chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered with the vaccine which has been stored in the refrigerator for more than 30 days; Stored in the refrigerator for more than 30 days; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Stored in the refrigerator for more than 30 days) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Stored in the refrigerator for more than 30 days). On 21-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Stored in the refrigerator for more than 30 days) 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 medication reported. No treatment information was provided.   This case was linked to MOD-2021-265450 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blood calcium, Chondrocalcinosis pyrophosphate, Decreased activity, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: she developed stiffness in all of her joints (knees, hips and shoulder); she developed stiffness in all of her joints (knees, hips and shoulder); The doctors found a little arthritis in the small of her back; They stated she has pseudo gout; she went from being very active to very inactive; This spontaneous case was reported by a patient and describes the occurrence of JOINT STIFFNESS (she developed stiffness in all of her joints (knees, hips and shoulder)), MUSCULOSKELETAL STIFFNESS (she developed stiffness in all of her joints (knees, hips and shoulder)), SPONDYLITIS (The doctors found a little arthritis in the small of her back), CHONDROCALCINOSIS PYROPHOSPHATE (They stated she has pseudo gout) and DECREASED ACTIVITY (she went from being very active to very inactive) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 002B21A) 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) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced JOINT STIFFNESS (she developed stiffness in all of her joints (knees, hips and shoulder)), MUSCULOSKELETAL STIFFNESS (she developed stiffness in all of her joints (knees, hips and shoulder)), SPONDYLITIS (The doctors found a little arthritis in the small of her back), CHONDROCALCINOSIS PYROPHOSPHATE (They stated she has pseudo gout) and DECREASED ACTIVITY (she went from being very active to very inactive). The patient was treated with DIHYDROCODEINE PHOSPHATE (HYDROCODEINE) for Pain, at an unspecified dose and frequency. At the time of the report, JOINT STIFFNESS (she developed stiffness in all of her joints (knees, hips and shoulder)), MUSCULOSKELETAL STIFFNESS (she developed stiffness in all of her joints (knees, hips and shoulder)), SPONDYLITIS (The doctors found a little arthritis in the small of her back), CHONDROCALCINOSIS PYROPHOSPHATE (They stated she has pseudo gout) and DECREASED ACTIVITY (she went from being very active to very inactive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Blood calcium: high (High) Blood calcium was high.         Patient was treated with unspecified steroids for pain. Concomitant medicine include (Blood pressure medication,Cholesterol Medication,Something for her stomach).   This case was linked to MOD-2021-265643 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Spondylitis
Clinical narrative: she developed stiffness in all of her joints (knees, hips and shoulder); she developed stiffness in all of her joints (knees, hips and shoulder); The doctors found a little arthritis in the small of her back; They stated she has pseudo gout; she went from being very active to very inactive; This spontaneous case was reported by a patient and describes the occurrence of JOINT STIFFNESS (she developed stiffness in all of her joints (knees, hips and shoulder)), MUSCULOSKELETAL STIFFNESS (she developed stiffness in all of her joints (knees, hips and shoulder)), SPONDYLITIS (The doctors found a little arthritis in the small of her back), CHONDROCALCINOSIS PYROPHOSPHATE (They stated she has pseudo gout) and DECREASED ACTIVITY (she went from being very active to very inactive) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 002B21A) 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) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced JOINT STIFFNESS (she developed stiffness in all of her joints (knees, hips and shoulder)), MUSCULOSKELETAL STIFFNESS (she developed stiffness in all of her joints (knees, hips and shoulder)), SPONDYLITIS (The doctors found a little arthritis in the small of her back), CHONDROCALCINOSIS PYROPHOSPHATE (They stated she has pseudo gout) and DECREASED ACTIVITY (she went from being very active to very inactive). The patient was treated with DIHYDROCODEINE PHOSPHATE (HYDROCODEINE) for Pain, at an unspecified dose and frequency. At the time of the report, JOINT STIFFNESS (she developed stiffness in all of her joints (knees, hips and shoulder)), MUSCULOSKELETAL STIFFNESS (she developed stiffness in all of her joints (knees, hips and shoulder)), SPONDYLITIS (The doctors found a little arthritis in the small of her back), CHONDROCALCINOSIS PYROPHOSPHATE (They stated she has pseudo gout) and DECREASED ACTIVITY (she went from being very active to very inactive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Blood calcium: high (High) Blood calcium was high.         