chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Myalgia, Pyrexia
Clinical narrative: excessive hair loss on the head; had bitty fever; soreness / arm is still sore; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (excessive hair loss on the head), PYREXIA (had bitty fever) and MYALGIA (soreness / arm is still sore) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (had been infected with Covid and hospitalized for 2-3 weeks.).    On 18-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 ALOPECIA (excessive hair loss on the head), PYREXIA (had bitty fever) and MYALGIA (soreness / arm is still sore). At the time of the report, ALOPECIA (excessive hair loss on the head) and PYREXIA (had bitty fever) outcome was unknown and MYALGIA (soreness / arm is still sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consumer stated that  she does not take any medications and had no medical history. No treatment information were provided.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Dysacusis, Fatigue
Clinical narrative: ringing in the right ear / right ear started popping loud / right ear started popping soft; tired; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in the right ear / right ear started popping loud / right ear started popping soft) and FATIGUE (tired) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (ringing in the right ear / right ear started popping loud / right ear started popping soft) and FATIGUE (tired). At the time of the report, TINNITUS (ringing in the right ear / right ear started popping loud / right ear started popping soft) and FATIGUE (tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided by the reporter. The patient contacted her health care provider, and she was referred to an Ear/Nose/Throat specialist.  She had not made an appointment yet.  Treatment included over-the-counter ear drops.   This case was linked to MOD-2021-304691 (Patient Link).
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site pain
Clinical narrative: injection site arm was black & blue; injection site arm was "very, very sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOLOURATION (injection site arm was black & blue) and INJECTION SITE PAIN (injection site arm was "very, very sore) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE DISCOLOURATION (injection site arm was black & blue) and INJECTION SITE PAIN (injection site arm was "very, very sore). At the time of the report, INJECTION SITE DISCOLOURATION (injection site arm was black & blue) and INJECTION SITE PAIN (injection site arm was "very, very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-304916 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: right arm pain; it was like he had the flu; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right arm pain) and INFLUENZA LIKE ILLNESS (it was like he had the flu) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease.   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 an unknown date, the patient experienced PAIN IN EXTREMITY (right arm pain) and INFLUENZA LIKE ILLNESS (it was like he had the flu). At the time of the report, PAIN IN EXTREMITY (right arm pain) and INFLUENZA LIKE ILLNESS (it was like he had the flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-304906 (Patient Link).
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (sore arm at the injection site, but not as sore as the with the 1st dose) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 3, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 3, 2021, patient experienced vaccination site pain (sore arm at the injection site, but not as sore as the with the 1st dose). At the time of the report, vaccination site pain (sore arm at the injection site, but not as sore as the with the 1st dose) outcome: unknown. No concomitant medications or treatment information provided. This case linked to MOD-2021-304896 (patient link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Myalgia, Product dose omission issue, SARS-CoV-2 test positive
Clinical narrative: received the first dose of the Moderna COVID-19 vaccine and then got COVID; a cough that got worse everyday; did not get the second dose of the vaccine when they were scheduled; bad headache; bad body aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (received the first dose of the Moderna COVID-19 vaccine and then got COVID), COUGH (a cough that got worse everyday), PRODUCT DOSE OMISSION ISSUE (did not get the second dose of the vaccine when they were scheduled), HEADACHE (bad headache) and MYALGIA (bad body aches) 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 SUSPECTED COVID-19 (received the first dose of the Moderna COVID-19 vaccine and then got COVID), COUGH (a cough that got worse everyday), PRODUCT DOSE OMISSION ISSUE (did not get the second dose of the vaccine when they were scheduled), HEADACHE (bad headache) and MYALGIA (bad body aches). At the time of the report, SUSPECTED COVID-19 (received the first dose of the Moderna COVID-19 vaccine and then got COVID), COUGH (a cough that got worse everyday), HEADACHE (bad headache) and MYALGIA (bad body aches) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not get the second dose of the vaccine when they were scheduled) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, SARS-CoV-2 test positive: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and Concomitant medications not reported by reporter.