chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Rash, Rash erythematous, Skin discolouration, Vaccine positive rechallenge
Clinical narrative: Shingrix vaccine August 2018 / 2nd dosage 19-Mar-2021; Her arm gets a rash / big red rash; Her arm gets / white  spots around the rash; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash erythematous (received 1st dose in August 2018, refer case US2021AMR068257).   On 19th March 2021, the patient received the 2nd dose of Shingrix. In March 2021, less than a week after receiving Shingrix, the patient experienced red rash and skin discoloration. On 19th March 2021, the patient experienced drug dose administration interval too long. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the red rash, skin discoloration and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the red rash and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced red rash and skin discoloration. The patient received received 2nd dose late, which led to lengthening of vaccinations schedule. The caller did not know if it was because of the length of the dosages were too far apart and had question towards if the patient had to take vaccine again.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR068257:Same reporter. US-GLAXOSMITHKLINE-US2021067596:FU1 deleted
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Altered state of consciousness, Asthenia, Depression, Dizziness, Dyspnoea
Clinical narrative: He almost passed out and felt like the life was going out of him; Feeling very weak; Little out of breath; Little lightheaded; Little depressed; Nausea; Vomiting; A spontaneous report  was received from a Consumer concerning a 73 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient experienced nausea, almost passed out and felt like the life was going out of him, very weak, vomiting, little out of breath, little lightheaded, depressed.  The patient did not take any medication . No relevant concomitant medications were reported.    On 11-02-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced nausea, almost passed out and felt like the life was going out of him which was assessed as medically significant based on IME list, very weak, vomiting, little out of breath, little lightheaded, depressed.  Laboratory details are not provided. The patient had not received any madication.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, nausea, almost passed out and felt like the life was going out of him, very weak, vomiting, little out of breath, little lightheaded, depressed were unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: He almost passed out and felt like the life was going out of him; Feeling very weak; Little out of breath; Little lightheaded; Little depressed; Nausea; Vomiting; A spontaneous report  was received from a Consumer concerning a 73 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient experienced nausea, almost passed out and felt like the life was going out of him, very weak, vomiting, little out of breath, little lightheaded, depressed.  The patient did not take any medication . No relevant concomitant medications were reported.    On 11-02-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced nausea, almost passed out and felt like the life was going out of him which was assessed as medically significant based on IME list, very weak, vomiting, little out of breath, little lightheaded, depressed.  Laboratory details are not provided. The patient had not received any madication.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, nausea, almost passed out and felt like the life was going out of him, very weak, vomiting, little out of breath, little lightheaded, depressed were unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Dizziness, Fatigue, Haematochezia
Clinical narrative: blood in stools; Cough; Body ache; Chills; Fever; tired; Dizziness; A spontaneous report was received by medical information from a nurse concerning a 63 year old, male patient who developed/experienced: cough (cough), body ache (myalgia), fever (pyrexia), chills (chills), dizziness( dizziness), fatigue (fatigue), tired (tiredness) and blood in stools (haematochezia).   The patient's medical history was not provided other than concomitant medications.  Products known to have been used by the patient, within two weeks prior to the events, included: Metformin, Zinc and B12.    The patient received their presumed first dose of the mRNA-1273 vaccine on 27Jan2021 (Batch #: 032L20A) as it was indicated by the reporter that the patient was due for the next dose around the time of the report. The events occurred following the first dose of the vaccine but exact dates of the events were not provided, only duration in days.   The day following the administration of the vaccine, the patient reported cough, body ache, fever, chills, fatigue and feeling tired. These symptoms lasted for 10 days.   Approximately 2 weeks following the administration of the vaccine, the patient reported dizziness which lasted for 5 days.   The patient took Tylenol for treatment and was noted to be feeling better as of 13Feb2021. No further outcome information was provided.   