chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Pyrexia, Syncope
Clinical narrative: Fainting; Back Ache; Fever; A Spontaneous report was received from Consumer concerning 65-year-old of male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fainting, fever, and back ache.  The patient's medical history and concomitant medication was not reported.  On 03 Feb 2021, 1 day prior to the onset of the events, the patient received their second dose of mRNA-1273 (Lot number: 029L20A, Expiration date: not provided) via intramuscular route in the in the deltoid muscle arm for prophylaxis of COVID-19 infection.   On 03 Feb 2021, after administration of vaccine, the patient experienced fever, back ache and fainting. The fainting was considered as medically significant.  Treatment information was not provided.  Action taken with the mRNA-1273 in response to the events was not applicable.   The outcome for all events was considered recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature decreased, Death, Dyspnoea, Fatigue
Clinical narrative: Patient passed away; Heavy breathing; Shortness of breath; Low temperature; Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (Patient passed away) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced BODY TEMPERATURE DECREASED (low temperature) and FATIGUE (tired). On 20-Mar-2021, the patient experienced DEATH (Patient passed away) (seriousness criterion death), DYSPNOEA (heavy breathing) and DYSPNOEA (shortness of breath). The patient died on 20-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (heavy breathing), DYSPNOEA (shortness of breath), BODY TEMPERATURE DECREASED (low temperature) and FATIGUE (tired) outcome was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient's pre-existing comorbidities. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Vaccination site reaction
Clinical narrative: hearing loss in left ear; All the other symptoms too; A spontaneous report was received from a consumer, concerning a male patient of unspecified age, who received Moderna's COVID-19 vaccine and experienced hearing loss in the left ear.  The patient's medical history and concomitant product were not reported                                                                                                   On 12 Feb 2021 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 12 Mar 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 12 Mar 2021, patient had experienced other symptoms too but did not elaborate the same.  On 15 Mar 2021 patient started noticing hearing loss in his left ear. The patient had not treated his ear loss.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Peripheral swelling, Pruritus
Clinical narrative: cellulitis; arm was raised up and swollen from top of arm to elbow; itchy; A spontaneous report  was received from a consumer concerning a 74-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event(s) Cellulitis, arm was raised up and swollen from top of arm to elbow and itchy.    The patient's medical history  was not provided. Concomitant medication included was also not reported.  On 04 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 002A21A) via unknown route in the left arm for prophylaxis of COVID-19 infection.     On 11 Mar 2021, the patient experienced Cellulitis, arm was raised up and swollen from top of arm to elbow and itchy.   Treatment details included cephalexin.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event(s)Cellulitis, arm was raised up and swollen from top of arm to elbow and itchy 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: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea haemorrhagic, Pain in extremity
Clinical narrative: Her rectum was bleeding, it was bright red blood; Her arm was also sore the same day she received the vaccine; A spontaneous report was received from a consumer concerning a 91-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bloody diarrhea and pain in extremity.  The patient's medical history was not provided. Concomitant medications included warfarin.    On 16 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 024M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 16 Mar 2021, the patient experienced arm was sore the same day she received the vaccine, but it went away the next day. On 19 Mar 2021, the patient experienced rectal bleeding, which was bright red blood and one bout of diarrhea. No treatment information was provided.   Action taken with the drug in response to the events was not applicable.  The outcome of the events were reported as resolved.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Cellulitis / red, hard, swollen, and itching / bacterial infection; A spontaneous report was received from a consumer concerning a 72-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm blew up, whole top part was red, hard, swollen, and itching and diagnosed with bacterial infection cellulitis.  The patient's medical history was not reported. No relevant concomitant medications were reported.  On 25 Feb 021, the patient received their first of two planned doses of mRNA-1273 (batch number: 010A21A) in the left arm for prophylaxis of COVID-19 infection.   On an unknown date, seven to eight days later, the patient's arm blew up, whole top part was red, hard, swollen, and itching. The patient husband took her to the urgent care about 10 days after the shot. The doctor diagnosed it as a medically signifant event of a bacterial infection- cellulitis. Treatment for the event included antibiotics. . Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event arm blew up, whole top part was red, hard, swollen, and itching and bacterial infection cellulitis 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, a causal relationship cannot be excluded. Further information has been requested.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Large intestinal obstruction