Patient was treated with unspecified steroids for pain. Concomitant medicine include (Blood pressure medication,Cholesterol Medication,Something for her stomach).   This case was linked to MOD-2021-265643 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Muscle spasms, Myalgia, Pain in extremity
Clinical narrative: Leg pain; Leg discomfort; Cramps; Joint pain; Muscular pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Leg pain), LIMB DISCOMFORT (Leg discomfort), MUSCLE SPASMS (Cramps), ARTHRALGIA (Joint pain) and MYALGIA (Muscular pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, SIMVASTATIN and ATENOLOL for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Leg pain), LIMB DISCOMFORT (Leg discomfort), MUSCLE SPASMS (Cramps), ARTHRALGIA (Joint pain) and MYALGIA (Muscular pain). The patient was treated with Physical therapy for Pain in extremity; Physical therapy for Limb discomfort; Physical therapy for Muscle spasms; Physical therapy for Arthralgia and Physical therapy for Myalgia. At the time of the report, PAIN IN EXTREMITY (Leg pain), MUSCLE SPASMS (Cramps), ARTHRALGIA (Joint pain) and MYALGIA (Muscular pain) outcome was unknown and LIMB DISCOMFORT (Leg discomfort) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: normal (normal) X-ray showed no arthritis or sciatica.         No concomitant and treatment medications were reported. Patient reported physical therapy to treat the condition.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Leg pain; Leg discomfort; Cramps; Joint pain; Muscular pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Leg pain), LIMB DISCOMFORT (Leg discomfort), MUSCLE SPASMS (Cramps), ARTHRALGIA (Joint pain) and MYALGIA (Muscular pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, SIMVASTATIN and ATENOLOL for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Leg pain), LIMB DISCOMFORT (Leg discomfort), MUSCLE SPASMS (Cramps), ARTHRALGIA (Joint pain) and MYALGIA (Muscular pain). The patient was treated with Physical therapy for Pain in extremity; Physical therapy for Limb discomfort; Physical therapy for Muscle spasms; Physical therapy for Arthralgia and Physical therapy for Myalgia. At the time of the report, PAIN IN EXTREMITY (Leg pain), MUSCLE SPASMS (Cramps), ARTHRALGIA (Joint pain) and MYALGIA (Muscular pain) outcome was unknown and LIMB DISCOMFORT (Leg discomfort) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: normal (normal) X-ray showed no arthritis or sciatica.         No concomitant and treatment medications were reported. Patient reported physical therapy to treat the condition.
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: swollen lip; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of LIP SWELLING (swollen lip) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (swollen lip). At the time of the report, LIP SWELLING (swollen lip) 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 medications were provided. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever after vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever after vaccinated) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever after vaccinated). At the time of the report, PYREXIA (fever after vaccinated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.   Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Feeling abnormal, Feeling jittery, Myalgia
Clinical narrative: Myalgia; Sleepiness; Fatigue extreme; Foggy feeling in head; Feeling jittery; Swollen arm; back pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Myalgia), SOMNOLENCE (Sleepiness), FATIGUE (Fatigue extreme), FEELING ABNORMAL (Foggy feeling in head) and FEELING JITTERY (Feeling jittery) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.      Medical history was not provided. .  Concomitant products included APPLE CIDER VINEGAR, WITHANIA SOMNIFERA ROOT (ASHWAGANDHA ROOT), SAMBUCUS NIGRA (ELDERBERRY EXTRACT), ZINC and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced MYALGIA (Myalgia), SOMNOLENCE (Sleepiness), FATIGUE (Fatigue extreme), FEELING ABNORMAL (Foggy feeling in head), FEELING JITTERY (Feeling jittery), PERIPHERAL SWELLING (Swollen arm) and BACK PAIN (back pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1000 mg. On 22-Jul-2021, BACK PAIN (back pain) had resolved. At the time of the report, MYALGIA (Myalgia), SOMNOLENCE (Sleepiness), FATIGUE (Fatigue extreme), FEELING ABNORMAL (Foggy feeling in head), FEELING JITTERY (Feeling jittery) and PERIPHERAL SWELLING (Swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Somnolence
