chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Bed rest, Body temperature, COVID-19, Cough, Decreased appetite
Clinical narrative: not been getting out of bed; not eating or drinking; fever of 101.6; positive covid test; body aches; cough; This spontaneous case was reported by a consumer and describes the occurrence of BED REST (not been getting out of bed), COUGH (cough), COVID-19 (positive covid test), DECREASED APPETITE (not eating or drinking) and MYALGIA (body aches) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced COUGH (cough) and MYALGIA (body aches). On 03-Apr-2021, the patient experienced COVID-19 (positive covid test). On an unknown date, the patient experienced BED REST (not been getting out of bed), DECREASED APPETITE (not eating or drinking) and PYREXIA (fever of 101.6). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (TYLENOL COLD & FLU SEVERE) at an unspecified dose and frequency. At the time of the report, BED REST (not been getting out of bed), COUGH (cough), COVID-19 (positive covid test), DECREASED APPETITE (not eating or drinking), MYALGIA (body aches) and PYREXIA (fever of 101.6) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Body temperature: 101.6 (High) got worse with a fever of 101.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications information was provided. Treatment included Tylenol cold and severe flu. Patient did not realize he had covid prior to receiving the vaccine.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: not been getting out of bed; not eating or drinking; fever of 101.6; positive covid test; body aches; cough; This spontaneous case was reported by a consumer and describes the occurrence of BED REST (not been getting out of bed), COUGH (cough), COVID-19 (positive covid test), DECREASED APPETITE (not eating or drinking) and MYALGIA (body aches) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced COUGH (cough) and MYALGIA (body aches). On 03-Apr-2021, the patient experienced COVID-19 (positive covid test). On an unknown date, the patient experienced BED REST (not been getting out of bed), DECREASED APPETITE (not eating or drinking) and PYREXIA (fever of 101.6). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (TYLENOL COLD & FLU SEVERE) at an unspecified dose and frequency. At the time of the report, BED REST (not been getting out of bed), COUGH (cough), COVID-19 (positive covid test), DECREASED APPETITE (not eating or drinking), MYALGIA (body aches) and PYREXIA (fever of 101.6) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Body temperature: 101.6 (High) got worse with a fever of 101.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications information was provided. Treatment included Tylenol cold and severe flu. Patient did not realize he had covid prior to receiving the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Cough, Neck mass, Neck pain
Clinical narrative: pain going into the back; chills; orange sized swelling at injection site; fever for one day (99.2F); bit of a cough; egg size lump on the neck above the clavicle; pain going into the neck; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (bit of a cough), NECK MASS (egg size lump on the neck above the clavicle), NECK PAIN (pain going into the neck), BACK PAIN (pain going into the back) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for Paracetamol.    The patient's past medical history included No adverse event (No reported medical history).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 01-Apr-2021, the patient experienced COUGH (bit of a cough), NECK MASS (egg size lump on the neck above the clavicle), NECK PAIN (pain going into the neck), CHILLS (chills), VACCINATION SITE SWELLING (orange sized swelling at injection site) and PYREXIA (fever for one day (99.2F)). On 05-Apr-2021, the patient experienced BACK PAIN (pain going into the back). On 02-Apr-2021, CHILLS (chills) and PYREXIA (fever for one day (99.2F)) had resolved. At the time of the report, COUGH (bit of a cough), NECK MASS (egg size lump on the neck above the clavicle), NECK PAIN (pain going into the neck), BACK PAIN (pain going into the back) and VACCINATION SITE SWELLING (orange sized swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was treated with Tylenol.   This case was linked to US-MODERNATX, INC.-MOD-2021-067350 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067350:
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site swelling
Clinical narrative: pain going into the back; chills; orange sized swelling at injection site; fever for one day (99.2F); bit of a cough; egg size lump on the neck above the clavicle; pain going into the neck; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (bit of a cough), NECK MASS (egg size lump on the neck above the clavicle), NECK PAIN (pain going into the neck), BACK PAIN (pain going into the back) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for Paracetamol.    The patient's past medical history included No adverse event (No reported medical history).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 01-Apr-2021, the patient experienced COUGH (bit of a cough), NECK MASS (egg size lump on the neck above the clavicle), NECK PAIN (pain going into the neck), CHILLS (chills), VACCINATION SITE SWELLING (orange sized swelling at injection site) and PYREXIA (fever for one day (99.2F)). On 05-Apr-2021, the patient experienced BACK PAIN (pain going into the back). On 02-Apr-2021, CHILLS (chills) and PYREXIA (fever for one day (99.2F)) had resolved. At the time of the report, COUGH (bit of a cough), NECK MASS (egg size lump on the neck above the clavicle), NECK PAIN (pain going into the neck), BACK PAIN (pain going into the back) and VACCINATION SITE SWELLING (orange sized swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was treated with Tylenol.   This case was linked to US-MODERNATX, INC.-MOD-2021-067350 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067350:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain in extremity, Vaccination site pain
