and itching in left side of her face, which has stayed. Then, almost immediately after shot she had an anaphylactic reaction: throat tightening and problems breathing. In the ER, they gave her Benadryl and that was enough to stop it. Now, she says the numbness is similar to being numb from going to the dentist.  On 16 Mar 2021, immediately after the shot, the patient experienced the event(s) anaphylatic reaction/anaphylactic reaction, generalized allergic reaction/hypersensitivity, tingling/parasthesia, itching/pruritis, throat tightening/throat tightness, problems breathing/dyspnoea. The event anaphylactic reaction is medially significant. So, this is a serious case.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), anaphylatic reaction/anaphylactic reaction, generalized allergic reaction/hypersensitivity, tingling/parasthesia, itching/pruritis, throat tightening/throat tightness, problems breathing/dyspnoea was unknown.; Reporter's Comments: This case concerns a 67 Y/O M had a serious expected event of anaphylactic reaction and nonserious unexpected hypersensitivity, pruritus, dyspnea, throat tightness, and paresthesia.  Event onset immediately after first dose mRNA-1273. Event outcomes unknown. 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: anaphylactic reaction; tingling; itching; throat tightening; problems breathing; generalized allergic reaction; 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, anaphylatic reaction/anaphylactic reaction, generalized allergic reaction/hypersensitivity, tingling/parasthesia, itching/pruritis, throat tightening/throat tightness, problems breathing/dyspnoea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch:unknown) for prophylaxis of COVID-19 infection. After that she had numbness, tingling and itching in left side of her face, which has stayed. Then, almost immediately after shot she had an anaphylactic reaction: throat tightening and problems breathing. In the ER, they gave her Benadryl and that was enough to stop it. Now, she says the numbness is similar to being numb from going to the dentist.  On 16 Mar 2021, immediately after the shot, the patient experienced the event(s) anaphylatic reaction/anaphylactic reaction, generalized allergic reaction/hypersensitivity, tingling/parasthesia, itching/pruritis, throat tightening/throat tightness, problems breathing/dyspnoea. The event anaphylactic reaction is medially significant. So, this is a serious case.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), anaphylatic reaction/anaphylactic reaction, generalized allergic reaction/hypersensitivity, tingling/parasthesia, itching/pruritis, throat tightening/throat tightness, problems breathing/dyspnoea was unknown.; Reporter's Comments: This case concerns a 67 Y/O M had a serious expected event of anaphylactic reaction and nonserious unexpected hypersensitivity, pruritus, dyspnea, throat tightness, and paresthesia.  Event onset immediately after first dose mRNA-1273. Event outcomes unknown. 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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Loss of consciousness, Vomiting
Clinical narrative: Almost passed out; Vomiting; Heat on side of head; A spontaneous report was received from a consumer concerning a 80-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced almost passed out/loss of consciousness, heat in head/feeling hot and vomiting.  The patient's medical history was not provided. Concomitant medications included inhaler and statin.  On 22 Feb 2021, approximately three hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 031L20A) for prophylaxis of COVID-19 infection.  On 22 Feb 2021, three hours later, the patient experienced heat on side of head and almost passed out a medically significant event. On 26 Feb 2021, the patient had heat in head again and did pass out and vomited. The patient was hospitalized when passed out and did tests and everything was ok. Treatment details included anti-nausea medication.  Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of the events almost passed out, heat in head and vomiting was resolved on 27 Feb 2021.; Reporter's Comments: This case concerns an 80-year-old female who had a serious unexpected event of loss of consciousness along with NS events of unexpected feeling hot and expected vomiting.  Event onset the same day as the first dose of mRNA-1273. Treatment with anti-nausea medication. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Thrombocytopenia, Vaccination site pain
Clinical narrative: Thrombocytopenia remission; Vaccination site pain; A spontaneous report  was received from?a consumer, concerning a 77-year-old, Male patient, who received Moderna's COVID-19 vaccine and experienced pain at injection site (left) arm (Vaccination site pain) and thrombocytopenia remission (Thrombocytopenia).  The patient's medical history included autoimmune disorder and thrombocytopenia remission. No relevant concomitant medications were reported.  On 11-Mar-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 040A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 11-Mar-2021, the patient experienced thrombocytopenia remission (Thrombocytopenia) considered medically significant and pain at injection site (left) arm (Vaccination site pain).   No treatment information provided.  Action taken with mRNA-1273 in response to the events?was?not?reported.??   At the time of the report, the outcome of?the events, thrombocytopenia remission and pain at injection site (left) arm was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.  However, patient's underlying autoimmune disorder and thrombocytopenia may have been contributory to thrombocytopenia remission.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Pancreatic enlargement