Clinical narrative: Patient was hospitalized because of blocked colon 6 days after receiving 2nd dose; A spontaneous report was received from a consumer concerning 92-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced colon obstruction and was hospitalized.  The patient's medical history was not provided. Concomitant medications as provided by the reporter included heart medicine, blood pressure medicine, multivitamins [vitamins nos], Vitamin D and acetylsalicylic acid.  On 01 Jan 2021, The patient had received the first of two planned doses of mRNA-1273 (Lot number: 012M20A). On 8 mar 2021, approximately 5 days prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 013A21A) for prophylaxis of COVID-19 infection.  On 14 Mar 2021, the patient was hospitalized because of blocked colon. As a result, on 18 Mar 2021, the patient had laparoscopic surgery and she stated that she knew it was from Moderna vaccine. Treatment for the events included high doses of antibiotics and lot of anesthesia at hospital.  Action taken with mRNA-1273 in response to the events was not applicable.   Outcome of the event of Colon obstruction was unknown.; Reporter's Comments: This case concerns a 92-year-old, female patient, who experienced colon obstruction. Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Diplopia, Dizziness, Magnetic resonance imaging
Clinical narrative: Infarct; Double vision; Dizziness; A spontaneous report (United States) was received from a consumer concerning a 77-years-old, patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed an infarct that effected the left thalamus of his brain (Thalamic infarction), double vision (Diplopia) and dizzinesss (Dizziness).   The patient's medical history was not provided. Concomitant medication included amlodipine for unknown indication.  On 02 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number004M20A) intramuscularly in the left ( non-dominant) arm and  on 02 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number- 001A21A) intramuscularly on the left (non-dominant) arm for prophylaxis of COVID-19 infection.    On 17Feb2021, patient states that he had an infarct that effected the left thalamus of his brain. On the same day around 8pm he was driving not far from his house and developed double vision and dizziness. Once reached home he went to bed, upon waking up in the morning symptoms were still present, at this time he went to the emergency room. Patient was hospitalized for 2 nights and 2 days.  While hospitalized he had several blood test done and a CAT scan done and also had an MRI on 24Feb2021, report details were not reported.  Treatment for the event included are plavix, Catapres, rosuvastatin and doxazosin.   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 events double vision and dizziness were as recovered on 19-feb-2021. The outcome of the event, Infarct 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 these events, a causal relationship cannot be excluded.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Thalamic infarction
Clinical narrative: Infarct; Double vision; Dizziness; A spontaneous report (United States) was received from a consumer concerning a 77-years-old, patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed an infarct that effected the left thalamus of his brain (Thalamic infarction), double vision (Diplopia) and dizzinesss (Dizziness).   The patient's medical history was not provided. Concomitant medication included amlodipine for unknown indication.  On 02 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number004M20A) intramuscularly in the left ( non-dominant) arm and  on 02 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number- 001A21A) intramuscularly on the left (non-dominant) arm for prophylaxis of COVID-19 infection.    On 17Feb2021, patient states that he had an infarct that effected the left thalamus of his brain. On the same day around 8pm he was driving not far from his house and developed double vision and dizziness. Once reached home he went to bed, upon waking up in the morning symptoms were still present, at this time he went to the emergency room. Patient was hospitalized for 2 nights and 2 days.  While hospitalized he had several blood test done and a CAT scan done and also had an MRI on 24Feb2021, report details were not reported.  Treatment for the event included are plavix, Catapres, rosuvastatin and doxazosin.   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 events double vision and dizziness were as recovered on 19-feb-2021. The outcome of the event, Infarct 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 these events, a causal relationship cannot be excluded.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy symptoms; A spontaneous report was received from a consumer concerning a 84-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy symptoms.    