chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin exfoliation, Urticaria
Clinical narrative: "more red spots"\ some of the red spots are the size of a quarter\rest of them (red spots) are smaller; Bumps on her scalp; Flaking scalp; This spontaneous case was reported by a pharmacist and describes the occurrence of ERYTHEMA ("more red spots"\ some of the red spots are the size of a quarter\rest of them (red spots) are smaller), URTICARIA (Bumps on her scalp) and SKIN EXFOLIATION (Flaking scalp) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Cholesterol. Concomitant products included ROSUVASTATIN for Cholesterol, EMPAGLIFLOZIN (JARDIANCE) for Diabetes.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA ("more red spots"\ some of the red spots are the size of a quarter\rest of them (red spots) are smaller), URTICARIA (Bumps on her scalp) and SKIN EXFOLIATION (Flaking scalp). At the time of the report, ERYTHEMA ("more red spots"\ some of the red spots are the size of a quarter\rest of them (red spots) are smaller), URTICARIA (Bumps on her scalp) and SKIN EXFOLIATION (Flaking scalp) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No  treatment medications were provided.   This case was linked to MOD-2021-250583, MOD-2021-252826 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: it hurt a little; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (it hurt a little) 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 PAIN (it hurt a little). At the time of the report, PAIN (it hurt a little) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient's concomitant medications were not reported.   No treatment information was provided by the reporter.     This case was linked to MOD-2021-250602 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 031A21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (sore arm). On 23-May-2021, MYALGIA (sore arm) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not reported. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD-2021-250606 (Patient Link).
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose after day 42) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose after day 42). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose after day 42) 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.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient is beyond the recommended window for the second dose and still has not got it; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient is beyond the recommended window for the second dose and still has not got it) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 PRODUCT DOSE OMISSION ISSUE (Patient is beyond the recommended window for the second dose and still has not got it). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient is beyond the recommended window for the second dose and still has not got it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information regarding concomitant medication was provided.   No information regarding treatment was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dry throat, Erythema, Induration, Influenza like illness
Clinical narrative: redness on her left arm; hardness on her arm; like a flu; dry throat; it hurts(on arm); fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness on her left arm), INDURATION (hardness on her arm), INFLUENZA LIKE ILLNESS (like a flu), DRY THROAT (dry throat) and MYALGIA (it hurts(on arm)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 06-Jul-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 06-Jul-2021, the patient experienced ERYTHEMA (redness on her left arm), INDURATION (hardness on her arm), INFLUENZA LIKE ILLNESS (like a flu), DRY THROAT (dry throat), MYALGIA (it hurts(on arm)), PYREXIA (fever) and CHILLS (chills). At the time of the report, ERYTHEMA (redness on her left arm), INDURATION (hardness on her arm), INFLUENZA LIKE ILLNESS (like a flu), DRY THROAT (dry throat), MYALGIA (it hurts(on arm)), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            Concomitant medications not provided. Treatment medications not provided.   This case was linked to MOD-2021-250592 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: redness on her left arm; hardness on her arm; like a flu; dry throat; it hurts(on arm); fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness on her left arm), INDURATION (hardness on her arm), INFLUENZA LIKE ILLNESS (like a flu), DRY THROAT (dry throat) and MYALGIA (it hurts(on arm)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 06-Jul-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 06-Jul-2021, the patient experienced ERYTHEMA (redness on her left arm), INDURATION (hardness on her arm), INFLUENZA LIKE ILLNESS (like a flu), DRY THROAT (dry throat), MYALGIA (it hurts(on arm)), PYREXIA (fever) and CHILLS (chills). At the time of the report, ERYTHEMA (redness on her left arm), INDURATION (hardness on her arm), INFLUENZA LIKE ILLNESS (like a flu), DRY THROAT (dry throat), MYALGIA (it hurts(on arm)), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            Concomitant medications not provided. Treatment medications not provided.   This case was linked to MOD-2021-250592 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received punctured vials beyond the recommended 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received punctured vials beyond the recommended 12 hours) 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 EXPIRED PRODUCT ADMINISTERED (Patients received punctured vials beyond the recommended 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received punctured vials beyond the recommended 12 hours) 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 medications were not reported no concomitant medications were reported
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Mental disorder, Muscle spasms, Myokymia, Pyrexia