The patient reported having blood in stools and was seen by their doctor, date of onset was not provided. The doctor indicated this was "probably hemmoroids" and that "he (the patient) was fine and drink lots of liquids." No other treatment or outcome information was provided.    It is unknown if the subject received the second dose of mRNA-1273.    No assessment of causality was provided by the reporting nurse or the patient's doctor.; 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: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: blood in stools; Cough; Body ache; Chills; Fever; tired; Dizziness; A spontaneous report was received by medical information from a nurse concerning a 63 year old, male patient who developed/experienced: cough (cough), body ache (myalgia), fever (pyrexia), chills (chills), dizziness( dizziness), fatigue (fatigue), tired (tiredness) and blood in stools (haematochezia).   The patient's medical history was not provided other than concomitant medications.  Products known to have been used by the patient, within two weeks prior to the events, included: Metformin, Zinc and B12.    The patient received their presumed first dose of the mRNA-1273 vaccine on 27Jan2021 (Batch #: 032L20A) as it was indicated by the reporter that the patient was due for the next dose around the time of the report. The events occurred following the first dose of the vaccine but exact dates of the events were not provided, only duration in days.   The day following the administration of the vaccine, the patient reported cough, body ache, fever, chills, fatigue and feeling tired. These symptoms lasted for 10 days.   Approximately 2 weeks following the administration of the vaccine, the patient reported dizziness which lasted for 5 days.   The patient took Tylenol for treatment and was noted to be feeling better as of 13Feb2021. No further outcome information was provided.   The patient reported having blood in stools and was seen by their doctor, date of onset was not provided. The doctor indicated this was "probably hemmoroids" and that "he (the patient) was fine and drink lots of liquids." No other treatment or outcome information was provided.    It is unknown if the subject received the second dose of mRNA-1273.    No assessment of causality was provided by the reporting nurse or the patient's doctor.; 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: M
Vaccine: COVID19
Symptoms: Dizziness, Pain, Pyrexia, Syncope
Clinical narrative: Fainted in shower; while having dinner fainted, dizziness, and light headed; Body ache; Extreme high fever; A spontaneous report was received from a consumer, concerning a male patient of unspecified age, who received Moderna's COVID-19 vaccine and experienced fever, body ache, fainting, dizziness and lightheadedness.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.   On 24-FEB-2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot number unknown) intramuscularly on left upper arm for COVID-19 infection prophylaxis.  On 24-FEB-2021, after second dose of vaccine, the patient experienced extreme high fever and body ache. Treatment medication included Tylenol for the event extreme high fever. On 26-FEB 2021, patient was feeling better and was able to walk for an hour. At night, he went to the restaurant for dinner and while having dinner, patient fainted, experienced dizziness and felt light headed. He had ongoing symptoms of dizziness while standing and sitting.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the event, fainting was unknown at the time of this report. The outcome of the events extreme high fever and body ache was resolved on 26-Feb-2021. The outcome of the event dizziness is not resolved/not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Middle ear effusion, Pain in jaw
Clinical narrative: Fluid on the ear; Bells palsy; Jaw pain; A spontaneous report was received from a consumer who was a 71-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced: Bells palsy(facial paralysis), jaw pain (pain in jaw), and fluid on ear (middle ear effusion).  The patient did not provide any relevant or specific medical history. Concomitant product use was not provided/unknown by the reporter   On 11 Feb 2021, the patient received her first of two planned doses of mRNA-1273 (Batch number 013M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 28 Feb 2021, the patient started to experience jawpain and went to see her doctor. The date of the doctor visit was not provided/unknown by the reporter. The patient was told by the doctor, "she had fluid on ear." Patient endorses, "she has had fluid on ear before and never had that type of pain."  Patient reports she returned for medical care on 06 Mar 2021 and was seen by a nurse practioner. The nurse practioner said she had Bells palsy. Patient indicated "she had all signs on(of) Bells palsy." The patient expressed concern regarding her eyesight as nurse practioner said "she could get dust in eye because of inability to close eye." Patient also wanted a call back on whether or not to take the second dose.   Treatment for the events included: "pregnisone" (presumed to be prednisone, reported as pregnisone 500mg/1000mg) and an anti-viral (reported as valacyclovir 1000mg) which was prescribed by the nurse practioner.   Action taken with mRNA-1273 in response to the events was not reported.   Outcome of the events of Bells palsy, jaw pain and fluid on ear was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Cold sweat, Confusional state, Diarrhoea, Dizziness
