chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of COVID-19 (COVID-19 positive after vaccination) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced COVID-19 (COVID-19 positive after vaccination). At the time of the report, COVID-19 (COVID-19 positive after vaccination) outcome: unknown. Diagnostic results: On an unknown date, SARS-CoV-2 test: positive. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever; Nausea; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 014C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 1980, Hypertension since 2004, High cholesterol since 2004, Prediabetes since 2015, Drug allergy (allergy to local Anaesthetics), Allergy to antibiotic (allergy to sulfa) and Allergy to venom (Bee wasp venom). Concomitant products included ATORVASTATIN for High cholesterol, METOPROLOL and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN + HIDROCLOROTIAZIDA) for Hypertension, LEVOTHYROXINE for Hypothyroidism, METFORMIN for Prediabetes, VITAMIN B COMPLEX and VITAMIN D NOS for an unknown indication.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021 at 10:50 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced PYREXIA (Fever), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with IBUPROFEN for Adverse event, at a dose of 600 milligram. On 28-May-2021, PYREXIA (Fever), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headache) had resolved.            This case was linked to MOD-2021-100659 (Patient Link).
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: arm sore; no strength on his arm; pain in his arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in his arm), FATIGUE (fatigue), MYALGIA (arm sore) and MUSCULAR WEAKNESS (no strength on his arm) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033b21a and 026d21a) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN from an unknown date to 19-Jul-2021 for an unknown indication.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jul-2021, the patient experienced PAIN IN EXTREMITY (pain in his arm), FATIGUE (fatigue) and MUSCULAR WEAKNESS (no strength on his arm). On an unknown date, the patient experienced MYALGIA (arm sore). On 20-Jul-2021, FATIGUE (fatigue) had resolved. At the time of the report, PAIN IN EXTREMITY (pain in his arm) and MYALGIA (arm sore) had not resolved and MUSCULAR WEAKNESS (no strength on his arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were not provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Feeling abnormal, Headache, Nasal congestion
Clinical narrative: she started feeling bad and had to stay in bed initially; dry mouth; stuffy nose (can't breathe through nose); headaches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she started feeling bad and had to stay in bed initially), DRY MOUTH (dry mouth), NASAL CONGESTION (stuffy nose (can't breathe through nose)) and HEADACHE (headaches) in an 84-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 FEELING ABNORMAL (she started feeling bad and had to stay in bed initially), DRY MOUTH (dry mouth), NASAL CONGESTION (stuffy nose (can't breathe through nose)) and HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (she started feeling bad and had to stay in bed initially), DRY MOUTH (dry mouth), NASAL CONGESTION (stuffy nose (can't breathe through nose)) and HEADACHE (headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment details include vicks, dry mouth spray.
Sex: U
Vaccine: COVID19
Symptoms: Anaemia, COVID-19
Clinical narrative: I then discovered I was severely anemic; Getting COVID After the Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (I then discovered I was severely anemic) and COVID-19 (Getting COVID After the Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAEMIA (I then discovered I was severely anemic) and COVID-19 (Getting COVID After the Vaccine). At the time of the report, ANAEMIA (I then discovered I was severely anemic) and COVID-19 (Getting COVID After the Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received and does not contain any new information
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose administered at <21 days after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered at <21 days after the first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered at <21 days after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered at <21 days after the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) was not applicable. Concomitant and Treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: soreness/How can i combat soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness/How can i combat 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (soreness/How can i combat soreness). At the time of the report, PAIN (soreness/How can i combat soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Emotional distress