The patient's medical history was not provided. Concomitant products included losartan and amlodipine for drug use for unknown indication.  On 11 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 015M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 11 Mar 2021, the patient received his second dose of two planned doses of mRNA-1273 (lot number: 026A21A) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection.   On 15 Mar 2021, the patient experienced Bell's palsy symptoms (important medical event term).  Patient did not take anything to treat symptoms.   Action taken with mRNA-1273 in response to the event was not applicable.    The outcome of the event 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 event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; A Spontaneous report was received from a nurse concerning unknown patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced Anaphylactic reaction.  The patient's medical history was unknown.  Concomitant medications are not reported.  On unknown date 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.  On an unknown date the patient experienced Anaphylactic reactions. The event is considered as medically significant.   No treatment was given. No lab details are provided.  No Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events were unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Feeling abnormal, Feeling hot, Headache, Hypertension
Clinical narrative: extremely high blood pressure; entire body filled with heat during high blood pressure episodes; Sore arm; itch all over body; feels terrible; can't eat anything but ice chips; Headache; A spontaneous report was received from a consumer concerning a 77-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, headache, itch all over body, extremely high blood pressure, feels terrible, can't eat anything but ice chips, and entire body filled with heat during high blood pressure episodes.  The patient's medical history was not provided. No relevant concomitant medications were reported. Additional suspected products included Prolia.  On Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch Number not provided) intramuscularly for prophylaxis of COVID-19 infection.  Patient received Prolia injection 2 weeks after 2nd dose of Moderna's COVID-19 vaccination. Patient side effects reported since Prolia injection are itch all over body, extremely high blood pressure, feels terrible, can't eat anything but ice chips, and entire body filled with heat during high blood pressure episodes. Patient has been hospitalized twice over the past 2 weeks. Treatment for the events included steroids and amlodipine.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The outcomes of the events were considered not recovered.; Reporter's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the Prolia injection received by the patient, which is known to cause these side effects.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: extremely high blood pressure; entire body filled with heat during high blood pressure episodes; Sore arm; itch all over body; feels terrible; can't eat anything but ice chips; Headache; A spontaneous report was received from a consumer concerning a 77-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, headache, itch all over body, extremely high blood pressure, feels terrible, can't eat anything but ice chips, and entire body filled with heat during high blood pressure episodes.  The patient's medical history was not provided. No relevant concomitant medications were reported. Additional suspected products included Prolia.  On Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch Number not provided) intramuscularly for prophylaxis of COVID-19 infection.  Patient received Prolia injection 2 weeks after 2nd dose of Moderna's COVID-19 vaccination. Patient side effects reported since Prolia injection are itch all over body, extremely high blood pressure, feels terrible, can't eat anything but ice chips, and entire body filled with heat during high blood pressure episodes. Patient has been hospitalized twice over the past 2 weeks. Treatment for the events included steroids and amlodipine.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The outcomes of the events were considered not recovered.; Reporter's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the Prolia injection received by the patient, which is known to cause these side effects.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Lower limb fracture, Product dose omission issue
Clinical narrative: Broken leg; missed second dose of vaccination; Fell down; A spontaneous report was received from a daughter, concerning her 90- year-old, female mother who received Moderna's COVID-19 vaccine (mRNA-1273) experienced fell down, broken leg/ limb fracture and missed second dose of vaccination.  The patient's medical history was not reported. Concomitant product use was not provided by the reporter.  On 25 Jan 2021,  patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route for prophylaxis of COVID-19 infection.  Approximately on 15 Feb 2021 or after 3 weeks of receiving mRNA-1273, the patient fell down; broken leg was reported and patient was  in the hospital and rehab now. Daughter wanted to learn if it is late for her to have the second dose of vaccine (missed second dose of vaccination).  No Treatment information was provided.  Action taken with mRNA-1273 in response to events were not reported.  The outcome of the events of fall, broken leg and missed second dose of vaccination 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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Acute haemorrhagic ulcerative colitis, Computerised tomogram, Cyanosis, Erythema, Lip swelling
