chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid-19) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced COVID-19 (Tested positive for Covid-19). At the time of the report, COVID-19 (Tested positive for Covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information mentioned.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Product administered to patient of inappropriate age
Clinical narrative: Headache; 17-year-old got his first dose of moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old got his first dose of moderna vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) 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) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced HEADACHE (Headache) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old got his first dose of moderna vaccine). On 01-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old got his first dose of moderna vaccine) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. The patient was supposed to get Pfizer vaccine but was accidentally given Moderna vaccine, site of vaccination has said that they will not give him  the second dose.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous case reported by a healthcare professional, describes the occurrence of vaccination site warmth (hot to the touch), vaccination site swelling (swollen injection site), pyrexia (fever) and chills in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 5, 2021, patient experienced pyrexia (fever). On Apr 7, 2021, patient experienced vaccination site warmth (hot to the touch), vaccination site swelling (swollen injection site) and chills. On Apr 6, 2021, pyrexia (fever) resolved. At the time of the report, vaccination site warmth (hot to the touch), vaccination site swelling (swollen injection site) and chills outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments. No concomitant medication or treatment information provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: left side of lower lip tingling; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (left side of lower lip tingling) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (AUROVELA 24 FE) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PARAESTHESIA ORAL (left side of lower lip tingling). At the time of the report, PARAESTHESIA ORAL (left side of lower lip tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-069607 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069607:Dose 2 case
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nasopharyngitis, Pain in extremity
Clinical narrative: cold symptoms; feels like been punched in the arm; body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold symptoms), PAIN IN EXTREMITY (feels like been punched in the arm), MYALGIA (body aches) and HEADACHE (headache) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 06-Apr-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced NASOPHARYNGITIS (cold symptoms), PAIN IN EXTREMITY (feels like been punched in the arm), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, NASOPHARYNGITIS (cold symptoms), PAIN IN EXTREMITY (feels like been punched in the arm), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Concomitant medications was  not provided by the reporter. Patient wanted to know if could take Tylenol and Allegra-D.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Diarrhoea, Ear congestion, Fatigue
Clinical narrative: diarrhea; cough; today cant hold food down; vertigo; ear pressure; legs feel like rubber; doesn't feel strong; nausea; fever; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (legs feel like rubber), VERTIGO (vertigo), MUSCULAR WEAKNESS (doesn't feel strong), EAR CONGESTION (ear pressure) and DIARRHOEA (diarrhea) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lymphoma (D-cell lymphoma of the spleen).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced MUSCULAR WEAKNESS (legs feel like rubber), MUSCULAR WEAKNESS (doesn't feel strong), NAUSEA (nausea), PYREXIA (fever) and FATIGUE (tiredness). On 06-Apr-2021, the patient experienced VERTIGO (vertigo) and EAR CONGESTION (ear pressure). On 07-Apr-2021, the patient experienced ASTHENIA (today cant hold food down). On an unknown date, the patient experienced DIARRHOEA (diarrhea) and COUGH (cough). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhoea, at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (legs feel like rubber), VERTIGO (vertigo), MUSCULAR WEAKNESS (doesn't feel strong), EAR CONGESTION (ear pressure), COUGH (cough), ASTHENIA (today cant hold food down), NAUSEA (nausea), PYREXIA (fever) and FATIGUE (tiredness) outcome was unknown and DIARRHOEA (diarrhea) had resolved.            For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was provided. Patient used inhaler for coughing.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Nausea, Pyrexia, Vertigo
