chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Big red square on the arm; Itching; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Big red square on the arm) and PRURITUS (Itching) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FREMANEZUMAB (AJOVY [FREMANEZUMAB]) for Headaches cluster.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, 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 ERYTHEMA (Big red square on the arm) and PRURITUS (Itching). At the time of the report, ERYTHEMA (Big red square on the arm) and PRURITUS (Itching) outcome was unknown.      Treatment medication was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Age: 76.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Feeling abnormal, Malaise
Clinical narrative: Feels bad; Feeling unwell; Tiredness; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (Feels bad), MALAISE (Feeling unwell) and FATIGUE (Tiredness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On 24-Apr-2021, the patient experienced MALAISE (Feeling unwell) and FATIGUE (Tiredness). On 26-Apr-2021, the patient experienced FEELING ABNORMAL (Feels bad). At the time of the report, FEELING ABNORMAL (Feels bad) had not resolved, MALAISE (Feeling unwell) outcome was unknown and FATIGUE (Tiredness) was resolving.        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 reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: periods laster longer than ususal; Got another periods after 13 days; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (periods laster longer than ususal) and POLYMENORRHOEA (Got another periods after 13 days) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (periods laster longer than ususal) and POLYMENORRHOEA (Got another periods after 13 days). At the time of the report, HEAVY MENSTRUAL BLEEDING (periods laster longer than ususal) and POLYMENORRHOEA (Got another periods after 13 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.   This case was linked to MOD-2021-103999 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Cough, Lethargy, Oxygen saturation, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: generally lethargic; non productive cough; runny nose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LETHARGY (generally lethargic), COUGH (non productive cough) and RHINORRHOEA (runny nose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 006M20A) 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 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced LETHARGY (generally lethargic), COUGH (non productive cough) and RHINORRHOEA (runny nose). At the time of the report, LETHARGY (generally lethargic), COUGH (non productive cough) and RHINORRHOEA (runny nose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Oxygen saturation: other (Low) other. On 28-Apr-2021, SARS-CoV-2 test: other (Negative) other.         No concomitant medication were reported. No treatment was received.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Email received on 21/6/2021 does not contain any new information
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Myalgia, Nausea
Clinical narrative: sore arm; nausea; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm), NAUSEA (nausea) and DIZZINESS (dizziness) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced MYALGIA (sore arm), NAUSEA (nausea) and DIZZINESS (dizziness). At the time of the report, MYALGIA (sore arm), NAUSEA (nausea) and DIZZINESS (dizziness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt sick) 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 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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (felt sick). At the time of the report, MALAISE (felt sick) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-100824 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-100824:dose 1
Sex: U
Vaccine: COVID19
Symptoms: Migraine, Vertigo
Clinical narrative: Migraine; Bad case of vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Bad case of vertigo) and MIGRAINE (Migraine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    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 VERTIGO (Bad case of vertigo) and MIGRAINE (Migraine). At the time of the report, VERTIGO (Bad case of vertigo) was resolving and MIGRAINE (Migraine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-105529 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: medical history was updated On 05-May-2021: outcome of the event was updated. On 09-May-2021: outcome of the event was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-105529:first dose case
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 years, 7 months old patient received the first dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-May-2021 and was forwarded to Moderna on 04-May-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years, 7 months old patient received the first dose) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years, 7 months old patient received the first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years, 7 months old patient received the first 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 concomitant medications were provided. No treatment drugs were reported. Caller consented to follow up: NO   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (slight fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, SERTRALINE and BUPROPION for Antidepressant therapy, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT RESPIMAT) for Asthma.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced CHILLS (chills) and PYREXIA (slight fever). At the time of the report, CHILLS (chills) and PYREXIA (slight fever) outcome was unknown. Not Provided      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 Treatment medications were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-104036 (E2B Linked Report). This case was linked to MOD-2021-104078 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-104036:dose 2