Clinical narrative: Fell after urinating and hit her head; Semi delirious and confused; Cramps were intermittent for 1-2 hours; Tremulous; Low blood pressure; Dizzy; Cold, clammy; Very sweaty; Severe diarrhea; Lost consciousness; Borderline in shock or in shock; Head injury; abdominal discomfort; A spontaneous report was received from a physician concerning a 63-year-old, female patient who developed severe diarrhea, abdominal discomfort, lost consciousness, fell after urinating and hit her head, cold and clammy, very sweaty, low blood pressure, semi delirious, confused, tremulous, cramps, in shock and dizzy.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On 03 Mar 2021, approximately four days prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 (Batch number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 06 Mar 2021, the patient experienced severe diarrhoea and abdominal discomfort. At 4 AM she had lost consciousness and fell after urinating and hit her head on the curb of the shower. Her husband found her and when he saw her, she was cold, clammy and very sweaty. Her husband reported that the patient had low blood pressure that caused syncope and caused her to fall. The patient was in a semi-delirious state and was confused, tremulous. The cramps were intermittent for 1-2 hours. The patient was in a borderline shock or in shock as she was very dizzy when she stood up. The events were resolved after four hours. On the next day her temperature was at 98.8 degrees Fahrenheit.   Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, diarrhea, abdominal discomfort, loss of consciousness, fall, cold sweats, hyperhidrosis, hypotension, syncope, confusional state, tremors, muscle spasms, shock and dizziness were recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Head injury, Hyperhidrosis, Hypotension, Loss of consciousness
Clinical narrative: Fell after urinating and hit her head; Semi delirious and confused; Cramps were intermittent for 1-2 hours; Tremulous; Low blood pressure; Dizzy; Cold, clammy; Very sweaty; Severe diarrhea; Lost consciousness; Borderline in shock or in shock; Head injury; abdominal discomfort; A spontaneous report was received from a physician concerning a 63-year-old, female patient who developed severe diarrhea, abdominal discomfort, lost consciousness, fell after urinating and hit her head, cold and clammy, very sweaty, low blood pressure, semi delirious, confused, tremulous, cramps, in shock and dizzy.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On 03 Mar 2021, approximately four days prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 (Batch number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 06 Mar 2021, the patient experienced severe diarrhoea and abdominal discomfort. At 4 AM she had lost consciousness and fell after urinating and hit her head on the curb of the shower. Her husband found her and when he saw her, she was cold, clammy and very sweaty. Her husband reported that the patient had low blood pressure that caused syncope and caused her to fall. The patient was in a semi-delirious state and was confused, tremulous. The cramps were intermittent for 1-2 hours. The patient was in a borderline shock or in shock as she was very dizzy when she stood up. The events were resolved after four hours. On the next day her temperature was at 98.8 degrees Fahrenheit.   Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, diarrhea, abdominal discomfort, loss of consciousness, fall, cold sweats, hyperhidrosis, hypotension, syncope, confusional state, tremors, muscle spasms, shock and dizziness were recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Shock, Tremor
Clinical narrative: Fell after urinating and hit her head; Semi delirious and confused; Cramps were intermittent for 1-2 hours; Tremulous; Low blood pressure; Dizzy; Cold, clammy; Very sweaty; Severe diarrhea; Lost consciousness; Borderline in shock or in shock; Head injury; abdominal discomfort; A spontaneous report was received from a physician concerning a 63-year-old, female patient who developed severe diarrhea, abdominal discomfort, lost consciousness, fell after urinating and hit her head, cold and clammy, very sweaty, low blood pressure, semi delirious, confused, tremulous, cramps, in shock and dizzy.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On 03 Mar 2021, approximately four days prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 (Batch number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 06 Mar 2021, the patient experienced severe diarrhoea and abdominal discomfort. At 4 AM she had lost consciousness and fell after urinating and hit her head on the curb of the shower. Her husband found her and when he saw her, she was cold, clammy and very sweaty. Her husband reported that the patient had low blood pressure that caused syncope and caused her to fall. The patient was in a semi-delirious state and was confused, tremulous. The cramps were intermittent for 1-2 hours. The patient was in a borderline shock or in shock as she was very dizzy when she stood up. The events were resolved after four hours. On the next day her temperature was at 98.8 degrees Fahrenheit.   Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, diarrhea, abdominal discomfort, loss of consciousness, fall, cold sweats, hyperhidrosis, hypotension, syncope, confusional state, tremors, muscle spasms, shock and dizziness were recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Fatigue, Headache, Loss of consciousness