Clinical narrative: mental weirdness; eye twitches; A week and 2 days after the vaccination had a rash on L arm where she was vaccinated; fever; cramps; felt quite sick, cramps, shakes, fever, mental weirdness; shakes; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramps), MENTAL DISORDER (mental weirdness), MYOKYMIA (eye twitches), ILLNESS (felt quite sick, cramps, shakes, fever, mental weirdness) and TREMOR (shakes) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034CZDA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.   On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced MUSCLE SPASMS (cramps), ILLNESS (felt quite sick, cramps, shakes, fever, mental weirdness), TREMOR (shakes) and PYREXIA (fever). On an unknown date, the patient experienced MENTAL DISORDER (mental weirdness), MYOKYMIA (eye twitches) and VACCINATION SITE RASH (A week and 2 days after the vaccination had a rash on L arm where she was vaccinated). At the time of the report, MUSCLE SPASMS (cramps), MENTAL DISORDER (mental weirdness), ILLNESS (felt quite sick, cramps, shakes, fever, mental weirdness), TREMOR (shakes), VACCINATION SITE RASH (A week and 2 days after the vaccination had a rash on L arm where she was vaccinated) and PYREXIA (fever) had resolved and MYOKYMIA (eye twitches) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medications included vitamins and unspecified inhaler.   No treatment reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vaccination site rash
Clinical narrative: mental weirdness; eye twitches; A week and 2 days after the vaccination had a rash on L arm where she was vaccinated; fever; cramps; felt quite sick, cramps, shakes, fever, mental weirdness; shakes; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramps), MENTAL DISORDER (mental weirdness), MYOKYMIA (eye twitches), ILLNESS (felt quite sick, cramps, shakes, fever, mental weirdness) and TREMOR (shakes) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034CZDA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.   On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced MUSCLE SPASMS (cramps), ILLNESS (felt quite sick, cramps, shakes, fever, mental weirdness), TREMOR (shakes) and PYREXIA (fever). On an unknown date, the patient experienced MENTAL DISORDER (mental weirdness), MYOKYMIA (eye twitches) and VACCINATION SITE RASH (A week and 2 days after the vaccination had a rash on L arm where she was vaccinated). At the time of the report, MUSCLE SPASMS (cramps), MENTAL DISORDER (mental weirdness), ILLNESS (felt quite sick, cramps, shakes, fever, mental weirdness), TREMOR (shakes), VACCINATION SITE RASH (A week and 2 days after the vaccination had a rash on L arm where she was vaccinated) and PYREXIA (fever) had resolved and MYOKYMIA (eye twitches) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medications included vitamins and unspecified inhaler.   No treatment reported.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: first dose of vaccine administered after excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (first dose of vaccine administered after excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  It was reported that approximately 250 to 300 hundred patients were administered  with first dose of the Moderna COVID-19 vaccine.  Treatment information not reported.   This case was linked to MOD-2021-250688 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: accidentally received three doses of the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (accidentally received three doses of the Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (accidentally received three doses of the Moderna COVID-19 vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (accidentally received three doses of the Moderna COVID-19 vaccine) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first dose > 35 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001658) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose > 35 days ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up information received on 23-JUL-2021 and contains non-significant information.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Illness, Oropharyngeal pain, Pyrexia
Clinical narrative: weakness; sick; sore throat; fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), ILLNESS (sick), OROPHARYNGEAL PAIN (sore throat) and PYREXIA (fever) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced ASTHENIA (weakness), ILLNESS (sick), OROPHARYNGEAL PAIN (sore throat) and PYREXIA (fever). On 16-Apr-2021, ILLNESS (sick), OROPHARYNGEAL PAIN (sore throat) and PYREXIA (fever) had resolved. At the time of the report, ASTHENIA (weakness) outcome was unknown.            No Concomitant medications were reported.  No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow-up received: events were updated On 26-Aug-2021: Follow-up information included no new information.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: High blood pressure problems; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure problems) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044H21H and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (High blood pressure problems). At the time of the report, HYPERTENSION (High blood pressure problems) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported.  No treatment drug details was reported.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Chills; Headache; Muscle ache/body aches; Bad fever, fever was 102; Really fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Muscle ache/body aches), PYREXIA (Bad fever, fever was 102), FATIGUE (Really fatigue) and CHILLS (Chills) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced HEADACHE (Headache), MYALGIA (Muscle ache/body aches), PYREXIA (Bad fever, fever was 102) and FATIGUE (Really fatigue). On an unknown date, the patient experienced CHILLS (Chills). On 21-Apr-2021, HEADACHE (Headache), MYALGIA (Muscle ache/body aches), PYREXIA (Bad fever, fever was 102) and FATIGUE (Really fatigue) had resolved. At the time of the report, CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102.         This case was linked to MOD-2021-060351 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up information received on 07 Jul 2021,doses information and  Chills as an event were added
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills; Headache; Muscle ache/body aches; Bad fever, fever was 102; Really fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Muscle ache/body aches), PYREXIA (Bad fever, fever was 102), FATIGUE (Really fatigue) and CHILLS (Chills) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced HEADACHE (Headache), MYALGIA (Muscle ache/body aches), PYREXIA (Bad fever, fever was 102) and FATIGUE (Really fatigue). On an unknown date, the patient experienced CHILLS (Chills). On 21-Apr-2021, HEADACHE (Headache), MYALGIA (Muscle ache/body aches), PYREXIA (Bad fever, fever was 102) and FATIGUE (Really fatigue) had resolved. At the time of the report, CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102.         This case was linked to MOD-2021-060351 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up information received on 07 Jul 2021,doses information and  Chills as an event were added