Clinical narrative: Myalgia; Sleepiness; Fatigue extreme; Foggy feeling in head; Feeling jittery; Swollen arm; back pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Myalgia), SOMNOLENCE (Sleepiness), FATIGUE (Fatigue extreme), FEELING ABNORMAL (Foggy feeling in head) and FEELING JITTERY (Feeling jittery) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.      Medical history was not provided. .  Concomitant products included APPLE CIDER VINEGAR, WITHANIA SOMNIFERA ROOT (ASHWAGANDHA ROOT), SAMBUCUS NIGRA (ELDERBERRY EXTRACT), ZINC and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced MYALGIA (Myalgia), SOMNOLENCE (Sleepiness), FATIGUE (Fatigue extreme), FEELING ABNORMAL (Foggy feeling in head), FEELING JITTERY (Feeling jittery), PERIPHERAL SWELLING (Swollen arm) and BACK PAIN (back pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1000 mg. On 22-Jul-2021, BACK PAIN (back pain) had resolved. At the time of the report, MYALGIA (Myalgia), SOMNOLENCE (Sleepiness), FATIGUE (Fatigue extreme), FEELING ABNORMAL (Foggy feeling in head), FEELING JITTERY (Feeling jittery) and PERIPHERAL SWELLING (Swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Unable to get the second dose/ received my first dose of the Moderna vaccine in December 2020; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Unable to get the second dose/ received my first dose of the Moderna vaccine in December 2020) and NO ADVERSE EVENT (She did not experience any side effects) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 (Unable to get the second dose/ received my first dose of the Moderna vaccine in December 2020) and NO ADVERSE EVENT (She did not experience any side effects). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Unable to get the second dose/ received my first dose of the Moderna vaccine in December 2020) had resolved and NO ADVERSE EVENT (She did not experience any side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received contains Reporter's information(Address1,phone number, email, state, postal code, city)updated. Patient details updated except initials. Event(no adverse effect)added.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: was sick for a few days; got a fever; 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 ILLNESS (was sick for a few days) and PYREXIA (got a fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (was sick for a few days) and PYREXIA (got a fever). At the time of the report, ILLNESS (was sick for a few days) and PYREXIA (got a fever) 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
Sex: U
Vaccine: COVID19
Symptoms: Injection site induration, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Sore hardened area at injection site; Had body aches; Lowfever; Sore hardened area at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (Sore hardened area at injection site), MYALGIA (Had body aches), PYREXIA (Lowfever) and VACCINATION SITE PAIN (Sore hardened area at injection site) 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 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, the patient experienced INJECTION SITE INDURATION (Sore hardened area at injection site), MYALGIA (Had body aches), PYREXIA (Lowfever) and VACCINATION SITE PAIN (Sore hardened area at injection site). At the time of the report, INJECTION SITE INDURATION (Sore hardened area at injection site), MYALGIA (Had body aches), PYREXIA (Lowfever) and VACCINATION SITE PAIN (Sore hardened area at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site; 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 VACCINATION SITE PAIN (pain at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Device connection issue
Clinical narrative: wrong with the syringe; most of the vaccine dose went down the patients arm; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (most of the vaccine dose went down the patients arm) and DEVICE CONNECTION ISSUE (wrong with the syringe) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced ACCIDENTAL UNDERDOSE (most of the vaccine dose went down the patients arm). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (wrong with the syringe). At the time of the report, ACCIDENTAL UNDERDOSE (most of the vaccine dose went down the patients arm) had resolved and DEVICE CONNECTION ISSUE (wrong with the syringe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up received non significant fax number added.
