chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Migraine
Clinical narrative: Got my second vaccine yesterday and i have a pounding migraine; feel like I'm bruised all over; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Got my second vaccine yesterday and i have a pounding migraine) and CONTUSION (feel like I'm bruised all over) 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, the patient experienced MIGRAINE (Got my second vaccine yesterday and i have a pounding migraine) and CONTUSION (feel like I'm bruised all over). At the time of the report, MIGRAINE (Got my second vaccine yesterday and i have a pounding migraine) and CONTUSION (feel like I'm bruised all over) outcome was unknown.            No concomitant medications were provided. No treatment details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired doses given to 53 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses given to 53 patients) 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 EXPIRED PRODUCT ADMINISTERED (Expired doses given to 53 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses given to 53 patients) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15 JUL 2021: No new information.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Vaccination site paraesthesia
Clinical narrative: Tingly feeling in the arm where I got my Moderna Vaccine shot; keep getting chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (Tingly feeling in the arm where I got my Moderna Vaccine shot) and CHILLS (keep getting chills) 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 09-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PARAESTHESIA (Tingly feeling in the arm where I got my Moderna Vaccine shot) and CHILLS (keep getting chills). At the time of the report, VACCINATION SITE PARAESTHESIA (Tingly feeling in the arm where I got my Moderna Vaccine shot) and CHILLS (keep getting chills) outcome was unknown.            No Concomitant and treatment  medication was mentioned.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Swelling
Clinical narrative: Swelling under my arm after my vaccine; pain under my arm after my vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling under my arm after my vaccine) and MYALGIA (pain under my arm after my vaccine) 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 SWELLING (Swelling under my arm after my vaccine) and MYALGIA (pain under my arm after my vaccine). At the time of the report, SWELLING (Swelling under my arm after my vaccine) and MYALGIA (pain under my arm after my vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided.  No treatment details were provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: weak; dizzy; 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 ASTHENIA (weak) and DIZZINESS (dizzy) 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 ASTHENIA (weak) and DIZZINESS (dizzy). At the time of the report, ASTHENIA (weak) and DIZZINESS (dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment medications were not provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Myalgia
Clinical narrative: Sharp stabbing pain like someone stabbing her in the back; Back muscles hurt; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Sharp stabbing pain like someone stabbing her in the back) and MYALGIA (Back muscles hurt) in a 40-year-old female patient 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 BACK PAIN (Sharp stabbing pain like someone stabbing her in the back) and MYALGIA (Back muscles hurt). At the time of the report, BACK PAIN (Sharp stabbing pain like someone stabbing her in the back) and MYALGIA (Back muscles hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 50 Days past 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (50 Days past 1st dose) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (50 Days past 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (50 Days past 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter had a patient at 50 days after her 1st dose of the Moderna vaccine and the reporter needs to know that how long a patient can go after the first dose of vaccine.  No concomitant products reported.  No treatment products reported.    This case was linked to MOD-2021-227886 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Followup received on 18 Jun 2021 contains no significant information
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: a patient tested positive for covid19 after getting a second dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (a patient tested positive for covid19 after getting a second dose of the vaccine) 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, the patient experienced COVID-19 (a patient tested positive for covid19 after getting a second dose of the vaccine). At the time of the report, COVID-19 (a patient tested positive for covid19 after getting a second dose of the vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Myalgia, Paraesthesia, Pyrexia
