chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Stress, Vaccination complication, Weight increased
Clinical narrative: discomfort in her eyes; Take naps/slept 10 hours last night; Gained 10 lbs after the 2nd dose in this 6 months.; Brain fog; Cannot handle stress anymore; Real bad side effects ever since the 2nd dose; Fatigue which is still ongoing after 6 months/severe fatigue; stabbing pain in both her eyes/feels like strain in eyes all the time/wears reading glasses a lot now/eye pain; developed photophobia; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (stabbing pain in both her eyes/feels like strain in eyes all the time/wears reading glasses a lot now/eye pain), PHOTOPHOBIA (developed photophobia), OCULAR DISCOMFORT (discomfort in her eyes), SOMNOLENCE (Take naps/slept 10 hours last night) and WEIGHT INCREASED (Gained 10 lbs after the 2nd dose in this 6 months.) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced EYE PAIN (stabbing pain in both her eyes/feels like strain in eyes all the time/wears reading glasses a lot now/eye pain) and PHOTOPHOBIA (developed photophobia). On an unknown date, the patient experienced OCULAR DISCOMFORT (discomfort in her eyes), SOMNOLENCE (Take naps/slept 10 hours last night), WEIGHT INCREASED (Gained 10 lbs after the 2nd dose in this 6 months.), FEELING ABNORMAL (Brain fog), STRESS (Cannot handle stress anymore), VACCINATION COMPLICATION (Real bad side effects ever since the 2nd dose) and FATIGUE (Fatigue which is still ongoing after 6 months/severe fatigue). The patient was treated with PREDNISOLONE at an unspecified dose and frequency. At the time of the report, EYE PAIN (stabbing pain in both her eyes/feels like strain in eyes all the time/wears reading glasses a lot now/eye pain), PHOTOPHOBIA (developed photophobia), OCULAR DISCOMFORT (discomfort in her eyes), SOMNOLENCE (Take naps/slept 10 hours last night), WEIGHT INCREASED (Gained 10 lbs after the 2nd dose in this 6 months.), FEELING ABNORMAL (Brain fog), STRESS (Cannot handle stress anymore), VACCINATION COMPLICATION (Real bad side effects ever since the 2nd dose) and FATIGUE (Fatigue which is still ongoing after 6 months/severe fatigue) outcome was unknown.            The concomitant medications were not reported   This case was linked to MOD-2021-293207 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Wheezing
Clinical narrative: Hurt chest; Wheezing; 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 CHEST PAIN (Hurt chest) and WHEEZING (Wheezing) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ALBUTEROL [SALBUTAMOL] for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Hurt chest) and WHEEZING (Wheezing). At the time of the report, CHEST PAIN (Hurt chest) and WHEEZING (Wheezing) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Treatment information were not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ears after 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 TINNITUS (Ringing in ears after vaccine). At the time of the report, TINNITUS (Ringing in ears after vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: very very itchy all over my body after the vaccine today; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (very very itchy all over my body after the vaccine today) 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 PRURITUS (very very itchy all over my body after the vaccine today). At the time of the report, PRURITUS (very very itchy all over my body after the vaccine today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: I am aching; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (I am aching) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    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 MYALGIA (I am aching) and HEADACHE (Headache). At the time of the report, MYALGIA (I am aching) and HEADACHE (Headache) outcome was unknown.            The concomitant medications were not reported.  The treatment information was not provided.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: administered Higher dose ( 1 ml ) -than-authorized dose ( 0.5 Ml ); This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (administered Higher dose ( 1 ml ) -than-authorized dose ( 0.5 Ml )) in a 45-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (administered Higher dose ( 1 ml ) -than-authorized dose ( 0.5 Ml )). At the time of the report, ACCIDENTAL OVERDOSE (administered Higher dose ( 1 ml ) -than-authorized dose ( 0.5 Ml )) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-293520, MOD-2021-292849, MOD-2021-292850, MOD-2021-293335 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle tightness