Clinical narrative: diarrhea; cough; today cant hold food down; vertigo; ear pressure; legs feel like rubber; doesn't feel strong; nausea; fever; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (legs feel like rubber), VERTIGO (vertigo), MUSCULAR WEAKNESS (doesn't feel strong), EAR CONGESTION (ear pressure) and DIARRHOEA (diarrhea) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lymphoma (D-cell lymphoma of the spleen).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced MUSCULAR WEAKNESS (legs feel like rubber), MUSCULAR WEAKNESS (doesn't feel strong), NAUSEA (nausea), PYREXIA (fever) and FATIGUE (tiredness). On 06-Apr-2021, the patient experienced VERTIGO (vertigo) and EAR CONGESTION (ear pressure). On 07-Apr-2021, the patient experienced ASTHENIA (today cant hold food down). On an unknown date, the patient experienced DIARRHOEA (diarrhea) and COUGH (cough). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhoea, at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (legs feel like rubber), VERTIGO (vertigo), MUSCULAR WEAKNESS (doesn't feel strong), EAR CONGESTION (ear pressure), COUGH (cough), ASTHENIA (today cant hold food down), NAUSEA (nausea), PYREXIA (fever) and FATIGUE (tiredness) outcome was unknown and DIARRHOEA (diarrhea) had resolved.            For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was provided. Patient used inhaler for coughing.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Back pain, COVID-19, Cough, Facial pain
Clinical narrative: Coughing; COVID-19; Felt bad; Face ache; Back ache; Headache; Felt tired; Shaking; Thought it was anxiety; Did not sleep well,  had awful night; Face was hot; Full of congestion; Racing heart rate; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), FEELING ABNORMAL (Felt bad), POOR QUALITY SLEEP (Did not sleep well,  had awful night), FEELING HOT (Face was hot) and NASAL CONGESTION (Full of congestion) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Panic attack (Has had panic attacks in the past.).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced POOR QUALITY SLEEP (Did not sleep well,  had awful night), FEELING HOT (Face was hot), NASAL CONGESTION (Full of congestion), HEART RATE INCREASED (Racing heart rate), TREMOR (Shaking) and ANXIETY (Thought it was anxiety). On 16-Mar-2021, the patient experienced FEELING ABNORMAL (Felt bad), FACIAL PAIN (Face ache), BACK PAIN (Back ache), HEADACHE (Headache) and FATIGUE (Felt tired). On 19-Mar-2021, the patient experienced COVID-19 (COVID-19). On 20-Mar-2021, the patient experienced COUGH (Coughing). The patient was treated with PARACETAMOL (TYNELOL) at an unspecified dose and frequency. On 16-Mar-2021, FEELING HOT (Face was hot), NASAL CONGESTION (Full of congestion), HEART RATE INCREASED (Racing heart rate) and TREMOR (Shaking) had resolved. On 17-Mar-2021, FATIGUE (Felt tired) had resolved. On 18-Mar-2021, FACIAL PAIN (Face ache), BACK PAIN (Back ache) and HEADACHE (Headache) had resolved. On 22-Mar-2021, COUGH (Coughing) was resolving. At the time of the report, COVID-19 (COVID-19), FEELING ABNORMAL (Felt bad), POOR QUALITY SLEEP (Did not sleep well,  had awful night) and ANXIETY (Thought it was anxiety) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Oxygen saturation: 95 (Inconclusive) 95% Oxygen levels improving now.. On 19-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No relevant concomitant medications were reported.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Feeling hot, Headache, Heart rate increased
Clinical narrative: Coughing; COVID-19; Felt bad; Face ache; Back ache; Headache; Felt tired; Shaking; Thought it was anxiety; Did not sleep well,  had awful night; Face was hot; Full of congestion; Racing heart rate; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), FEELING ABNORMAL (Felt bad), POOR QUALITY SLEEP (Did not sleep well,  had awful night), FEELING HOT (Face was hot) and NASAL CONGESTION (Full of congestion) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Panic attack (Has had panic attacks in the past.).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced POOR QUALITY SLEEP (Did not sleep well,  had awful night), FEELING HOT (Face was hot), NASAL CONGESTION (Full of congestion), HEART RATE INCREASED (Racing heart rate), TREMOR (Shaking) and ANXIETY (Thought it was anxiety). On 16-Mar-2021, the patient experienced FEELING ABNORMAL (Felt bad), FACIAL PAIN (Face ache), BACK PAIN (Back ache), HEADACHE (Headache) and FATIGUE (Felt tired). On 19-Mar-2021, the patient experienced COVID-19 (COVID-19). On 20-Mar-2021, the patient experienced COUGH (Coughing). The patient was treated with PARACETAMOL (TYNELOL) at an unspecified dose and frequency. On 16-Mar-2021, FEELING HOT (Face was hot), NASAL CONGESTION (Full of congestion), HEART RATE INCREASED (Racing heart rate) and TREMOR (Shaking) had resolved. On 17-Mar-2021, FATIGUE (Felt tired) had resolved. On 18-Mar-2021, FACIAL PAIN (Face ache), BACK PAIN (Back ache) and HEADACHE (Headache) had resolved. On 22-Mar-2021, COUGH (Coughing) was resolving. At the time of the report, COVID-19 (COVID-19), FEELING ABNORMAL (Felt bad), POOR QUALITY SLEEP (Did not sleep well,  had awful night) and ANXIETY (Thought it was anxiety) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Oxygen saturation: 95 (Inconclusive) 95% Oxygen levels improving now.. On 19-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No relevant concomitant medications were reported.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion, Oxygen saturation, Poor quality sleep, SARS-CoV-2 test, Tremor