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: drippy nose; This spontaneous case was reported by a non-health professional and describes the occurrence of RHINORRHEA (drippy nose) in a 91-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 25-Apr-2021, the patient experienced RHINORRHEA (drippy nose). At the time of the report, RHINORRHEA (drippy nose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-086723 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086723:
Sex: M
Vaccine: COVID19
Symptoms: Cough, Lethargy, Oxygen saturation, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Non productive cough; Runny nose; Generally lethargic; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Non productive cough), RHINORRHOEA (Runny nose) and LETHARGY (Generally lethargic) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 006M20A) 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 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced COUGH (Non productive cough), RHINORRHOEA (Runny nose) and LETHARGY (Generally lethargic). At the time of the report, COUGH (Non productive cough), RHINORRHOEA (Runny nose) and LETHARGY (Generally lethargic) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Oxygen saturation: 93% (Borderline) Lower oxygenation readings than normal, 93%. On 28-Apr-2021, SARS-CoV-2 test: other (Negative) COVID test was negative..         No concomitant medications were provided. No treatment medications were taken   This case was linked to MOD-2021-103910 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: No new information was provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Myalgia, Periorbital swelling
Clinical narrative: diarrhea; abdominal cramping; Very bad sore arm ,bodyache which lasted for 36 hrs; chills which lasted for 36 hrs; Full body rash,rash spots in head / rash on scalp; scalp was itchy; puffy eyes; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (scalp was itchy), PERIORBITAL SWELLING (puffy eyes), DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping) and RASH (Full body rash,rash spots in head / rash on scalp) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Hives and body rash). Concomitant products included BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]).   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PRURITUS (scalp was itchy) and PERIORBITAL SWELLING (puffy eyes). On 26-Apr-2021, the patient experienced RASH (Full body rash,rash spots in head / rash on scalp). On an unknown date, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), MYALGIA (Very bad sore arm ,bodyache which lasted for 36 hrs) and CHILLS (chills which lasted for 36 hrs). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) from 26-Apr-2021 to 28-Apr-2021 for Antihistamine therapy, at a dose of 1 dosage form and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) from 26-Apr-2021 to 28-Apr-2021 for Antihistamine therapy, at a dose of 1 dosage form. At the time of the report, PRURITUS (scalp was itchy), PERIORBITAL SWELLING (puffy eyes), DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), RASH (Full body rash,rash spots in head / rash on scalp), MYALGIA (Very bad sore arm ,bodyache which lasted for 36 hrs) and CHILLS (chills which lasted for 36 hrs) outcome was unknown.            This case was linked to MOD-2021-103899 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up ADR form appended on 3-JUN-2021:Patient race and ethnicity ,Other relevant history, concomitant medications New events were added
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: diarrhea; abdominal cramping; Very bad sore arm ,bodyache which lasted for 36 hrs; chills which lasted for 36 hrs; Full body rash,rash spots in head / rash on scalp; scalp was itchy; puffy eyes; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (scalp was itchy), PERIORBITAL SWELLING (puffy eyes), DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping) and RASH (Full body rash,rash spots in head / rash on scalp) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Hives and body rash). Concomitant products included BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]).   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PRURITUS (scalp was itchy) and PERIORBITAL SWELLING (puffy eyes). On 26-Apr-2021, the patient experienced RASH (Full body rash,rash spots in head / rash on scalp). On an unknown date, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), MYALGIA (Very bad sore arm ,bodyache which lasted for 36 hrs) and CHILLS (chills which lasted for 36 hrs). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) from 26-Apr-2021 to 28-Apr-2021 for Antihistamine therapy, at a dose of 1 dosage form and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) from 26-Apr-2021 to 28-Apr-2021 for Antihistamine therapy, at a dose of 1 dosage form. At the time of the report, PRURITUS (scalp was itchy), PERIORBITAL SWELLING (puffy eyes), DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), RASH (Full body rash,rash spots in head / rash on scalp), MYALGIA (Very bad sore arm ,bodyache which lasted for 36 hrs) and CHILLS (chills which lasted for 36 hrs) outcome was unknown.            This case was linked to MOD-2021-103899 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up ADR form appended on 3-JUN-2021:Patient race and ethnicity ,Other relevant history, concomitant medications New events were added
