chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Haematochezia, Vomiting
Clinical narrative: Relentless vomiting 24 hours; Bloody stool; A spontaneous report was received from a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced relentless vomiting 24 hours and bloody stool.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 19 Mar 2021, prior to the onset of the symptoms, the patient received their planned dose of mRNA-1273 (batch number not provided) for prophylaxis of COVID-19 infection.   On unknown date, the patient reported relentless vomiting for twenty-four hours and bloody stool. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, relentless vomiting 24 hours and bloody stool, were considered unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: Confusion to the point of hospitalization; A spontaneous report was received from a consumer concerning her mother, an 82 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Confusion to the point of hospitalization/Confusional state.  The patient's current condition includes Blood pressure, Arrhythmia, Arthritis pain. Concomitant medications includes water pills, Blood pressure pills, Heart medicines for Arrhythmia, Arthritis pain pills.  On 18 Mar 2021, prior to the onset of event, the patient received the first of two planned doses of mRNA-1273 (batch number: 006B21A) via unknown route for prophylaxis of COVID-19 infection.  On 19 Mar 2021, the patient developed extreme confusion to the point where she was admitted. She was still in the hospital on Admission today 23Mar2021. No Treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, confusion to the point of hospitalization 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: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cellulitis, Chills, Discomfort, Dyspnoea
Clinical narrative: Diagnosed with  cellulitis; Diagnosed with sepsis; Temperature 102 degrees F/104 degrees F; Chills/Shivering; Discomfort; Difficulty breathing; Felt cold; Not feeling good; In a lot of pain; A spontaneous report was received from a pharmacist concerning a 44-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed cellulitis, sepsis, temperature was 102 and 104 degrees F/fever, dyspnoea/difficulty breathing, feeling cold, malaise/unwell, pain, discomfort and chills.  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 11 Mar 2021, the patient consulted wound care for his foot and was told to be fine.  On 13 Mar 2021, prior to the onset of the symptoms, the patient received their dose of two planned doses of mRNA-1273 (batch number: unknown) for prophylaxis of COVID-19 infection.   On 13 Mar 2021, within eight to ten minutes, after vaccination patient felt cold .The patient's temperature was noted to be 102 degree Fahrenheit. Also, patient reported a lot of pain and discomfort. Patient also complained about chills, cold and shivering and he was given an orange juice and blanket after five to ten minutes by the pharmacist.  Pharmacist called patients wife and by that time patient developed breathing difficulty. Patient's temperature was raised to 104-degree Fahrenheit by that time and was taken by the emergency medical service to the hospital. The patient was hospitalised. On 16 Mar 2021, after 2 days, patients wife reported to pharmacist that the patient was diagnosed with sepsis and cellulitis and was given two antibiotics. The events sepsis and cellulitis were considered as serious (medically significant). The patient's wife reported that the patient was about to have an amputation in this past weekend.  Treatment for the event included two unknown antibiotics.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events cellulitis, sepsis, temperature was 102 and 104 degrees F/fever, dyspnea /difficulty breathing, feeling cold, malaise/unwell, pain, discomfort and chills were considered to be 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: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Malaise, Pain, Pyrexia, Sepsis
Clinical narrative: Diagnosed with  cellulitis; Diagnosed with sepsis; Temperature 102 degrees F/104 degrees F; Chills/Shivering; Discomfort; Difficulty breathing; Felt cold; Not feeling good; In a lot of pain; A spontaneous report was received from a pharmacist concerning a 44-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed cellulitis, sepsis, temperature was 102 and 104 degrees F/fever, dyspnoea/difficulty breathing, feeling cold, malaise/unwell, pain, discomfort and chills.  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 11 Mar 2021, the patient consulted wound care for his foot and was told to be fine.  On 13 Mar 2021, prior to the onset of the symptoms, the patient received their dose of two planned doses of mRNA-1273 (batch number: unknown) for prophylaxis of COVID-19 infection.   On 13 Mar 2021, within eight to ten minutes, after vaccination patient felt cold .The patient's temperature was noted to be 102 degree Fahrenheit. Also, patient reported a lot of pain and discomfort. Patient also complained about chills, cold and shivering and he was given an orange juice and blanket after five to ten minutes by the pharmacist.  Pharmacist called patients wife and by that time patient developed breathing difficulty. Patient's temperature was raised to 104-degree Fahrenheit by that time and was taken by the emergency medical service to the hospital. The patient was hospitalised. On 16 Mar 2021, after 2 days, patients wife reported to pharmacist that the patient was diagnosed with sepsis and cellulitis and was given two antibiotics. The events sepsis and cellulitis were considered as serious (medically significant). The patient's wife reported that the patient was about to have an amputation in this past weekend.  Treatment for the event included two unknown antibiotics.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events cellulitis, sepsis, temperature was 102 and 104 degrees F/fever, dyspnea /difficulty breathing, feeling cold, malaise/unwell, pain, discomfort and chills were considered to be 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: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Loss of consciousness, Seizure