Clinical narrative: Enlargement of pancreas; A spontaneous report was received from a consumer concerning a 73-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced enlargement of pancreas.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 11 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) of unknown route of administration on unknown location for prophylaxis of COVID-19 infection.   On 16 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 038A21A) of unknown route of administration on unknown location for prophylaxis of COVID-19 infection.    On 08 Mar 2021 a CAT Scan was performed, and it showed an enlargement of pancreas. The reviewer told him they should perform a MRI to confirm  what they have seen.   Action taken with mRNA-1273 in response to the event was not applicable.   Outcome of the event of enlargement of pancreas was not resolved at the time of report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Headache, Magnetic resonance imaging
Clinical narrative: Internal brain bleeding; Bad headaaches; A spontaneous report was received from a consumer concerning a 74-year-old, elderly female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bad headaches/headache and internal brain bleeding/cerebral haemorrhage.  The patient's medical history was not provided. Past medication included unspecified blood thinner. Concomitant product use was not provided by the reporter.  On an unspecified date, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis. On 18 Feb 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.  On an unspecified date, after second dose of vaccine, the patient bad headaches due to which patient had an MRI (magnetic resonance imaging) which showed internal brain bleeding. The event led to hospitalization. She had been in and out of the hospital two more times before since getting a shot. No treatment medication was reported.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events, bad headaches and internal brain bleeding was 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 these events, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cardiac stress test, Chills, Diarrhoea, Fatigue
Clinical narrative: brain fog; itchy spot; headache; Little bit nauseous; feels tired; chills; Felt like almost passed away; Fast heart palpitations; Slept all next day more than usual; pain in her left jaw; diarrhea; A spontaneous report was received from a Consumer herself concerning as a 79 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fast heart palpitations, bad headache, felt like she almost passed away, slept all next day more than usual and had chills, pain in her left jaw, little bit nauseous, itchy spot in the injection arm, diarrhea, feels tired and brain fog.   The patient's historical conditions were mentioned as High blood pressure and cholesterol. No relevant concomitant medications were reported.   On 27 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 001A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 01 Mar 2021, the patient experienced fast heart palpitations, bad headache, felt like she almost passed away which was a serious condition and considered as medically significant. Slept all next day more than usual and had chills, pain in her left jaw, little bit nauseous, itchy spot in the injection arm, diarrhea, feels tired.   On an unknown date patient experienced brain fog.   On 01 mar 2021, blood pressure was raised to 199/120, cardiac stress test as normal and low pulse rate.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was unknown.  The headache, tired and brain fog was ongoing 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 these events, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Heart rate, Hypersomnia, Nausea
Clinical narrative: brain fog; itchy spot; headache; Little bit nauseous; feels tired; chills; Felt like almost passed away; Fast heart palpitations; Slept all next day more than usual; pain in her left jaw; diarrhea; A spontaneous report was received from a Consumer herself concerning as a 79 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fast heart palpitations, bad headache, felt like she almost passed away, slept all next day more than usual and had chills, pain in her left jaw, little bit nauseous, itchy spot in the injection arm, diarrhea, feels tired and brain fog.   The patient's historical conditions were mentioned as High blood pressure and cholesterol. No relevant concomitant medications were reported.   On 27 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 001A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 01 Mar 2021, the patient experienced fast heart palpitations, bad headache, felt like she almost passed away which was a serious condition and considered as medically significant. Slept all next day more than usual and had chills, pain in her left jaw, little bit nauseous, itchy spot in the injection arm, diarrhea, feels tired.   On an unknown date patient experienced brain fog.   On 01 mar 2021, blood pressure was raised to 199/120, cardiac stress test as normal and low pulse rate.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was unknown.  The headache, tired and brain fog was ongoing 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 these events, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw, Palpitations, Presyncope, Vaccination site pruritus