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore 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 MYALGIA (Sore arm) 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 MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown   This case was linked to MOD-2021-103413 (E2B Linked Report).; Sender's Comments:  MOD-2021-103413:Cluster case for other people who took second shot and fell ill
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Myalgia
Clinical narrative: lost his sense of smell and taste; Muscles in arm aching; Sense of smell comes and goes similiar to when he had Covid; This spontaneous case was reported by a non-health professional and describes the occurrence of ANOSMIA (Sense of smell comes and goes similiar to when he had Covid), AGEUSIA (lost his sense of smell and taste) and MYALGIA (Muscles in arm aching) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced ANOSMIA (Sense of smell comes and goes similiar to when he had Covid) and MYALGIA (Muscles in arm aching). On an unknown date, the patient experienced AGEUSIA (lost his sense of smell and taste). At the time of the report, ANOSMIA (Sense of smell comes and goes similiar to when he had Covid) and MYALGIA (Muscles in arm aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: body aches; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) and PYREXIA (low grade fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 002B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, SERTRALINE and BUPROPION for Antidepressant therapy, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT) for Asthma.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced MYALGIA (body aches) and PYREXIA (low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (body aches) and PYREXIA (low grade fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient went today 04-May-2021, to pharmacy, in order to receive the 2nd dose of Shingles vaccine and accidentally patient received the 3rd dose of Moderna vaccine in the left arm.  Action taken with mRNA-1273 in response to the event was not applicable    This case was linked to MODERNATX, INC.-MOD-2021-103961 (E2B Linked Report). This case was linked to MOD-2021-104078 (Patient Link).; Sender's Comments:  MODERNATX, INC.-MOD-2021-103961:dose 1
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: Dizzy; Blood pressure increased; This spontaneous case was reported by a non-health professional and describes the occurrence of DIZZINESS (Dizzy) and BLOOD PRESSURE INCREASED (Blood pressure increased) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Doesnt have @ this time) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced DIZZINESS (Dizzy) and BLOOD PRESSURE INCREASED (Blood pressure increased). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) at an unspecified dose and frequency. On 01-Mar-2021, DIZZINESS (Dizzy) and BLOOD PRESSURE INCREASED (Blood pressure increased) had resolved. Not Provided      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.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: a lump 1/2 the size of a golf ball in the lymph node; This spontaneous case was reported by an other caregiver and describes the occurrence of LYMPHADENOPATHY (a lump 1/2 the size of a golf ball in the lymph node) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced LYMPHADENOPATHY (a lump 1/2 the size of a golf ball in the lymph node). On 04-May-2021, LYMPHADENOPATHY (a lump 1/2 the size of a golf ball in the lymph node) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-104092 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Extra dose administered; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra dose administered) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Allergy NOS and Depression. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy NOS, SERTRALINE and BUPROPION for Antidepressant therapy, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT) for Asthma.    On 04-May-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On 04-May-2021, EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received a third dose of the Moderna COVID-19 vaccine on 04May2021 instead of a desired shingles vaccination.  Per the pharmacy intern, no symptoms were reported by the patient.   This case was linked to MOD-2021-104036, MOD-2021-103961 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Lot number and expiration date of third dose provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Sluggishness
Clinical narrative: Body aches and pains; Sluggishness; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches and pains), SLUGGISHNESS (Sluggishness) and PYREXIA (Fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches and pains), SLUGGISHNESS (Sluggishness) and PYREXIA (Fever). At the time of the report, PAIN (Body aches and pains), SLUGGISHNESS (Sluggishness) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Pyrexia
Clinical narrative: felt so cold; chills/ teeth chattered; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (felt so cold), CHILLS (chills/ teeth chattered) and PYREXIA (fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 039B21A) 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) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced FEELING COLD (felt so cold), CHILLS (chills/ teeth chattered) and PYREXIA (fever). At the time of the report, FEELING COLD (felt so cold), CHILLS (chills/ teeth chattered) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported. Treatment information included electric blanket. patient applied electric blankets for the symptoms developed after the 1st dose The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable    This case was linked to MOD-2021-104231 (Patient Link).