Clinical narrative: pain in the left arm,; burning sensation at the site of the injection on her left arm; swollen lymph nodes in left arm; mild fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the left arm,), VACCINATION SITE PAIN (burning sensation at the site of the injection on her left arm), LYMPHADENOPATHY (swollen lymph nodes in left arm) and FATIGUE (mild fatigue) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 026A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in the left arm,), VACCINATION SITE PAIN (burning sensation at the site of the injection on her left arm), LYMPHADENOPATHY (swollen lymph nodes in left arm) and FATIGUE (mild fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in the left arm,) and LYMPHADENOPATHY (swollen lymph nodes in left arm) was resolving and VACCINATION SITE PAIN (burning sensation at the site of the injection on her left arm) and FATIGUE (mild fatigue) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Vaccination site erythema, Vaccination site pain
Clinical narrative: itchy; red; painful; The muscle is sore; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PAIN (painful) and MYALGIA (The muscle is sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hay fever and Shoulder fracture (Metal plate in her arm).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PAIN (painful) and MYALGIA (The muscle is sore). At the time of the report, PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PAIN (painful) and MYALGIA (The muscle is sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Skin warm
Clinical narrative: itching; swollen arm; skin warm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), PERIPHERAL SWELLING (swollen arm) and SKIN WARM (skin warm) 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 27-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 PRURITUS (itching), PERIPHERAL SWELLING (swollen arm) and SKIN WARM (skin warm). At the time of the report, PRURITUS (itching), PERIPHERAL SWELLING (swollen arm) and SKIN WARM (skin warm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drugs were not provided. concomitant drugs were not provided
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: temperature of 100.3°F; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), CHILLS (chills) and PYREXIA (temperature of 100.3°F) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), AMLODIPINE, ATORVASTATIN, HYDROCHLOROTHIAZIDE, METOPROLOL (METOPROLOL ER) and TIMOLOL for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced NAUSEA (nausea) and CHILLS (chills). On 27-Mar-2021, the patient experienced PYREXIA (temperature of 100.3°F). At the time of the report, NAUSEA (nausea), CHILLS (chills) and PYREXIA (temperature of 100.3°F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took Tylenol (Acetaminophen) and within an hour, the symptoms subsided.   This case was linked to INC.-MOD-2021-067156 (E2B Linked Report).; Sender's Comments:  INC.-MOD-2021-067156:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Has not been able to get the second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not been able to get the second dose yet) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not been able to get the second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not been able to get the second dose yet) 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. No treatment information was provided.  This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: neck a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (neck a little swollen) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Colon cancer (Colon cancer no problem for the past five years). Concomitant products included VITAMIN D3, EZETIMIBE (ZETIA), FENOFIBRATE (TRICOR [FENOFIBRATE]), COLESEVELAM HYDROCHLORIDE (WELCHOL), ROSUVASTATIN CALCIUM (CRESTOR), LISINOPRIL, METOPROLOL, METFORMIN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (neck a little swollen). At the time of the report, SWELLING (neck a little swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-068435 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Diarrhoea, Fatigue, Grip strength decreased