Clinical narrative: Leg muscle cramps or spasms; experiencing a thingness in her left leg; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (experiencing a thingness in her left leg) and MUSCLE SPASMS (Leg muscle cramps or spasms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced MUSCLE TIGHTNESS (experiencing a thingness in her left leg). On 21-Aug-2021, the patient experienced MUSCLE SPASMS (Leg muscle cramps or spasms). On 21-Aug-2021, MUSCLE TIGHTNESS (experiencing a thingness in her left leg) had resolved. At the time of the report, MUSCLE SPASMS (Leg muscle cramps or spasms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided. No treatment information was mentioned.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered expired vaccine; 12 hour punctured vial expiration time 8:00 PM, 19/Aug/2021) to the immunocompromised patient at 11:00 AM on 20/Aug/2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) and PRODUCT STORAGE ERROR (12 hour punctured vial expiration time 8:00 PM, 19/Aug/2021) to the immunocompromised patient at 11:00 AM on 20/Aug/2021) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A, 026L20A and 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021 at 11:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) and PRODUCT STORAGE ERROR (12 hour punctured vial expiration time 8:00 PM, 19/Aug/2021) to the immunocompromised patient at 11:00 AM on 20/Aug/2021). On 20-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) and PRODUCT STORAGE ERROR (12 hour punctured vial expiration time 8:00 PM, 19/Aug/2021) to the immunocompromised patient at 11:00 AM on 20/Aug/2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Inflammation
Clinical narrative: inflammation of the sternum; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation of the sternum) and CHEST PAIN (Chest 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (inflammation of the sternum) and CHEST PAIN (Chest pain). At the time of the report, INFLAMMATION (inflammation of the sternum) outcome was unknown and CHEST PAIN (Chest pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment details were provided.  Reportedly, patient's doctor revealed the event of chest pain was unrelated to vaccination and was due to inflammation of the sternum.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm (1st dose)) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm (1st dose)). At the time of the report, PAIN IN EXTREMITY (Sore arm (1st dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided by the reporter.    This case was linked to MOD-2021-293176 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain in extremity, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: a little bit of increased fever for a few hours; Painful arm; Allergic reaction; constant sneezing; nose is just running; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), SNEEZING (constant sneezing), RHINORRHOEA (nose is just running), PYREXIA (a little bit of increased fever for a few hours) and PAIN IN EXTREMITY (Painful arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), SNEEZING (constant sneezing) and RHINORRHOEA (nose is just running). On an unknown date, the patient experienced PYREXIA (a little bit of increased fever for a few hours) and PAIN IN EXTREMITY (Painful arm). At the time of the report, HYPERSENSITIVITY (Allergic reaction), SNEEZING (constant sneezing), RHINORRHOEA (nose is just running), PYREXIA (a little bit of increased fever for a few hours) and PAIN IN EXTREMITY (Painful arm) 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.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.  Patient received her first dose of Moderna COVID19 Vaccine two weeks ago (exact date unknown). Nothing had been different for her. Patient was like she had hay fever allergies. It happened when she ate something the same morning. She never experienced before.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: Sore arm; Other stuff; 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 PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (Other stuff) 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 PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (Other stuff). At the time of the report, PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (Other stuff) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was provided.  Treatment information was not provided.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Pyrexia, Vaccination site erythema