Clinical narrative: A spontaneous report was received from a consumer (United States) concerning a 21-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fell out of the chair and passed out/Loss of consciousness, fell out of the chair and passed out/Fall, may have been a seizure but unsure/seizure.    The patient's medical history included psychological problems. Concomitant product use was not 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) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, after the injection he "fell out of the chair and passed out". The reporter stated that she heard it "may have been a seizure but unsure". She reported the male was obese. The events passed out and seizure was considered as medically significant. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events fell out of the chair and passed out, may have been a seizure but unsure was unknown at the time of this report.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Nephrolithiasis, Pyrexia
Clinical narrative: Passed one stone that week on Saturday after shot; Fever was almost 102degF; Woke up at 5am with chills; Normally sore in my right arm/all the way down to right elbow; Extreme pain in right kidney; Extreme back pain between my shoulder blade; A spontaneous report was received from a consumer concerning a 64-years-old female patient (weight: 240 lbs.), who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore in my right arm, all the way down to right elbow/pain in extremity, chills, extreme back pain between my shoulder blade/back pain, extreme pain in right kidney/renal pain, passed one stone/nephrolithiasis, fever was almost 102degF/pyrexia.   The patient's medical history was not reported. Products that have been known to be used by the patient were not reported.   The patient received the first of planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection on an unknown date. On 04 Mar 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 010A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 04 Mar 2021, the patient experienced soreness in my right arm, next day at 5 am with chills, extreme pain in right kidney and fever was almost 102-degree F. On unknown Saturday, the patient passed one stone. The patient also experienced extreme back pain between shoulder blade and all the way down to right elbow. Treatment information was provided as ice packs, heating pads, pain killers.   Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events were considered as unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain, Vaccination site pain
Clinical narrative: Passed one stone that week on Saturday after shot; Fever was almost 102degF; Woke up at 5am with chills; Normally sore in my right arm/all the way down to right elbow; Extreme pain in right kidney; Extreme back pain between my shoulder blade; A spontaneous report was received from a consumer concerning a 64-years-old female patient (weight: 240 lbs.), who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore in my right arm, all the way down to right elbow/pain in extremity, chills, extreme back pain between my shoulder blade/back pain, extreme pain in right kidney/renal pain, passed one stone/nephrolithiasis, fever was almost 102degF/pyrexia.   The patient's medical history was not reported. Products that have been known to be used by the patient were not reported.   The patient received the first of planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection on an unknown date. On 04 Mar 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 010A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 04 Mar 2021, the patient experienced soreness in my right arm, next day at 5 am with chills, extreme pain in right kidney and fever was almost 102-degree F. On unknown Saturday, the patient passed one stone. The patient also experienced extreme back pain between shoulder blade and all the way down to right elbow. Treatment information was provided as ice packs, heating pads, pain killers.   Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events were considered as unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Ankle fracture, Inappropriate schedule of product administration
Clinical narrative: broke his ankle; due to get second vaccine; A spontaneous report was received from a 70 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced broke his ankle and due to get second vaccine.  The patient's medical history not reported. No concomitant product use was reported.  On 16-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 042(6)?20A) intramuscularly for prophylaxis of COVID-19 infection. The patient stated that, the patient was due to receive second vaccine on 20-FEB-2021 and he broke his ankle on the same day and went into the hospital for surgery. While the patient was in hospital, he received a flu shot and pneumonia shot, and hospital recommended him to wait 2 more weeks for his second COVID shot. Since that time patient had been at home on clutches and was waiting on someone to help him get to clinic and receive second shot vaccine which was scheduled for Monday 22-MAR-2021. The patient was to know if he need a third dose.  The seriousness of the event broke his ankle was medically significant.  Action taken with mRNA-1273 in response to events was unknown.  The outcome of the event(s) broke his ankle was unknown and the outcome for event due to get second vaccine was recovered/ resolved.; Reporter's Comments: This report refers to a case of a 70-year old male patient who received the first dose of Moderna's COVID-19  vaccine (Lot # 0426?20A)and experienced ankle fracture, and received the second dose later than scheduled. The causality of the event ankle fracture is assessed as unlikely related to mRNA-1273.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Pneumonia