Clinical narrative: Emotional distress; 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 EMOTIONAL DISTRESS (Emotional distress) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EMOTIONAL DISTRESS (Emotional distress). At the time of the report, EMOTIONAL DISTRESS (Emotional distress) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Not sure if got second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Not sure if got second dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043221A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not sure if got second dose). On 20-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Not sure if got second dose) had resolved.            Concomitant product use was not provided. Treatment information was not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Myalgia
Clinical narrative: Foggy memory; Arm soreness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Foggy memory), MYALGIA (Arm soreness) and FATIGUE (Tiredness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (Foggy memory), MYALGIA (Arm soreness) and FATIGUE (Tiredness). At the time of the report, CONFUSIONAL STATE (Foggy memory), MYALGIA (Arm soreness) and FATIGUE (Tiredness) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product dose omission issue
Clinical narrative: never received a second dose; 12 year old  Vaccinated with Moderna COVID-19 Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old  Vaccinated with Moderna COVID-19 Vaccine) and PRODUCT DOSE OMISSION ISSUE (never received a second dose) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old  Vaccinated with Moderna COVID-19 Vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (never received a second dose). On 17-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old  Vaccinated with Moderna COVID-19 Vaccine) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (never received a second dose) 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 were not reported. No treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received on 21-JUL-2021 contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received second  dose  5 days after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second  dose  5 days after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second  dose  5 days after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second  dose  5 days after first dose) 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 were reported.  No treatment information was provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site mass, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: I couldn't lift my arm the next day/it hurt just to move it; arm had a lump in it/lump was bigger than half dollar/I could feel the lump/super lumpy felt like peanut butter under my skin; but it was somewhat painful; really, really red; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (I couldn't lift my arm the next day/it hurt just to move it), VACCINATION SITE MASS (arm had a lump in it/lump was bigger than half dollar/I could feel the lump/super lumpy felt like peanut butter under my skin), VACCINATION SITE PAIN (but it was somewhat painful), VACCINATION SITE ERYTHEMA (really, really red) and MYALGIA (sore arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included USTEKINUMAB (STELARA) and INDOMETHACIN [INDOMETACIN] for an unknown indication.    On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (I couldn't lift my arm the next day/it hurt just to move it), VACCINATION SITE MASS (arm had a lump in it/lump was bigger than half dollar/I could feel the lump/super lumpy felt like peanut butter under my skin), VACCINATION SITE PAIN (but it was somewhat painful), VACCINATION SITE ERYTHEMA (really, really red) and MYALGIA (sore arm). The patient was treated with TEA TREE OIL at an unspecified dose and frequency. On 05-Jul-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (I couldn't lift my arm the next day/it hurt just to move it), VACCINATION SITE MASS (arm had a lump in it/lump was bigger than half dollar/I could feel the lump/super lumpy felt like peanut butter under my skin), VACCINATION SITE PAIN (but it was somewhat painful), VACCINATION SITE ERYTHEMA (really, really red) and MYALGIA (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       for mRNA-1273 (Moderna COVID-19 Vaccine) (intamuscular), the reporter did not provide any causality assessment.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Illness, Myalgia
Clinical narrative: Foggy memory; Her husband got sick; Arm soreness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Foggy memory), ILLNESS (Her husband got sick), MYALGIA (Arm soreness) and FATIGUE (Tiredness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   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. In May 2021, the patient experienced CONFUSIONAL STATE (Foggy memory). In 2021, the patient experienced ILLNESS (Her husband got sick), MYALGIA (Arm soreness) and FATIGUE (Tiredness). At the time of the report, CONFUSIONAL STATE (Foggy memory), MYALGIA (Arm soreness) and FATIGUE (Tiredness) outcome was unknown and ILLNESS (Her husband got sick) had resolved.            Concomitant medications details are not provided by the Reporter. No treatment information is provided. Action taken with mRNA is not applicable.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Inappropriate schedule of product administration