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: received the first dose of the Moderna COVID-19 vaccine and then got COVID; a cough that got worse everyday; did not get the second dose of the vaccine when they were scheduled; bad headache; bad body aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (received the first dose of the Moderna COVID-19 vaccine and then got COVID), COUGH (a cough that got worse everyday), PRODUCT DOSE OMISSION ISSUE (did not get the second dose of the vaccine when they were scheduled), HEADACHE (bad headache) and MYALGIA (bad body aches) 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 SUSPECTED COVID-19 (received the first dose of the Moderna COVID-19 vaccine and then got COVID), COUGH (a cough that got worse everyday), PRODUCT DOSE OMISSION ISSUE (did not get the second dose of the vaccine when they were scheduled), HEADACHE (bad headache) and MYALGIA (bad body aches). At the time of the report, SUSPECTED COVID-19 (received the first dose of the Moderna COVID-19 vaccine and then got COVID), COUGH (a cough that got worse everyday), HEADACHE (bad headache) and MYALGIA (bad body aches) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not get the second dose of the vaccine when they were scheduled) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, SARS-CoV-2 test positive: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and Concomitant medications not reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Vision blurred
Clinical narrative: dizzy; blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) and VISION BLURRED (blurred vision) 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 DIZZINESS (dizzy) and VISION BLURRED (blurred vision). At the time of the report, DIZZINESS (dizzy) and VISION BLURRED (blurred vision) outcome was unknown.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: people ask HCP what to do if they are beyond the window for administration of the second dose and they have not received it yet; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (people ask HCP what to do if they are beyond the window for administration of the second dose and they have not received it yet) 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 PRODUCT DOSE OMISSION ISSUE (people ask HCP what to do if they are beyond the window for administration of the second dose and they have not received it yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (people ask HCP what to do if they are beyond the window for administration of the second dose and they have not received it yet) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  Treatment information was not provided
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Gait inability, Muscular weakness, Somnolence
Clinical narrative: no appetite; severe fatigue; slept 32hs; not able to walk; legs were so weak that she had to crawl; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept 32hs), GAIT INABILITY (not able to walk), MUSCULAR WEAKNESS (legs were so weak that she had to crawl), DECREASED APPETITE (no appetite) and FATIGUE (severe fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022c21a, 038a21a and 004m20a) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included LISINOPRIL, ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN CALCIUM (ATORVASTATIN [ATORVASTATIN CALCIUM]), AMLODIPINE BESILATE (NORVASC), METOPROLOL TARTRATE, METHOTREXATE SODIUM (METHOTREXATE ACCORD), CALCIUM FOLINATE (LEUCOVORIN [CALCIUM FOLINATE]) and ABATACEPT (ORENSIA) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced SOMNOLENCE (slept 32hs), GAIT INABILITY (not able to walk), MUSCULAR WEAKNESS (legs were so weak that she had to crawl) and FATIGUE (severe fatigue). On an unknown date, the patient experienced DECREASED APPETITE (no appetite). At the time of the report, SOMNOLENCE (slept 32hs), GAIT INABILITY (not able to walk), MUSCULAR WEAKNESS (legs were so weak that she had to crawl), DECREASED APPETITE (no appetite) and FATIGUE (severe fatigue) had not resolved.            Patient took biologics for arthritis Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Terribly ill after booster of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Terribly ill after booster of Moderna) 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 third 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 and 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 VACCINATION COMPLICATION (Terribly ill after booster of Moderna). At the time of the report, VACCINATION COMPLICATION (Terribly ill after booster of Moderna) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: stored in the fridge for 40 days so 10 days over our recommended storage; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (stored in the fridge for 40 days so 10 days over our recommended storage) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 31-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 31-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (stored in the fridge for 40 days so 10 days over our recommended storage). On 31-Aug-2021, EXPIRED PRODUCT ADMINISTERED (stored in the fridge for 40 days so 10 days over our recommended storage) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Limb discomfort, Pain in extremity