Clinical narrative: brain fog; itchy spot; headache; Little bit nauseous; feels tired; chills; Felt like almost passed away; Fast heart palpitations; Slept all next day more than usual; pain in her left jaw; diarrhea; A spontaneous report was received from a Consumer herself concerning as a 79 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fast heart palpitations, bad headache, felt like she almost passed away, slept all next day more than usual and had chills, pain in her left jaw, little bit nauseous, itchy spot in the injection arm, diarrhea, feels tired and brain fog.   The patient's historical conditions were mentioned as High blood pressure and cholesterol. No relevant concomitant medications were reported.   On 27 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 001A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 01 Mar 2021, the patient experienced fast heart palpitations, bad headache, felt like she almost passed away which was a serious condition and considered as medically significant. Slept all next day more than usual and had chills, pain in her left jaw, little bit nauseous, itchy spot in the injection arm, diarrhea, feels tired.   On an unknown date patient experienced brain fog.   On 01 mar 2021, blood pressure was raised to 199/120, cardiac stress test as normal and low pulse rate.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was unknown.  The headache, tired and brain fog was ongoing 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 these events, a causal relationship cannot be excluded.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Sepsis, Urinary tract infection
Clinical narrative: Close to "urea sepsis"; severe UTI; A spontaneous report  was received from consumer concerning a 82-years old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced severe UTI/urinary tract infection and close to urea sepsis/sepsis.  The patient's medical history was not provided. Concomitant medications was not provided by the reporter.  On 16-Feb-2021, the patient received second of the two planned doses of mRNA-1273 (lot number: 006M20A) in the left arm for the prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient developed a severe UTI. Close to urea sepsis. Took antibiotics.  Treatment medication included antibiotics.  No lab tests were mentioned.  The events severe UTI and close to urea sepsis were considered to be serious with criteria of important medical event.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the events severe UTI and close to urea sepsis 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: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Nephrolithiasis, Pain in extremity, Urinary tract infection bacterial
Clinical narrative: Had kidney stone problem; Urine test showed bacteria; Sore arm; A spontaneous report was received from a consumer  concerning a 76-years-old, female patient, who received Moderna's COVID-19 vaccine  (mRNA-1273) and experienced sore arm / pain in extremity, had kidney stone problem / nephrolithiasis and urine test showed bacteria / urinary tract infection bacterial.  The patient's medical history was not provided. Concomitant medications reported included potassium and nebivolol hydrochloride administered half a pill.  On 03 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On 03 Mar 2021, the patient experienced sore arm. On 13 Mar 2021, the patient had kidney stone problem and urine test showed bacteria. The event kidney stone was found to be medically significant.  Treatment drug administered was amoxicillin and clavulanate potassium on 18 Mar 2021 and on 19 Mar 2021. On an unspecified date, treatment drug was switched to ciprofloxacin.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the events, sore arm, had kidney stone problem and urine test showed bacteria was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of sore arm, a causal relationship cannot be excluded. Very limited information regarding the events of nephrolithiasis and urinary tract infection bacterial has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Cough
Clinical narrative: Within 48 hours of receiving 2nd dose, she has developed intense dry cough that is not going away; She went to ER, and they said it was angioedema; A spontaneous report was received from a consumer concerning a 31-years-old, female patient who experienced angioedema, and cough.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included tofacitinib citrate, duloxetine, ferrous sulfate and famciclovir.   On 11 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 batch number not provided intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 11 Feb 2021, the patient experienced lip swelling, tongue swelling and trouble breathing within twenty-four hours from vaccination. She went to the emergency room where that said she has angioedema.  On 13 Feb 2021, the patient reported that she developed intense dry cough that is not going away. Treatment for the event included humidifier and Tessalon pearls.    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 was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Loss of consciousness, Nausea
Clinical narrative: Passed Out in Bathroom; Bloody Nose; Nausea; A spontaneous report  was received from a consumer concerning for his wife, a 70-year-old, female patient who received Moderna (mRNA-1273) vaccine and experienced events Bloody Nose/Epistaxis, Nausea, and passed out in the bathroom/Loss of consciousness.  The patient's medical history was not provided. No relevant concomitant medications were provided by the reporter.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via an unknown route for prophylaxis of COVID-19 infection. On 17 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) via an intramuscularly on Arm for prophylaxis of COVID-19 infection.   On 17 Mar 2021, Bloody Nose, Nausea, and the consumer Passed Out in the Bathroom before being taken to the Emergency Room. Seriousness criteria for all events was considered as Hospitalisation. No Treatment information was provided.   The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.  The outcome of the events, Bloody Nose, Nausea, and passed out in the Bathroom 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 these events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Biliary obstruction, Cholelithiasis, Sepsis