Clinical narrative: 20 something days prior to the second; Numbness in his biceps (in both arms)/numbness in his fingertips (in both arms); This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in his biceps (in both arms)/numbness in his fingertips (in both arms)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (20 something days prior to the second) in a 44-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) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced HYPOAESTHESIA (Numbness in his biceps (in both arms)/numbness in his fingertips (in both arms)). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (20 something days prior to the second). At the time of the report, HYPOAESTHESIA (Numbness in his biceps (in both arms)/numbness in his fingertips (in both arms)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (20 something days prior to the second) 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 relevant concomitant medications were reported. No treatment information was provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: aches; stiffness; numbness; tingling/needle like feeling in her  left arm.; ache in her neck and left shoulder; upon pressing the injection; tiredness; ache in her neck and left shoulder; soreness; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), MUSCULOSKELETAL STIFFNESS (stiffness), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling/needle like feeling in her  left arm.) and NECK PAIN (ache in her neck and left shoulder) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IRON for an unknown indication.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, 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 PAIN (aches), MUSCULOSKELETAL STIFFNESS (stiffness), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling/needle like feeling in her  left arm.), NECK PAIN (ache in her neck and left shoulder), VACCINATION SITE PAIN (upon pressing the injection), FATIGUE (tiredness), ARTHRALGIA (ache in her neck and left shoulder), MYALGIA (soreness), PYREXIA (fever) and HEADACHE (headache). The patient was treated with MELOXICAM at a dose of 15 mg once a day. At the time of the report, PAIN (aches), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling/needle like feeling in her  left arm.), NECK PAIN (ache in her neck and left shoulder), VACCINATION SITE PAIN (upon pressing the injection), FATIGUE (tiredness), ARTHRALGIA (ache in her neck and left shoulder), MYALGIA (soreness), PYREXIA (fever) and HEADACHE (headache) outcome was unknown and MUSCULOSKELETAL STIFFNESS (stiffness) was resolving.            Patient was referred to physical therapy for 6 week  Patient was  ordered EMG test by her doctor.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Pain, Paraesthesia, Pyrexia
Clinical narrative: aches; stiffness; numbness; tingling/needle like feeling in her  left arm.; ache in her neck and left shoulder; upon pressing the injection; tiredness; ache in her neck and left shoulder; soreness; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), MUSCULOSKELETAL STIFFNESS (stiffness), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling/needle like feeling in her  left arm.) and NECK PAIN (ache in her neck and left shoulder) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IRON for an unknown indication.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, 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 PAIN (aches), MUSCULOSKELETAL STIFFNESS (stiffness), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling/needle like feeling in her  left arm.), NECK PAIN (ache in her neck and left shoulder), VACCINATION SITE PAIN (upon pressing the injection), FATIGUE (tiredness), ARTHRALGIA (ache in her neck and left shoulder), MYALGIA (soreness), PYREXIA (fever) and HEADACHE (headache). The patient was treated with MELOXICAM at a dose of 15 mg once a day. At the time of the report, PAIN (aches), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling/needle like feeling in her  left arm.), NECK PAIN (ache in her neck and left shoulder), VACCINATION SITE PAIN (upon pressing the injection), FATIGUE (tiredness), ARTHRALGIA (ache in her neck and left shoulder), MYALGIA (soreness), PYREXIA (fever) and HEADACHE (headache) outcome was unknown and MUSCULOSKELETAL STIFFNESS (stiffness) was resolving.            Patient was referred to physical therapy for 6 week  Patient was  ordered EMG test by her doctor.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: aches; stiffness; numbness; tingling/needle like feeling in her  left arm.; ache in her neck and left shoulder; upon pressing the injection; tiredness; ache in her neck and left shoulder; soreness; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), MUSCULOSKELETAL STIFFNESS (stiffness), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling/needle like feeling in her  left arm.) and NECK PAIN (ache in her neck and left shoulder) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IRON for an unknown indication.