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Syringe was prefilled outside in room temparature; Patient received the dose which was prefilled syringe from (26Apr2021 to 29Apr2021); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the dose which was prefilled syringe from (26Apr2021 to 29Apr2021)) and PRODUCT STORAGE ERROR (Syringe was prefilled outside in room temparature) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the dose which was prefilled syringe from (26Apr2021 to 29Apr2021)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Syringe was prefilled outside in room temparature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the dose which was prefilled syringe from (26Apr2021 to 29Apr2021)) and PRODUCT STORAGE ERROR (Syringe was prefilled outside in room temparature) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pruritus, Psoriasis
Clinical narrative: Itchy; Psoriasis flare-up; Tiredness; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (Itchy), PSORIASIS (Psoriasis flare-up) and FATIGUE (Tiredness) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ADALIMUMAB (HUMIRA).    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 PRURITUS (Itchy), PSORIASIS (Psoriasis flare-up) and FATIGUE (Tiredness). At the time of the report, PRURITUS (Itchy), PSORIASIS (Psoriasis flare-up) and FATIGUE (Tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (Itchy), PSORIASIS (Psoriasis flare-up) and FATIGUE (Tiredness) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ADALIMUMAB (HUMIRA).    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 PRURITUS (Itchy), PSORIASIS (Psoriasis flare-up) and FATIGUE (Tiredness). At the time of the report, PRURITUS (Itchy), PSORIASIS (Psoriasis flare-up) and FATIGUE (Tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On an unknown date, post vaccination, the patient reported that he experienced symptoms of tiredness, itching and psoriasis.   No treatment information was provided
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Lymphadenopathy, Muscle spasms, Pain of skin
Clinical narrative: bleeding or spotting per vagina; Cramps; extremely swollen lymph node in the groin; lack of sleep; joint pains; fever; Tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (bleeding or spotting per vagina), MUSCLE SPASMS (Cramps), LYMPHADENOPATHY (extremely swollen lymph node in the groin), INSOMNIA (lack of sleep) and ARTHRALGIA (joint pains) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 29-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 VAGINAL HAEMORRHAGE (bleeding or spotting per vagina), MUSCLE SPASMS (Cramps), LYMPHADENOPATHY (extremely swollen lymph node in the groin), INSOMNIA (lack of sleep), ARTHRALGIA (joint pains), PYREXIA (fever) and PAIN OF SKIN (Tender to touch). At the time of the report, VAGINAL HAEMORRHAGE (bleeding or spotting per vagina), MUSCLE SPASMS (Cramps), LYMPHADENOPATHY (extremely swollen lymph node in the groin), INSOMNIA (lack of sleep), ARTHRALGIA (joint pains), PYREXIA (fever) and PAIN OF SKIN (Tender to touch) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable No Relevant concomitant medications was reported.  Treatment information included Excedrin medication.   This case was linked to US-MODERNATX, INC.-MOD-2021-104140 (E2B Linked Report). This case was linked to MOD-2021-104140 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-104140:For first dose
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaginal haemorrhage
Clinical narrative: bleeding or spotting per vagina; Cramps; extremely swollen lymph node in the groin; lack of sleep; joint pains; fever; Tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (bleeding or spotting per vagina), MUSCLE SPASMS (Cramps), LYMPHADENOPATHY (extremely swollen lymph node in the groin), INSOMNIA (lack of sleep) and ARTHRALGIA (joint pains) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 29-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 VAGINAL HAEMORRHAGE (bleeding or spotting per vagina), MUSCLE SPASMS (Cramps), LYMPHADENOPATHY (extremely swollen lymph node in the groin), INSOMNIA (lack of sleep), ARTHRALGIA (joint pains), PYREXIA (fever) and PAIN OF SKIN (Tender to touch). At the time of the report, VAGINAL HAEMORRHAGE (bleeding or spotting per vagina), MUSCLE SPASMS (Cramps), LYMPHADENOPATHY (extremely swollen lymph node in the groin), INSOMNIA (lack of sleep), ARTHRALGIA (joint pains), PYREXIA (fever) and PAIN OF SKIN (Tender to touch) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable No Relevant concomitant medications was reported.  Treatment information included Excedrin medication.   This case was linked to US-MODERNATX, INC.-MOD-2021-104140 (E2B Linked Report). This case was linked to MOD-2021-104140 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-104140:For first dose
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Mobility decreased, Vaccination site erythema, Vaccination site induration
Clinical narrative: Patient is not able to move her arm; loss of appetite.; warmth; hardness; redness; swelling; headache; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Patient is not able to move her arm), DECREASED APPETITE (loss of appetite.), VACCINATION SITE WARMTH (warmth), VACCINATION SITE INDURATION (hardness) and VACCINATION SITE ERYTHEMA (redness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 24-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (Patient is not able to move her arm), DECREASED APPETITE (loss of appetite.), VACCINATION SITE WARMTH (warmth), VACCINATION SITE INDURATION (hardness), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swelling) and HEADACHE (headache). The patient was treated with CHONDROITIN SULFATE, COLLAGEN, GLUCOSAMINE SULFATE, HYALURONIC ACID, METHYLSULFONYLMETHANE (FLEX 5) for Joint pain, at an unspecified dose and frequency. On 25-Apr-2021, MOBILITY DECREASED (Patient is not able to move her arm), DECREASED APPETITE (loss of appetite.), VACCINATION SITE WARMTH (warmth), VACCINATION SITE INDURATION (hardness), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swelling) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also include: Vitamin alkaloid