Clinical narrative: A spontaneous report was received from a  consumer concerning a 82-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hives on her legs/ urticaria, a very bad rash/ rash, blood was coming out in her stool/ hematochezia, ulcerative colitis/ colitis ulcerative, her lips swollen/ lip swelling, her face turned red and hot/ erythema, she feels her teeth burning/ oral discomfort, lips turned blue/ cyanosis, had a 98 °F temperature/pyrexia and had a lump on her back/ vaccination site mass.   The patient's medical history as provided by the reporter included prior breast cancer. No relevant concomitant medications were reported.    On 26 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 011A21A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced hives on her legs and a very bad rash. She had to go back to the ER (emergency room) because blood was coming out in her stool, she had a CT (computerized tomogram) scan and was diagnosed with ulcerative colitis, she had never had that before. On an unspecified date she had her lips swollen, her face turned red and hot and she feels her teeth burning. Her lips turned blue. The patient had a 98 ° F temperature and she had a lump on her back. The event ulcerative colitis and hematochezia were medically significant. Treatment for the events included Benadryl.   Lab data included on an unspecified date, the patient had a 98 ° F temperature and underwent a CT (computerized tomogram) scan and was diagnosed with ulcerative colitis on 27-FEB-2021.   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, hives on her legs, a very bad rash, blood was coming out in her stool, ulcerative colitis, her lips swollen, her face turned red and hot, she feels her teeth burning, lips turned blue, had a 98 °F temperature and had a lump on her back was not reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Oral discomfort, Pyrexia, Rash, Urticaria
Clinical narrative: A spontaneous report was received from a  consumer concerning a 82-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hives on her legs/ urticaria, a very bad rash/ rash, blood was coming out in her stool/ hematochezia, ulcerative colitis/ colitis ulcerative, her lips swollen/ lip swelling, her face turned red and hot/ erythema, she feels her teeth burning/ oral discomfort, lips turned blue/ cyanosis, had a 98 °F temperature/pyrexia and had a lump on her back/ vaccination site mass.   The patient's medical history as provided by the reporter included prior breast cancer. No relevant concomitant medications were reported.    On 26 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 011A21A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced hives on her legs and a very bad rash. She had to go back to the ER (emergency room) because blood was coming out in her stool, she had a CT (computerized tomogram) scan and was diagnosed with ulcerative colitis, she had never had that before. On an unspecified date she had her lips swollen, her face turned red and hot and she feels her teeth burning. Her lips turned blue. The patient had a 98 ° F temperature and she had a lump on her back. The event ulcerative colitis and hematochezia were medically significant. Treatment for the events included Benadryl.   Lab data included on an unspecified date, the patient had a 98 ° F temperature and underwent a CT (computerized tomogram) scan and was diagnosed with ulcerative colitis on 27-FEB-2021.   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, hives on her legs, a very bad rash, blood was coming out in her stool, ulcerative colitis, her lips swollen, her face turned red and hot, she feels her teeth burning, lips turned blue, had a 98 °F temperature and had a lump on her back was not reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Loss of consciousness, Pain
Clinical narrative: A spontaneous report was received from a consumer, concerning a female patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced chills, fatigue, achy/pain, couldn't get warm/feeling cold and passed out/loss of consciousness.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event were not reported.  On 28-Jan-2021, the patient received first of two planned doses of mRNA-1273 (Lot number: 02RL20A) intramuscularly for prophylaxis of COVID-19 infection. She had had no reaction with her first vaccine dose.  On 25-Feb-2021, the patient received her second of two planned doses of mRNA-1273 (Lot number: 02YM20A) intramuscularly for prophylaxis of COVID-19 infection.  On 26-Feb-2021, the patient felt achy. About 2 weeks later, the patient experienced chills, fatigue, aches and couldn't get warm. On an unknown date, the patient blacked out /passed out and found herself on the floor when she got up to go to the bathroom. The patient weighed only 97-100 lbs. The event blacked out/loss of consciousness was considered as serious (medically significant).  Treatment information was unknown.  Action taken with mRNA-1273 was not applicable since the patient received both the doses of the vaccine.  