Clinical narrative: His stomach was a little uneasy; It was huge, burning hot to the touch for a few days; The injection site on the arm turned really red.; woke up with a breaking fever, which lasted about 7 hours; Little bit of a headache; He did not take his own temperature, but it was so bad he was shaking uncontrollably; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (His stomach was a little uneasy), VACCINATION SITE WARMTH (It was huge, burning hot to the touch for a few days), VACCINATION SITE ERYTHEMA (The injection site on the arm turned really red.), PYREXIA (woke up with a breaking fever, which lasted about 7 hours) and HEADACHE (Little bit of a headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-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 ABDOMINAL DISCOMFORT (His stomach was a little uneasy), VACCINATION SITE WARMTH (It was huge, burning hot to the touch for a few days), VACCINATION SITE ERYTHEMA (The injection site on the arm turned really red.), PYREXIA (woke up with a breaking fever, which lasted about 7 hours), HEADACHE (Little bit of a headache) and CHILLS (He did not take his own temperature, but it was so bad he was shaking uncontrollably). At the time of the report, ABDOMINAL DISCOMFORT (His stomach was a little uneasy), VACCINATION SITE WARMTH (It was huge, burning hot to the touch for a few days), VACCINATION SITE ERYTHEMA (The injection site on the arm turned really red.), PYREXIA (woke up with a breaking fever, which lasted about 7 hours), HEADACHE (Little bit of a headache) and CHILLS (He did not take his own temperature, but it was so bad he was shaking uncontrollably) outcome was unknown.            Concomitant medication include: Blood pressure medication Treatment information was not reported
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: His stomach was a little uneasy; It was huge, burning hot to the touch for a few days; The injection site on the arm turned really red.; woke up with a breaking fever, which lasted about 7 hours; Little bit of a headache; He did not take his own temperature, but it was so bad he was shaking uncontrollably; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (His stomach was a little uneasy), VACCINATION SITE WARMTH (It was huge, burning hot to the touch for a few days), VACCINATION SITE ERYTHEMA (The injection site on the arm turned really red.), PYREXIA (woke up with a breaking fever, which lasted about 7 hours) and HEADACHE (Little bit of a headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-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 ABDOMINAL DISCOMFORT (His stomach was a little uneasy), VACCINATION SITE WARMTH (It was huge, burning hot to the touch for a few days), VACCINATION SITE ERYTHEMA (The injection site on the arm turned really red.), PYREXIA (woke up with a breaking fever, which lasted about 7 hours), HEADACHE (Little bit of a headache) and CHILLS (He did not take his own temperature, but it was so bad he was shaking uncontrollably). At the time of the report, ABDOMINAL DISCOMFORT (His stomach was a little uneasy), VACCINATION SITE WARMTH (It was huge, burning hot to the touch for a few days), VACCINATION SITE ERYTHEMA (The injection site on the arm turned really red.), PYREXIA (woke up with a breaking fever, which lasted about 7 hours), HEADACHE (Little bit of a headache) and CHILLS (He did not take his own temperature, but it was so bad he was shaking uncontrollably) outcome was unknown.            Concomitant medication include: Blood pressure medication Treatment information was not reported
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Sense of oppression
Clinical narrative: on the third day of the application he felt pain in his torax on the left side,; oppressive and a sensation of shortness of breath; oppressive; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (on the third day of the application he felt pain in his torax on the left side,), DYSPNOEA (oppressive and a sensation of shortness of breath) and SENSE OF OPPRESSION (oppressive) in a 23-year-old male 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 CHEST PAIN (on the third day of the application he felt pain in his torax on the left side,), DYSPNOEA (oppressive and a sensation of shortness of breath) and SENSE OF OPPRESSION (oppressive). At the time of the report, CHEST PAIN (on the third day of the application he felt pain in his torax on the left side,), DYSPNOEA (oppressive and a sensation of shortness of breath) and SENSE OF OPPRESSION (oppressive) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment details were provided.