Clinical narrative: Coughing; COVID-19; Felt bad; Face ache; Back ache; Headache; Felt tired; Shaking; Thought it was anxiety; Did not sleep well,  had awful night; Face was hot; Full of congestion; Racing heart rate; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), FEELING ABNORMAL (Felt bad), POOR QUALITY SLEEP (Did not sleep well,  had awful night), FEELING HOT (Face was hot) and NASAL CONGESTION (Full of congestion) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Panic attack (Has had panic attacks in the past.).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced POOR QUALITY SLEEP (Did not sleep well,  had awful night), FEELING HOT (Face was hot), NASAL CONGESTION (Full of congestion), HEART RATE INCREASED (Racing heart rate), TREMOR (Shaking) and ANXIETY (Thought it was anxiety). On 16-Mar-2021, the patient experienced FEELING ABNORMAL (Felt bad), FACIAL PAIN (Face ache), BACK PAIN (Back ache), HEADACHE (Headache) and FATIGUE (Felt tired). On 19-Mar-2021, the patient experienced COVID-19 (COVID-19). On 20-Mar-2021, the patient experienced COUGH (Coughing). The patient was treated with PARACETAMOL (TYNELOL) at an unspecified dose and frequency. On 16-Mar-2021, FEELING HOT (Face was hot), NASAL CONGESTION (Full of congestion), HEART RATE INCREASED (Racing heart rate) and TREMOR (Shaking) had resolved. On 17-Mar-2021, FATIGUE (Felt tired) had resolved. On 18-Mar-2021, FACIAL PAIN (Face ache), BACK PAIN (Back ache) and HEADACHE (Headache) had resolved. On 22-Mar-2021, COUGH (Coughing) was resolving. At the time of the report, COVID-19 (COVID-19), FEELING ABNORMAL (Felt bad), POOR QUALITY SLEEP (Did not sleep well,  had awful night) and ANXIETY (Thought it was anxiety) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Oxygen saturation: 95 (Inconclusive) 95% Oxygen levels improving now.. On 19-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No relevant concomitant medications were reported.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Headache, Pain
Clinical narrative: Tested positive for COVID-19; Excruciating back pain from neck down to the buttocks; Mild soreness at the injection site; Headache; Fatigue; Chills; Second dose not administered within 35 days; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19), PRODUCT DOSE OMISSION ISSUE (Second dose not administered within 35 days), PAIN (Excruciating back pain from neck down to the buttocks), VACCINATION SITE PAIN (Mild soreness at the injection site) and HEADACHE (Headache) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 31-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not administered within 35 days). On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (Mild soreness at the injection site), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills). On 05-Apr-2021, the patient experienced PAIN (Excruciating back pain from neck down to the buttocks). On 07-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID-19). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 31-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Second dose not administered within 35 days) had resolved. On 04-Apr-2021, VACCINATION SITE PAIN (Mild soreness at the injection site) and HEADACHE (Headache) had resolved. At the time of the report, COVID-19 (Tested positive for COVID-19), PAIN (Excruciating back pain from neck down to the buttocks), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, SARS-CoV-2 test: positive (Positive) Patient rushed to Emergency Room and he was tested positive for COVID-19..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. On 05Apr2021, patient mentioned that together with the fatigue and chills, Patient had experienced excruciating back pain from the neck down to the buttocks rated as 10/10. On 07Apr2021, Patient's pain has gone down to 2-4/10.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Patient's initials, Patient Route of administration and batch number in product tab added. New event added as COVID-19 positive. On 18-May-2021: New event added as Product dose omission. On 02-Jun-2021: Reporter's email address, Address, City and Postal code updated.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Tested positive for COVID-19; Excruciating back pain from neck down to the buttocks; Mild soreness at the injection site; Headache; Fatigue; Chills; Second dose not administered within 35 days; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19), PRODUCT DOSE OMISSION ISSUE (Second dose not administered within 35 days), PAIN (Excruciating back pain from neck down to the buttocks), VACCINATION SITE PAIN (Mild soreness at the injection site) and HEADACHE (Headache) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 31-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not administered within 35 days). On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (Mild soreness at the injection site), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills). On 05-Apr-2021, the patient experienced PAIN (Excruciating back pain from neck down to the buttocks). On 07-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID-19). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 31-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Second dose not administered within 35 days) had resolved. On 04-Apr-2021, VACCINATION SITE PAIN (Mild soreness at the injection site) and HEADACHE (Headache) had resolved. At the time of the report, COVID-19 (Tested positive for COVID-19), PAIN (Excruciating back pain from neck down to the buttocks), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, SARS-CoV-2 test: positive (Positive) Patient rushed to Emergency Room and he was tested positive for COVID-19..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. On 05Apr2021, patient mentioned that together with the fatigue and chills, Patient had experienced excruciating back pain from the neck down to the buttocks rated as 10/10. On 07Apr2021, Patient's pain has gone down to 2-4/10.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Patient's initials, Patient Route of administration and batch number in product tab added. New event added as COVID-19 positive. On 18-May-2021: New event added as Product dose omission. On 02-Jun-2021: Reporter's email address, Address, City and Postal code updated.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The  concomitant medications on use were not provided. No laboratory data was provided. No treatment information was provided.   This case was linked to MOD-2021-149880 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow-up document was received on 19-MAY-2021. The outcome of event sore arm was updated to recovered. It contains significant information.; Sender's Comments:  MOD-2021-149880:Same patient, 2nd dose
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sore shoulders; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulders) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) 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-Feb-2021, the patient experienced ARTHRALGIA (Sore shoulders). At the time of the report, ARTHRALGIA (Sore shoulders) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant and treatment medications were provided.   This case was linked to MOD21-070927, MOD-2021-069954, MOD-2021-069633, MOD-2021-069962 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Tremor
Clinical narrative: He experienced headache; He experienced shakiness; He experienced dizziness; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (He experienced shakiness), DIZZINESS (He experienced dizziness) and HEADACHE (He experienced headache) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) 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 06-Mar-2021, the patient experienced TREMOR (He experienced shakiness) and DIZZINESS (He experienced dizziness). On 06-Apr-2021, the patient experienced HEADACHE (He experienced headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TREMOR (He experienced shakiness), DIZZINESS (He experienced dizziness) and HEADACHE (He experienced headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medications were provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Product dose omission issue
Clinical narrative: decided not to get the second dose.; severe head pain/headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (decided not to get the second dose.), HEADACHE (severe head pain/headache) and FATIGUE (fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 08-Jan-2021.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced HEADACHE (severe head pain/headache) and FATIGUE (fatigue). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (decided not to get the second dose.). On 01-Feb-2021, FATIGUE (fatigue) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (decided not to get the second dose.) and HEADACHE (severe head pain/headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received the 2nd dose 12 days early; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 2nd dose 12 days early) in a 68-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) (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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 2nd dose 12 days early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 2nd dose 12 days early) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of myalgia (muscle pain), chills, pyrexia (fever) and fatigue (tiredness) in a 53-year-old male patient 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 myalgia (muscle pain), chills, pyrexia (fever) and fatigue (tiredness). At the time of the report, myalgia (muscle pain), chills, pyrexia (fever) and fatigue (tiredness) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Pain in extremity
Clinical narrative: After 1st dose, she was really tired and slept for 2 days; After 1st dose, she was really tired and slept for 2 days; Her arm was very sore for 3 to 4 days; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (After 1st dose, she was really tired and slept for 2 days), PAIN IN EXTREMITY (Her arm was very sore for 3 to 4 days) and FATIGUE (After 1st dose, she was really tired and slept for 2 days) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Diabetes, Acid reflux (esophageal), Fibromyalgia and Allergy.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Mar-2021, the patient experienced HYPERSOMNIA (After 1st dose, she was really tired and slept for 2 days) and PAIN IN EXTREMITY (Her arm was very sore for 3 to 4 days). On an unknown date, the patient experienced FATIGUE (After 1st dose, she was really tired and slept for 2 days). At the time of the report, HYPERSOMNIA (After 1st dose, she was really tired and slept for 2 days), PAIN IN EXTREMITY (Her arm was very sore for 3 to 4 days) and FATIGUE (After 1st dose, she was really tired and slept for 2 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications includes Allergy medicine, BP medicine, Diabetes medicine, Acid reflux medicine and Fibromyalgia medicine.    This case was linked to MOD-2021-069632 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Fatigue, Feeling cold, Feeling hot