Clinical narrative: Could not hold anything down due to vomiting. Says today she feels 80% better. Vomiting has stopped as of today.; toes curling from dehydration; diarrhea "like water out of sink"; chills; tender arm; fever; fatigue; Could not hold anything down due to vomiting. Says today she feels 80% better. Vomiting has stopped as of today.; This spontaneous case was reported by a consumer and describes the occurrence of GRIP STRENGTH DECREASED (Could not hold anything down due to vomiting. Says today she feels 80% better. Vomiting has stopped as of today.), DEHYDRATION (toes curling from dehydration), DIARRHOEA (diarrhea "like water out of sink"), CHILLS (chills) and TENDERNESS (tender arm) in a 55-year-old female 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.     The patient's past medical history included Type 2 diabetes mellitus and Hypertension NOS. Concomitant products included ALPRAZOLAM (XANAX), GLUCOSAMINE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), MULTIVITAMIN FOR WOMEN and BIOTIN (HAIR, SKIN & NAILS [BIOTIN]) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced GRIP STRENGTH DECREASED (Could not hold anything down due to vomiting. Says today she feels 80% better. Vomiting has stopped as of today.), DEHYDRATION (toes curling from dehydration), DIARRHOEA (diarrhea "like water out of sink"), CHILLS (chills), TENDERNESS (tender arm), PYREXIA (fever), FATIGUE (fatigue) and VOMITING (Could not hold anything down due to vomiting. Says today she feels 80% better. Vomiting has stopped as of today.). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever and Chills, at an unspecified dose and frequency. On 02-Apr-2021, VOMITING (Could not hold anything down due to vomiting. Says today she feels 80% better. Vomiting has stopped as of today.) had resolved. At the time of the report, GRIP STRENGTH DECREASED (Could not hold anything down due to vomiting. Says today she feels 80% better. Vomiting has stopped as of today.), DEHYDRATION (toes curling from dehydration), DIARRHOEA (diarrhea "like water out of sink"), CHILLS (chills), TENDERNESS (tender arm), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications included Blood pressure pill, supplements, muscle relaxer.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tenderness, Vomiting
Clinical narrative: Could not hold anything down due to vomiting. Says today she feels 80% better. Vomiting has stopped as of today.; toes curling from dehydration; diarrhea "like water out of sink"; chills; tender arm; fever; fatigue; Could not hold anything down due to vomiting. Says today she feels 80% better. Vomiting has stopped as of today.; This spontaneous case was reported by a consumer and describes the occurrence of GRIP STRENGTH DECREASED (Could not hold anything down due to vomiting. Says today she feels 80% better. Vomiting has stopped as of today.), DEHYDRATION (toes curling from dehydration), DIARRHOEA (diarrhea "like water out of sink"), CHILLS (chills) and TENDERNESS (tender arm) in a 55-year-old female 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.     The patient's past medical history included Type 2 diabetes mellitus and Hypertension NOS. Concomitant products included ALPRAZOLAM (XANAX), GLUCOSAMINE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), MULTIVITAMIN FOR WOMEN and BIOTIN (HAIR, SKIN & NAILS [BIOTIN]) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced GRIP STRENGTH DECREASED (Could not hold anything down due to vomiting. Says today she feels 80% better. Vomiting has stopped as of today.), DEHYDRATION (toes curling from dehydration), DIARRHOEA (diarrhea "like water out of sink"), CHILLS (chills), TENDERNESS (tender arm), PYREXIA (fever), FATIGUE (fatigue) and VOMITING (Could not hold anything down due to vomiting. Says today she feels 80% better. Vomiting has stopped as of today.). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever and Chills, at an unspecified dose and frequency. On 02-Apr-2021, VOMITING (Could not hold anything down due to vomiting. Says today she feels 80% better. Vomiting has stopped as of today.) had resolved. At the time of the report, GRIP STRENGTH DECREASED (Could not hold anything down due to vomiting. Says today she feels 80% better. Vomiting has stopped as of today.), DEHYDRATION (toes curling from dehydration), DIARRHOEA (diarrhea "like water out of sink"), CHILLS (chills), TENDERNESS (tender arm), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications included Blood pressure pill, supplements, muscle relaxer.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site lymphadenopathy
Clinical narrative: the lymph nodes under armpit on the injection arm were sore; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (the lymph nodes under armpit on the injection arm were sore) and FATIGUE (fatigued) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0219B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 30-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 VACCINATION SITE LYMPHADENOPATHY (the lymph nodes under armpit on the injection arm were sore) and FATIGUE (fatigued). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (the lymph nodes under armpit on the injection arm were sore) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Insomnia, Pruritus, Rash
Clinical narrative: Rash; Itchy face; Burning sensation; couldnt sleep; redness; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), PRURITUS (Itchy face), BURNING SENSATION (Burning sensation), INSOMNIA (couldnt sleep) and ERYTHEMA (redness) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced RASH (Rash), PRURITUS (Itchy face), BURNING SENSATION (Burning sensation), INSOMNIA (couldnt sleep) and ERYTHEMA (redness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at a dose of 1 dosage form. At the time of the report, RASH (Rash), PRURITUS (Itchy face), BURNING SENSATION (Burning sensation), INSOMNIA (couldnt sleep) and ERYTHEMA (redness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Headache, Nausea, Peripheral swelling
