chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose of the vaccine was administered to a patient at 20 days instead of 28 days.; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of the vaccine was administered to a patient at 20 days instead of 28 days.) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of the vaccine was administered to a patient at 20 days instead of 28 days.). On 01-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of the vaccine was administered to a patient at 20 days instead of 28 days.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products reported  No treatment products reported
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Ear pain, Eye pain, Headache, Influenza like illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), EYE PAIN (eyes and ears ache), ASTHENIA (feels very weak), EAR PAIN (eyes and ears ache) and MYALGIA (whole body is aching) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024A20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-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 INFLUENZA LIKE ILLNESS (flu like symptoms), EYE PAIN (eyes and ears ache), ASTHENIA (feels very weak), EAR PAIN (eyes and ears ache), MYALGIA (whole body is aching) and HEADACHE (head hurts). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), EYE PAIN (eyes and ears ache), ASTHENIA (feels very weak), EAR PAIN (eyes and ears ache), MYALGIA (whole body is aching) and HEADACHE (head hurts) outcome was unknown. No concomitant medications were reported. The patient reported symptoms were just steady and not getting better for 3 weeks now. He had not yet reported them to his HCP. No treatment medications were reported. Action taken with the product mRNA-1273 was not Applicable.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), EYE PAIN (eyes and ears ache), ASTHENIA (feels very weak), EAR PAIN (eyes and ears ache) and MYALGIA (whole body is aching) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024A20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-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 INFLUENZA LIKE ILLNESS (flu like symptoms), EYE PAIN (eyes and ears ache), ASTHENIA (feels very weak), EAR PAIN (eyes and ears ache), MYALGIA (whole body is aching) and HEADACHE (head hurts). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), EYE PAIN (eyes and ears ache), ASTHENIA (feels very weak), EAR PAIN (eyes and ears ache), MYALGIA (whole body is aching) and HEADACHE (head hurts) outcome was unknown. No concomitant medications were reported. The patient reported symptoms were just steady and not getting better for 3 weeks now. He had not yet reported them to his HCP. No treatment medications were reported. Action taken with the product mRNA-1273 was not Applicable.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of bad headaches in a 68-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, the patient experienced bad headaches. At the time of the report, bad headaches outcome: unknown. No concomitant medication or treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: Big hives in the area where the vaccine was administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Big hives in the area where the vaccine was administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 URTICARIA (Big hives in the area where the vaccine was administered). At the time of the report, VACCINATION SITE URTICARIA (Big hives in the area where the vaccine was administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain lower
Clinical narrative: 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 ABDOMINAL PAIN LOWER (pain in my lower left stomach) 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 ABDOMINAL PAIN LOWER (pain in my lower left stomach). At the time of the report, ABDOMINAL PAIN LOWER (pain in my lower left stomach) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd moderna shot to on day 22 after the 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd moderna shot to on day 22 after the 1st dose) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 004B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd moderna shot to on day 22 after the 1st dose). On 01-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd moderna shot to on day 22 after the 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Crying, Dyspnoea, Nausea, Pyrexia