Clinical narrative: More than 35 days after the first dose without receiving the second dose; feet started hurting,they hurt so much; She feels her feet very tight since she received the vaccine,like if she has her feet tied; felt dizzy; had high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (feet started hurting,they hurt so much), LIMB DISCOMFORT (She feels her feet very tight since she received the vaccine,like if she has her feet tied), DIZZINESS (felt dizzy), BLOOD PRESSURE INCREASED (had high blood pressure) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     Concurrent medical conditions included Varicose vein (it is too thick). Concomitant products included CARVEDILOL for Blood pressure increased, LISINOPRIL and SPIRONOLACTONE for an unknown indication.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced PAIN IN EXTREMITY (feet started hurting,they hurt so much), LIMB DISCOMFORT (She feels her feet very tight since she received the vaccine,like if she has her feet tied), DIZZINESS (felt dizzy) and BLOOD PRESSURE INCREASED (had high blood pressure). On 24-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose). On 27-Jul-2021, DIZZINESS (felt dizzy) and BLOOD PRESSURE INCREASED (had high blood pressure) had resolved. On 24-Aug-2021, PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved. At the time of the report, PAIN IN EXTREMITY (feet started hurting,they hurt so much) and LIMB DISCOMFORT (She feels her feet very tight since she received the vaccine,like if she has her feet tied) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2021, Blood pressure measurement: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 35 days after the first dose without receiving the second dose; feet started hurting,they hurt so much; She feels her feet very tight since she received the vaccine,like if she has her feet tied; felt dizzy; had high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (feet started hurting,they hurt so much), LIMB DISCOMFORT (She feels her feet very tight since she received the vaccine,like if she has her feet tied), DIZZINESS (felt dizzy), BLOOD PRESSURE INCREASED (had high blood pressure) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     Concurrent medical conditions included Varicose vein (it is too thick). Concomitant products included CARVEDILOL for Blood pressure increased, LISINOPRIL and SPIRONOLACTONE for an unknown indication.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced PAIN IN EXTREMITY (feet started hurting,they hurt so much), LIMB DISCOMFORT (She feels her feet very tight since she received the vaccine,like if she has her feet tied), DIZZINESS (felt dizzy) and BLOOD PRESSURE INCREASED (had high blood pressure). On 24-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose). On 27-Jul-2021, DIZZINESS (felt dizzy) and BLOOD PRESSURE INCREASED (had high blood pressure) had resolved. On 24-Aug-2021, PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved. At the time of the report, PAIN IN EXTREMITY (feet started hurting,they hurt so much) and LIMB DISCOMFORT (She feels her feet very tight since she received the vaccine,like if she has her feet tied) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2021, Blood pressure measurement: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Mobility decreased, Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: So painful that she could hardly touch her arm; Patient has to stop everything she's doing / can't do anything though it doesn't last long; Pain is also getting sooner than later, more often than before , almost everyday; Severe pain in her left side where she got the shot; Pain in the middle of her upper arm, in the inside muscle like if someone was twisting the muscles; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (So painful that she could hardly touch her arm), MOBILITY DECREASED (Patient has to stop everything she's doing / can't do anything though it doesn't last long), CONDITION AGGRAVATED (Pain is also getting sooner than later, more often than before , almost everyday), VACCINATION SITE PAIN (Severe pain in her left side where she got the shot) and MYALGIA (Pain in the middle of her upper arm, in the inside muscle like if someone was twisting the muscles) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (So painful that she could hardly touch her arm), MOBILITY DECREASED (Patient has to stop everything she's doing / can't do anything though it doesn't last long), CONDITION AGGRAVATED (Pain is also getting sooner than later, more often than before , almost everyday), VACCINATION SITE PAIN (Severe pain in her left side where she got the shot) and MYALGIA (Pain in the middle of her upper arm, in the inside muscle like if someone was twisting the muscles). At the time of the report, PAIN IN EXTREMITY (So painful that she could hardly touch her arm), MOBILITY DECREASED (Patient has to stop everything she's doing / can't do anything though it doesn't last long), CONDITION AGGRAVATED (Pain is also getting sooner than later, more often than before , almost everyday), VACCINATION SITE PAIN (Severe pain in her left side where she got the shot) and MYALGIA (Pain in the middle of her upper arm, in the inside muscle like if someone was twisting the muscles) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided.   Patient has not taken any medication for the pain as it comes in short episodes and last a few seconds.   This case was linked to MOD-2021-305118 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: neck swelling; 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 SWELLING (neck swelling) 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 SWELLING (neck swelling). At the time of the report, SWELLING (neck swelling) 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.   Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Hypersensitivity, Mouth swelling, Pain in extremity, Product dose omission issue