Clinical narrative: dizziness; nausea; headache; hives; left arm was swollen all the way down to the elbow; left arm was red all the way down to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA, PERIPHERAL SWELLING, ERYTHEMA, DIZZINESS, and NAUSEA in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PERIPHERAL SWELLING and ERYTHEMA. On 13-Mar-2021, the patient experienced URTICARIA. On an unknown date, the patient experienced DIZZINESS, NAUSEA, and HEADACHE. On 21-Mar-2021, URTICARIA had resolved. At the time of the report, PERIPHERAL SWELLING, ERYTHEMA, DIZZINESS, NAUSEA, and HEADACHE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: dizziness; nausea; headache; hives; left arm was swollen all the way down to the elbow; left arm was red all the way down to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA, PERIPHERAL SWELLING, ERYTHEMA, DIZZINESS, and NAUSEA in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PERIPHERAL SWELLING and ERYTHEMA. On 13-Mar-2021, the patient experienced URTICARIA. On an unknown date, the patient experienced DIZZINESS, NAUSEA, and HEADACHE. On 21-Mar-2021, URTICARIA had resolved. At the time of the report, PERIPHERAL SWELLING, ERYTHEMA, DIZZINESS, NAUSEA, and HEADACHE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: needle wasn't tight on the barrel and a little bit came out; needle wasn't tight on the barrel and a little bit came out; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (needle wasn't tight on the barrel and a little bit came out) and UNDERDOSE (needle wasn't tight on the barrel and a little bit came out) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   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 DEVICE CONNECTION ISSUE (needle wasn't tight on the barrel and a little bit came out) and UNDERDOSE (needle wasn't tight on the barrel and a little bit came out). On 05-Apr-2021, DEVICE CONNECTION ISSUE (needle wasn't tight on the barrel and a little bit came out) and UNDERDOSE (needle wasn't tight on the barrel and a little bit came out) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to events was not applicable. No treatment details were provided.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Arm soreness; felt cold and had chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and CHILLS (felt cold and had chills) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included HYDROCHLOROTHIAZIDE, FINASTERIDE, OLMESARTAN, SIMVASTATIN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), VITAMIN D NOS and PARACETAMOL (TYLENOL) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness) and CHILLS (felt cold and had chills). At the time of the report, PAIN IN EXTREMITY (Arm soreness) and CHILLS (felt cold and had chills) 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.   Treatment information was not provided for first dose events.   This case was linked to US-MODERNATX, INC.-MOD-2021-067204 (Linked Report). This case was linked to US-MODERNATX, INC.-MOD-2021-067247 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Event added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067204:Crosslinked (family member)
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Decreased appetite, Illness, Insomnia, Nausea
Clinical narrative: hasn't eaten much; nauseous; trouble sleeping; Sick; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (trouble sleeping), ILLNESS (Sick), DECREASED APPETITE (hasn't eaten much) and NAUSEA (nauseous) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (The patient blood pressure would normally be high). Concomitant products included VALSARTAN for an unknown indication.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced INSOMNIA (trouble sleeping), ILLNESS (Sick) and NAUSEA (nauseous). On an unknown date, the patient experienced DECREASED APPETITE (hasn't eaten much). At the time of the report, INSOMNIA (trouble sleeping), ILLNESS (Sick), DECREASED APPETITE (hasn't eaten much) and NAUSEA (nauseous) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Blood pressure measurement: 120/80 mmHg (normal) 120/80.         Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant medications included Valsartan, but the patient did not take medicine as blood pressure was in normal range, which would normally be high.  The patient did not experience any side effects with first dose.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Mass, Swelling face
Clinical narrative: knot and lump on face; swelling of lips; swelling of face, cheek; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling of face, cheek), MASS (knot and lump on face) and LIP SWELLING (swelling of lips) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) 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 01-Apr-2021, the patient experienced SWELLING FACE (swelling of face, cheek) and LIP SWELLING (swelling of lips). On 02-Apr-2021, the patient experienced MASS (knot and lump on face). At the time of the report, SWELLING FACE (swelling of face, cheek), MASS (knot and lump on face) and LIP SWELLING (swelling of lips) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were reported.  Patient reported that his symptoms appeared worse at night and swelling goes down in the day.  No treatment was provided.   This case was linked to MOD21-068892 (E2B Linked Report).; Sender's Comments:  MOD21-068892:Crosslink