Clinical narrative: Feeling sleepy yesterday; Itching around the neck and arm  but no rash; Chills; Headache; Nausea; Fever; Body ache; Felt tired; Vomiting; Tired muscle; Passed out in kitchen; Heavy chest which did not affect her breathing but it felt like adrenalin rush; A spontaneous report was received from a 51 year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, headache, nausea (nausea), vomiting (vomiting), fever (pyrexia), itching around the neck and arm but no rash (pruritus), body ache (pain) with tired muscle (muscle fatigue), felt tired (fatigue), passed out in the kitchen (loss of consciousness), heavy chest which did not affect the breathing but it felt like adrenalin rush (chest discomfort) and felt sleepy (somnolence).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 012A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 06 Mar 2021, 5 to 6 hours after the vaccination, the patient experienced chills, headache, nausea and vomiting, fever, itching around the neck and arm but no rash, body ache, felt tired and passed out in the kitchen. The patient also had heavy chest which did not affect the breathing, but it felt like adrenalin rush. On 07 Mar 2021, the patient felt sleepy and had muscle tiredness. Treatment included paracetamol and ibuprofen every 4 hours to treat the symptoms..  Action taken with mRNA-1273 in response to the events was not applicable.  The outcomes of the events, chills, headache, nausea and vomiting, fever, itching around the neck and arm but no rash, body ache with tired muscle felt tired and passed out in the kitchen, heavy chest which did not affect the breathing but it felt like adrenalin rush and felt sleepy, 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle fatigue, Nausea, Pain, Pruritus, Pyrexia
Clinical narrative: Feeling sleepy yesterday; Itching around the neck and arm  but no rash; Chills; Headache; Nausea; Fever; Body ache; Felt tired; Vomiting; Tired muscle; Passed out in kitchen; Heavy chest which did not affect her breathing but it felt like adrenalin rush; A spontaneous report was received from a 51 year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, headache, nausea (nausea), vomiting (vomiting), fever (pyrexia), itching around the neck and arm but no rash (pruritus), body ache (pain) with tired muscle (muscle fatigue), felt tired (fatigue), passed out in the kitchen (loss of consciousness), heavy chest which did not affect the breathing but it felt like adrenalin rush (chest discomfort) and felt sleepy (somnolence).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 012A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 06 Mar 2021, 5 to 6 hours after the vaccination, the patient experienced chills, headache, nausea and vomiting, fever, itching around the neck and arm but no rash, body ache, felt tired and passed out in the kitchen. The patient also had heavy chest which did not affect the breathing, but it felt like adrenalin rush. On 07 Mar 2021, the patient felt sleepy and had muscle tiredness. Treatment included paracetamol and ibuprofen every 4 hours to treat the symptoms..  Action taken with mRNA-1273 in response to the events was not applicable.  The outcomes of the events, chills, headache, nausea and vomiting, fever, itching around the neck and arm but no rash, body ache with tired muscle felt tired and passed out in the kitchen, heavy chest which did not affect the breathing but it felt like adrenalin rush and felt sleepy, 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vomiting
Clinical narrative: Feeling sleepy yesterday; Itching around the neck and arm  but no rash; Chills; Headache; Nausea; Fever; Body ache; Felt tired; Vomiting; Tired muscle; Passed out in kitchen; Heavy chest which did not affect her breathing but it felt like adrenalin rush; A spontaneous report was received from a 51 year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, headache, nausea (nausea), vomiting (vomiting), fever (pyrexia), itching around the neck and arm but no rash (pruritus), body ache (pain) with tired muscle (muscle fatigue), felt tired (fatigue), passed out in the kitchen (loss of consciousness), heavy chest which did not affect the breathing but it felt like adrenalin rush (chest discomfort) and felt sleepy (somnolence).