Clinical narrative: Sepsis; Gall bladder stone; the bile was blocked in the gall bladder; A spontaneous report was received from a Consumer concerning a 49 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sepsis, bile was blocked in the gall bladder and gall bladder stones.   The patient's medical history was included Down's syndrome and he had gall bladder problem from 5 years. No relevant concomitant medications were reported.    On 05 Mar 2021, prior to the onset of the events, the patient received their first of the two planned vaccine doses of mRNA-1273 (lot/batch: 012A21A) intramuscularly in an unspecified location for prophylaxis of COVID-19 infection.  On 12 Mar 2021, the patient experienced Sepsis, the bile was blocked in the gall bladder with Gall bladder stones with the seriousness criteria hospitalization.  Laboratory details were not provided. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, sepsis, bile was blocked in the gall bladder and gall bladder stones, was recovering, but still in the hospital at the time of report.; Reporter's Comments: Based on the current available information and lack of temporal association between the use of the product and the start date of the events, the events were assessed as Unlikely Related to study drug. The subject's underlying five year history of gall bladder disease can be a confounding factor as gallstones can lead to inflammation of gall bladder and blockage of bile ducts which can then lead to infection and ultimately, any complication can cause sepsis.; Sender's Comments:  MOD21-047715:mother case
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Cystitis, Diplegia, Incontinence
Clinical narrative: Her legs and feet became paralyzed and she also became incontinent.; Her legs and feet became paralyzed and she also became incontinent.; Bladder infection; A spontaneous report was received from a consumer concerning a 65-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced legs and feet paralyzed after 2nd shot/diplegia, became incontinent after 2nd shot, blood potassium was low and bladder infection/cystitis.  The patient's medical history was not provided. Concomitant medications were not provided.  On an unmentioned date, the patient received their first of the two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection. On 08 Mar 2021, prior to the events, the patient received their second of the two planned doses of mRNA-1273 (Batch number: 023m20a) in the left arm for prophylaxis of COVID-19 infection.  On 08 Mar 2021, 11 hours after the mRNA-1273 shot, her legs and feet became paralyzed and she also became incontinent. The EMT's came twice and she said she ended up in the ER. Bloodwork was done and found her potassium was low and that she had a bladder infection as well. Lab tests mentioned were a CAT scan and nothing significant was found. Events legs and feet paralyzed after 2nd shot and bladder infection were assessed as medically significant as per IME. Treatment information mentions potassium pills and antibiotics.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the events, legs and feet paralyzed after 2nd shot and became incontinent after 2nd shot was reported resolved on 08 Mar 2021.  The outcome of the events, blood potassium was low and bladder infection/cystitis 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 these events, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Computerised tomogram, Fatigue
Clinical narrative: Covid pneumonia; Tired and gets tired going up the stairs; A spontaneous report was received from a consumer concerning a 57-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Covid pneumonia/ COVID-19 pneumonia and was tired/ fatigue.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 28 Feb 2021, approximately few days prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.   On an unspecified day in Mar 2021, the patient experienced a medically significant event of Covid pneumonia. On an unspecified day in Mar 2021, the patient experienced tiredness. Treatment for the event included antibiotics and the patient completed the course of prescribed antibiotics on 19 Mar 2021.  Laboratory details included had a CT scan done with contrast that showed the patient had multifocal pneumonia.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event Covid pneumonia was resolving. The outcome of the event, tired, was 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 event, a causal relationship cannot be excluded except for the event of COVID pneumonia. The event of COVID pneumonia is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing pneumonia.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Death, Dyspnoea, Hyperhidrosis, Hypothermia
Clinical narrative: Death; Trouble in breathing; chills; sweating; his body was really cold; A spontaneous report was received from a consumer concerning a 79 years old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events death, trouble in breathing/dyspnoea, chills, sweating/hyperhidrosis and his body was really cold/hypothermia.  The patient's medical history included blood clotting, blood pressure and diabetes. The relevant concomitant medications reported were provided as medications for blood thinner, blood pressure medication and diabetes medication.  On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA (Lot number: unknown) through intramuscular route of administration for prophylaxis of COVID-19 infection.  On 03 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA (Lot number: unknown) through unknown route of administration for prophylaxis of COVID-19 infection.  