Clinical narrative: mouth swolled up; Like some allergic reaction thing; Some type of reaction on the plate; Did not get the second one/ doctor told her not to take the second dose; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (mouth swolled up), HYPERSENSITIVITY (Like some allergic reaction thing), PAIN IN EXTREMITY (Pain in the arm), ADVERSE REACTION (Some type of reaction on the plate) and PRODUCT DOSE OMISSION ISSUE (Did not get the second one/ doctor told her not to take the second dose) 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 16-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 PAIN IN EXTREMITY (Pain in the arm). On an unknown date, the patient experienced MOUTH SWELLING (mouth swolled up), HYPERSENSITIVITY (Like some allergic reaction thing), ADVERSE REACTION (Some type of reaction on the plate) and PRODUCT DOSE OMISSION ISSUE (Did not get the second one/ doctor told her not to take the second dose). On 17-Feb-2021, PAIN IN EXTREMITY (Pain in the arm) had resolved. At the time of the report, MOUTH SWELLING (mouth swolled up), HYPERSENSITIVITY (Like some allergic reaction thing), ADVERSE REACTION (Some type of reaction on the plate) and PRODUCT DOSE OMISSION ISSUE (Did not get the second one/ doctor told her not to take the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was not allergic to anything before.  Treatment medication include antibiotics.  Patient stated that she did not think that the events were related to the vaccine because she took antibiotics and it cleared up.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Neck mass, Vaccination site pain
Clinical narrative: started creating knots in my nexk; pain shooting down my left arem all the way to the elbow; muscle soreness; pain shooting down my left arem all the way to the elbow; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NECK MASS (started creating knots in my nexk), VACCINATION SITE PAIN (pain shooting down my left arem all the way to the elbow), MYALGIA (muscle soreness) and ARTHRALGIA (pain shooting down my left arem all the way to the elbow) 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 NECK MASS (started creating knots in my nexk), VACCINATION SITE PAIN (pain shooting down my left arem all the way to the elbow), MYALGIA (muscle soreness) and ARTHRALGIA (pain shooting down my left arem all the way to the elbow). At the time of the report, NECK MASS (started creating knots in my nexk), VACCINATION SITE PAIN (pain shooting down my left arem all the way to the elbow), MYALGIA (muscle soreness) and ARTHRALGIA (pain shooting down my left arem all the way to the elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter  Treatment information was not provided
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Insomnia, Magnetic resonance imaging, Paraesthesia
Clinical narrative: tingling that went down his arm; no strength in hand; Arthritis and Tendonitis in the arms and legs thinks the vaccine had activated it; prevented him from sleeping; After the second dose it got worse; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA (tingling that went down his arm), ASTHENIA (no strength in hand), VACCINATION COMPLICATION (Arthritis and Tendonitis in the arms and legs thinks the vaccine had activated it), INSOMNIA (prevented him from sleeping) and CONDITION AGGRAVATED (After the second dose it got worse) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, Tendonitis and Diabetic.    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 PARAESTHESIA (tingling that went down his arm), ASTHENIA (no strength in hand), VACCINATION COMPLICATION (Arthritis and Tendonitis in the arms and legs thinks the vaccine had activated it), INSOMNIA (prevented him from sleeping) and CONDITION AGGRAVATED (After the second dose it got worse). The patient was treated with PREDNISONE for Pain, at a dose of 1 dosage form. At the time of the report, PARAESTHESIA (tingling that went down his arm), ASTHENIA (no strength in hand), VACCINATION COMPLICATION (Arthritis and Tendonitis in the arms and legs thinks the vaccine had activated it), INSOMNIA (prevented him from sleeping) and CONDITION AGGRAVATED (After the second dose it got worse) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) showed arthritis and tendonitis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient confirmed that the tingling stared after the first dose and after the second dose it got worse and also took advil as treatment  No concomitant medications were provided by reporter.  Patient had MRI showed arthritis and tendonitis in him.   