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, Decreased appetite
Clinical narrative: no smell; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (no smell) and DECREASED APPETITE (no appetite) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ANOSMIA (no smell) and DECREASED APPETITE (no appetite). At the time of the report, ANOSMIA (no smell) and DECREASED APPETITE (no appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications was provided.  No treatment medications was provided.   Reporter did not allow further contact
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in her arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (Soreness in her arm). At the time of the report, PAIN IN EXTREMITY (Soreness in her arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided.   Treatment information was not  provided.   This case was linked to MOD-2021-293312 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Experienced some side effects after second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experienced some side effects after second shot) 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 09-Apr-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 09-Apr-2021, the patient experienced VACCINATION COMPLICATION (Experienced some side effects after second shot). At the time of the report, VACCINATION COMPLICATION (Experienced some side effects after second shot) outcome was unknown.            No concomitant product use was provided by the reporter.   No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding
Clinical narrative: had the worse period after first shot and still spotting now; still spotting; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (had the worse period after first shot and still spotting now) and INTERMENSTRUAL BLEEDING (still spotting) 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 HEAVY MENSTRUAL BLEEDING (had the worse period after first shot and still spotting now) and INTERMENSTRUAL BLEEDING (still spotting). At the time of the report, HEAVY MENSTRUAL BLEEDING (had the worse period after first shot and still spotting now) and INTERMENSTRUAL BLEEDING (still spotting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided.  Treatment information was not provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Patient received her second dose of Moderna from an expired vial; Patient received her second dose of Moderna on 20/Aug/2021 (day 61); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received her second dose of Moderna from an expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her second dose of Moderna on 20/Aug/2021 (day 61)) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 011D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received her second dose of Moderna from an expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her second dose of Moderna on 20/Aug/2021 (day 61)). On 20-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Patient received her second dose of Moderna from an expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her second dose of Moderna on 20/Aug/2021 (day 61)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Is it normal that I feel mild dizziness after getting the Moderna vaccine; 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 (Is it normal that I feel mild dizziness after getting the Moderna 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 DIZZINESS (Is it normal that I feel mild dizziness after getting the Moderna vaccine). At the time of the report, DIZZINESS (Is it normal that I feel mild dizziness after getting the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient got Covid 5 days after receiving the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient got Covid 5 days after receiving the 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Hypertensive.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced COVID-19 (Patient got Covid 5 days after receiving the 1st dose). At the time of the report, COVID-19 (Patient got Covid 5 days after receiving the 1st dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive. In April 2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter. Treatment medications were not provided by reporter.   This case was linked to MOD-2021-294004 (Patient Link).
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Feeling abnormal, Head discomfort
Clinical narrative: glands underneath ears seem to be bothering me; head feels full/ seems to be all in my head; not feeling like myself; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (glands underneath ears seem to be bothering me), HEAD DISCOMFORT (head feels full/ seems to be all in my head) and FEELING ABNORMAL (not feeling like myself) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028220A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EAR DISCOMFORT (glands underneath ears seem to be bothering me), HEAD DISCOMFORT (head feels full/ seems to be all in my head) and FEELING ABNORMAL (not feeling like myself). At the time of the report, EAR DISCOMFORT (glands underneath ears seem to be bothering me), HEAD DISCOMFORT (head feels full/ seems to be all in my head) and FEELING ABNORMAL (not feeling like myself) outcome was unknown.            No relevant concomitant medications were reported by reporter It was reported that the patient wanted to get tested for COVID and was not sure if she had contracted COVID Treatment information was not provided by reporter
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Lymph node pain, Pyrexia