On 04 Mar 2021, after second dose patient experienced sweating, his body was really cold. His wife called ambulance and paramedics had quoted that these were usual symptoms of second shot and if they want, they can take him to hospital for monitoring. The patient doesn't want to go hospital and wanted to take rest in bed.  On 05 Mar 2021, at 2am, four hours after first ambulance call, his wife noticed that he was still sweating, had chills and also had trouble in breathing. She called the ambulance second time and while it arrived at home it was too late and he was already passed. All the events were provided as intervention/medically important.  No laboratory data was provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The events trouble in breathing, chills, sweating and body was really cold were not recovered.  The patient died on 05 Mar 2021, due to unknown cause of death but On 19 Mar 2021, his wife talked with primary care physician and he mentioned that vaccine is one of the contributing factors to his death and it is noted on his death certificate. Plans for autopsy was unknown.; Reporter's Comments: This is a case of sudden death in a 79-year-old fmale patient with a history of blood clotting, abnormal blood pressure and diabetes, who died 2 days after receiving second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Pain, Paraesthesia, Shock symptom
Clinical narrative: little waves of shock up back, neck, bones, and down sides; foot and toes felt numb and tingly; foot and toes felt numb and tingly; little pains rotating around body; leg felt heavier; A spontaneous report was received from a consumer concerning a 54-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events leg felt heavier, foot and toes felt numb and tingly, little pains rotating around body, little waves of shock up back, neck, bones, and down sides.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 023M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  The patient reported on 23-Mar-2021 that she got her first shot on 17Mar2021 in her left arm. The minute they gave it to her, her leg that has edema felt heavier and her foot and toes felt numb and tingly. It didn't wear off until she walked around for a couple of hours. At night, she started to experience little pains rotating around her body. It felt like little waves of shock going up her back, neck, bones, and down her sides. She described that pain as strong originally and then it tapered down. The patient did suffer from photophobia and she had experienced that from the different medications that she was on.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), leg felt heavier, foot and toes felt numb and tingly, little pains rotating around body, little waves of shock up back, neck, bones, and down sides was unknown.; Reporter's Comments: Based on the current available information which includes a strong 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.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Asthma, Chills, Contusion, Hyperhidrosis
Clinical narrative: She's been nauseated, cannot drink or eat; She feels like sleeping a lot; Feeling weak; Her teeth were chattering for 2 hours; She was shaking compulsively for 2 hours; She had asthma very bad; Was sweating compulsively; She has passed out 3 times; She had bruises everywhere; She has had pain in the arm; A spontaneous report was received from a consumer concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events She has passed out 3 times/ Loss of consciousness, She had bruises everywhere/ Contusion, She was shaking compulsively for 2 hours/ Tremor, She had asthma very bad/ asthma, Was sweating compulsively/ hyperhidrosis, She feels like sleeping a lot/ sleepy, feeling weak/ Asthenia, She has had pain in the arm/ vaccination site pain, She's been nauseated, cannot eat or drink/ nausea, Her teeth were chattering for 2 hours/ Chills.  The patient's current condition includes asthma and she's losing weight since February and this is ongoing. No relevant concomitant medications were reported.  On 21 Mar 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 21Mar2021, she has had pain in the arm, she has passed out 3 times, she had bruises everywhere, and at 2AM of 22Mar2021 she was shaking compulsively for 2 hours, her teeth were chattering for 2 hours, went to hospital, she had asthma very bad, was sweating compulsively. On 23Mar2021 she feels like sleeping a lot and feeling weak. She's been nauseated, cannot drink or eat on an unknown date. The event Loss of consciousness was considered as medically significant. No treatment information was reported.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events pain in the arm, passed out 3 times, bruises everywhere, shaking compulsively for two hours, teeth chattering for two hours, had asthma very bad and was sweating compulsively, she felt like sleeping a lot, weak, nauseated, cannot drink or eat, 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: Loss of consciousness, Nausea, Somnolence, Tremor, Vaccination site pain
Clinical narrative: She's been nauseated, cannot drink or eat; She feels like sleeping a lot; Feeling weak; Her teeth were chattering for 2 hours; She was shaking compulsively for 2 hours; She had asthma very bad; Was sweating compulsively; She has passed out 3 times; She had bruises everywhere; She has had pain in the arm; A spontaneous report was received from a consumer concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events She has passed out 3 times/ Loss of consciousness, She had bruises everywhere/ Contusion, She was shaking compulsively for 2 hours/ Tremor, She had asthma very bad/ asthma, Was sweating compulsively/ hyperhidrosis, She feels like sleeping a lot/ sleepy, feeling weak/ Asthenia, She has had pain in the arm/ vaccination site pain, She's been nauseated, cannot eat or drink/ nausea, Her teeth were chattering for 2 hours/ Chills.  