Clinical narrative: tingling in arm; muscle soreness; chills; fever; felt sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick), PARAESTHESIA (tingling in arm), MYALGIA (muscle soreness), CHILLS (chills) and PYREXIA (fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047a21a and 036B21a) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced ILLNESS (felt sick), CHILLS (chills) and PYREXIA (fever). On 28-Apr-2021, the patient experienced PARAESTHESIA (tingling in arm) and MYALGIA (muscle soreness). At the time of the report, ILLNESS (felt sick), PARAESTHESIA (tingling in arm), MYALGIA (muscle soreness), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Concomitant product use was not provided by the reporter.   ? No treatment information was provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: soreness and muscle aching in vaccine arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness and muscle aching in vaccine arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (soreness and muscle aching in vaccine arm). The patient was treated with IBUPROFEN for Myalgia, at an unspecified dose and frequency. At the time of the report, MYALGIA (soreness and muscle aching in vaccine arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Diarrhea after Vaccination; Nauseous after Vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea after Vaccination) and NAUSEA (Nauseous after Vaccination) 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. In 2021, the patient experienced DIARRHOEA (Diarrhea after Vaccination) and NAUSEA (Nauseous after Vaccination). At the time of the report, DIARRHOEA (Diarrhea after Vaccination) and NAUSEA (Nauseous after Vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had experienced a side effect diarrhea and nauseous. Concomitant medications and treatment were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Haven't had their period; This case was received via Agency Regulatory Authority(Reference number: US-irms-MOD21-112982) on 18-Jun-2021 and was forwarded to Moderna on 18-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (Haven't had their period) 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, the patient experienced MENSTRUATION DELAYED (Haven't had their period). At the time of the report, MENSTRUATION DELAYED (Haven't had their period) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment information was reported.  Patient got vaccine just over a month ago and still haven't had period. Patient was very regular typically and was concerned.  New information in Follow-up : Since she had the Moderna Covid vaccination my periods had been extremely irregular. This was never been a problem in the past with her.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up was received on 10-AUG-2021 and it is  Nonsignificant follow-up: Email ID added.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I currently have a patient in my store who is past due for her 2nd shot. Shot 1 was given on 4/30/21; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I currently have a patient in my store who is past due for her 2nd shot. Shot 1 was given on 4/30/21) 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 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I currently have a patient in my store who is past due for her 2nd shot. Shot 1 was given on 4/30/21). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I currently have a patient in my store who is past due for her 2nd shot. Shot 1 was given on 4/30/21) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment information reported.   This case was linked to MOD-2021-227837 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Palpitations
Clinical narrative: I feel dizzy; and my heart is pounding; and very tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jun-2021 and was forwarded to Moderna on 18-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I feel dizzy), PALPITATIONS (and my heart is pounding) and FATIGUE (and very tired) 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 DIZZINESS (I feel dizzy), PALPITATIONS (and my heart is pounding) and FATIGUE (and very tired). At the time of the report, DIZZINESS (I feel dizzy), PALPITATIONS (and my heart is pounding) and FATIGUE (and very tired) 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.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Injection site is lumpy; Injection site is red; Injection site is itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Injection site is lumpy), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE PRURITUS (Injection site is itchy) 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 SITE MASS (Injection site is lumpy), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE PRURITUS (Injection site is itchy). At the time of the report, VACCINATION SITE MASS (Injection site is lumpy), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE PRURITUS (Injection site is itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Dyspnoea, Fatigue, Ultrasound scan
Clinical narrative: Difficulty breathing/trouble breathing; Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Difficulty breathing/trouble breathing) and FATIGUE (Tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 044A21A) for COVID-19 vaccination.     Concomitant products included EVOLOCUMAB (REPATHA) for Hypercholesteraemia, LOSARTAN for Hypertension, PRASUGREL and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing/trouble breathing) and FATIGUE (Tired). At the time of the report, DYSPNOEA (Difficulty breathing/trouble breathing) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: normal (normal) normal. On an unknown date, Ultrasound scan: normal (normal) normal.         Patient reported on 22-APR-2021, breathing trouble  increased, but was not gasping for air, Consumer saw her cardiologist on Friday. Consumer reported that she had a heart test on 19-MAY-2021 and got 2 stents. Consumer reported that her breathing is better after the stents were put in, but not perfect. patient was in cardiac rehab and has not returned back to work.  Treatment information in response to events was not provided.  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. However, based on the available data previously undiagnosed cardiac disorder may be at least partially responsible for the reported events. After the stent placement the patient reported improvement.   This case was linked to MOD-2021-227938 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received on 07-Jul-2021 contains no new information.; 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. However, based on the available data previously undiagnosed cardiac disorder may be at least partially responsible for the reported events. After the stent placement the patient reported improvement.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Product administration error, Wrong technique in device usage process