Clinical narrative: Felt like she was hit by a truck; Fever; Weird fatigue; Pain in lymph nodes under arms; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like she was hit by a truck), PYREXIA (Fever), FATIGUE (Weird fatigue) and LYMPH NODE PAIN (Pain in lymph nodes under arms) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-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 FEELING ABNORMAL (Felt like she was hit by a truck), PYREXIA (Fever), FATIGUE (Weird fatigue) and LYMPH NODE PAIN (Pain in lymph nodes under arms). At the time of the report, FEELING ABNORMAL (Felt like she was hit by a truck), PYREXIA (Fever), FATIGUE (Weird fatigue) and LYMPH NODE PAIN (Pain in lymph nodes under arms) outcome was unknown.             3rd dose on 16-AUG-2021 with lot number 002F21A. As she was cancer patient doctor advised to take 3rd dose. No concomitant medications reported. No treatment information was reported by reporter.   This case was linked to MOD-2021-293269 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced CHILLS (Chills) and HEADACHE (Headache). At the time of the report, CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were provided. Treatment information was not provided. The reporter wanted to know if the patient could take Ibuprofen.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: really dizzy; pale; sweaty; weak; lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (really dizzy), PALLOR (pale), HYPERHIDROSIS (sweaty), ASTHENIA (weak) and DIZZINESS (lightheaded) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced DIZZINESS (really dizzy), PALLOR (pale), HYPERHIDROSIS (sweaty), ASTHENIA (weak) and DIZZINESS (lightheaded). At the time of the report, DIZZINESS (really dizzy), PALLOR (pale), HYPERHIDROSIS (sweaty), ASTHENIA (weak) and DIZZINESS (lightheaded) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment information was mentioned. Patient laid down and feels a little better now.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Gave a second dose from vials that were expired past the 12 hours mark this morning; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave a second dose from vials that were expired past the 12 hours mark this morning) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave a second dose from vials that were expired past the 12 hours mark this morning). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave a second dose from vials that were expired past the 12 hours mark this morning) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was provided.   No Treatment information was provided.  Pharmacist stated that one of her interns accidentally gave 2 patients a second dose from vials that were expired past the 12 hours mark this morning 21Aug2021 at 8:25am (vial was open since yesterday 20Aug2021, punctured at 1:35pm). She wanted to know if they need to be revaccinated right away or not?  Both shots (first and second) were given in the left deltoid muscle for both patients.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Decreased appetite, Erythema, Feeling abnormal
Clinical narrative: no appetite; huge red blotch under vaccination site the size of a mango; which blistered and peeled; left breast red/part of right breast were all red; breasts were real itchy; 2nd dose 08Feb2021/3rd on16Aug; has no energy; On the day after her 3rd shot she woke up with a mild 99.3 fever; felt like freight train ran over her; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like freight train ran over her), DECREASED APPETITE (no appetite), RASH MACULAR (huge red blotch under vaccination site the size of a mango), VACCINATION SITE VESICLES (which blistered and peeled) and ERYTHEMA (left breast red/part of right breast were all red) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A, 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced FEELING ABNORMAL (felt like freight train ran over her) and PYREXIA (On the day after her 3rd shot she woke up with a mild 99.3 fever). On 20-Aug-2021, the patient experienced ASTHENIA (has no energy). On an unknown date, the patient experienced DECREASED APPETITE (no appetite), RASH MACULAR (huge red blotch under vaccination site the size of a mango), VACCINATION SITE VESICLES (which blistered and peeled), ERYTHEMA (left breast red/part of right breast were all red), PRURITUS (breasts were real itchy) and INCORRECT DOSE ADMINISTERED (2nd dose 08Feb2021/3rd on16Aug). At the time of the report, FEELING ABNORMAL (felt like freight train ran over her), DECREASED APPETITE (no appetite), RASH MACULAR (huge red blotch under vaccination site the size of a mango), VACCINATION SITE VESICLES (which blistered and peeled), ERYTHEMA (left breast red/part of right breast were all red), PRURITUS (breasts were real itchy) and PYREXIA (On the day after her 3rd shot she woke up with a mild 99.3 fever) was resolving and ASTHENIA (has no energy) and INCORRECT DOSE ADMINISTERED (2nd dose 08Feb2021/3rd on16Aug) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.3 (High) high.         Concomitant medication were not reported. Treatment medication were not reported. Patent was a cancer survivor   This case was linked to MOD-2021-293260 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Pruritus, Pyrexia, Rash macular, Vaccination site vesicles