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Pain in extremity, Vaccination site pain
Clinical narrative: can't lift his arm horizontally without pain.; shoulder and arm soreness; hurt at injection site; shoulder and arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (can't lift his arm horizontally without pain.), PAIN IN EXTREMITY (shoulder and arm soreness), VACCINATION SITE PAIN (hurt at injection site) and ARTHRALGIA (shoulder and arm soreness) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (can't lift his arm horizontally without pain.), PAIN IN EXTREMITY (shoulder and arm soreness), VACCINATION SITE PAIN (hurt at injection site) and ARTHRALGIA (shoulder and arm soreness). At the time of the report, LIMB DISCOMFORT (can't lift his arm horizontally without pain.), PAIN IN EXTREMITY (shoulder and arm soreness), VACCINATION SITE PAIN (hurt at injection site) and ARTHRALGIA (shoulder and arm soreness) outcome was unknown.            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 and treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Product dose omission issue, Rash, Urticaria
Clinical narrative: I had flushing; hives in my head; due for 2nd dose yesterday. pharamacist refused to administer; rashes on face; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (I had flushing), URTICARIA (hives in my head), PRODUCT DOSE OMISSION ISSUE (due for 2nd dose yesterday. pharamacist refused to administer) and RASH (rashes on face) 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 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FLUSHING (I had flushing), URTICARIA (hives in my head), PRODUCT DOSE OMISSION ISSUE (due for 2nd dose yesterday. pharamacist refused to administer) and RASH (rashes on face). At the time of the report, FLUSHING (I had flushing), URTICARIA (hives in my head) and RASH (rashes on face) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (due for 2nd dose yesterday. pharamacist refused to administer) had resolved.        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 concomitant medication was reported. No treatment medication was provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Rash, Vaccination site erythema
Clinical narrative: Bad arm pain from shoulders to elbow; arm was very itchy  from elbow to the shoulder; arm was red from elbow to shoulder; rash stayed for 2 weeks then went away; Sore at Injection site; red (4" radius) & itchy at injection site; slight itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Bad arm pain from shoulders to elbow), PRURITUS (arm was very itchy  from elbow to the shoulder), ERYTHEMA (arm was red from elbow to shoulder), RASH (rash stayed for 2 weeks then went away) and VACCINATION SITE PRURITUS (slight itching at the injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient's medical history included No Adverse event,.  Concurrent medical conditions included Drug allergy (Macrodantin), Drug allergy (Demerol), Drug allergy (Dicyclomine) and Drug allergy (Cefpodoxime).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (slight itching at the injection site). On 03-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (red (4" radius) & itchy at injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (Bad arm pain from shoulders to elbow), PRURITUS (arm was very itchy  from elbow to the shoulder), ERYTHEMA (arm was red from elbow to shoulder), RASH (rash stayed for 2 weeks then went away) and VACCINATION SITE PAIN (Sore at Injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; HYDROCORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Bad arm pain from shoulders to elbow), PRURITUS (arm was very itchy  from elbow to the shoulder), ERYTHEMA (arm was red from elbow to shoulder), RASH (rash stayed for 2 weeks then went away), VACCINATION SITE PRURITUS (slight itching at the injection site), VACCINATION SITE ERYTHEMA (red (4" radius) & itchy at injection site) and VACCINATION SITE PAIN (Sore at Injection site) had resolved.            No concomitant medications were provided.      Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Additional doc 1 On 26-May-2021: Additional doc 2 On 28-Jun-2021: TCR: additional event reported (Bad arm pain from shoulders to elbow).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Bad arm pain from shoulders to elbow; arm was very itchy  from elbow to the shoulder; arm was red from elbow to shoulder; rash stayed for 2 weeks then went away; Sore at Injection site; red (4" radius) & itchy at injection site; slight itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Bad arm pain from shoulders to elbow), PRURITUS (arm was very itchy  from elbow to the shoulder), ERYTHEMA (arm was red from elbow to shoulder), RASH (rash stayed for 2 weeks then went away) and VACCINATION SITE PRURITUS (slight itching at the injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient's medical history included No Adverse event,.  Concurrent medical conditions included Drug allergy (Macrodantin), Drug allergy (Demerol), Drug allergy (Dicyclomine) and Drug allergy (Cefpodoxime).