Clinical narrative: Trouble breathing; Pneumonia; A spontaneous report was received from a consumer, concerning patient (unknown age and gender) who received Moderna's COVID-19 (mRNA-1273) and experienced pneumonia and trouble breathing/dyspnea.   The patient's medical history included chronic obstructive pulmonary disease (COPD). Products known to have been used by the patient, within two weeks prior to the events were not reported.  The patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection on an unknown date.   On 04 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.    On an unknown date, the patient had trouble breathing and was diagnosed with pneumonia. The event pneumonia was considered as serious (medically significant).   Treatment of the event was not provided.   Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event pneumonia and trouble breathing was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blister rupture, Oral mucosal blistering, Oropharyngeal blistering, Throat tightness
Clinical narrative: Several blisters on outside of mouth, some bleeding blisters; Several blisters on outside of mouth, some bleeding blisters; throat almost closing; Layers of blister in throat, throat almost closing; A spontaneous report was received from a consumer concerning a 68 year old, female patient who received Moderna's COVID-19 vaccine and experienced events Layers of blister in throat, throat almost closing, Several blisters in throat, some bleeding blisters, Several blisters on outside of mouth.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 04Mar2021, prior to the onset of event, the patient received her first of two planned doses of mRNA-1273 (Batch/Lot number: 027A21A) via Intramuscular route on Left Arm for COVID-19 infection prophylaxis  On 05 March 2021, patient had blisters in their throat, in/around mouth, and  nose. Patient stated the clusters in the throat were extremely bad for 48 hours, during the 48 hours patient states there were layers of blisters in throat so bad that the patient felt as if their throat was closing. Patient states the blister on them mouth was also excessive and bleeding, patient reports using a whole tube Abreva and almost a whole tube of generic Lysine. On 14 March 2021 the patient went to Urgent Care, patient could not open mouth due to blisters  inside of mouth. The HCP at Urgent Care was able to open the mouth  leaving the corners of the mouth bleeding on the outside. Once HCP looked in, they immediately referred patient to Throat Specialist due to concern of the patient possibly having throat cancer. Patient went to Throat Specialist; HCP confirmed the patient did not have throat cancer and was having a severe reaction to the vaccination. Since the patient could not afford treatment HCP recommended taking Allegra D 2 tablets every 12 hours  Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the events Layers of blister in throat, throat almost closing, Several blisters on outside of mouth, some bleeding blisters/Blister rupture, Oral mucosal blistering 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 events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Cellulitis, Erythema, Feeling hot, Pain in extremity
Clinical narrative: Possible cellulitis; Sore in arm; Swelled up ,when touched it; I had heat in it; Red,when touched it; Arm is sore to shoulder; A spontaneous report was received from a consumer concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore in arm/pain in extremity, red and swelled up when touched in it/erythema and swelling, had heat in it/feeling hot, possible cellulitis and arm was sore to shoulder/arthralgia.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, approximately 10 days prior to the onset of the events, the patient received their doses of mRNA-1273 (Batch number:not provided) via unknown route for prophylaxis of COVID-19 infection.   On an unknown date, the patient complained sore arm radiating to shoulder, which was red, swollen and warm  and could be cellulitis.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events was unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. No follow up is possible.; Sender's Comments:
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Possible cellulitis; Sore in arm; Swelled up ,when touched it; I had heat in it; Red,when touched it; Arm is sore to shoulder; A spontaneous report was received from a consumer concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore in arm/pain in extremity, red and swelled up when touched in it/erythema and swelling, had heat in it/feeling hot, possible cellulitis and arm was sore to shoulder/arthralgia.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, approximately 10 days prior to the onset of the events, the patient received their doses of mRNA-1273 (Batch number:not provided) via unknown route for prophylaxis of COVID-19 infection.   On an unknown date, the patient complained sore arm radiating to shoulder, which was red, swollen and warm  and could be cellulitis.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events was unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. No follow up is possible.; Sender's Comments:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Appendicitis