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient is not able to move her arm; loss of appetite.; warmth; hardness; redness; swelling; headache; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Patient is not able to move her arm), DECREASED APPETITE (loss of appetite.), VACCINATION SITE WARMTH (warmth), VACCINATION SITE INDURATION (hardness) and VACCINATION SITE ERYTHEMA (redness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 24-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (Patient is not able to move her arm), DECREASED APPETITE (loss of appetite.), VACCINATION SITE WARMTH (warmth), VACCINATION SITE INDURATION (hardness), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swelling) and HEADACHE (headache). The patient was treated with CHONDROITIN SULFATE, COLLAGEN, GLUCOSAMINE SULFATE, HYALURONIC ACID, METHYLSULFONYLMETHANE (FLEX 5) for Joint pain, at an unspecified dose and frequency. On 25-Apr-2021, MOBILITY DECREASED (Patient is not able to move her arm), DECREASED APPETITE (loss of appetite.), VACCINATION SITE WARMTH (warmth), VACCINATION SITE INDURATION (hardness), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swelling) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also include: Vitamin alkaloid
Sex: U
Vaccine: COVID19, UNK
Symptoms: Blood test, Chills, Vaccination site induration, Vaccination site warmth
Clinical narrative: Vaccination site warmth; Vaccination site induration; chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE INDURATION (Vaccination site induration) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product PALBOCICLIB (IBRANCE) for Breast cancer.    The patient's past medical history included COVID-19. Concurrent medical conditions included Breast cancer. Concomitant products included LETROZOLE for an unknown indication.   In December 2020, the patient started PALBOCICLIB (IBRANCE) (Oral) 125 milligram once a day. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE INDURATION (Vaccination site induration) and CHILLS (chills). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE INDURATION (Vaccination site induration) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal.     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 medication were provided.  Patient was taking Ibrance 125 mg table for 3 weeks on and 1 week off with letrozole daily. Patient was scheduled for 2nd dose on2nd weekend of May 2021.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthenia, Cough, Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms; Weakness; Coughing; Fever; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (Weakness), COUGH (Coughing) and PYREXIA (Fever) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    No medical history was provided by reporter.  No concomitant medication reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (Weakness), COUGH (Coughing) and PYREXIA (Fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (Weakness), COUGH (Coughing) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.      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 INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (Weakness), COUGH (Coughing) and PYREXIA (Fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (Weakness), COUGH (Coughing) and PYREXIA (Fever) 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.   On an unknown date, post vaccination, the patient reported that she experienced flu like symptoms, weakness, fever, and coughing,
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This spontaneous case was reported by a physician and describes the occurrence of VERTIGO (Vertigo) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection, solution for Psoriatic arthritis.    No medical history was reported.  Concomitant products included SODIUM CITRATE (CITRATE) for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) was resolving.        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 was reported.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Head discomfort, Headache, Insomnia
Clinical narrative: stress would make the headaches come back; never had headaches before this, Headache moved from the back of his neck to the front of his forehead; a little fatigue; soreness around the injection site; couldn't sleep on that arm, it would wake him up; felt like someone was holding a candle inside of my head; there was a pressure inside my brain; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep on that arm, it would wake him up), FEELING ABNORMAL (felt like someone was holding a candle inside of my head), HEAD DISCOMFORT (there was a pressure inside my brain), STRESS (stress would make the headaches come back) and HEADACHE (never had headaches before this, Headache moved from the back of his neck to the front of his forehead) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced INSOMNIA (couldn't sleep on that arm, it would wake him up), FEELING ABNORMAL (felt like someone was holding a candle inside of my head), HEAD DISCOMFORT (there was a pressure inside my brain), HEADACHE (never had headaches before this, Headache moved from the back of his neck to the front of his forehead), FATIGUE (a little fatigue) and VACCINATION SITE PAIN (soreness around the injection site). On an unknown date, the patient experienced STRESS (stress would make the headaches come back). At the time of the report, INSOMNIA (couldn't sleep on that arm, it would wake him up), FEELING ABNORMAL (felt like someone was holding a candle inside of my head), HEAD DISCOMFORT (there was a pressure inside my brain), STRESS (stress would make the headaches come back), HEADACHE (never had headaches before this, Headache moved from the back of his neck to the front of his forehead), FATIGUE (a little fatigue) and VACCINATION SITE PAIN (soreness around the injection site) outcome was unknown.            This case was linked to MOD-2021-104324 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Non-Significant Follow-up