Clinical narrative: shortness of breath; She can't stop crying; fever; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNEA (shortness of breath), CRYING (She can't stop crying), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced DYSPNEA (shortness of breath), CRYING (She can't stop crying), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea). At the time of the report, DYSPNEA (shortness of breath), CRYING (She can't stop crying), PYREXIA (fever), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.            No relevant concomitant medications were reported.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Got covid; 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 COVID-19 (Got covid) 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 COVID-19 (Got covid). At the time of the report, COVID-19 (Got covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided No treatment medication information was provided
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Movement disorder, Nausea, Pain, Pain in extremity
Clinical narrative: pain under clavicle; limited mobility; moving her arm is very painful/pain around her triceps; cannot twist her arm back to wash her back; developed pains in her arm going downwards from the injection site; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain under clavicle), MOBILITY DECREASED (limited mobility), PAIN IN EXTREMITY (moving her arm is very painful/pain around her triceps), MOVEMENT DISORDER (cannot twist her arm back to wash her back) and VACCINATION SITE PAIN (developed pains in her arm going downwards from the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (pain under clavicle), MOBILITY DECREASED (limited mobility), PAIN IN EXTREMITY (moving her arm is very painful/pain around her triceps), MOVEMENT DISORDER (cannot twist her arm back to wash her back), VACCINATION SITE PAIN (developed pains in her arm going downwards from the injection site) and NAUSEA (nausea). The patient was treated with Physical therapy (range of motion exercises) for Mobility decreased; Physical therapy (range of motion exercises) for Pain in extremity and Physical therapy (range of motion exercises) for Movement disorder. At the time of the report, PAIN (pain under clavicle), MOVEMENT DISORDER (cannot twist her arm back to wash her back), VACCINATION SITE PAIN (developed pains in her arm going downwards from the injection site) and NAUSEA (nausea) outcome was unknown, MOBILITY DECREASED (limited mobility) had not resolved and PAIN IN EXTREMITY (moving her arm is very painful/pain around her triceps) was resolving.            No relevant concomitant medications were reported.   Treatment information was not provided.  The patient reported she had not done any strenuous activity. Arm was imperceptibly better with time although she continued to have limited mobility.   This case was linked to MOD-2021-200202 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up information received and does not contain any new information.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain under clavicle; limited mobility; moving her arm is very painful/pain around her triceps; cannot twist her arm back to wash her back; developed pains in her arm going downwards from the injection site; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain under clavicle), MOBILITY DECREASED (limited mobility), PAIN IN EXTREMITY (moving her arm is very painful/pain around her triceps), MOVEMENT DISORDER (cannot twist her arm back to wash her back) and VACCINATION SITE PAIN (developed pains in her arm going downwards from the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (pain under clavicle), MOBILITY DECREASED (limited mobility), PAIN IN EXTREMITY (moving her arm is very painful/pain around her triceps), MOVEMENT DISORDER (cannot twist her arm back to wash her back), VACCINATION SITE PAIN (developed pains in her arm going downwards from the injection site) and NAUSEA (nausea). The patient was treated with Physical therapy (range of motion exercises) for Mobility decreased; Physical therapy (range of motion exercises) for Pain in extremity and Physical therapy (range of motion exercises) for Movement disorder. At the time of the report, PAIN (pain under clavicle), MOVEMENT DISORDER (cannot twist her arm back to wash her back), VACCINATION SITE PAIN (developed pains in her arm going downwards from the injection site) and NAUSEA (nausea) outcome was unknown, MOBILITY DECREASED (limited mobility) had not resolved and PAIN IN EXTREMITY (moving her arm is very painful/pain around her triceps) was resolving.            No relevant concomitant medications were reported.   Treatment information was not provided.  The patient reported she had not done any strenuous activity. Arm was imperceptibly better with time although she continued to have limited mobility.   This case was linked to MOD-2021-200202 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up information received and does not contain any new information.