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Vaccine came out of a joint between the needle and syringe  and he  must have missed the portion of  the dose.; Vaccine came out of a joint between the needle and syringe  and he  must have missed the portion of  the dose.; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Vaccine came out of a joint between the needle and syringe  and he  must have missed the portion of  the dose.) and DEVICE CONNECTION ISSUE (Vaccine came out of a joint between the needle and syringe  and he  must have missed the portion of  the dose.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    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 UNDERDOSE (Vaccine came out of a joint between the needle and syringe  and he  must have missed the portion of  the dose.) and DEVICE CONNECTION ISSUE (Vaccine came out of a joint between the needle and syringe  and he  must have missed the portion of  the dose.). At the time of the report, UNDERDOSE (Vaccine came out of a joint between the needle and syringe  and he  must have missed the portion of  the dose.) and DEVICE CONNECTION ISSUE (Vaccine came out of a joint between the needle and syringe  and he  must have missed the portion of  the dose.) had resolved.            No concomitant medications were reported.  No treatment information was provided.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: 18 years old and right now she's experiencing a lot of pain; little fever going on it seems to be 101; lots of body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (18 years old and right now she's experiencing a lot of pain), PYREXIA (little fever going on it seems to be 101) and MYALGIA (lots of body aches) in an 18-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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (18 years old and right now she's experiencing a lot of pain), PYREXIA (little fever going on it seems to be 101) and MYALGIA (lots of body aches). At the time of the report, PAIN (18 years old and right now she's experiencing a lot of pain), PYREXIA (little fever going on it seems to be 101) and MYALGIA (lots of body aches) had not resolved.            No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Hypoaesthesia
Clinical narrative: numbness on the left side of the body; Balance issues; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness on the left side of the body) and BALANCE DISORDER (balance issues) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012MQ0A and 001A21A) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (OLMESARTAN + HIDROCLOROTIAZIDA SANDOZ) and METOPROLOL for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-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 HYPOAESTHESIA (numbness on the left side of the body) and BALANCE DISORDER (balance issues). At the time of the report, HYPOAESTHESIA (numbness on the left side of the body) and BALANCE DISORDER (balance issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered with the vaccine which has been stored in the refrigerator for more than 30 days; administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 19-Jul-2021, the patient experienced PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days). At the time of the report, PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.     Reporter did not allow further contact
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Illness
Clinical narrative: unbearable abdominal pain; extremely sick; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (unbearable abdominal pain) and ILLNESS (extremely sick) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 039BZIA) 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) (unknown route) 1 dosage form. On 18-Jul-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 PAIN (unbearable abdominal pain) and ILLNESS (extremely sick). At the time of the report, ABDOMINAL PAIN (unbearable abdominal pain) and ILLNESS (extremely sick) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: a patient who had previously had 2 doses of Pfizer vaccine (he doesn't know when) received 1 dose of the Moderna vaccine on 21Jul2021; This spontaneous case was reported by a health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (a patient who had previously had 2 doses of Pfizer vaccine (he doesn't know when) received 1 dose of the Moderna vaccine on 21Jul2021) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 21-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 21-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (a patient who had previously had 2 doses of Pfizer vaccine (he doesn't know when) received 1 dose of the Moderna vaccine on 21Jul2021). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (a patient who had previously had 2 doses of Pfizer vaccine (he doesn't know when) received 1 dose of the Moderna vaccine on 21Jul2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was received by the patient No Treatment was received by the patient.  Patient had had 2 doses of Pfizer vaccine (he doesn't know when it has been administered)
Sex: F
Vaccine: COVID19
Symptoms: Sinus tachycardia
Clinical narrative: She has been to a cardiologist, who diagnosed her with IST; This spontaneous case was reported by a consumer and describes the occurrence of SINUS TACHYCARDIA (She has been to a cardiologist, who diagnosed her with IST) 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 26-Apr-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 an unknown date, the patient experienced SINUS TACHYCARDIA (She has been to a cardiologist, who diagnosed her with IST). At the time of the report, SINUS TACHYCARDIA (She has been to a cardiologist, who diagnosed her with IST) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.   Reporter did not allow further contact
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered with the vaccine which has been stored in the refrigerator for more than 30 days; administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) in an 82-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 19-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 19-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Limb mass, Pruritus, Swelling, Tenderness