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 012A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 06 Mar 2021, 5 to 6 hours after the vaccination, the patient experienced chills, headache, nausea and vomiting, fever, itching around the neck and arm but no rash, body ache, felt tired and passed out in the kitchen. The patient also had heavy chest which did not affect the breathing, but it felt like adrenalin rush. On 07 Mar 2021, the patient felt sleepy and had muscle tiredness. Treatment included paracetamol and ibuprofen every 4 hours to treat the symptoms..  Action taken with mRNA-1273 in response to the events was not applicable.  The outcomes of the events, chills, headache, nausea and vomiting, fever, itching around the neck and arm but no rash, body ache with tired muscle felt tired and passed out in the kitchen, heavy chest which did not affect the breathing but it felt like adrenalin rush and felt sleepy, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Confusional state, Fatigue, Hallucination
Clinical narrative: Arm so painful; Hallucinating; Shaking and shivering; Fatigue; Headache; Muscle aches; Fever; Threw up x1; Didn't know who I was; I couldnt lift my arm; Getting weak; Arm got severely swollen; A spontaneous report was received from a consumer concerning a 66-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and  experienced hallucinating (hallucination), didn't know who I was (confusional state), couldn't lift arm (muscular weakness), got weak (asthenia), arm got severely swollen  (peripheral swelling), pain (pain in extremity), fever (pyrexia), headache, fatigue, threw up (vomiting), shaking and shivering (chills) and muscle aches (myalgia).   The patient's medical history and concomitant products used were unknown.   On 03-MAR-2021, approximately 12 hours prior to onset of first event, the patient received their first planned dose of mRNA-1273 (Lot/Batch number: 022M28A) intramuscularly for prophylaxis of COVID-19 infection.   Within the first 12 hours of being vaccinated, the patient experienced minor arm soreness, which ended the same day. The next day, she experienced fatigue, headache, shaking and shivering, muscle aches, was getting weak, threwup once, fever, and didn't know who she was. She lived alone and was hollering for someone to help her. She couldn't get out of bed. She was hallucinating; she thought the floor was wet. Her arm was severely swollen and painful.  The patient couldn't lift her arm.  Treatments of these events were not provided.  Action taken with mRNA-1273 in response to the event is unknown.  The outcome for the events, hallucinations, confusional state, muscular weakness, asthenia, peripheral swelling, pain, fever, headache, fatigue, vomiting, shaking/shivering and muscle aches, 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, confusional state, muscular weakness, asthenia, peripheral swelling, pain, fever, headache, fatigue, vomiting, shaking/shivering and muscle aches, a causal relationship cannot be excluded. Very limited information regarding the hallucinations has been provided at this time.  Further information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscular weakness, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Arm so painful; Hallucinating; Shaking and shivering; Fatigue; Headache; Muscle aches; Fever; Threw up x1; Didn't know who I was; I couldnt lift my arm; Getting weak; Arm got severely swollen; A spontaneous report was received from a consumer concerning a 66-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and  experienced hallucinating (hallucination), didn't know who I was (confusional state), couldn't lift arm (muscular weakness), got weak (asthenia), arm got severely swollen  (peripheral swelling), pain (pain in extremity), fever (pyrexia), headache, fatigue, threw up (vomiting), shaking and shivering (chills) and muscle aches (myalgia).   The patient's medical history and concomitant products used were unknown.   On 03-MAR-2021, approximately 12 hours prior to onset of first event, the patient received their first planned dose of mRNA-1273 (Lot/Batch number: 022M28A) intramuscularly for prophylaxis of COVID-19 infection.   Within the first 12 hours of being vaccinated, the patient experienced minor arm soreness, which ended the same day. The next day, she experienced fatigue, headache, shaking and shivering, muscle aches, was getting weak, threwup once, fever, and didn't know who she was. She lived alone and was hollering for someone to help her. She couldn't get out of bed. She was hallucinating; she thought the floor was wet. Her arm was severely swollen and painful.  The patient couldn't lift her arm.  Treatments of these events were not provided.  Action taken with mRNA-1273 in response to the event is unknown.  The outcome for the events, hallucinations, confusional state, muscular weakness, asthenia, peripheral swelling, pain, fever, headache, fatigue, vomiting, shaking/shivering and muscle aches, 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, confusional state, muscular weakness, asthenia, peripheral swelling, pain, fever, headache, fatigue, vomiting, shaking/shivering and muscle aches, a causal relationship cannot be excluded. Very limited information regarding the hallucinations has been provided at this time.  