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, 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 PAIN (aches), MUSCULOSKELETAL STIFFNESS (stiffness), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling/needle like feeling in her  left arm.), NECK PAIN (ache in her neck and left shoulder), VACCINATION SITE PAIN (upon pressing the injection), FATIGUE (tiredness), ARTHRALGIA (ache in her neck and left shoulder), MYALGIA (soreness), PYREXIA (fever) and HEADACHE (headache). The patient was treated with MELOXICAM at a dose of 15 mg once a day. At the time of the report, PAIN (aches), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling/needle like feeling in her  left arm.), NECK PAIN (ache in her neck and left shoulder), VACCINATION SITE PAIN (upon pressing the injection), FATIGUE (tiredness), ARTHRALGIA (ache in her neck and left shoulder), MYALGIA (soreness), PYREXIA (fever) and HEADACHE (headache) outcome was unknown and MUSCULOSKELETAL STIFFNESS (stiffness) was resolving.            Patient was referred to physical therapy for 6 week  Patient was  ordered EMG test by her doctor.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: My left shoulder after 2 months is in constant pain; Second shot in my right arm shoulder, I'm starting to get the same pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (My left shoulder after 2 months is in constant pain) and ARTHRALGIA (Second shot in my right arm shoulder, I'm starting to get the same pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 ARTHRALGIA (My left shoulder after 2 months is in constant pain) and ARTHRALGIA (Second shot in my right arm shoulder, I'm starting to get the same pain). At the time of the report, ARTHRALGIA (My left shoulder after 2 months is in constant pain) and ARTHRALGIA (Second shot in my right arm shoulder, I'm starting to get the same pain) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to a patient.( It was administed out a of vial that was punctured more than 12 hours ago); 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 EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient.( It was administed out a of vial that was punctured more than 12 hours ago)) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient.( It was administed out a of vial that was punctured more than 12 hours ago)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to a patient.( It was administed out a of vial that was punctured more than 12 hours 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.   Concomitant medication was not provided  Treatment information was not reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Joint range of motion decreased, Mobility decreased, Pain in extremity
Clinical narrative: 1 week after receiving Moderna booster, patient experienced difficulty moving her right arm. She does not have full range of motion. She cannot put her arm behind her back and has some pain in her right arm. Last week she asked about it and all the doctor said was maybe the pharmacist hit a bone.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pruritus, Urticaria
Clinical narrative: five (5)  hives on her body; itchy hives/itching; she could not sleep last night; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (five (5)  hives on her body), PRURITUS (itchy hives/itching) and INSOMNIA (she could not sleep last night) 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 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, the patient experienced URTICARIA (five (5)  hives on her body), PRURITUS (itchy hives/itching) and INSOMNIA (she could not sleep last night). At the time of the report, URTICARIA (five (5)  hives on her body), PRURITUS (itchy hives/itching) and INSOMNIA (she could not sleep last night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Faeces discoloured, Fatigue, Hot flush
Clinical narrative: Hot flashes radiating from feet to my head still going on 2 weeks. Extreme fatigue last  2 weeks. Nausea on off for 2 weeks Vomiting for first 3 days. Extreme muscle pain for over week, to the point of unable to do much. Diarrahea that is yellowish tint for over a week. Extreme dizziness.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Vomiting
Clinical narrative: Hot flashes radiating from feet to my head still going on 2 weeks. Extreme fatigue last  2 weeks. Nausea on off for 2 weeks Vomiting for first 3 days. Extreme muscle pain for over week, to the point of unable to do much. Diarrahea that is yellowish tint for over a week. Extreme dizziness.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Erythema, Swelling
Clinical narrative: Two days after vaccination, I had swelling from the left side chest cavity and underarm. Also, some skin redness and soreness in armpit! It lasted 3-4 days.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Menstrual disorder, Smear cervix, Ultrasound pelvis, Uterine haemorrhage
Clinical narrative: I began having uterine bleeding a little over 2 weeks (6/17/2021) after the 2nd vaccine on 6/1/2021. First vaccine 5/11/2021. I am 69 years old. I have had regular menstrual bleeding every month since then. I have been in menopause since age 50. My doctors have done ultrasound and  labs. They found no reason for the bleeding.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chronic fatigue syndrome, Condition aggravated, Diarrhoea, Feeling abnormal
Clinical narrative: It cause my relapse to worsen and I have had diarrhea since. Still dealing with it. I have lost weight and feel horrible.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pancreatic enzymes, Post viral fatigue syndrome, Weight decreased