The patient's current condition includes asthma and she's losing weight since February and this is ongoing. No relevant concomitant medications were reported.  On 21 Mar 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 21Mar2021, she has had pain in the arm, she has passed out 3 times, she had bruises everywhere, and at 2AM of 22Mar2021 she was shaking compulsively for 2 hours, her teeth were chattering for 2 hours, went to hospital, she had asthma very bad, was sweating compulsively. On 23Mar2021 she feels like sleeping a lot and feeling weak. She's been nauseated, cannot drink or eat on an unknown date. The event Loss of consciousness was considered as medically significant. No treatment information was reported.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events pain in the arm, passed out 3 times, bruises everywhere, shaking compulsively for two hours, teeth chattering for two hours, had asthma very bad and was sweating compulsively, she felt like sleeping a lot, weak, nauseated, cannot drink or eat, 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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: Diagnosed with pneumonia having a cough, Covid 19 positive; Has been over 42 days since she received first dose; 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 was diagnosed with pneumonia (COVID-19 pneumonia), was tested positive for COVID (COVID-19 ) and it was over 42 days since the patient received first dose (product dose omission issue).  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin.  On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: U10M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient had cough and was diagnosed with pneumonia. On 17 Feb 2021, the patient was tested positive for Covid and was quarantined for 10 days. It has been over 42 days since the patient received first dose of the Moderna COVID-19 vaccine   Treatment information for the events was not reported.  Laboratory information included COVID-19 positive.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, diagnosed with pneumonia, was unknown. The outcome of the events, tested positive for COVID, was resolved and it was over 42 days since the patient received first dose, was considered as resolved on 03 Feb 2021.; Reporter's Comments: Based on MAH causality and It has been over 42 days since the patient received  her first dose of the Moderna COVID-19 vaccine the event is assessed as unlikely related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood potassium increased, Chest pain, Dyspnoea
Clinical narrative: back was hurting; chest was hurting; Couldn't breathe; very high potassium levels; A spontaneous report , was received from a consumer, concerning herself an 81 -year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Couldn't  breathe, back was hurting , chest was hurting, very high potassium levels.  The patient's medical history was not reported by the reporter .miralax , Flonase nitroglycerin , ondansetron hydrocodone , ranolavine, floresimide, loretedine, clotigogrel, Tamsulosin, gabapentin,sadrovastadin, sertraline , sinoxidil  for drug use for unknown indication.  On 03 MAR 2021, the patient received the first of two planned doses of mRNA-1273 (Batch number: 012A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 03 MAR 2021, the patient couldn't breathe, hurting back, hurting chest ,high potassium levels .The patient took nitroglycerin and was admitted to hospital, vitals were ok. The patient was administered with breathing treatment.  The action taken with the first dose of mRNA-1273 in response to the events was not reported.   The outcome of the events Couldn't breathe, back was hurting , chest was hurting, very high potassium levels was resolving .; 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: Haemophilus infection, Insomnia, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Flu that feels like haemophilus influenza; Sore throat; Not able to sleep; Body aches all over; Fever; A spontaneous report was received from a female patient of unspecified age , who received Moderna's COVID-19 vaccine(mRNA-1273)  and experienced events flu that feels like haemophilus influenza/haemophilus infection, sore throat/oropharyngeal pain, fever/pyrexia, not able to sleep/insomnia, body aches all over/pain.  The patient's medical history was not provided. Concomitant product use was not provided.  On 21 Mar 2021 , patient received their second  of two planned  doses of mRNA-1273(Lot/batch: unknown) vaccine through intramuscular route of administration , for prophylaxis of COVID-19 infection.  On  22 Mar 2021 , patient experienced flu that felt like haemophilus influenza, sore throat, fever, was not able to sleep, body aches all over. The event flu that feels like haemophilus influenza was considered as medically significant. Treatment  information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.  The outcome of the events, flu that feels like haemophilus influenza, sore throat, fever, not able to sleep and body aches all  over 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: Bell's palsy
Clinical narrative: Bell's Palsy on the Left side; A Spontaneous report from was received from a Healthcare professional concerning a 64-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy on the left side of her face.    The patient's medical history was not provided. The patient's concomitant medication was not provided.    On 02 Mar 2021, the patient received  their first of two planned doses of mRNA-1273 (Lot number : unknown) intramuscular for prophylaxis of COVID-19 infection.  On 14 Mar 2021, the patient experienced Bell's palsy on the left side of her face. The event was considered medically significant.  Laboratory details was not provided. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.