chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I was positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (I was positive for covid-19) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced SARS-COV-2 TEST POSITIVE (I was positive for covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (I was positive for covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided. Treatment information was not provided.  Company Comment: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 and mRNA-1273 is assessed as not applicable.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 and mRNA-1273 is assessed as not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Have a cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Have a cough) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Have a cough). At the time of the report, COUGH (Have a cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No Treatment information  was reported..
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Mobility decreased, Nausea
Clinical narrative: Cannot even stand; Dizzy; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Cannot even stand), DIZZINESS (Dizzy) and NAUSEA (Nauseous) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced MOBILITY DECREASED (Cannot even stand), DIZZINESS (Dizzy) and NAUSEA (Nauseous). At the time of the report, MOBILITY DECREASED (Cannot even stand), DIZZINESS (Dizzy) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant was not provided. Treatment was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. No treatment medication were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: her arm was hurting immediately after,it was very painful; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm was hurting immediately after,it was very painful) and HEADACHE (headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B-2A and 045B21A) for COVID-19 vaccination.     The patient's past medical history included Menopause, Migraine, Mood swings, Hot flashes and Insomnia. Concomitant products included ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (her arm was hurting immediately after,it was very painful) (seriousness criterion disability) and HEADACHE (headache) (seriousness criterion disability). At the time of the report, PAIN IN EXTREMITY (her arm was hurting immediately after,it was very painful) and HEADACHE (headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication was not reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events after the patient´s first vaccination, a causal relationship cannot be excluded.   This case was linked to MOD-2021-287660, MOD-2021-287660 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events after the patient´s first vaccination, a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Back disorder, Condition aggravated, Incomplete course of vaccination, Musculoskeletal discomfort
Clinical narrative: Crack in the back/ severe back problems; Severe back problems; was hospitalized for back problems that she was having prior to receiving the vaccine; has missed her 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Crack in the back/ severe back problems), BACK DISORDER (Severe back problems) and CONDITION AGGRAVATED (was hospitalized for back problems that she was having prior to receiving the vaccine) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0251421A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Concurrent medical conditions included Back discomfort (was hospitalized for back problems and had crack back.).  On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Crack in the back/ severe back problems) (seriousness criterion hospitalization), BACK DISORDER (Severe back problems) (seriousness criterion hospitalization), CONDITION AGGRAVATED (was hospitalized for back problems that she was having prior to receiving the vaccine) (seriousness criterion hospitalization) and INCOMPLETE COURSE OF VACCINATION (has missed her 2nd dose). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Crack in the back/ severe back problems), BACK DISORDER (Severe back problems), CONDITION AGGRAVATED (was hospitalized for back problems that she was having prior to receiving the vaccine) and INCOMPLETE COURSE OF VACCINATION (has missed her 2nd dose) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medications were provided by the reporter.  The patient was recently discharged from the hospital and had missed 2nd dose  No treatment information was provided by the reporter.  Company Comment: Very limited information regarding hospitalization has been provided. Yet, consumer states that patient was hospitalized due to back problems that she was having prior to receiving the vaccine. Consumer states that her back problems were not caused by vaccine as it was already ongoing. Based on reporter´s causality the event is assessed as unlikely related to mRNA-1273.; Sender's Comments: Very limited information regarding hospitalization has been provided. Yet, consumer states that patient was hospitalized due to back problems that she was having prior to receiving the vaccine. Consumer states that her back problems were not caused by vaccine as it was already ongoing. Based on reporter´s causality the event is assessed as unlikely related to mRNA-1273.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: possible 3rd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (possible 3rd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ACETAMINOPHEN and IBUPROFEN for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (possible 3rd dose). At the time of the report, EXTRA DOSE ADMINISTERED (possible 3rd dose) had resolved.            Patient has taken 3rd dose No concomitant medications were reported. No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Influenza like illness, Pain, Pain in extremity