Clinical narrative: Appendicitis; Stomach cramps; A  spontaneous case report was received from  a consumer concerning a 25 years old, female patient  who had received Moderna's COVID-19 and experienced  events as appendicitis, stomach cramps.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter..   On 17 Mar 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch number: 047A21A) via Intramuscular route on Left Arm for COVID-19 infection prophylaxis.   On 20 Mar 2021, the patient experienced stomach cramps.  on 21Mar and was diagnosed to have Appendicitis and underwent appendicectomy on the same day. The patient was treated with Tylenol  and Advil for stomach cramps. The event Appendicitis seriousness were considered as hospitalization and medically significant.   The action taken with mRNA-1273, in response to events was unknown.  The outcome of the events appendicitis and stomach cramps was not resolved at the time of this report.; Reporter's Comments: This case concerns a 25 Y/O F hospitalized with a serious unexpected event of appendicitis and nonserious unexpected abdominal pain upper.  Event onset 4 days after first dose mRNA-1273. Events ongoing. 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Stroke; Bad headache; Very tired; Right side of her body numb; A spontaneous report was received from a consumer, concerning a female patient (herself) of 64-years-old, who received Moderna's COVID-19 vaccine and experienced headache, tiredness, stroke/ Cerebrovascular accident and right side of her body numb/hypoaesthesia.   The patient's medical history included high blood pressure, migraine, high cholesterol, obesity, fusion of spine and neck surgery and numbness on the right side. Products known to have been used by the patient, within two weeks prior to the event included unspecified blood pressure medications.  On 18 Mar 2021, approximately four days prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number: 006B21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 18 Jan 2021 night, the patient experienced a bad headache and was very tired. On 20-Mar-2021, the patient felt better and went for a walk. On 21 Mar 2021, Sunday, at 1:00 am the patient experienced stroke and was hospitalized subsequently. The event stroke was considered as medically significant and required hospitalization.  On 24 Mar 2021, the patient was discharged from hospital and she stated that the stroke had left her entire right side of the body numb.   Treatment for the events included atorvastatin, aspirin.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events headache, tiredness, stroke/cerebrovascular accident was considered as resolved/recovered on 24 Mar 2021. The outcome of the event right side of her body numb/hypoaesthesia was considered as not  recovered 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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Dizziness, Loss of consciousness
Clinical narrative: Passed out; Bruising her head; Dizziness; A spontaneous report was received from a 58-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event passed out/loss of consciousness, bruising her head/contusion and dizziness.  The patient's medical history included diabetes mellitus, blood pressure and cholesterol. Concomitant medications included glyburide, cholesterol medication and blood pressure medication.  On 24 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot#: unknown) in the right arm for prophylaxis of COVID-19 infection.  On 24 Mar 2021, the patient experienced dizziness, passed out and bruised her head. Treatment for the event, bruised her head included applying ice.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events; passed out, bruising her head and dizziness 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.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Loss of consciousness, Paraesthesia, Pruritus, Rash macular
Clinical narrative: Patient reports of "passing out 5 minutes after getting the vaccination; felt tingly; Felt fuzzy; Blotchy skin; Itching all over; A spontaneous report was received from a consumer and concerning a 46-year-old female patient who received Moderna's COVID-19 vaccine and experienced Passing out 5 minutes after getting the vaccination while waiting in the monitor room, felt tingly and fuzzy, itching all over and blotchy skin.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Mar 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via intramuscular route for COVID-19 infection prophylaxis.   On 22 Mar 2021, after first dose of vaccine, the patient experienced Passing out 5 minutes after getting the vaccination while waiting in the monitor room, felt tingly and fuzzy was hospitalized for 3-4 fours. The event passed out was medically significant. Treatment for the events itching all over, blotchy skin included Claritin or Benadryl. No lab details were provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, Passing out 5 minutes after getting the vaccination while waiting in the monitor room, felt tingly and fuzzy, itching all over and blotchy skin were 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