Clinical narrative: It cause my relapse to worsen and I have had diarrhea since. Still dealing with it. I have lost weight and feel horrible.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia oral, Lip swelling, Paraesthesia, Vaccination complication
Clinical narrative: Issues after first dose (A few hours after first vaccine); Numbness in the Lips  (A few hours after first vaccine); Swollen Lips  (A few hours after first vaccine); Short Breath  (A few hours after first vaccine); Tingling on one side of the Face and Lips  (A few hours after first vaccine); This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Issues after first dose (A few hours after first vaccine)), HYPOAESTHESIA ORAL (Numbness in the Lips  (A few hours after first vaccine)), LIP SWELLING (Swollen Lips  (A few hours after first vaccine)), DYSPNOEA (Short Breath  (A few hours after first vaccine)) and PARAESTHESIA (Tingling on one side of the Face and Lips  (A few hours after first vaccine)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced VACCINATION COMPLICATION (Issues after first dose (A few hours after first vaccine)), HYPOAESTHESIA ORAL (Numbness in the Lips  (A few hours after first vaccine)), LIP SWELLING (Swollen Lips  (A few hours after first vaccine)), DYSPNOEA (Short Breath  (A few hours after first vaccine)) and PARAESTHESIA (Tingling on one side of the Face and Lips  (A few hours after first vaccine)). At the time of the report, VACCINATION COMPLICATION (Issues after first dose (A few hours after first vaccine)), HYPOAESTHESIA ORAL (Numbness in the Lips  (A few hours after first vaccine)), LIP SWELLING (Swollen Lips  (A few hours after first vaccine)), DYSPNOEA (Short Breath  (A few hours after first vaccine)) and PARAESTHESIA (Tingling on one side of the Face and Lips  (A few hours after first vaccine)) 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 reported It was reported that the patient was admitted to the emergency room after the first shot and failed to inform the ER about  taking the vaccine. Pharmacist was unaware of patient taking antihistamine. It was reported that the patient had a Thyroid biopsy after the first shot. Pharmacist did not give the second shot to the patient.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain, Pain in extremity
Clinical narrative: severe shooting pain to his neck; severe shooting pain down his left arm/sever shooting pain down to his left hand/severe shooting pain in his toes; severe shooting pain in his left shoulder, to his neck, down his left arm, to his hand, knee joints and toes.; severe shooting pain in his left shoulder//severe shooting pain in his knee joints; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (severe shooting pain to his neck), PAIN IN EXTREMITY (severe shooting pain down his left arm/sever shooting pain down to his left hand/severe shooting pain in his toes), PAIN (severe shooting pain in his left shoulder, to his neck, down his left arm, to his hand, knee joints and toes.) and ARTHRALGIA (severe shooting pain in his left shoulder//severe shooting pain in his knee joints) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced NECK PAIN (severe shooting pain to his neck), PAIN IN EXTREMITY (severe shooting pain down his left arm/sever shooting pain down to his left hand/severe shooting pain in his toes), PAIN (severe shooting pain in his left shoulder, to his neck, down his left arm, to his hand, knee joints and toes.) and ARTHRALGIA (severe shooting pain in his left shoulder//severe shooting pain in his knee joints). On 10-Feb-2021, NECK PAIN (severe shooting pain to his neck), PAIN IN EXTREMITY (severe shooting pain down his left arm/sever shooting pain down to his left hand/severe shooting pain in his toes), PAIN (severe shooting pain in his left shoulder, to his neck, down his left arm, to his hand, knee joints and toes.) and ARTHRALGIA (severe shooting pain in his left shoulder//severe shooting pain in his knee joints) had resolved.            Concomitant product was not provided by the reporter  Treatment information was not provided   This case was linked to MOD-2021-261775 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Not receiving the 2nd dose after receiving 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Not receiving the 2nd dose after receiving 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2020, 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 (Not receiving the 2nd dose after receiving 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Not receiving the 2nd dose after receiving 1st dose) 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 relevant concomitant medication was reported. The treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: partial dose; syringe was faulty; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Jul-2021 and was forwarded to Moderna on 20-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (partial dose) and DEVICE CONNECTION ISSUE (syringe was faulty) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 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 UNDERDOSE (partial dose) and DEVICE CONNECTION ISSUE (syringe was faulty). At the time of the report, UNDERDOSE (partial dose) and DEVICE CONNECTION ISSUE (syringe was faulty) outcome was unknown.            Concomitant product was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Past the 42 day mark, 6 weeks since 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Past the 42 day mark, 6 weeks since 1st dose) in a 62-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past the 42 day mark, 6 weeks since 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Past the 42 day mark, 6 weeks since 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Updated contact details and patient information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Pruritus, Rash, Urticaria