The outcome of the events chills, fatigue, achy/pain, couldn't get warm/ feeling cold and passed out/loss of consciousness 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 these events, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: Blood clot in the lung; A spontaneous report was received from a consumer concerning a 70-years-old, female patient who received  Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood clot in the lung/ Pulmonary thrombosis.  The patient's medical history included hyperthyroidism.  Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine for hyperthyroidism.  On 10 Mar 2021, approximately five days prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) via unknown route for prophylaxis of COVID-19 infection.  On 15 Mar 2021, the patient developed a medically significant event of blood clot in her lung and was hospitalized for 2 days followed by short of breath and cannot walk very far.  Treatment for the event included blood thinner.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, blood clot in the lung/t Pulmonary thrombosis was not provided.; 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: Frequent bowel movements, Loss of consciousness, Urinary tract infection, Vomiting
Clinical narrative: asymptomatic urinary tract infection; threw up; Passed out; defecated on themself; A spontaneous report from was received from a healthcare professional concerning a 64 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Passed out, defecated on themself and threw up very hard and had asymptomatic urinary tract infection.  The patient's medical history was not provided.The patient was taking sitagliptin phosphate, ezetimiab, dulaglutide, glipizide as concomitant medication.    On 27 Feb 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 batch no: 025L20A  intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 28 Feb 2021, the patient passed out, defecated on herself and threw up very hard.  On 01 Mar 2021, the patient passed out again and threw up. Went to emergency room and was told she had an asymptomatic urinary tract infection.  Laboratory details was not provided.  The patient took antibiotic and nausea medicine administered at ER as treatment medication.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown.; Reporter's Comments: This refers to a loss of consciousness case of a 64 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient was taking various hypoglycemic agents as concomitant medication. 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Cellulitis in their arm; Injection site became hot; Injection site became itchy; Injection site became hard; Injection site became red; Injection site became swollen; A spontaneous report was received from a consumer concerning a 60-years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events cellulitis in their arm/cellulitis, injection site became hot/vaccination site warmth, injection site became itchy/vaccination site pruritus, injection site became hard/vaccination site induration, injection site became red/ Vaccination site erythema and injection site became swollen/ Vaccination site swelling.   The patient's medical history was not provided. No relevant concomitant product use was reported.  On 09 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 022M20A) in the left arm for prophylaxis of COVID-19 infection. The route of administration was unknown.    On 09 Mar 2021, the patient reported that the injection site was itchy, red, hot, swollen, and hard. On 19 Mar 2021, the patient consulted her doctor, who determined that the patient's arm was infected, and she has developed cellulitis in her arm.  The event cellulitis was considered as medically significant event.  The doctor prescribed a course of antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event of the injection site was itchy, red, hot, swollen, hard, and cellulitis 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 these events, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Cellulitis in their arm; Injection site became hot; Injection site became itchy; Injection site became hard; Injection site became red; Injection site became swollen; A spontaneous report was received from a consumer concerning a 60-years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events cellulitis in their arm/cellulitis, injection site became hot/vaccination site warmth, injection site became itchy/vaccination site pruritus, injection site became hard/vaccination site induration, injection site became red/ Vaccination site erythema and injection site became swollen/ Vaccination site swelling.   The patient's medical history was not provided. No relevant concomitant product use was reported.  On 09 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 022M20A) in the left arm for prophylaxis of COVID-19 infection. The route of administration was unknown.    On 09 Mar 2021, the patient reported that the injection site was itchy, red, hot, swollen, and hard. On 19 Mar 2021, the patient consulted her doctor, who determined that the patient's arm was infected, and she has developed cellulitis in her arm.  The event cellulitis was considered as medically significant event.  The doctor prescribed a course of antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event of the injection site was itchy, red, hot, swollen, hard, and cellulitis 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 these events, a causal relationship cannot be excluded.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haemorrhagic stroke, Headache, Speech disorder