Clinical narrative: Today my arm has a knot; Arm itches; Soft, tender area near collar bone; Swollen area near my collar bone; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Jul-2021 and was forwarded to Moderna on 25-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LIMB MASS (Today my arm has a knot), PRURITUS (Arm itches), TENDERNESS (Soft, tender area near collar bone) and SWELLING (Swollen area near my collar bone) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIMB MASS (Today my arm has a knot), PRURITUS (Arm itches), TENDERNESS (Soft, tender area near collar bone) and SWELLING (Swollen area near my collar bone). At the time of the report, LIMB MASS (Today my arm has a knot), PRURITUS (Arm itches), TENDERNESS (Soft, tender area near collar bone) and SWELLING (Swollen area near my collar bone) outcome was unknown.            No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site got very swollen, itchy, warm to the touch; A rash spreading almost to her elbow; Injection site got very swollen, itchy, warm to the touch, hard and red; The injection site got very itchy; Injection site got very swollen; injection site got very swollen, itchy, warm to the touch, hard and red; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE WARMTH (Injection site got very swollen, itchy, warm to the touch), RASH (A rash spreading almost to her elbow), VACCINATION SITE INDURATION (Injection site got very swollen, itchy, warm to the touch, hard and red), VACCINATION SITE PRURITUS (The injection site got very itchy) and VACCINATION SITE SWELLING (Injection site got very swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced VACCINATION SITE WARMTH (Injection site got very swollen, itchy, warm to the touch), RASH (A rash spreading almost to her elbow), VACCINATION SITE INDURATION (Injection site got very swollen, itchy, warm to the touch, hard and red), VACCINATION SITE PRURITUS (The injection site got very itchy), VACCINATION SITE SWELLING (Injection site got very swollen) and VACCINATION SITE ERYTHEMA (injection site got very swollen, itchy, warm to the touch, hard and red). At the time of the report, VACCINATION SITE WARMTH (Injection site got very swollen, itchy, warm to the touch), RASH (A rash spreading almost to her elbow), VACCINATION SITE INDURATION (Injection site got very swollen, itchy, warm to the touch, hard and red), VACCINATION SITE PRURITUS (The injection site got very itchy), VACCINATION SITE SWELLING (Injection site got very swollen) and VACCINATION SITE ERYTHEMA (injection site got very swollen, itchy, warm to the touch, hard and red) had not 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 medication were reported.   No treatment medication was reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Injection site got very swollen, itchy, warm to the touch; A rash spreading almost to her elbow; Injection site got very swollen, itchy, warm to the touch, hard and red; The injection site got very itchy; Injection site got very swollen; injection site got very swollen, itchy, warm to the touch, hard and red; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE WARMTH (Injection site got very swollen, itchy, warm to the touch), RASH (A rash spreading almost to her elbow), VACCINATION SITE INDURATION (Injection site got very swollen, itchy, warm to the touch, hard and red), VACCINATION SITE PRURITUS (The injection site got very itchy) and VACCINATION SITE SWELLING (Injection site got very swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced VACCINATION SITE WARMTH (Injection site got very swollen, itchy, warm to the touch), RASH (A rash spreading almost to her elbow), VACCINATION SITE INDURATION (Injection site got very swollen, itchy, warm to the touch, hard and red), VACCINATION SITE PRURITUS (The injection site got very itchy), VACCINATION SITE SWELLING (Injection site got very swollen) and VACCINATION SITE ERYTHEMA (injection site got very swollen, itchy, warm to the touch, hard and red). At the time of the report, VACCINATION SITE WARMTH (Injection site got very swollen, itchy, warm to the touch), RASH (A rash spreading almost to her elbow), VACCINATION SITE INDURATION (Injection site got very swollen, itchy, warm to the touch, hard and red), VACCINATION SITE PRURITUS (The injection site got very itchy), VACCINATION SITE SWELLING (Injection site got very swollen) and VACCINATION SITE ERYTHEMA (injection site got very swollen, itchy, warm to the touch, hard and red) had not 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 medication were reported.   No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: soreness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (soreness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (soreness). At the time of the report, ARTHRALGIA (soreness) outcome was unknown.            No concomitant medicines were reported Treatment information was not provided   Reporter did not allow further contact
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: Pretty bad anxiety; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Pretty bad anxiety) in a 20-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) at an unspecified dose. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced ANXIETY (Pretty bad anxiety). At the time of the report, ANXIETY (Pretty bad anxiety) had not resolved.            Patient reports not taking any concomitant medications. No treatment details were reported.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered with the vaccine which has been stored in the refrigerator for more than 30 days; administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days). On 19-Jul-2021, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-265450 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Neck pain, Oropharyngeal pain
Clinical narrative: sore throat; Neck pain; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and NECK PAIN (Neck pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and NECK PAIN (Neck pain). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and NECK PAIN (Neck pain) outcome was unknown.            Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-239060 (Patient Link).
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Tinnitus
Clinical narrative: Ringing in both ears; Soreness in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in both ears) and MYALGIA (Soreness in injection arm) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     Concomitant products included FINASTERIDE (PROPECIA) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced MYALGIA (Soreness in injection arm). On 23-Jul-2021, the patient experienced TINNITUS (Ringing in both ears). At the time of the report, TINNITUS (Ringing in both ears) and MYALGIA (Soreness in injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.