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (slight itching at the injection site). On 03-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (red (4" radius) & itchy at injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (Bad arm pain from shoulders to elbow), PRURITUS (arm was very itchy  from elbow to the shoulder), ERYTHEMA (arm was red from elbow to shoulder), RASH (rash stayed for 2 weeks then went away) and VACCINATION SITE PAIN (Sore at Injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; HYDROCORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Bad arm pain from shoulders to elbow), PRURITUS (arm was very itchy  from elbow to the shoulder), ERYTHEMA (arm was red from elbow to shoulder), RASH (rash stayed for 2 weeks then went away), VACCINATION SITE PRURITUS (slight itching at the injection site), VACCINATION SITE ERYTHEMA (red (4" radius) & itchy at injection site) and VACCINATION SITE PAIN (Sore at Injection site) had resolved.            No concomitant medications were provided.      Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Additional doc 1 On 26-May-2021: Additional doc 2 On 28-Jun-2021: TCR: additional event reported (Bad arm pain from shoulders to elbow).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Bradyphrenia, Dreamy state, Feeling abnormal, Thinking abnormal, Vaccination site pain
Clinical narrative: feeling off; very foggy; thoughts were cloudy; feeling off; very foggy; thoughts were cloudy; feeling off; very foggy; thoughts were cloudy; thought process feels sluggish; kinda feels a dreamlike; thought process feels sluggish; kinda feels a dreamlike; soreness in the arm after second dose; This spontaneous case was reported by a consumer and describes the occurrence of THINKING ABNORMAL (feeling off; very foggy; thoughts were cloudy), the first episode of FEELING ABNORMAL (feeling off; very foggy; thoughts were cloudy), the second episode of FEELING ABNORMAL (feeling off; very foggy; thoughts were cloudy), BRADYPHRENIA (thought process feels sluggish; kinda feels a dreamlike) and DREAMY STATE (thought process feels sluggish; kinda feels a dreamlike) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-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) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced THINKING ABNORMAL (feeling off; very foggy; thoughts were cloudy), the first episode of FEELING ABNORMAL (feeling off; very foggy; thoughts were cloudy), the second episode of FEELING ABNORMAL (feeling off; very foggy; thoughts were cloudy), BRADYPHRENIA (thought process feels sluggish; kinda feels a dreamlike), DREAMY STATE (thought process feels sluggish; kinda feels a dreamlike) and VACCINATION SITE PAIN (soreness in the arm after second dose). The patient was treated with PARACETAMOL (TYLENOL) for Foggy feeling in head, at an unspecified dose and frequency. At the time of the report, THINKING ABNORMAL (feeling off; very foggy; thoughts were cloudy), the last episode of FEELING ABNORMAL (feeling off; very foggy; thoughts were cloudy), BRADYPHRENIA (thought process feels sluggish; kinda feels a dreamlike), DREAMY STATE (thought process feels sluggish; kinda feels a dreamlike) and VACCINATION SITE PAIN (soreness in the arm after second dose) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (Headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headaches). At the time of the report, PYREXIA (Fever) and HEADACHE (Headaches) outcome was unknown.        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.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: administered the second dose earlier than 28 days; mental disorientation; dizziness; itching at injection site; headaches; muscle pain; fatigue; chills; swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered the second dose earlier than 28 days), HEADACHE (headaches), MYALGIA (muscle pain), FATIGUE (fatigue) and CHILLS (chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Allergy.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced HEADACHE (headaches), MYALGIA (muscle pain), FATIGUE (fatigue), CHILLS (chills), VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE SWELLING (swelling at injection site), DIZZINESS (dizziness) and MENTAL DISORDER (mental disorientation). On 27-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered the second dose earlier than 28 days). The patient was treated with PARACETAMOL (TYLENOL) in February 2021 for Adverse reaction, at a dose of 1 dosage form. On 27-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered the second dose earlier than 28 days) had resolved. At the time of the report, HEADACHE (headaches), MYALGIA (muscle pain), FATIGUE (fatigue), CHILLS (chills), VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE SWELLING (swelling at injection site), DIZZINESS (dizziness) and MENTAL DISORDER (mental disorientation) had not resolved.            Patient's concomitant medications included unspecified medicines for asthma and allergies.  Patient experienced these symptoms following both the vaccination doses. Patient took Acetaminophen as treatment as reported that it had helped. Patient also reported that a lot the adverse events she experienced would come and go, and the patient was not fully recovered from it.   This case was linked to MOD-2021-037556 (Patient Link).