This case was linked to MOD-2021-305218 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: tingling that went down his arm; no strength in hand; Arthritis and Tendonitis in the arms and legs thinks the vaccine had activated it; prevented him from sleeping; After the second dose it got worse; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA (tingling that went down his arm), ASTHENIA (no strength in hand), VACCINATION COMPLICATION (Arthritis and Tendonitis in the arms and legs thinks the vaccine had activated it), INSOMNIA (prevented him from sleeping) and CONDITION AGGRAVATED (After the second dose it got worse) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, Tendonitis and Diabetic.    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 PARAESTHESIA (tingling that went down his arm), ASTHENIA (no strength in hand), VACCINATION COMPLICATION (Arthritis and Tendonitis in the arms and legs thinks the vaccine had activated it), INSOMNIA (prevented him from sleeping) and CONDITION AGGRAVATED (After the second dose it got worse). The patient was treated with PREDNISONE for Pain, at a dose of 1 dosage form. At the time of the report, PARAESTHESIA (tingling that went down his arm), ASTHENIA (no strength in hand), VACCINATION COMPLICATION (Arthritis and Tendonitis in the arms and legs thinks the vaccine had activated it), INSOMNIA (prevented him from sleeping) and CONDITION AGGRAVATED (After the second dose it got worse) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) showed arthritis and tendonitis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient confirmed that the tingling stared after the first dose and after the second dose it got worse and also took advil as treatment  No concomitant medications were provided by reporter.  Patient had MRI showed arthritis and tendonitis in him.   This case was linked to MOD-2021-305218 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of illness (she got sick with the second dose/really sick) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the 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; 1 dosage form. On an unknown date, patient experienced illness (she got sick with the second dose/really sick). At the time of the report, illness (she got sick with the second dose/really sick) outcome: unknown. No concomitant medication or treatment information provided. Most recent follow-up information incorporated: On Sep 2, 2021: Follow-up received contained patient identifier.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Pyrexia
Clinical narrative: Dizzy/slightly dizzy; Sweating; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy/slightly dizzy), HYPERHIDROSIS (Sweating) and PYREXIA (Feverish) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy/slightly dizzy), HYPERHIDROSIS (Sweating) and PYREXIA (Feverish). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy/slightly dizzy), HYPERHIDROSIS (Sweating) and PYREXIA (Feverish) outcome was unknown.            Concomitant product use was not provided by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Headache, Oropharyngeal pain
Clinical narrative: "A little weak"; Fever of 100 degrees Fahrenheit/fever (ongoing); Very sore throat/sore throat (ongoing); Headaches; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Very sore throat/sore throat (ongoing)), ASTHENIA ("A little weak"), ARTHRALGIA (Joint pain), PYREXIA (Fever of 100 degrees Fahrenheit/fever (ongoing)) and HEADACHE (Headaches) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 012M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced ARTHRALGIA (Joint pain) and HEADACHE (Headaches). On 01-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (Very sore throat/sore throat (ongoing)) and PYREXIA (Fever of 100 degrees Fahrenheit/fever (ongoing)). On an unknown date, the patient experienced ASTHENIA ("A little weak"). At the time of the report, OROPHARYNGEAL PAIN (Very sore throat/sore throat (ongoing)) and PYREXIA (Fever of 100 degrees Fahrenheit/fever (ongoing)) had not resolved and ASTHENIA ("A little weak"), ARTHRALGIA (Joint pain) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) 100 degrees Fahrenheit.         Concomitant medication reported as unknown cholesterol medication. No treatment medication were provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: "A little weak"; Fever of 100 degrees Fahrenheit/fever (ongoing); Very sore throat/sore throat (ongoing); Headaches; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Very sore throat/sore throat (ongoing)), ASTHENIA ("A little weak"), ARTHRALGIA (Joint pain), PYREXIA (Fever of 100 degrees Fahrenheit/fever (ongoing)) and HEADACHE (Headaches) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 012M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced ARTHRALGIA (Joint pain) and HEADACHE (Headaches). On 01-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (Very sore throat/sore throat (ongoing)) and PYREXIA (Fever of 100 degrees Fahrenheit/fever (ongoing)). On an unknown date, the patient experienced ASTHENIA ("A little weak"). At the time of the report, OROPHARYNGEAL PAIN (Very sore throat/sore throat (ongoing)) and PYREXIA (Fever of 100 degrees Fahrenheit/fever (ongoing)) had not resolved and ASTHENIA ("A little weak"), ARTHRALGIA (Joint pain) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) 100 degrees Fahrenheit.         Concomitant medication reported as unknown cholesterol medication. No treatment medication were provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to a 17 years old male patient by mistake; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 17 years old male patient by mistake) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 17 years old male patient by mistake). On 30-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 17 years old male patient by mistake) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant and treatment drugs were not provided