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Loss of hearing; Tinnitus; A spontaneous report was received from a consumer concerning a 77-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced deafness/hearing loss and tinnitus.   The patient's medical history, was not  provided. Concomitant medications reported included prednisone.   On 21 Jan 2021, prior to the onset of the events, the patient received their dose of two planned doses of mRNA-1273 (Lot number: 012L20A) intramuscularly in an unknown location for prophylaxis of COVID-19 infection.  Approximately two days after vaccination the patient developed hearing loss in his left ear. He consulted doctor but was unable to find the medical reason for his loss of hearing. Also, the patient reported tinnitus. The patient has another appointment with ENT on 06 Apr 2021. The patient is going for a blood work for to confirm for the antibodies after the vaccination.  The event deafness was considered as serious and medically significant.  The treatment information was not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The events, loss of hearing and tinnitus was not reported.; 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: F
Vaccine: COVID19
Symptoms: Lower respiratory tract infection, Nasopharyngitis
Clinical narrative: Chest infection; Cold; A spontaneous report was received from a 67 year old female patient, who received Moderna's COVID-19 vaccine and experienced chest infection/ lower respiratory tract infection and cold/ nasopharyngitis.  The patient's medical history was not provided. Concomitant product use was not provided.  On 22 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number unknown) via unknown route for COVID-19 infection prophylaxis.  On an unspecified date, after vaccination, when patient was due for second dose on 22 Mar 2021, she experienced chest infection and cold. Hence second dose was delayed. No treatment information was provided.  The outcomes of the events, chest infection and cold were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Loss of consciousness, Myalgia
Clinical narrative: Passed out; Foggy; Dull headache; Achy; Very tired; Nausea; 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 foggy, passed out, dull headache, achy, very tired, nausea.   The patient's medical history was not provided. Concomitant medications reported included insulin, pravastatin, enalapril maleate.  On an unspecified date, the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route  and site for prophylaxis of COVID-19 infection. On 11 Mar 2021, approximately 7 hours prior to the event, the patient received her second dose of mRNA-1273 (Lot number: unknown) intramuscular in right arm deltoid for prophylaxis of COVID-19 infection  On 11 Mar 2021, the patient experienced foggy, passed out, dull headache, achy, very tired, nausea. . Treatment for the events included paracetamol.  Action taken with mRNA-1273 in response to the events is not applicable.   The events, dull headache, achy, foggy, passed out, very tired, nausea were considered recovered after week and half.; 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Passed out; Foggy; Dull headache; Achy; Very tired; Nausea; 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 foggy, passed out, dull headache, achy, very tired, nausea.   The patient's medical history was not provided. Concomitant medications reported included insulin, pravastatin, enalapril maleate.  On an unspecified date, the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route  and site for prophylaxis of COVID-19 infection. On 11 Mar 2021, approximately 7 hours prior to the event, the patient received her second dose of mRNA-1273 (Lot number: unknown) intramuscular in right arm deltoid for prophylaxis of COVID-19 infection  On 11 Mar 2021, the patient experienced foggy, passed out, dull headache, achy, very tired, nausea. . Treatment for the events included paracetamol.  Action taken with mRNA-1273 in response to the events is not applicable.   The events, dull headache, achy, foggy, passed out, very tired, nausea were considered recovered after week and half.; 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Haematochezia
Clinical narrative: Some blood in the stool; Stomach cramps; Diarrhea; A spontaneous report was received from a consumer, concerning herself, a 68-years-old, Female patient, who received Moderna's COVID-19 vaccine and experienced Stomach cramps/ Abdominal pain upper, Some blood in the stool/ Haematochezia, diarrhea.  The patient's medical history was not provided. Concomitant medication includes Blood Thinners.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Batch number unknown) intramuscular route for COVID-19 infection prophylaxis.   On an unspecified date, Patient experienced Stomach cramps, Blood in stool and diarrhea. She thinks it was either related to vaccine or new fruit she was eating. Treatment information was not Provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, Stomach cramps, Blood in stool and diarrhea were 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.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Colitis ulcerative, Fatigue, Headache, Pain in extremity
Clinical narrative: Ulcerative colitis; fever; lost over 20 pounds; extreme fatigue; chills; severe body aches; severe headache; A spontaneous report, was received from a  consumer concerning himself a 38 male patient , who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced an ulcerative colitis, chills, severe body aches, fever, severe headache, extreme fatigue, lost over 20 pounds .  The patient's medical history was not provided by the reporter. Concomitant medications included Seroquel 15mg, Clonazepam 0.25mg, Omeprazole, Albuterol.  On 05 FEB 2021 the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 05 MAR 2021, the patient experienced headache, body ache, chills .on 11 MAR 2021,The patient experienced ulcerative colitis, lost 20 pounds, fever. the ulcerative colitis flared up after second dose . patient have the predisposition and overactive immune system". the patient was not hospitalized.   The treatment taken by the patient was IV 3 rounds of Gluthathione hydrocortisone suppositories, herbal supplements, ibuprofen  The Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The  outcome of the events were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The causality of the event ulcerative colitis (UC) is related to the patient's past medical history of UC.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Weight decreased