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Consumer passed 49 days since the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Consumer passed 49 days since the first dose) 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 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Consumer passed 49 days since the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Consumer passed 49 days since the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot
Clinical narrative: Red patch; Warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red patch) and FEELING HOT (Warm to the touch) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078CUA) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced ERYTHEMA (Red patch) and FEELING HOT (Warm to the touch). At the time of the report, ERYTHEMA (Red patch) and FEELING HOT (Warm to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.   Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea
Clinical narrative: Body Pain; Nausea; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Body Pain), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.    Co-suspect product included non-company product NALTREXONE (VIVITROL) injection for Alcohol dependence syndrome.    Concurrent medical conditions included Alcohol dependence syndrome.   On 20-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and NALTREXONE (VIVITROL) (Intramuscular) 380 milligram once a month. On 02-Jun-2021, NALTREXONE (VIVITROL) (Intramuscular) dosage was changed to 380 mg once a month. In 2021, the patient experienced MYALGIA (Body Pain), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, MYALGIA (Body Pain), NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medication was not reported.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Movement disorder, Paraesthesia
Clinical narrative: Tingling sensation; Numbness in left foot; moved into right foot and left leg; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation), HYPOAESTHESIA (Numbness in left foot) and MOVEMENT DISORDER (moved into right foot and left leg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation in 2015 and Cardiac ablation in June 2016. Concurrent medical conditions included Food allergy (Gluten). Concomitant products included PROTANDIM for Antioxidant therapy, CALCIUM, MAGNESIUM, GLUCOSAMINE, MYROXYLON BALSAMUM SYRUP, TERPIN (TERPINE), COLECALCIFEROL (D3), ASCORBIC ACID (C VITAMIN) and VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced MOVEMENT DISORDER (moved into right foot and left leg). On 07-May-2021, the patient experienced PARAESTHESIA (Tingling sensation) and HYPOAESTHESIA (Numbness in left foot). At the time of the report, PARAESTHESIA (Tingling sensation) and MOVEMENT DISORDER (moved into right foot and left leg) had not resolved and HYPOAESTHESIA (Numbness in left foot) outcome was unknown. Not Provided          No treatment medications were provided.   This case was linked to MOD-2021-023882 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (average temperature was 82 to 88 degrees F) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 027B21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (average temperature was 82 to 88 degrees F). On 11-Mar-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (average temperature was 82 to 88 degrees F) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Provider reported that her supervisor instructed the school nurses not to chart the doses administered because the clinic that provided the vaccines to the school district had to complete the charting and documentation. Per the Health regulations, there was no provider agreement for their school nurses to administer vaccines. School nurses never temperature checked throughout the day and did not keep track, it was above 46 degrees F after transport, and believed it was exposed to temperatures of 77 degrees F or higher after being transported in hot car 4 times. She stated the vaccines were kept in hot weather during transport, and believed the vaccine could have been exposed to temperatures around 90 degrees F in the car. She reported that the average temperature was 82 to 88 degrees F in April-2021. No relevant concomitant medications were reported. Treatment information was unknown. This case was linked to MOD-2021-250613 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: aches; fever; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (aches), PYREXIA (fever) and FATIGUE (tiredness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 632L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (Flu shot) in 2006. Past adverse reactions to the above products included Guillain-Barre syndrome with Flu shot. Concurrent medical conditions included Cholesterol since 1999, Diverticulitis since 2002 and Premature ventricular contractions since 2007. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Cardiac disorder, ROSUVASTATIN, ROSUVASTATIN CALCIUM (CRESTOR) and PRAVASTATIN SODIUM (PRAVACHOL) for Cholesterol, PLANTAGO OVATA (METAMUCIL [PLANTAGO OVATA]) for an unknown indication.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (aches), PYREXIA (fever) and FATIGUE (tiredness). At the time of the report, MYALGIA (aches), PYREXIA (fever) and FATIGUE (tiredness) outcome was unknown. Not Provided          No treatment medication was reported.   This case was linked to MOD-2021-011434 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: slightly less terrible reaction to the second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (slightly less terrible reaction to the 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (slightly less terrible reaction to the second shot). At the time of the report, VACCINATION COMPLICATION (slightly less terrible reaction to the second shot) outcome was unknown.            Patient stated she had a immunoglobulin deficiency, and that might have affected the way her body reacted to the vaccine.  Concomitant medication were not reported.  Treatment information was not provided.   