Clinical narrative: stroke; Trouble speaking; Terrible headache; A spontaneous report was received from a reporter like a consumer concerning an 84 year old male patient  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced terrible headache/ headache, trouble speaking/ speech disorder, stroke/ haemorrhagic stroke.  The patient's medical history included stroke and prior stress test on 10 Feb 2021. Concomitant medications were not provided.  On 11 Feb 2021, prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273(lot/batch: unknown) intramuscularly in the anatomical position for prophylaxis of COVID-19 infection.  On 11 Feb 2021, patient experienced a terrible headache and was having trouble speaking. On 12 Feb 2021, the patient was told at the hospital he had a stroke. He was told that the bleeding was in the same place of the previous stroke.  Treatment information was unknown.  Action taken with mRNA-1273 in response to the events was unknown.  At the time of this report, the outcome of the events 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 event, a causal relationship cannot be excluded. However, patient's advanced age and prior history of stroke may have been contributory.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Haemorrhagic stroke, Headache
Clinical narrative: stroke; Trouble speaking; Terrible headache; A spontaneous report was received from a reporter like a consumer concerning an 84 year old male patient  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced terrible headache/ headache, trouble speaking/ speech disorder, stroke/ haemorrhagic stroke.  The patient's medical history included stroke and prior stress test on 10 Feb 2021. Concomitant medications were not provided.  On 11 Feb 2021, prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273(lot/batch: unknown) intramuscularly in the anatomical position for prophylaxis of COVID-19 infection.  On 11 Feb 2021, patient experienced a terrible headache and was having trouble speaking. On 12 Feb 2021, the patient was told at the hospital he had a stroke. He was told that the bleeding was in the same place of the previous stroke.  Treatment information was unknown.  Action taken with mRNA-1273 in response to the events was unknown.  At the time of this report, the outcome of the events 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 event, a causal relationship cannot be excluded. However, patient's advanced age and prior history of stroke may have been contributory.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19 pneumonia, Fatigue, SARS-CoV-2 test positive
Clinical narrative: pneumonia; with no energy; felt really tired; A spontaneous report was received from a consumer, concerning a male patient of 71-year- old who received Moderna Covid-19 vaccine and experienced tiredness, COVID-19 pneumonia, and no energy.  Medical history included heart operation eight months ago, and since then he has pulmonary problems and respiratory insufficiency. It was reported that he uses Ventolin.  Concomitant  products used are reported as cortisone, salbutamol sulfate and anti histaminic drugs.  On 14-JAN-2021, 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 15-JAN-2021, the patient experienced tiredness, with no energy and thought it was due to the vaccine.  On 18-JAN-2021, the patient was tested positive for COVID-19 in a rapid test and PCR test. He was feeling well but consulted a HCP while abroad, who detected pneumonia. The HCP prescribed cortisone, anti histaminic and isolation.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, was considered to be resolving at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient's advanced age along with underlying conditions and recent travel history may have been contributory for the occurrence of the events.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-005846:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Bone contusion, Computerised tomogram, Dizziness, Feeling abnormal, Head injury
Clinical narrative: Collapsed; head injury from hitting the corner of the cabinet; dizzy; Lumbar contusion; she didn't feel so good; A spontaneous report was received from a consumer concerning a 75 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced syncope, collapsed (syncope), head injury from hitting the corner of the cabinet (head injury), didn't feel so good (feeling abnormal), dizzy, and lumber contusion (bone contusion).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 19 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) via unknown route for prophylaxis of COVID-19 infection. On 18 March 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 040A21A) via unknown route for prophylaxis of COVID-19 infection.  On 20 March 2021, she was dizzy and passed out  and ended up on the floor unconscious and was taken to the ER in an ambulance. The patient had a CT scan done and was diagnosed with syncope, head injury from hitting the corner of the cabinet and lumbar contusion.No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   At the time of this report, the outcome of the event syncope, collapsed (syncope), head injury from hitting the corner of the cabinet , didn't feel so good were not reported. The events dizzy and lumber contusion  were not recovered.