Clinical narrative: Ulcerative colitis; fever; lost over 20 pounds; extreme fatigue; chills; severe body aches; severe headache; A spontaneous report, was received from a  consumer concerning himself a 38 male patient , who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced an ulcerative colitis, chills, severe body aches, fever, severe headache, extreme fatigue, lost over 20 pounds .  The patient's medical history was not provided by the reporter. Concomitant medications included Seroquel 15mg, Clonazepam 0.25mg, Omeprazole, Albuterol.  On 05 FEB 2021 the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 05 MAR 2021, the patient experienced headache, body ache, chills .on 11 MAR 2021,The patient experienced ulcerative colitis, lost 20 pounds, fever. the ulcerative colitis flared up after second dose . patient have the predisposition and overactive immune system". the patient was not hospitalized.   The treatment taken by the patient was IV 3 rounds of Gluthathione hydrocortisone suppositories, herbal supplements, ibuprofen  The Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The  outcome of the events were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The causality of the event ulcerative colitis (UC) is related to the patient's past medical history of UC.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Epistaxis, Fatigue, Gait inability
Clinical narrative: Black out; Bloody head; Bloody nose; Very dizzy; Could not walk; felt unusually tired for mid afternoon that day; A spontaneous report was received from a consumer concerning a 55-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt unusually tired for midafternoon/fatigue, experienced a black out/loss of consciousness and woke up face down with a bloody nose/ epistaxis and head/head injury, was very dizzy and couldn't walk/gait inability.  The patient's medical history was not provided. Concomitant medications included dolutegravir sodium;lamivudine, pregabalin, and modafinil for unknown indication.  On 19 Feb 2021, approximately two days prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 21 Feb 2021, after receiving mRNA-1273, the patient felt unusually tired for midafternoon that day. The patient had suffered from chronic fatigue issues but never felt more tired than usual at that point in the day. The patient then experienced a black out and woke up face down with a bloody nose and head. The patient felt very dizzy, was not able to walk and crawled to their mattress and fell asleep. The patient managed to get himself to the Emergency room, a CT scan of the head was performed, and it was revealed that the patient had a fracture that had occurred before the vaccine and was not related to the vaccine. The doctor thought the vaccine however maybe related to the blackout or have exaggerated a concussion and have caused these delayed symptoms. 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 event experienced a black out was resolved at the time of this report and the outcome of the events, felt unusually tired for midafternoon, woke up face down with a bloody nose and head, was very dizzy and couldn't walk was not reported.; Reporter's Comments: Based on reporter's causality and patient's skull fracture that had occurred before the vaccine the event is assessed as unlikely related to mRNA-1273.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-057947:Second Dose Case
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Black out; Bloody head; Bloody nose; Very dizzy; Could not walk; felt unusually tired for mid afternoon that day; A spontaneous report was received from a consumer concerning a 55-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt unusually tired for midafternoon/fatigue, experienced a black out/loss of consciousness and woke up face down with a bloody nose/ epistaxis and head/head injury, was very dizzy and couldn't walk/gait inability.  The patient's medical history was not provided. Concomitant medications included dolutegravir sodium;lamivudine, pregabalin, and modafinil for unknown indication.  On 19 Feb 2021, approximately two days prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 21 Feb 2021, after receiving mRNA-1273, the patient felt unusually tired for midafternoon that day. The patient had suffered from chronic fatigue issues but never felt more tired than usual at that point in the day. The patient then experienced a black out and woke up face down with a bloody nose and head. The patient felt very dizzy, was not able to walk and crawled to their mattress and fell asleep. The patient managed to get himself to the Emergency room, a CT scan of the head was performed, and it was revealed that the patient had a fracture that had occurred before the vaccine and was not related to the vaccine. The doctor thought the vaccine however maybe related to the blackout or have exaggerated a concussion and have caused these delayed symptoms. 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 event experienced a black out was resolved at the time of this report and the outcome of the events, felt unusually tired for midafternoon, woke up face down with a bloody nose and head, was very dizzy and couldn't walk was not reported.; Reporter's Comments: Based on reporter's causality and patient's skull fracture that had occurred before the vaccine the event is assessed as unlikely related to mRNA-1273.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-057947:Second Dose Case