Clinical narrative: On-off stomach ache; Feeling hot and her feet were sweaty; Started feeling cold; Feeling hot and her feet were sweaty; Little body ache; Little bit of fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (On-off stomach ache), FEELING HOT (Feeling hot and her feet were sweaty), FEELING COLD (Started feeling cold), HYPERHIDROSIS (Feeling hot and her feet were sweaty) and MYALGIA (Little body ache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, CITALOPRAM and ALPRAZOLAM (XANAX) for an unknown indication.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (On-off stomach ache), FEELING HOT (Feeling hot and her feet were sweaty), FEELING COLD (Started feeling cold), HYPERHIDROSIS (Feeling hot and her feet were sweaty), MYALGIA (Little body ache), FATIGUE (Little bit of fatigue) and CHILLS (Chills). On 07-Apr-2021, ABDOMINAL PAIN UPPER (On-off stomach ache), FEELING HOT (Feeling hot and her feet were sweaty), FEELING COLD (Started feeling cold), HYPERHIDROSIS (Feeling hot and her feet were sweaty), MYALGIA (Little body ache), FATIGUE (Little bit of fatigue) and CHILLS (Chills) had resolved.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia
Clinical narrative: On-off stomach ache; Feeling hot and her feet were sweaty; Started feeling cold; Feeling hot and her feet were sweaty; Little body ache; Little bit of fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (On-off stomach ache), FEELING HOT (Feeling hot and her feet were sweaty), FEELING COLD (Started feeling cold), HYPERHIDROSIS (Feeling hot and her feet were sweaty) and MYALGIA (Little body ache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, CITALOPRAM and ALPRAZOLAM (XANAX) for an unknown indication.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (On-off stomach ache), FEELING HOT (Feeling hot and her feet were sweaty), FEELING COLD (Started feeling cold), HYPERHIDROSIS (Feeling hot and her feet were sweaty), MYALGIA (Little body ache), FATIGUE (Little bit of fatigue) and CHILLS (Chills). On 07-Apr-2021, ABDOMINAL PAIN UPPER (On-off stomach ache), FEELING HOT (Feeling hot and her feet were sweaty), FEELING COLD (Started feeling cold), HYPERHIDROSIS (Feeling hot and her feet were sweaty), MYALGIA (Little body ache), FATIGUE (Little bit of fatigue) and CHILLS (Chills) had resolved.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose, Vaccination site discharge
Clinical narrative: A lot of vaccine squirted from her arm during administration; Did not receive the entire dosage; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCHARGE (A lot of vaccine squirted from her arm during administration) and UNDERDOSE (Did not receive the entire dosage) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE DISCHARGE (A lot of vaccine squirted from her arm during administration) and UNDERDOSE (Did not receive the entire dosage). On 17-Mar-2021, VACCINATION SITE DISCHARGE (A lot of vaccine squirted from her arm during administration) and UNDERDOSE (Did not receive the entire dosage) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: extreme dizziness; developed hives and itchiness on both arms and both legs; She developed hives and itchiness on both arms and both legs; Nausea; headache; weakness; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (extreme dizziness), URTICARIA (developed hives and itchiness on both arms and both legs), PRURITUS (She developed hives and itchiness on both arms and both legs) and NAUSEA (Nausea) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gastrointestinal bleeding. Concurrent medical conditions included Allergy to vaccine. Concomitant products included RIVAROXABAN (XARELTO) and GABAPENTIN for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ASTHENIA (weakness) and FATIGUE (tiredness). On 31-Mar-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (headache). On 01-Apr-2021, the patient experienced URTICARIA (developed hives and itchiness on both arms and both legs) and PRURITUS (She developed hives and itchiness on both arms and both legs). On 03-Apr-2021, the patient experienced DIZZINESS (extreme dizziness). At the time of the report, ASTHENIA (weakness), DIZZINESS (extreme dizziness), URTICARIA (developed hives and itchiness on both arms and both legs), PRURITUS (She developed hives and itchiness on both arms and both legs), NAUSEA (Nausea), FATIGUE (tiredness) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: extreme dizziness; developed hives and itchiness on both arms and both legs; She developed hives and itchiness on both arms and both legs; Nausea; headache; weakness; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (extreme dizziness), URTICARIA (developed hives and itchiness on both arms and both legs), PRURITUS (She developed hives and itchiness on both arms and both legs) and NAUSEA (Nausea) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gastrointestinal bleeding. Concurrent medical conditions included Allergy to vaccine. Concomitant products included RIVAROXABAN (XARELTO) and GABAPENTIN for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ASTHENIA (weakness) and FATIGUE (tiredness). On 31-Mar-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (headache). On 01-Apr-2021, the patient experienced URTICARIA (developed hives and itchiness on both arms and both legs) and PRURITUS (She developed hives and itchiness on both arms and both legs). On 03-Apr-2021, the patient experienced DIZZINESS (extreme dizziness). At the time of the report, ASTHENIA (weakness), DIZZINESS (extreme dizziness), URTICARIA (developed hives and itchiness on both arms and both legs), PRURITUS (She developed hives and itchiness on both arms and both legs), NAUSEA (Nausea), FATIGUE (tiredness) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Sensation of foreign body
Clinical narrative: sensation of a lump in throat; Increased heart rate; Ten minutes after receiving the vaccine she experienced a slight headache; This spontaneous case was reported by a consumer and describes the occurrence of SENSATION OF FOREIGN BODY (sensation of a lump in throat), HEART RATE INCREASED (Increased heart rate) and HEADACHE (Ten minutes after receiving the vaccine she experienced a slight headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety disorder, Overweight and Difficulty breathing. Concomitant products included ALPRAZOLAM for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced SENSATION OF FOREIGN BODY (sensation of a lump in throat), HEART RATE INCREASED (Increased heart rate) and HEADACHE (Ten minutes after receiving the vaccine she experienced a slight headache). At the time of the report, SENSATION OF FOREIGN BODY (sensation of a lump in throat), HEART RATE INCREASED (Increased heart rate) and HEADACHE (Ten minutes after receiving the vaccine she experienced a slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Hot flush, Migraine
Clinical narrative: Armpit hurts; hot flashes; Her whole body was shaking; massive migraine; felt tired, tired all daynext day; Headache; Her arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm hurt), AXILLARY PAIN (Armpit hurts), HOT FLUSH (hot flashes), TREMOR (Her whole body was shaking) and MIGRAINE (massive migraine) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure management, Fibromyalgia, Diabetes, Acid reflux (oesophageal) and Allergy NOS.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (Her arm hurt), FATIGUE (felt tired, tired all daynext day) and HEADACHE (Headache). On 06-Apr-2021, the patient experienced HOT FLUSH (hot flashes), TREMOR (Her whole body was shaking) and MIGRAINE (massive migraine). On 07-Apr-2021, the patient experienced AXILLARY PAIN (Armpit hurts). At the time of the report, PAIN IN EXTREMITY (Her arm hurt) and AXILLARY PAIN (Armpit hurts) had not resolved and HOT FLUSH (hot flashes), TREMOR (Her whole body was shaking), MIGRAINE (massive migraine), FATIGUE (felt tired, tired all daynext day) and HEADACHE (Headache) outcome was unknown. Not Provided          The patient reported that her arm hurts more than first dose. On 06-Apr-2021, she was tired all day.  The patient received unspecified medication for migraine.   This case was linked to MOD-2021-069627 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor
Clinical narrative: Armpit hurts; hot flashes; Her whole body was shaking; massive migraine; felt tired, tired all daynext day; Headache; Her arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm hurt), AXILLARY PAIN (Armpit hurts), HOT FLUSH (hot flashes), TREMOR (Her whole body was shaking) and MIGRAINE (massive migraine) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure management, Fibromyalgia, Diabetes, Acid reflux (oesophageal) and Allergy NOS.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (Her arm hurt), FATIGUE (felt tired, tired all daynext day) and HEADACHE (Headache). On 06-Apr-2021, the patient experienced HOT FLUSH (hot flashes), TREMOR (Her whole body was shaking) and MIGRAINE (massive migraine). On 07-Apr-2021, the patient experienced AXILLARY PAIN (Armpit hurts). At the time of the report, PAIN IN EXTREMITY (Her arm hurt) and AXILLARY PAIN (Armpit hurts) had not resolved and HOT FLUSH (hot flashes), TREMOR (Her whole body was shaking), MIGRAINE (massive migraine), FATIGUE (felt tired, tired all daynext day) and HEADACHE (Headache) outcome was unknown. Not Provided          The patient reported that her arm hurts more than first dose. On 06-Apr-2021, she was tired all day.  The patient received unspecified medication for migraine.   This case was linked to MOD-2021-069627 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Polyuria
Clinical narrative: Urinated lot of times; This spontaneous case was reported by a consumer and describes the occurrence of POLYURIA (Urinated lot of times) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POLYURIA (Urinated lot of times). At the time of the report, POLYURIA (Urinated lot of times) outcome was unknown. Not Provided          Concomitant medications were not provided. Treatment information was not reported.   This case was linked to MOD-2021-069622 (Patient Link).