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Collapsed; head injury from hitting the corner of the cabinet; dizzy; Lumbar contusion; she didn't feel so good; A spontaneous report was received from a consumer concerning a 75 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced syncope, collapsed (syncope), head injury from hitting the corner of the cabinet (head injury), didn't feel so good (feeling abnormal), dizzy, and lumber contusion (bone contusion).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 19 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) via unknown route for prophylaxis of COVID-19 infection. On 18 March 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 040A21A) via unknown route for prophylaxis of COVID-19 infection.  On 20 March 2021, she was dizzy and passed out  and ended up on the floor unconscious and was taken to the ER in an ambulance. The patient had a CT scan done and was diagnosed with syncope, head injury from hitting the corner of the cabinet and lumbar contusion.No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   At the time of this report, the outcome of the event syncope, collapsed (syncope), head injury from hitting the corner of the cabinet , didn't feel so good were not reported. The events dizzy and lumber contusion  were not recovered.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypokinesia, Loss of consciousness, Nausea, Pain in extremity
Clinical narrative: Passed out on driveway; Arm Pain; Tremors in hand; Could not get up; Headache; Nausea; Vomiting; A spontaneous report was received from a consumer concerning an 81-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm pain/ pain in extremity, headache, nausea, vomiting, passing out on the driveway/ loss of consciousness, could not get up/ hypokinesia and tremors in hand/ tremor.  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 xylometazoline hydrochloride, simvastatin, cyanocobalamin, folic acid, metformin, lisinopril, propanol, hydrochlorothiazide and levothyroxine.  On 01 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) intramuscularly on right upper arm for prophylaxis of COVID-19 infection. On 01 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number: Unknown) intramuscularly on left upper arm for prophylaxis of COVID-19 infection.   On 02 Mar 2021, the patient experienced arm pain, headache, nausea, vomiting, medically significant event of passing out on the driveway, could not get up and tremors in hand.  Treatment for the event included nausea medication.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events, arm pain, headache, nausea, vomiting, passing out on the driveway, could not get up and tremors in hand was resolved on 06 Mar 2021.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273 and the reported events, a causal relationship with the events cannot be excluded.  Fever, nausea and vomiting are consistent with the product safety profile.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Passed out on driveway; Arm Pain; Tremors in hand; Could not get up; Headache; Nausea; Vomiting; A spontaneous report was received from a consumer concerning an 81-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm pain/ pain in extremity, headache, nausea, vomiting, passing out on the driveway/ loss of consciousness, could not get up/ hypokinesia and tremors in hand/ tremor.  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 xylometazoline hydrochloride, simvastatin, cyanocobalamin, folic acid, metformin, lisinopril, propanol, hydrochlorothiazide and levothyroxine.  On 01 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) intramuscularly on right upper arm for prophylaxis of COVID-19 infection. On 01 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number: Unknown) intramuscularly on left upper arm for prophylaxis of COVID-19 infection.   On 02 Mar 2021, the patient experienced arm pain, headache, nausea, vomiting, medically significant event of passing out on the driveway, could not get up and tremors in hand.  Treatment for the event included nausea medication.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events, arm pain, headache, nausea, vomiting, passing out on the driveway, could not get up and tremors in hand was resolved on 06 Mar 2021.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273 and the reported events, a causal relationship with the events cannot be excluded.  Fever, nausea and vomiting are consistent with the product safety profile.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died from the Moderna vaccine; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and died from the Moderna vaccine/death.   The patient's medical history was not provided. No concomitant product use was reported.  On unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On unknown date, the patient died after receiving the Moderna vaccine (Seriousness criteria: death, medically significant).   The date of death was unknown. Autopsy results not provided.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.    The outcome of the event, died from the Moderna vaccine/death, was considered fatal. .; Reporter's Comments: Very limited information regarding the event of death has been provided at this time. No further information has been requested.; Reported Cause(s) of Death: Died from the Moderna vaccine