Clinical narrative: 3rd dose: 14Aug2021; My arm was sore after third dose; My arm was sore; general achiness; flu-like symptoms; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (My arm was sore), PAIN (general achiness), INFLUENZA LIKE ILLNESS (flu-like symptoms), IMMUNISATION (3rd dose: 14Aug2021) and PAIN IN EXTREMITY (My arm was sore after third dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (My arm was sore), PAIN (general achiness) and INFLUENZA LIKE ILLNESS (flu-like symptoms). On 14-Aug-2021, the patient experienced IMMUNISATION (3rd dose: 14Aug2021) and PAIN IN EXTREMITY (My arm was sore after third dose). At the time of the report, PAIN IN EXTREMITY (My arm was sore), PAIN (general achiness), INFLUENZA LIKE ILLNESS (flu-like symptoms), IMMUNISATION (3rd dose: 14Aug2021) and PAIN IN EXTREMITY (My arm was sore after third dose) outcome was unknown.            11 Feb 2021: Patient received 2nd dose of the Moderna Covid-19 vaccine. Reported that her arm was sore, had general achiness, & had flu-like symptoms. Said she did not had a fever, though. 3rd dose: 14  Aug 2021.  No concomitant and treatment drugs were provided.   This case was linked to MOD-2021-287560 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Head discomfort, Pain in jaw
Clinical narrative: jaw pain; chest pain; severe pressure in his head.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (jaw pain), CHEST PAIN (chest pain) and HEAD DISCOMFORT (severe pressure in his head.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 026C21A) for COVID-19 vaccination.     no medical history was provided.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], AMLODIPINE and LOSARTAN for an unknown indication.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced PAIN IN JAW (jaw pain) (seriousness criteria hospitalization and medically significant), CHEST PAIN (chest pain) (seriousness criteria hospitalization and medically significant) and HEAD DISCOMFORT (severe pressure in his head.) (seriousness criteria hospitalization and medically significant). The patient was hospitalized until 26-May-2021 due to CHEST PAIN, HEAD DISCOMFORT and PAIN IN JAW. At the time of the report, PAIN IN JAW (jaw pain), CHEST PAIN (chest pain) and HEAD DISCOMFORT (severe pressure in his head.) outcome was unknown.            No treatment medication information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. However, patient's concomitant medication may suggest underlying cardiovascular risk factors that could be confounders. No further information is expected at this time.   This case was linked to MOD-2021-273538 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. However, patient's concomitant medication may suggest underlying cardiovascular risk factors that could be confounders. No further information is expected at this time.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Aches and pains ,had the shot 2 days ago; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches and pains ,had the shot 2 days ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Aches and pains ,had the shot 2 days ago). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (Aches and pains ,had the shot 2 days ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Eye swelling
Clinical narrative: Triggered an autoimmune disorder Igg4; Swollen left eye; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (Triggered an autoimmune disorder Igg4) and EYE SWELLING (Swollen left eye) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 04CB21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced EYE SWELLING (Swollen left eye) (seriousness criterion medically significant). On an unknown date, the patient experienced AUTOIMMUNE DISORDER (Triggered an autoimmune disorder Igg4) (seriousness criterion medically significant). The patient was treated with PREDNISONE at a dose of 100 mg. At the time of the report, AUTOIMMUNE DISORDER (Triggered an autoimmune disorder Igg4) and EYE SWELLING (Swollen left eye) outcome was unknown.            No concomitant medications were provided. It was reported after her second dose the patient left eye had been swollen and was still in treatment. The vaccine triggered an autoimmune disorder Igg4. The patient had been taking steroid to treat the side effect, 100 mg Prednisone.  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.; Sender'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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive for COVID-19 Disease, Minimal COVID-19 Disease symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive for COVID-19 Disease, Minimal COVID-19 Disease symptoms) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced COVID-19 (Positive for COVID-19 Disease, Minimal COVID-19 Disease symptoms). At the time of the report, COVID-19 (Positive for COVID-19 Disease, Minimal COVID-19 Disease symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant products were reported . The patient was treated with OTC drugs at home and did not see a physician.   The patient's spouse reported that the pharmacist refused to schedule the second shot and told them that they have to wait 90 days before getting the second dose.  Company Comment: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Significant Follow up received : patient initials added; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: I am continuing to feel bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I am continuing to feel bad) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (I am continuing to feel bad). At the time of the report, FEELING ABNORMAL (I am continuing to feel bad) outcome was unknown.            No concomitants were provided. No treatment was provided.