Further information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Arm so painful; Hallucinating; Shaking and shivering; Fatigue; Headache; Muscle aches; Fever; Threw up x1; Didn't know who I was; I couldnt lift my arm; Getting weak; Arm got severely swollen; A spontaneous report was received from a consumer concerning a 66-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and  experienced hallucinating (hallucination), didn't know who I was (confusional state), couldn't lift arm (muscular weakness), got weak (asthenia), arm got severely swollen  (peripheral swelling), pain (pain in extremity), fever (pyrexia), headache, fatigue, threw up (vomiting), shaking and shivering (chills) and muscle aches (myalgia).   The patient's medical history and concomitant products used were unknown.   On 03-MAR-2021, approximately 12 hours prior to onset of first event, the patient received their first planned dose of mRNA-1273 (Lot/Batch number: 022M28A) intramuscularly for prophylaxis of COVID-19 infection.   Within the first 12 hours of being vaccinated, the patient experienced minor arm soreness, which ended the same day. The next day, she experienced fatigue, headache, shaking and shivering, muscle aches, was getting weak, threwup once, fever, and didn't know who she was. She lived alone and was hollering for someone to help her. She couldn't get out of bed. She was hallucinating; she thought the floor was wet. Her arm was severely swollen and painful.  The patient couldn't lift her arm.  Treatments of these events were not provided.  Action taken with mRNA-1273 in response to the event is unknown.  The outcome for the events, hallucinations, confusional state, muscular weakness, asthenia, peripheral swelling, pain, fever, headache, fatigue, vomiting, shaking/shivering and muscle aches, 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, confusional state, muscular weakness, asthenia, peripheral swelling, pain, fever, headache, fatigue, vomiting, shaking/shivering and muscle aches, a causal relationship cannot be excluded. Very limited information regarding the hallucinations has been provided at this time.  Further information has been requested.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Dehydration, Urinary tract infection
Clinical narrative: Acute renal failure; Dehydration; Urinary tract infection; A spontaneous report was received from a nurse concerning a 90-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed acute renal failure/acute kidney injury, urinary tract infection, dehydration and vaccine administered intramuscularly in the right thigh.  Medical history or concomitant medications were not reported.   On 24 Feb 2021, the patient received his first planned dose of mRNA-1273 (batch number: 029K20A) intramuscularly in the right thigh for prophylaxis of COVID-19 infection.   On 08 Mar 2021, he went for cystoscopy and bioscopy with unknown results. On 09 Mar 21, he was sent to the ER for acute renal failure, dehydration and Urinary tract infection (UTI). He was admitted to the hospital.  The events acute renal failure and urinary tract infection were considered to be medically significant.  The action taken with mRNA-1273 in response to the acute renal failure, dehydration and Urinary tract infection was unknown.  The outcome of the events acute renal failure, dehydration and Urinary tract infection was not provided.  The outcome of the event, vaccine administered intramuscularly in the right thigh, was considered resolved on 24 Feb 2021.    The reporter did not provide any causal relationship between mRNA-1273 and the events acute renal failure, dehydration and Urinary tract infection.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Movement disorder, Neuralgia, Pain, Paralysis
Clinical narrative: Arms, legs and body was paralyzed; Nerve pain that travel from her head to the back; Excruciating pain,Pain is still remaining; Not being able to get up from bed; Lightning pain in the back; A spontaneous report was received from a 76 year old female patient  concerning herself, who received Moderna's COVID-19 vaccine (mRNA-1273)  and experienced excruciating pain and the feeling of not being able to get up from bed, because her arms, legs and body was paralyzed, nerve pain that travel from her head to the back and patient had lightning pain in the back.  The patient's medical history was not provided.   Concomitant medications were not reported.   On 26 Feb 2021, the patient received the first of two planned doses of mRNA-1273 intramuscularly on left arm for prophylaxis of COVID-19 infection.   On 01 Mar 2021, after receiving the first dose of the mRNA-1273, the patient experienced excruciating pain, feeling of not being able to get up from bed, because her arms, legs and body was paralyzed (Other Important Medically Significant). This pain was still remained, kind of nerve pain that travel from her head to the back and also the patient had lightning pain in the back.   Laboratory investigation details was not provided.  Treatment details included Tylenol for pain.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, excruciating pain, feeling of not being able to get up from bed, because her arms, legs and body was paralyzed, nerve pain that travel from her head to the back and lightning pain in the back was not recovered/not resolved at the time of reporting.; 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: M