Clinical narrative: no appetite; huge red blotch under vaccination site the size of a mango; which blistered and peeled; left breast red/part of right breast were all red; breasts were real itchy; 2nd dose 08Feb2021/3rd on16Aug; has no energy; On the day after her 3rd shot she woke up with a mild 99.3 fever; felt like freight train ran over her; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like freight train ran over her), DECREASED APPETITE (no appetite), RASH MACULAR (huge red blotch under vaccination site the size of a mango), VACCINATION SITE VESICLES (which blistered and peeled) and ERYTHEMA (left breast red/part of right breast were all red) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A, 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced FEELING ABNORMAL (felt like freight train ran over her) and PYREXIA (On the day after her 3rd shot she woke up with a mild 99.3 fever). On 20-Aug-2021, the patient experienced ASTHENIA (has no energy). On an unknown date, the patient experienced DECREASED APPETITE (no appetite), RASH MACULAR (huge red blotch under vaccination site the size of a mango), VACCINATION SITE VESICLES (which blistered and peeled), ERYTHEMA (left breast red/part of right breast were all red), PRURITUS (breasts were real itchy) and INCORRECT DOSE ADMINISTERED (2nd dose 08Feb2021/3rd on16Aug). At the time of the report, FEELING ABNORMAL (felt like freight train ran over her), DECREASED APPETITE (no appetite), RASH MACULAR (huge red blotch under vaccination site the size of a mango), VACCINATION SITE VESICLES (which blistered and peeled), ERYTHEMA (left breast red/part of right breast were all red), PRURITUS (breasts were real itchy) and PYREXIA (On the day after her 3rd shot she woke up with a mild 99.3 fever) was resolving and ASTHENIA (has no energy) and INCORRECT DOSE ADMINISTERED (2nd dose 08Feb2021/3rd on16Aug) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.3 (High) high.         Concomitant medication were not reported. Treatment medication were not reported. Patent was a cancer survivor   This case was linked to MOD-2021-293260 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Red Right Arm Injection Site (3" wide and 2.4" Long)/ Redness is getting worst and spreading to the back of the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red Right Arm Injection Site (3" wide and 2.4" Long)/ Redness is getting worst and spreading to the back of the arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: Tetanus (Patient had similar reaction to tetanus shot a few years ago and she was told its an allergic reaction). Past adverse reactions to the above products included Allergic reaction with Tetanus.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red Right Arm Injection Site (3" wide and 2.4" Long)/ Redness is getting worst and spreading to the back of the arm). At the time of the report, VACCINATION SITE ERYTHEMA (Red Right Arm Injection Site (3" wide and 2.4" Long)/ Redness is getting worst and spreading to the back of the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided Treatment information was not provided.  Since vaccination the Right Arm became Red (3" wide and 2.4" Long), and getting worst. It looks like spreading to the back of the arm.  The patient had a similar reaction to Tetanus shot a few years ago and she was told that it was an allergic reaction.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Joint injury, Vaccination complication, X-ray
Clinical narrative: Significant reaction; patient's arm felt significantly injured around the joint/something was physically attacking area around joint; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Significant reaction) and JOINT INJURY (patient's arm felt significantly injured around the joint/something was physically attacking area around joint) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION COMPLICATION (Significant reaction) and JOINT INJURY (patient's arm felt significantly injured around the joint/something was physically attacking area around joint). At the time of the report, VACCINATION COMPLICATION (Significant reaction) and JOINT INJURY (patient's arm felt significantly injured around the joint/something was physically attacking area around joint) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: abnormal (abnormal) Osteoarthritis.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.    This case was linked to MOD-2021-293274 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Limb injury, Osteoarthritis, X-ray
Clinical narrative: injured arm internally; osteoarthritis; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (injured arm internally) and OSTEOARTHRITIS (osteoarthritis) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIMB INJURY (injured arm internally). In 2021, the patient experienced OSTEOARTHRITIS (osteoarthritis). The patient was treated with CORTISONE from August 2021 to August 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, LIMB INJURY (injured arm internally) and OSTEOARTHRITIS (osteoarthritis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, X-ray: osteoarthritis (abnormal) osteoarthritis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was not taking any concomitant medications.   Patient reported that the cortisone shot did not help   This case was linked to MOD-2021-293273 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) 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.    In March 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 DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment information provided. The patient's husband wanted to know if his wife could receive the Johnson and Johnson vaccine as the second dose.   Reporter did not allow further contact