Clinical narrative: Patient got more than half of the dose; Beville disengaged from the needle; Some of the liquid squirted in to her eye; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient got more than half of the dose), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Beville disengaged from the needle) and PRODUCT ADMINISTRATION ERROR (Some of the liquid squirted in to her eye) 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) (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 18-Jun-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient got more than half of the dose), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Beville disengaged from the needle) and PRODUCT ADMINISTRATION ERROR (Some of the liquid squirted in to her eye). On 18-Jun-2021, ACCIDENTAL UNDERDOSE (Patient got more than half of the dose), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Beville disengaged from the needle) and PRODUCT ADMINISTRATION ERROR (Some of the liquid squirted in to her eye) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Product dose omission issue
Clinical narrative: sore neck; second dose not administered for more than 35 days; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (sore neck) and PRODUCT DOSE OMISSION ISSUE (second dose not administered for more than 35 days) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Aspirin) and Drug allergy (antihistamines). Concomitant products included METOPROLOL for an unknown indication.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced NECK PAIN (sore neck) and PRODUCT DOSE OMISSION ISSUE (second dose not administered for more than 35 days). At the time of the report, NECK PAIN (sore neck) and PRODUCT DOSE OMISSION ISSUE (second dose not administered for more than 35 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient called in and stated that he got the 1st shot of the Moderna vaccine back in March at a Convention center. His neck was sore for about a couple days after, it resolved a few days after. He was not sure if this was due to the vaccine or if he hurt himself. That was why he opted not to take the scheduled second shot.patient did not took anything for the sore neck as it went away eventually. No treatment drugs are not provided by reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Lethargy
Clinical narrative: Stomach problems; Lethargy; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach problems) and LETHARGY (Lethargy) 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 ABDOMINAL DISCOMFORT (Stomach problems) and LETHARGY (Lethargy). At the time of the report, ABDOMINAL DISCOMFORT (Stomach problems) and LETHARGY (Lethargy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment details were provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Decreased activity, Fatigue
Clinical narrative: One month after my second shot of the Moderna I have struggled with exercise intolerance; Exercise fatigue/barely run 5 minutes without feeling exhausted and winded and totally defeated; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED ACTIVITY (One month after my second shot of the Moderna I have struggled with exercise intolerance) and FATIGUE (Exercise fatigue/barely run 5 minutes without feeling exhausted and winded and totally defeated) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (The patient recovered and waited two weeks before resuming a modified running program, very light. The patient was progressing nicely and feeling good.) in December 2020.   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 DECREASED ACTIVITY (One month after my second shot of the Moderna I have struggled with exercise intolerance) and FATIGUE (Exercise fatigue/barely run 5 minutes without feeling exhausted and winded and totally defeated). At the time of the report, DECREASED ACTIVITY (One month after my second shot of the Moderna I have struggled with exercise intolerance) and FATIGUE (Exercise fatigue/barely run 5 minutes without feeling exhausted and winded and totally defeated) outcome was unknown.            No concomitant product use was provided by the reporter.  The patient had second dose of the vaccine a month ago. It was reported that ever since then the patient noticed exercise intolerance every time she tried to go for an easy run. The patient struggled with exercise fatigue. It was daunting and very maddening and frustrating seeing that. The patient could barely run 5 minutes without feeling exhausted and winded and totally defeated.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Additional event was added.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: is a rash a side effect of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (is a rash a side effect of the vaccine) 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 RASH (is a rash a side effect of the vaccine). At the time of the report, RASH (is a rash a side effect of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Intense Migraines; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Intense Migraines) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Coeliac disease, Graves' disease, Pernicious anemia and Anemia. Concomitant products included VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) for Anemia.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced MIGRAINE (Intense Migraines). On 25-Feb-2021, MIGRAINE (Intense Migraines) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       The patient's physician did not recommend that the patient should get the second dose of the vaccine.  Treatment included Ice packs.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Trigger finger