Clinical narrative: felt like got  an  infection; small red welts rash/Rash like big round red welts all over; itched a lot; small rash/Rash like big round red welts all over; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (felt like got  an  infection), URTICARIA (small red welts rash/Rash like big round red welts all over), PRURITUS (itched a lot) and RASH (small rash/Rash like big round red welts all over) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027821A and 010A21A) for COVID-19 vaccination.     Concomitant products included VITAMIN D [VITAMIN D NOS], METFORMIN, AMLODIPINE, GLIMEPIRIDE, LOVASTATIN, SITAGLIPTIN PHOSPHATE (JANUVIA), METOPROLOL and INSULIN GLARGINE (LANTUS) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced INFECTION (felt like got  an  infection), URTICARIA (small red welts rash/Rash like big round red welts all over), PRURITUS (itched a lot) and RASH (small rash/Rash like big round red welts all over). The patient was treated with HYDROCORTISONE (topical) for Rash and Itch, at an unspecified dose and frequency; CLOBETASOL (topical) for Itch and Rash, at an unspecified dose and frequency and TRIAMCINOLONE (topical) for Infection, Rash and Itch, at an unspecified dose and frequency. At the time of the report, INFECTION (felt like got  an  infection), URTICARIA (small red welts rash/Rash like big round red welts all over), PRURITUS (itched a lot) and RASH (small rash/Rash like big round red welts all over) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included Muscle Relaxer, Blood pressure medications, Gout medication, Pain medication, Stomach medication, Cholesterol medication.  Treatment medications oral steroid to treat the symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up document contained information such as patient details, concomitant and treatment medications, additional events which were updated.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Exertional headache, Product dose omission issue
Clinical narrative: 6 weeks since my 21 year old son got the first dose of vaccine; he is having exertional headaches; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (6 weeks since my 21 year old son got the first dose of vaccine) and EXERTIONAL HEADACHE (he is having exertional headaches) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (6 weeks since my 21 year old son got the first dose of vaccine) and EXERTIONAL HEADACHE (he is having exertional headaches). At the time of the report, PRODUCT DOSE OMISSION ISSUE (6 weeks since my 21 year old son got the first dose of vaccine) and EXERTIONAL HEADACHE (he is having exertional headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment drugs were reported
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Gait disturbance, Joint swelling, Myalgia
Clinical narrative: Burning sensation on the bottom of their feet; Body aches; Joint pain (elbows, knees, and ankles); Low grade fever; Could hardly walk; Both knees were swollen; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Could hardly walk), JOINT SWELLING (Both knees were swollen), BURNING SENSATION (Burning sensation on the bottom of their feet), MYALGIA (Body aches) and ARTHRALGIA (Joint pain (elbows, knees, and ankles)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007D21A and 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis, Blood pressure high and Hypercholesteremia. Concomitant products included AMLODIPINE for Blood pressure high, PRAVASTATIN for Hypercholesteraemia, HYDROXYCHLOROQUINE for Rheumatoid arthritis, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]), VITAMIN D [VITAMIN D NOS], VITAMIN K3 [MENADIONE] and FOLIC ACID for an unknown indication.   On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jul-2021, the patient experienced GAIT DISTURBANCE (Could hardly walk), JOINT SWELLING (Both knees were swollen), MYALGIA (Body aches), ARTHRALGIA (Joint pain (elbows, knees, and ankles)) and PYREXIA (Low grade fever). On 20-Jul-2021, the patient experienced BURNING SENSATION (Burning sensation on the bottom of their feet). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Jul-2021, JOINT SWELLING (Both knees were swollen) and PYREXIA (Low grade fever) had resolved. At the time of the report, GAIT DISTURBANCE (Could hardly walk), BURNING SENSATION (Burning sensation on the bottom of their feet), MYALGIA (Body aches) and ARTHRALGIA (Joint pain (elbows, knees, and ankles)) outcome was unknown.