Sex: U
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: Transverse Myelitis; This spontaneous case was reported by a consumer and describes the occurrence of MYELITIS TRANSVERSE (Transverse Myelitis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYELITIS TRANSVERSE (Transverse Myelitis) (seriousness criterion medically significant). At the time of the report, MYELITIS TRANSVERSE (Transverse Myelitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant or treatment medications were reported.  Company Comment: 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.  Further information is  expected.; Sender'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.  Further information is  expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This spontaneous case was reported by a non-health professional and describes the occurrence of DIZZINESS (dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Injection site pain, Pyrexia
Clinical narrative: Extremely hot; High fever; Chills; sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Extremely hot), PYREXIA (High fever), CHILLS (Chills) and INJECTION SITE PAIN (sore arm at injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Extremely hot), PYREXIA (High fever), CHILLS (Chills) and INJECTION SITE PAIN (sore arm at injection site). At the time of the report, FEELING HOT (Extremely hot) and PYREXIA (High fever) was resolving and CHILLS (Chills) and INJECTION SITE PAIN (sore arm at injection site) had not resolved.            No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-049747 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Vaccination complication
Clinical narrative: unusual side effect after my 1st dose; and I am scared to get 2nd.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (unusual side effect after my 1st dose) and ANXIETY (and I am scared to get 2nd.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (unusual side effect after my 1st dose) and ANXIETY (and I am scared to get 2nd.). At the time of the report, VACCINATION COMPLICATION (unusual side effect after my 1st dose) and ANXIETY (and I am scared to get 2nd.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Decreased appetite, Headache, Illness, Mental impairment
Clinical narrative: Did not get the 2nd dose of the vaccine; Horrible headache; Could not think; Got very very sick; Could not eat; Could not get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (Could not think) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced MENTAL IMPAIRMENT (Could not think) (seriousness criterion medically significant), ILLNESS (Got very very sick), DECREASED APPETITE (Could not eat), BEDRIDDEN (Could not get out of bed) and HEADACHE (Horrible headache). On 16-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not get the 2nd dose of the vaccine). In April 2021, MENTAL IMPAIRMENT (Could not think), ILLNESS (Got very very sick), DECREASED APPETITE (Could not eat), BEDRIDDEN (Could not get out of bed) and HEADACHE (Horrible headache) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not get the 2nd dose of the vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter. 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.; Sender'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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Did not get the 2nd dose of the vaccine; Horrible headache; Could not think; Got very very sick; Could not eat; Could not get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (Could not think) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced MENTAL IMPAIRMENT (Could not think) (seriousness criterion medically significant), ILLNESS (Got very very sick), DECREASED APPETITE (Could not eat), BEDRIDDEN (Could not get out of bed) and HEADACHE (Horrible headache). On 16-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not get the 2nd dose of the vaccine). In April 2021, MENTAL IMPAIRMENT (Could not think), ILLNESS (Got very very sick), DECREASED APPETITE (Could not eat), BEDRIDDEN (Could not get out of bed) and HEADACHE (Horrible headache) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not get the 2nd dose of the vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter. 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.; Sender'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: SARS-CoV-2 test positive
Clinical narrative: tested positive for covid-19 in July; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for covid-19 in July) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for covid-19 in July). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for covid-19 in July) outcome was unknown.            No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  Company Comment: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID virus test positive and mRNA-1273 is assessed as not applicable. The date of vaccination was not recorded, hence could not establish a temporal association or a causal relationship between the mRNA-1273 vaccine and the event reported. further FU is required to clarify the AE.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID virus test positive and mRNA-1273 is assessed as not applicable. The date of vaccination was not recorded, hence could not establish a temporal association or a causal relationship between the mRNA-1273 vaccine and the event reported. further FU is required to clarify the AE..