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Computerised tomogram, Confusional state, Feeling abnormal, Malaise
Clinical narrative: She kinda knew she wasn't with it but not really /really don't know what to do. She didn't know what she wanted for breakfast; She seemed a little confused; She seemed a little off; Fever of 99.8; You could tell something was off; A spontaneous report was received from Consumer and Healthcare Professional concerning a patient 98 years old , female and who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced a little confusion, she seemed a little off, you could tell something was off, memory impairment and fever. It is a serious case; Seriousness criteria: Hospitalization  The patient's medical history was not provided. The patient's lab data was provided- did a CAT scan, chest x-ray, urine sample (which was negative). Everything was clear. Concomitant products were not provided.  On 12 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number unknown) via unknown route on left arm for prophylaxis of COVID-19 infection. The patient waited 15 min after shot. (it was Friday at 1:00) she was fine Friday and Saturday and Sunday morning. She seemed a little confused and didn't know how the remote(to her recliner) worked. She seemed a little off. She really don't know what to do. She didn't know what she wanted for breakfast.  She didn't know how to use her nose drops (caller states her mother had difficulty expressing this). The consumer stated that "This woman is very sharp." I put her thru some memory test. she couldn't tell me (her birthday), you could tell something was off. She didn't know how to use the phone, TV remote, remote for recliner, she wasn't really talking from Sunday. Took her to ER at hospital they did a CAT scan, chest x-ray, she had a fever 99.8, urine sample (which was negative). everything was clear. They kept her for observation overnight. Thursday her doctor (through her insurance) wanted to come check her out. He gave her a memory test. She was coming into herself again and she remembered the 3 words. We then handed her the phone (which she was able to use). Within half an hour of him arriving she was completely fine (last Thursday) and has continued to be. Caller states regrading her mother she "kinda knew she wasn't with it but not really." They called the patients neurologist and they said it should clear up in 10days regarding her side effects.  Treatment provided was unknown.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events she seemed a little confused, She seemed a little off, you could tell something was off, she kinda knew she wasn't with it but not really  were Not Resolved / Not recovered and for  fever 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: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Pyrexia, Urine analysis normal
Clinical narrative: She kinda knew she wasn't with it but not really /really don't know what to do. She didn't know what she wanted for breakfast; She seemed a little confused; She seemed a little off; Fever of 99.8; You could tell something was off; A spontaneous report was received from Consumer and Healthcare Professional concerning a patient 98 years old , female and who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced a little confusion, she seemed a little off, you could tell something was off, memory impairment and fever. It is a serious case; Seriousness criteria: Hospitalization  The patient's medical history was not provided. The patient's lab data was provided- did a CAT scan, chest x-ray, urine sample (which was negative). Everything was clear. Concomitant products were not provided.  On 12 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number unknown) via unknown route on left arm for prophylaxis of COVID-19 infection. The patient waited 15 min after shot. (it was Friday at 1:00) she was fine Friday and Saturday and Sunday morning. She seemed a little confused and didn't know how the remote(to her recliner) worked. She seemed a little off. She really don't know what to do. She didn't know what she wanted for breakfast.  She didn't know how to use her nose drops (caller states her mother had difficulty expressing this). The consumer stated that "This woman is very sharp." I put her thru some memory test. she couldn't tell me (her birthday), you could tell something was off. She didn't know how to use the phone, TV remote, remote for recliner, she wasn't really talking from Sunday. Took her to ER at hospital they did a CAT scan, chest x-ray, she had a fever 99.8, urine sample (which was negative). everything was clear. They kept her for observation overnight. Thursday her doctor (through her insurance) wanted to come check her out. He gave her a memory test. She was coming into herself again and she remembered the 3 words. We then handed her the phone (which she was able to use). Within half an hour of him arriving she was completely fine (last Thursday) and has continued to be. Caller states regrading her mother she "kinda knew she wasn't with it but not really." They called the patients neurologist and they said it should clear up in 10days regarding her side effects.  Treatment provided was unknown.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events she seemed a little confused, She seemed a little off, you could tell something was off, she kinda knew she wasn't with it but not really  were Not Resolved / Not recovered and for  fever 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.