Sex: U
Vaccine: COVID19
Symptoms: Flushing, Rash pruritic, Vaccination site swelling
Clinical narrative: flushed; itchy rash; swollen at shot 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 FLUSHING (flushed), RASH PRURITIC (itchy rash) and VACCINATION SITE SWELLING (swollen at shot 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 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 FLUSHING (flushed), RASH PRURITIC (itchy rash) and VACCINATION SITE SWELLING (swollen at shot site). At the time of the report, FLUSHING (flushed), RASH PRURITIC (itchy rash) and VACCINATION SITE SWELLING (swollen at shot site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. The patient reported that the events started 2 weeks after the first dose. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: We are wanting to get our sceond dose we had our original April 19"; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (We are wanting to get our sceond dose we had our original April 19") in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (We are wanting to get our sceond dose we had our original April 19"). At the time of the report, PRODUCT DOSE OMISSION ISSUE (We are wanting to get our sceond dose we had our original April 19") had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extremely tired) 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 FATIGUE (Extremely tired). At the time of the report, FATIGUE (Extremely tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Big red spot; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Big red spot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Big red spot). At the time of the report, ERYTHEMA (Big red spot) outcome was unknown.            No relevant concomitant medications were reported.   Treatment information was not provided.  Patient has got a big red spot after second dose of vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of pain 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 a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain. At the time of the report, pain outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: the second shot is due that he received his 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (the second shot is due that he received his 1st shot) 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 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (the second shot is due that he received his 1st shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (the second shot is due that he received his 1st shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: She had awful smell; Awful taste in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (She had awful smell) and TASTE DISORDER (Awful taste in her mouth) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 031A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE BESILATE (NORVASC), BACLOFEN, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), CARBAMAZEPINE (TEGRETOL), CELECOXIB (CELEXA [CELECOXIB]), HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), ONDANSETRON HYDROCHLORIDE (ZOFRAN [ONDANSETRON HYDROCHLORIDE]) and VALACICLOVIR for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced PAROSMIA (She had awful smell) and TASTE DISORDER (Awful taste in her mouth). At the time of the report, PAROSMIA (She had awful smell) had not resolved and TASTE DISORDER (Awful taste in her mouth) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up received on 10-Jun-2021 contains significant information where the outcome of the event parosmia changed from unknown to not recovered.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: consumer was accidentally administered 2nd dose at 14 days; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (consumer was accidentally administered 2nd dose at 14 days) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (consumer was accidentally administered 2nd dose at 14 days). On 31-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (consumer was accidentally administered 2nd dose at 14 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Patient demographics added. First dose date updated. Second dose details added.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) 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 HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not provided. Treatment medication was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Reporter did not allow further contact.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Road traffic accident, SARS-CoV-2 test
Clinical narrative: has not received 2nd dose; got into car accident; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has not received 2nd dose) and ROAD TRAFFIC ACCIDENT (got into car accident) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007821A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes. Concomitant products included LIDOCAINE HYDROCHLORIDE (LIDOCAINE [LIDOCAINE HYDROCHLORIDE]) for Anaesthesia, ENOXAPARIN SODIUM (LOVENOX HP) for Anticoagulant therapy, LISINOPRIL for Blood pressure management, METFORMIN for Diabetes mellitus, TRAMADOL for Pain, VITAMIN D NOS for Supplementation therapy, PARACETAMOL (TYLENOL) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced ROAD TRAFFIC ACCIDENT (got into car accident). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not received 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not received 2nd dose) had resolved and ROAD TRAFFIC ACCIDENT (got into car accident) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2020, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Patient got into a car accident same day second dose was due on 19-Apr-2021 and skipped the second dose.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: exceeded days to receive second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (exceeded days to receive second dose) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (exceeded days to receive second dose). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (exceeded days to receive second dose) 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 provided  No treatment medications provided