Vaccine: COVID19
Symptoms: Asthenia, Fall, Infection, Pulmonary oedema, Renal function test abnormal
Clinical narrative: fell into his head; Little red bumps on chest, back,head,face; Looked like he had chicken pox; Bumps developed white pus on top; Little red bumps got bigger and bigger; White blood cells count was high; Fluid building up in his lungs; Weak; Kidney numbers were high; A spontaneous report was received from a consumer concerning a 79 year old male patient who experienced fluid building up in his lungs, weak, kidney numbers were high, fell into his head, back, head, face, little red bumps got bigger and bigger, bumps developed white pus on top, looked like he had chicken pox.   The patient's medical history included rheumatoid arthritis. Concomitant product include methotrexate indicated for rheumatoid Arthritis (He stopped taking that 2 weeks before the Moderna vaccine and hasn't taken it again since then), allopurinol, acetyl salicylic acid, folic acid, prednisone, hydroxychloroquine, amlodipine and Irbesartan, all were used for an unknown indication.   On 07 Jan 2021, prior to the onset of the event(s), the patient received their first of two planned doses of mRNA-1273 (Batch number: 037K20A] intramuscularly in the arm for prophylaxis of COVID-19 infection.  On an unknown date, Approximately a week later, he started presenting little red bumps, that got bigger and bigger and developed white pus on top of every one of them. He had hundreds of bumps on his chest, back, head and face. On 06 Feb 2021, he was supposed to get the second, but previously to that he went to the MD and was told not to get it. That day he was feeling so weak that he fell into his head and had to get stitches, at the hospital. Tests were run and he was told that his kidney numbers were high, his white blood cells count was high and he had fluid building up in his lungs. He was hospitalized for seven days. It was reported that the bumps looked in appearance like he had chicken pox. He still had the bumps, but they were dry, not as big and have no pus.   Treatment information was not provided.  The seriousness criterion for the events weak, fell into his head, kidney numbers were high, white blood cells count was high and fluid building up in his lungs was considered as prolonged hospitalization.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, weak, fell into his head, kidney numbers were high, white blood cells count was high and fluid building up in his lungs was considered as recovered on 13 Feb 2021. The outcome of the event(s), little red bumps, bumps got bigger and bigger, bumps developed white pus on top, hundreds of bumps on his chest, back, head and face and looked like he had chicken pox was unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Skin mass, Swelling, Varicella, White blood cell count, White blood cell count increased
Clinical narrative: fell into his head; Little red bumps on chest, back,head,face; Looked like he had chicken pox; Bumps developed white pus on top; Little red bumps got bigger and bigger; White blood cells count was high; Fluid building up in his lungs; Weak; Kidney numbers were high; A spontaneous report was received from a consumer concerning a 79 year old male patient who experienced fluid building up in his lungs, weak, kidney numbers were high, fell into his head, back, head, face, little red bumps got bigger and bigger, bumps developed white pus on top, looked like he had chicken pox.   The patient's medical history included rheumatoid arthritis. Concomitant product include methotrexate indicated for rheumatoid Arthritis (He stopped taking that 2 weeks before the Moderna vaccine and hasn't taken it again since then), allopurinol, acetyl salicylic acid, folic acid, prednisone, hydroxychloroquine, amlodipine and Irbesartan, all were used for an unknown indication.   On 07 Jan 2021, prior to the onset of the event(s), the patient received their first of two planned doses of mRNA-1273 (Batch number: 037K20A] intramuscularly in the arm for prophylaxis of COVID-19 infection.  On an unknown date, Approximately a week later, he started presenting little red bumps, that got bigger and bigger and developed white pus on top of every one of them. He had hundreds of bumps on his chest, back, head and face. On 06 Feb 2021, he was supposed to get the second, but previously to that he went to the MD and was told not to get it. That day he was feeling so weak that he fell into his head and had to get stitches, at the hospital. Tests were run and he was told that his kidney numbers were high, his white blood cells count was high and he had fluid building up in his lungs. He was hospitalized for seven days. It was reported that the bumps looked in appearance like he had chicken pox. He still had the bumps, but they were dry, not as big and have no pus.   Treatment information was not provided.  The seriousness criterion for the events weak, fell into his head, kidney numbers were high, white blood cells count was high and fluid building up in his lungs was considered as prolonged hospitalization.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, weak, fell into his head, kidney numbers were high, white blood cells count was high and fluid building up in his lungs was considered as recovered on 13 Feb 2021. The outcome of the event(s), little red bumps, bumps got bigger and bigger, bumps developed white pus on top, hundreds of bumps on his chest, back, head and face and looked like he had chicken pox was unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness neurosensory