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test positive, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID19 and received both Moderna doses.; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID19 and received both Moderna doses.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID19 and received both Moderna doses.). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID19 and received both Moderna doses.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test positive: positive (Positive) positive antibody test.         No treatment medication provided by reporter. No concomitant medication provided by reporter. Suspect product batch number is unknown.   Action taken with mRNA-1273 (Moderna Covid-19 vaccine) was not applicable.   Reportedly, the patient was tested positive for COVID 19 after both doses of the vaccine, however, there were no any reported signs or symptoms of COVID-19 disease. The exact dates of the first and the second vaccination were not reported. The company causality for the event SARS-CoV-2 test positive is not applicable having in mind that the mRNA-1273 does not contain a virus capable of causing infection.; Sender's Comments: Reportedly, the patient was tested positve for COVID 19 after both doses of the vaccine, however, there were no any reported signs or symptoms of COVID-19 disease. The exact dates of the first and the second vaccination were not reported. The company causality for the event SARS-CoV-2 test positive is not applicable having in mind that the mRNA-1273 does not contain a virus capable of causing infection.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Magnetic resonance imaging, Vertigo
Clinical narrative: vertigo/ extreme episode of vertigo; lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo/ extreme episode of vertigo) and DIZZINESS (lightheadedness) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 631M20A and 026A21A) for COVID-19 vaccination.     No medial history was reported.  Concomitant products included METOPROLOL, MULTIVITAMIN [VITAMINS NOS], ESCITALOPRAM OXALATE (LEXAPRO), APIXABAN (ELIQUIS) and GLUCOSAMINE for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced VERTIGO (vertigo/ extreme episode of vertigo) (seriousness criterion hospitalization) and DIZZINESS (lightheadedness) (seriousness criterion hospitalization). The patient was treated with PROMETHAZINE HYDROCHLORIDE (METHAZINE) for Adverse event, at an unspecified dose and frequency and SCOPOLAMINE [HYOSCINE] for Adverse event, at an unspecified dose and frequency. At the time of the report, VERTIGO (vertigo/ extreme episode of vertigo) and DIZZINESS (lightheadedness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Computerised tomogram: normal (normal) Normal. In February 2021, Magnetic resonance imaging: normal (normal) Normal.         It was reported that the patient had seen an ear, nose, throat health care provider and test were run, everything had come back as normal.  The patient was hospitalized for about 3 or 4 days. The patient had a MRI and CT scan and everything came back normal.  Company comment: 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. Further information has been requested.; Sender'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. Further information has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at the injection site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (sore arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-058023 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Diaphragmatic paralysis, Exercise tolerance decreased, X-ray
Clinical narrative: Paralized right diaphragm; One day to the next, she couldn't do 2 minutes in the treadmill; This spontaneous case was reported by a consumer and describes the occurrence of DIAPHRAGMATIC PARALYSIS (Paralized right diaphragm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIAPHRAGMATIC PARALYSIS (Paralized right diaphragm) (seriousness criterion medically significant) and EXERCISE TOLERANCE DECREASED (One day to the next, she couldn't do 2 minutes in the treadmill). At the time of the report, DIAPHRAGMATIC PARALYSIS (Paralized right diaphragm) and EXERCISE TOLERANCE DECREASED (One day to the next, she couldn't do 2 minutes in the treadmill) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: abnormal (abnormal) paralized right diaphragm.         Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company comment: Very limited information regarding the event Diaphragmatic Paralysis has been provided at this time. The event Exercise Tolerance Decreased may rather be a consequence of the paralized right diaphragm than be due to the vaccination product. Further information can be requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the event Diaphragmatic Paralysis has been provided at this time. The event Exercise Tolerance Decreased may rather be a consequence of the paralized right diaphragm than be due to the vaccination product. Further information can be requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: received a positive Covid 19 test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (received a positive Covid 19 test) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced COVID-19 (received a positive Covid 19 test). At the time of the report, COVID-19 (received a positive Covid 19 test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, SARS-CoV-2 test: positive (Positive) Result-Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were provided.  