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Feeling dizzy; This spontaneous case was reported by a health care professional and describes the occurrence of DIZZINESS (Feeling dizzy) 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 DIZZINESS (Feeling dizzy). At the time of the report, DIZZINESS (Feeling dizzy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. No treatment was reported.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: missing first vaccine date \ a wrong second vaccination date; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missing first vaccine date \ a wrong second vaccination date) in a 53-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 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missing first vaccine date \ a wrong second vaccination date). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (missing first vaccine date \ a wrong second vaccination date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the correct information on the patient's vaccine card, regarding a missing first vaccine date and a wrong second vaccination date in the data at the clinic. Patient took part in a COVE study program, in which he may or may not have received his study vaccination at clinic, as the second dose records were put in wrong, then erased, and are no longer available there. Concomitant medications were not provided. Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: First dose administered 5Feb2021 has not received 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose administered 5Feb2021 has not received 2nd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose administered 5Feb2021 has not received 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose administered 5Feb2021 has not received 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Joint pain; General body ache; 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 ARTHRALGIA (Joint pain) and MYALGIA (General body ache) 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 ARTHRALGIA (Joint pain) and MYALGIA (General body ache). At the time of the report, ARTHRALGIA (Joint pain) and MYALGIA (General body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Muscle spasum; 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 MUSCLE SPASMS (Muscle spasum) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Muscle spasum). At the time of the report, MUSCLE SPASMS (Muscle spasum) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments   Reporter did not allow further contact
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Headache, Nasopharyngitis, Rhinorrhoea
Clinical narrative: Lost taste; Lost smell; Runny nose; Head cold; Headache; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lost taste), ANOSMIA (Lost smell), RHINORRHEA (Runny nose), NASOPHARYNGITIS (Head cold) and HEADACHE (Headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced RHINORRHEA (Runny nose), NASOPHARYNGITIS (Head cold) and HEADACHE (Headache). On 30-May-2021, the patient experienced AGEUSIA (Lost taste) and ANOSMIA (Lost smell). At the time of the report, AGEUSIA (Lost taste), ANOSMIA (Lost smell), RHINORRHEA (Runny nose), NASOPHARYNGITIS (Head cold) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication was reported.  Patient  tested positive for covid after receiving both doses of the vaccine and wanted to know if this has happened to others.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Patient reported that she will confirm the batch lot and inform.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Peripheral coldness, Skin discolouration
Clinical narrative: Her toes ankle and feet were becoming discolored; Bottom of feet feel like ice; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Her toes ankle and feet were becoming discolored), PERIPHERAL COLDNESS (Bottom of feet feel like ice) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced CHILLS (Chills). On 23-Apr-2021, the patient experienced SKIN DISCOLOURATION (Her toes ankle and feet were becoming discolored) and PERIPHERAL COLDNESS (Bottom of feet feel like ice). At the time of the report, SKIN DISCOLOURATION (Her toes ankle and feet were becoming discolored), PERIPHERAL COLDNESS (Bottom of feet feel like ice) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) body temperature was increased.         Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had one shot a couple of months ago and didn't get second one; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had one shot a couple of months ago and didn't get second one) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had one shot a couple of months ago and didn't get second one). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had one shot a couple of months ago and didn't get second one) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Preferred Term updated from Product dose omission issue to Inappropriate schedule of product administration. Verbatim updated.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Arm was sore a few days ago again after not being sore for a while; Fever two weeks after the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore a few days ago again after not being sore for a while) and PYREXIA (Fever two weeks after the first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore a few days ago again after not being sore for a while) and PYREXIA (Fever two weeks after the first dose). At the time of the report, PAIN IN EXTREMITY (Arm was sore a few days ago again after not being sore for a while) and PYREXIA (Fever two weeks after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed shingles after the first shot.; 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 HERPES ZOSTER (Developed shingles after the first shot.) 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 HERPES ZOSTER (Developed shingles after the first shot.). At the time of the report, HERPES ZOSTER (Developed shingles after the first shot.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myalgia, Pain in extremity
Clinical narrative: whole body starting aching and she had to lay down; delayed dose; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delayed dose), PAIN IN EXTREMITY (Pain in arm) and MYALGIA (whole body starting aching and she had to lay down) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delayed dose) and PAIN IN EXTREMITY (Pain in arm). On 02-Jun-2021, the patient experienced MYALGIA (whole body starting aching and she had to lay down). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 01-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delayed dose) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in arm) outcome was unknown and MYALGIA (whole body starting aching and she had to lay down) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was also using a heating pad.  No relevant concomitant medications were reported.    This case was linked to MOD-2021-200455 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; 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 VERTIGO (Vertigo) 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 VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nasal congestion
Clinical narrative: Congestion; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion) and DIARRHOEA (Diarrhea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-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 NASAL CONGESTION (Congestion) and DIARRHOEA (Diarrhea). At the time of the report, NASAL CONGESTION (Congestion) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment medication was Honey and cough medicine.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient experienced congestion after the first dose, was mowing to the lawn and had allergies.  Second dose was scheduled on 06 JUN 2021.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up received and contains no new information
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Covid arm; 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 COMPLICATION (Covid arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 COMPLICATION (Covid arm). At the time of the report, VACCINATION COMPLICATION (Covid arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.