Clinical narrative: left finger started to trigger up; Joint sore/strong pain on his right knee/thumb click on joint/Left shoulder hurt; This spontaneous case was reported by a consumer and describes the occurrence of TRIGGER FINGER (left finger started to trigger up) and ARTHRALGIA (Joint sore/strong pain on his right knee/thumb click on joint/Left shoulder hurt) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Blood pressure.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TRIGGER FINGER (left finger started to trigger up) and ARTHRALGIA (Joint sore/strong pain on his right knee/thumb click on joint/Left shoulder hurt). At the time of the report, TRIGGER FINGER (left finger started to trigger up) and ARTHRALGIA (Joint sore/strong pain on his right knee/thumb click on joint/Left shoulder hurt) outcome was unknown.            Patient took relevant concomitant medication for blood pressure and cholesterol. Patient took a corticosteroid injection to help him calm the pain, but he saw no improvement yet. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Pain
Clinical narrative: lumbar injection for pain; neck is stiff; terrible head ache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (neck is stiff), HEADACHE (terrible head ache) and VACCINATION SITE PAIN (lumbar injection for pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009021A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CARBAMAZEPINE (CARBATROL), PRAVASTATIN, LEVOTHYROXINE SODIUM (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]), ACETYLSALICYLIC ACID (BABY ASPIRIN) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (neck is stiff) and HEADACHE (terrible head ache). On an unknown date, the patient experienced VACCINATION SITE PAIN (lumbar injection for pain). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Headache, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (neck is stiff), HEADACHE (terrible head ache) and VACCINATION SITE PAIN (lumbar injection for pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment- Excedrin Migraine yesterday and today (June 17th and 18th) The patient also mentioned that last Monday had a lumbar injection for pain.
Sex: U
Vaccine: COVID19
Symptoms: Dissociation, Dizziness, Fatigue, Headache, Insomnia
Clinical narrative: Dizziness; Lack of sleep; Disassociation; Nausea; Headaches; Aching muscles; Tiredness; 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 DIZZINESS (Dizziness), INSOMNIA (Lack of sleep), DISSOCIATION (Disassociation), NAUSEA (Nausea) and HEADACHE (Headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included ADHD and Asperger's syndrome.    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 DIZZINESS (Dizziness), INSOMNIA (Lack of sleep), DISSOCIATION (Disassociation), NAUSEA (Nausea), HEADACHE (Headaches), MYALGIA (Aching muscles) and FATIGUE (Tiredness). At the time of the report, DIZZINESS (Dizziness), INSOMNIA (Lack of sleep), DISSOCIATION (Disassociation), NAUSEA (Nausea), HEADACHE (Headaches), MYALGIA (Aching muscles) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. Concomitant medication were not given. It was reported that patient took first moderna vaccine on the 14.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Dizziness; Lack of sleep; Disassociation; Nausea; Headaches; Aching muscles; Tiredness; 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 DIZZINESS (Dizziness), INSOMNIA (Lack of sleep), DISSOCIATION (Disassociation), NAUSEA (Nausea) and HEADACHE (Headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included ADHD and Asperger's syndrome.    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 DIZZINESS (Dizziness), INSOMNIA (Lack of sleep), DISSOCIATION (Disassociation), NAUSEA (Nausea), HEADACHE (Headaches), MYALGIA (Aching muscles) and FATIGUE (Tiredness). At the time of the report, DIZZINESS (Dizziness), INSOMNIA (Lack of sleep), DISSOCIATION (Disassociation), NAUSEA (Nausea), HEADACHE (Headaches), MYALGIA (Aching muscles) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. Concomitant medication were not given. It was reported that patient took first moderna vaccine on the 14.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment
Clinical narrative: I got my sec9nd shot yesterday. I was able to move it fine until.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (I got my sec9nd shot yesterday. I was able to move it fine until.) 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) (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 18-Jun-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (I got my sec9nd shot yesterday. I was able to move it fine until.). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (I got my sec9nd shot yesterday. I was able to move it fine until.) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Red, sore, hot and bumps around the red splotch; Big red splotch on left arm of the injection site; Red, sore, hot and bumps around the red splotch; Red, sore, hot and bumps around the red splotch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Red, sore, hot and bumps around the red splotch), VACCINATION SITE ERYTHEMA (Big red splotch on left arm of the injection site), VACCINATION SITE PAIN (Red, sore, hot and bumps around the red splotch) and VACCINATION SITE SWELLING (Red, sore, hot and bumps around the red splotch) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, 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 SITE WARMTH (Red, sore, hot and bumps around the red splotch), VACCINATION SITE ERYTHEMA (Big red splotch on left arm of the injection site), VACCINATION SITE PAIN (Red, sore, hot and bumps around the red splotch) and VACCINATION SITE SWELLING (Red, sore, hot and bumps around the red splotch). At the time of the report, VACCINATION SITE WARMTH (Red, sore, hot and bumps around the red splotch), VACCINATION SITE ERYTHEMA (Big red splotch on left arm of the injection site), VACCINATION SITE PAIN (Red, sore, hot and bumps around the red splotch) and VACCINATION SITE SWELLING (Red, sore, hot and bumps around the red splotch) 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.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: constant leg pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (constant leg pain) 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 PAIN IN EXTREMITY (constant leg pain). At the time of the report, PAIN IN EXTREMITY (constant leg pain) outcome was unknown.            No concomitant medications were provided. No treatment details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Dysstasia, Gait disturbance, Hypoaesthesia, Sensory loss
Clinical narrative: Numbness Left Foot/Fall if use Left Foot; Hard to Stand on the Left Foot; Hard to Walk on the Left Foot; No feeling on top; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness Left Foot/Fall if use Left Foot), DYSSTASIA (Hard to Stand on the Left Foot), GAIT DISTURBANCE (Hard to Walk on the Left Foot) and SENSORY LOSS (No feeling on top) 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 HYPOAESTHESIA (Numbness Left Foot/Fall if use Left Foot), DYSSTASIA (Hard to Stand on the Left Foot), GAIT DISTURBANCE (Hard to Walk on the Left Foot) and SENSORY LOSS (No feeling on top). At the time of the report, HYPOAESTHESIA (Numbness Left Foot/Fall if use Left Foot), DYSSTASIA (Hard to Stand on the Left Foot), GAIT DISTURBANCE (Hard to Walk on the Left Foot) and SENSORY LOSS (No feeling on top) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had experienced a side numbness on left foot that made fall or make it hard to stand or walk on it. The patient had  no feeling on top. No concomitant medications were mentioned. No treatment details were reported.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Hypoaesthesia
Clinical narrative: Shingles on left arm and back/shingles but only on the side where she got her shot; Back of hand is still numb; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles on left arm and back/shingles but only on the side where she got her shot) and HYPOAESTHESIA (Back of hand is still numb) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A214 and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-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 HERPES ZOSTER (Shingles on left arm and back/shingles but only on the side where she got her shot) and HYPOAESTHESIA (Back of hand is still numb). At the time of the report, HERPES ZOSTER (Shingles on left arm and back/shingles but only on the side where she got her shot) and HYPOAESTHESIA (Back of hand is still numb) outcome was unknown.            Concomitant product was not provided by the reporter. No laboratory provided by reporter Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow up document contain no new information
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot to the touch; knot at the injection sight that is red; knot at the injection sight; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE ERYTHEMA (knot at the injection sight that is red) and VACCINATION SITE SWELLING (knot at the injection sight) 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, the patient experienced VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE ERYTHEMA (knot at the injection sight that is red) and VACCINATION SITE SWELLING (knot at the injection sight). At the time of the report, VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE ERYTHEMA (knot at the injection sight that is red) and VACCINATION SITE SWELLING (knot at the injection sight) 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.  For mRNA-1273 (COVID 19 Vaccine Moderna), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first dose >42 days ago; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose >42 days ago) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EW0153) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose >42 days ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose >42 days ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.  Patient received first dose of Moderna COVID19 Vaccine on 05May2021 and missed second appointment. Reporter confirmed that patient did not receive second dose yet and that it has been 43 days since first dose.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Toothache, Vaccination complication
Clinical narrative: Adverse event; Teeth hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse event) and TOOTHACHE (Teeth hurting) 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 (Adverse event) and TOOTHACHE (Teeth hurting). At the time of the report, VACCINATION COMPLICATION (Adverse event) and TOOTHACHE (Teeth hurting) 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.  Patient reported that since did receive first Moderna vaccine teeth have been bothering ever.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15-JUL-2021 Contains no new information. On 10-Aug-2021: Significant FU information addedd: Additional event was added as Toothache.