No treatment drugs were provided.  Patient was asking if still second dose of the vaccine can get after the quarantine/isolation ends, or do have to wait 90 days.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Moderna COVID-19 Vaccine and experienced a side effect.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Moderna COVID-19 Vaccine and experienced a side effect.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Moderna COVID-19 Vaccine and experienced a side effect.). At the time of the report, VACCINATION COMPLICATION (Moderna COVID-19 Vaccine and experienced a side effect.) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication information was provided.  No treatment medication information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: full body paralyzation; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (full body paralyzation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARALYSIS (full body paralyzation) (seriousness criterion medically significant). At the time of the report, PARALYSIS (full body paralyzation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company Comment: Very limited information regarding this event has been provided at this time.  However, 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.; Sender's Comments: Very limited information regarding this event has been provided at this time.  However, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's palsy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's palsy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication information provided. No relevant treatment medication information provided. Company Comment : Reportedly the patient developed Bell's palsy after vaccination. In the setting of a likely temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded. Additional information has been requested.   This case was linked to MOD-2021-288145 (Patient Link).; Sender's Comments: Reportedly the patient developed Bell's palsy after vaccination. In the setting of a likely temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: My son got  both  moderna shots in april. they now have been told they have the covid virus; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (My son got  both  moderna shots in april. they now have been told they have the covid virus) and DRUG INEFFECTIVE (Lack of drug effect) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (My son got  both  moderna shots in april. they now have been told they have the covid virus) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (My son got  both  moderna shots in april. they now have been told they have the covid virus) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.            Concomitant products were not provided. Treatment medication were not reported.  This is a case of COVID test positive and is unrelated because the vaccine does not contain viruses, although the patient can be infected independently from the vaccination, hence the MAH causality is not applicable.   Reporter did not allow further contact; Sender's Comments: This is a case of COVID test positive and is unrelated because the vaccine does not contain viruses, although the patient can be infected independently from the vaccination, hence the MAH causality is not applicable.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Myalgia, Vaccination site pain
Clinical narrative: sore arm the first day; tired for about four hours; soreness at injection site; last night/night before he can feel his heart beat in the middle of stomach/happens when he lies on his back; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (sore arm the first day), FATIGUE (tired for about four hours), VACCINATION SITE PAIN (soreness at injection site) and FEELING ABNORMAL (last night/night before he can feel his heart beat in the middle of stomach/happens when he lies on his back) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy, Allergy to antibiotic and Milk protein allergy.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm the first day) (seriousness criterion medically significant), FATIGUE (tired for about four hours) (seriousness criterion medically significant), VACCINATION SITE PAIN (soreness at injection site) (seriousness criterion medically significant) and FEELING ABNORMAL (last night/night before he can feel his heart beat in the middle of stomach/happens when he lies on his back) (seriousness criterion medically significant). At the time of the report, MYALGIA (sore arm the first day), FATIGUE (tired for about four hours), VACCINATION SITE PAIN (soreness at injection site) and FEELING ABNORMAL (last night/night before he can feel his heart beat in the middle of stomach/happens when he lies on his back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company comment: 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.; Sender'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: Vaccination complication
Clinical narrative: Mild side effects after receiving a booster yesterday; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Mild side effects after receiving a booster yesterday) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Mild side effects after receiving a booster yesterday). At the time of the report, VACCINATION COMPLICATION (Mild side effects after receiving a booster yesterday) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.  The patient asked if it was okay to take Tylenol.   Reporter did not allow further contact