This case was linked to MOD-2021-022457 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: Covid-19 infection; missed 42 days interval period; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Covid-19 infection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed 42 days interval period) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19 infection). an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed 42 days interval period). At the time of the report, COVID-19 (Covid-19 infection) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missed 42 days interval period) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment information not provided.   This case was linked to MOD21-118609 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 031A21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 16-Apr-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (second dose of vaccine administered after excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. 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 reported. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD-2021-250494 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Accidental overdose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Accidental overdose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-2021 at 9:12 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced ACCIDENTAL OVERDOSE (Accidental overdose). On 21-May-2021, ACCIDENTAL OVERDOSE (Accidental overdose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not reported. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-162399 (Linked Report).; Sender's Comments:  MOD-2021-162399:Patient no. 4 case linked
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: volume of 1 mL was administered; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (volume of 1 mL was administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced ACCIDENTAL OVERDOSE (volume of 1 mL was administered). On 21-May-2021, ACCIDENTAL OVERDOSE (volume of 1 mL was administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were not provided. No treatment medications were not provided.   This case was linked to MOD-2021-250762, MOD-2021-162399, MOD-2021-250948 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Accidental overdose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Accidental overdose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced ACCIDENTAL OVERDOSE (Accidental overdose). At the time of the report, ACCIDENTAL OVERDOSE (Accidental overdose) outcome was unknown. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitent medications were provided  No treatment medications were provided
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site reaction; Injection site swelling; Injection site redness; Vaccination site Itching; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE REACTION (Injection site reaction), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE PRURITUS (Vaccination site Itching) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis since 2016.    On 18-Feb-2021 at 1:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021 at 9:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE REACTION (Injection site reaction). In 2021, the patient experienced VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE PRURITUS (Vaccination site Itching). On 06-Feb-2021, VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE PRURITUS (Vaccination site Itching) had resolved. On 06-Feb-2021 at 9:00 AM, INJECTION SITE REACTION (Injection site reaction) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported. Treatment Information was not provided by Reporter.   This case was linked to MOD-2021-019671, MOD-2021-019671 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Pain in extremity, Pyrexia, Tendon pain
Clinical narrative: Tendon pain; Aches; Joint pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TENDON PAIN (Tendon pain), PAIN IN EXTREMITY (Aches), ARTHRALGIA (Joint pain) and PYREXIA (Fever) in an 85-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDON PAIN (Tendon pain), PAIN IN EXTREMITY (Aches), ARTHRALGIA (Joint pain) and PYREXIA (Fever). At the time of the report, TENDON PAIN (Tendon pain), PAIN IN EXTREMITY (Aches), ARTHRALGIA (Joint pain) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Increased and 99 (High) Increased.         No concomitant medication was provided.  No treatment medication was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (sore arm). At the time of the report, INJECTION SITE PAIN (sore arm) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not reported. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Body temperature, Chills, Dry eye, Eye pruritus
Clinical narrative: eyes do seem dry; allergic reaction all over the inside and outside of her eyes; slightly warm and a little chilly; eyes also became itchy; feels like a mix of a sunburn and poison ivy in that area; shooting pain up her arm, neck and head; shooting pain up her arm, neck and head; shooting pain up her arm, neck and head; slightly warm and a little chilly; This spontaneous case was reported by a consumer and describes the occurrence of DRY EYE (eyes do seem dry), ALLERGY TO VACCINE (allergic reaction all over the inside and outside of her eyes), FEELING HOT (slightly warm and a little chilly), EYE PRURITUS (eyes also became itchy; feels like a mix of a sunburn and poison ivy in that area) and VACCINATION SITE PAIN (shooting pain up her arm, neck and head) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DRY EYE (eyes do seem dry), ALLERGY TO VACCINE (allergic reaction all over the inside and outside of her eyes), FEELING HOT (slightly warm and a little chilly), EYE PRURITUS (eyes also became itchy; feels like a mix of a sunburn and poison ivy in that area), VACCINATION SITE PAIN (shooting pain up her arm, neck and head), NECK PAIN (shooting pain up her arm, neck and head), HEADACHE (shooting pain up her arm, neck and head) and CHILLS (slightly warm and a little chilly). At the time of the report, DRY EYE (eyes do seem dry), ALLERGY TO VACCINE (allergic reaction all over the inside and outside of her eyes), FEELING HOT (slightly warm and a little chilly), EYE PRURITUS (eyes also became itchy; feels like a mix of a sunburn and poison ivy in that area), VACCINATION SITE PAIN (shooting pain up her arm, neck and head), NECK PAIN (shooting pain up her arm, neck and head), HEADACHE (shooting pain up her arm, neck and head) and CHILLS (slightly warm and a little chilly) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.8 100.8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. treatment to the events given as some eye drops.   This case was linked to MOD-2021-251046 (Patient Link).