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Heart rate, Heart rate increased, Vaccination complication
Clinical narrative: vision issue with one eyes/eyes not being synchronized/one is not performing as well as the other; some elevated heart rate; Having adverse events to the vaccine; it is getting worse; Prolonged headaches; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (vision issue with one eyes/eyes not being synchronized/one is not performing as well as the other), HEART RATE INCREASED (some elevated heart rate), VACCINATION COMPLICATION (Having adverse events to the vaccine), CONDITION AGGRAVATED (it is getting worse) and HEADACHE (Prolonged headaches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (had COVID  a year ago).   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 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 VISUAL IMPAIRMENT (vision issue with one eyes/eyes not being synchronized/one is not performing as well as the other), HEART RATE INCREASED (some elevated heart rate), VACCINATION COMPLICATION (Having adverse events to the vaccine), CONDITION AGGRAVATED (it is getting worse) and HEADACHE (Prolonged headaches). The patient was treated with PREDNISONE at an unspecified dose and frequency; LOTEPREDNOL ETABONATE (LOTEMAX) (ophthalmic) at an unspecified dose and frequency and PROMETHAZINE at an unspecified dose and frequency. At the time of the report, VISUAL IMPAIRMENT (vision issue with one eyes/eyes not being synchronized/one is not performing as well as the other), HEART RATE INCREASED (some elevated heart rate), VACCINATION COMPLICATION (Having adverse events to the vaccine), CONDITION AGGRAVATED (it is getting worse) and HEADACHE (Prolonged headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 90 (High) elevated heart rate of 90 (as opposed to a resting heart rate of 60).         Concomitant medication was not provided.  The patient received both doses of the vaccine around mid-May and late May. The patient got the second vaccine, delayed by 1 to 2 weeks. The condition have aggravated for the last 3 months. The patient was previously not on any medications.  The patient have seen a cardiologist, neurologist and ophthalmologist. There has not been any confirmed diagnosis of the issue. The ophthalmologist had seen that in many cases, it could be a result of the virus or vaccine, an inflammation of the eye and the brain.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: vision issue with one eyes/eyes not being synchronized/one is not performing as well as the other; some elevated heart rate; Having adverse events to the vaccine; it is getting worse; Prolonged headaches; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (vision issue with one eyes/eyes not being synchronized/one is not performing as well as the other), HEART RATE INCREASED (some elevated heart rate), VACCINATION COMPLICATION (Having adverse events to the vaccine), CONDITION AGGRAVATED (it is getting worse) and HEADACHE (Prolonged headaches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (had COVID  a year ago).   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 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 VISUAL IMPAIRMENT (vision issue with one eyes/eyes not being synchronized/one is not performing as well as the other), HEART RATE INCREASED (some elevated heart rate), VACCINATION COMPLICATION (Having adverse events to the vaccine), CONDITION AGGRAVATED (it is getting worse) and HEADACHE (Prolonged headaches). The patient was treated with PREDNISONE at an unspecified dose and frequency; LOTEPREDNOL ETABONATE (LOTEMAX) (ophthalmic) at an unspecified dose and frequency and PROMETHAZINE at an unspecified dose and frequency. At the time of the report, VISUAL IMPAIRMENT (vision issue with one eyes/eyes not being synchronized/one is not performing as well as the other), HEART RATE INCREASED (some elevated heart rate), VACCINATION COMPLICATION (Having adverse events to the vaccine), CONDITION AGGRAVATED (it is getting worse) and HEADACHE (Prolonged headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 90 (High) elevated heart rate of 90 (as opposed to a resting heart rate of 60).         Concomitant medication was not provided.  The patient received both doses of the vaccine around mid-May and late May. The patient got the second vaccine, delayed by 1 to 2 weeks. The condition have aggravated for the last 3 months. The patient was previously not on any medications.  The patient have seen a cardiologist, neurologist and ophthalmologist. There has not been any confirmed diagnosis of the issue. The ophthalmologist had seen that in many cases, it could be a result of the virus or vaccine, an inflammation of the eye and the brain.