Clinical narrative: Sudden sensorial hearing loss; A spontaneous report was received from a consumer who of 65-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and had sudden sensorial hearing loss/ deafness.   The patient's current conditions included high blood pressure, gastric issue- acid reflux and cholesterol unspecified. Products known to have been used by the patient, within two weeks prior to the event, included medications for high blood pressure, gastric issue- acid reflux and cholesterol unspecified.  On 11 Feb 2021, approximately 8 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 0104M20A) in the right arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient was diagnosed with an ear issue. Later on, 18 Mar 2021, a week after vaccination the patient had sudden sensorial hearing loss.  Treatment for the event included steroids for ear issues.  The seriousness criteria for the event deafness was assessed as serious.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event 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.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Illness
Clinical narrative: Caller's mom was really sick and was hospitalized; As per caller's mom's physician, his mom's body is too weak and needs to wait to receive 2nd; She was tested positive for covid in hospital; A spontaneous report was received from a consumer concerning his mother, a 69-year-old, female patient who received Moderna (mRNA-1273) vaccine and was really sick,  and was hospitalized, tested positive for Covid-19 and advised by the patient's physician to wait to receive the second dose as their body is too weak.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 12 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 015M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Feb 2021 the patient was really sick and was hospitalized and tested positive for Covid-19. The patient finished their 14 days quarantine period. As per the patient's physician, the patient's body was too weak and needs to wait to receive the second dose of Moderna (mRNA-1273).  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event(s) was unknown.  The event of was really sick, and was hospitalized was considered to be serious due to hospitalization.  The outcome of the events was really sick, and was hospitalized, tested positive for Covid-19 and advised by the patient's physician to wait to receive the second dose as their body is too weak were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events Illness and asthenia , a causal relationship cannot be excluded. Based on reporter's causality and the current available information ,the event COVID-19 is assessed as unlikely related to mRNA-1273.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Blood clot in my left leg; A spontaneous report was received from a consumer concerning a 71-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced deep vein thrombosis.   The patient's medical history was not provided.Concomitant medications  was not reported.  On 14-FEB-2021 prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 030M20A)  in the left arm for prophylaxis of COVID-19 infection.   The next day after receiving mRNA-1273, the patient developed a blood clot in  left leg and extended from upper left leg  down  into his lower leg. He went to the emergency room and was treated for the event with Xarelto.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event deep vein thrombosis 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.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: fainted; A spontaneous report was received from a consumer who was an 83-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and fainted.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Mar 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030421a) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 5 Mar 2021, the patient reported that he fainted and had to be taken to the hospital by a family member.  He reported that he had been hooked up to multiple machines for testing.  He believed that the syncopal event was related to his heart rate.  No treatment information was provided.  Patient received both scheduled doses of mRNA-1273, therefore, action taken with the drug in response to the event was not applicable.   The outcome of event, fainted the day after 2nd dose, was considered unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.