chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: diarrhea; Doesn't remember an entire day; Altered mental status; Injection site warm to touch; Headache; Swollen red injection site; Swollen red injection site; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL STATUS CHANGES (Altered mental status), DIARRHOEA (diarrhea), MEMORY IMPAIRMENT (Doesn't remember an entire day), VACCINATION SITE WARMTH (Injection site warm to touch) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient reports contracting COVID-19 for 8 days in December) in December 2020. Concomitant products included METFORMIN, OMEPRAZOLE SODIUM (OMEPRAZOLE [OMEPRAZOLE SODIUM]), FAMOTIDINE, LEVOTHYROXINE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm to touch), HEADACHE (Headache), VACCINATION SITE SWELLING (Swollen red injection site) and VACCINATION SITE ERYTHEMA (Swollen red injection site). On 20-Mar-2021, the patient experienced MENTAL STATUS CHANGES (Altered mental status) and MEMORY IMPAIRMENT (Doesn't remember an entire day). On 21-Mar-2021, the patient experienced DIARRHOEA (diarrhea). On 20-Mar-2021, MENTAL STATUS CHANGES (Altered mental status) and MEMORY IMPAIRMENT (Doesn't remember an entire day) had resolved. On 21-Mar-2021, DIARRHOEA (diarrhea) had resolved. On 26-Mar-2021, VACCINATION SITE WARMTH (Injection site warm to touch), VACCINATION SITE SWELLING (Swollen red injection site) and VACCINATION SITE ERYTHEMA (Swollen red injection site) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, COVID-19: positive (Positive) Positive. On 18-Jan-2021, COVID-19: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she did not took any treatment for the adverse events.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow up was received on 06-Apr-2021 which did not update any new information.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Cerebral congestion, Chills, Feeling abnormal, Inappropriate schedule of product administration
Clinical narrative: Feels like the vaccine is stuck in his system; Dose past 36 days; Chills; Clogged his brain/brain fog; Closed his stomach/stomach closed up; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Closed his stomach/stomach closed up), FEELING ABNORMAL (Feels like the vaccine is stuck in his system), CEREBRAL CONGESTION (Clogged his brain/brain fog), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose past 36 days) and CHILLS (Chills) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O12H2OA) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included PARACETAMOL (TYLENOL) and NAPROXEN SODIUM (ALEVE) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Closed his stomach/stomach closed up) and CEREBRAL CONGESTION (Clogged his brain/brain fog). On 01-Apr-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced FEELING ABNORMAL (Feels like the vaccine is stuck in his system) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose past 36 days). At the time of the report, ABDOMINAL DISCOMFORT (Closed his stomach/stomach closed up), FEELING ABNORMAL (Feels like the vaccine is stuck in his system) and CHILLS (Chills) outcome was unknown, CEREBRAL CONGESTION (Clogged his brain/brain fog) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose past 36 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events, included paracetamol. Patient reported that he took Tylenol and after 14 days took Aleve for his Multiple Sclerosis.   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Follow up information was received on 04-APR-2021, which included patient date of birth and home address are provided. Patient's age is also updated ( from 71 years to 70 years). Additional event, Inappropriate schedule of vaccine administered is provided. Treatment drug  was provided which included Tylenol( paracetamol). Patient reported that he will not have second dose On 14-Apr-2021: NNI; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Dyspepsia, Fear
Clinical narrative: Really sick; belly burning; watery diarrhea; dizzy; scared; don't normally get sick; intestinal distress; felt weak; a little nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Really sick), DYSPEPSIA (belly burning), DIARRHOEA (watery diarrhea), DIZZINESS (dizzy) and FEAR (scared) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 039b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced ILLNESS (Really sick), DYSPEPSIA (belly burning), DIARRHOEA (watery diarrhea), DIZZINESS (dizzy), FEAR (scared), ILLNESS (don't normally get sick), DYSPEPSIA (intestinal distress), ASTHENIA (felt weak) and NAUSEA (a little nauseous). At the time of the report, ILLNESS (Really sick), DYSPEPSIA (belly burning), DIARRHOEA (watery diarrhea), DIZZINESS (dizzy), FEAR (scared), ILLNESS (don't normally get sick), DYSPEPSIA (intestinal distress), ASTHENIA (felt weak) and NAUSEA (a little nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment medications include Tried to treat with a homeopathic remedy for intestinal distress with some relief.   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Follow-up information received on 15-MAY-2021 contains significant information- Patient demographics, event, second dose details.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea
Clinical narrative: Really sick; belly burning; watery diarrhea; dizzy; scared; don't normally get sick; intestinal distress; felt weak; a little nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Really sick), DYSPEPSIA (belly burning), DIARRHOEA (watery diarrhea), DIZZINESS (dizzy) and FEAR (scared) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 039b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced ILLNESS (Really sick), DYSPEPSIA (belly burning), DIARRHOEA (watery diarrhea), DIZZINESS (dizzy), FEAR (scared), ILLNESS (don't normally get sick), DYSPEPSIA (intestinal distress), ASTHENIA (felt weak) and NAUSEA (a little nauseous). At the time of the report, ILLNESS (Really sick), DYSPEPSIA (belly burning), DIARRHOEA (watery diarrhea), DIZZINESS (dizzy), FEAR (scared), ILLNESS (don't normally get sick), DYSPEPSIA (intestinal distress), ASTHENIA (felt weak) and NAUSEA (a little nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment medications include Tried to treat with a homeopathic remedy for intestinal distress with some relief.   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Follow-up information received on 15-MAY-2021 contains significant information- Patient demographics, event, second dose details.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years old female patient called on 02Apr2021 to report that she received the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old female patient called on 02Apr2021 to report that she received the first dose) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old female patient called on 02Apr2021 to report that she received the first dose). On 16-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old female patient called on 02Apr2021 to report that she received the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment details were provided.  This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: Not Provided) with no associated AEs.; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: Not Provided) with no associated AEs.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 45-year-old male 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 recorded medical history).    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. On 02 Apr 2021, there have been a power outage and the vials were in freezer and refrigerator where temperature dropped to -13.79 C for frozen vaccine for about 47Minutes and 12 C for refrigerator for about 59 Minutes. No treatment information was provided.   This case was linked to MOD21-068620 (E2B Linked Report).; Sender's Comments:  MOD21-068620:crosslinked case
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal discharge, Vaginal haemorrhage
Clinical narrative: vaginal bleeding/wasn't like a heavy period but like something during the last day of period would look like, it was light; when wiped, something pink is still there but not red/it was more like a little discharge; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (vaginal bleeding/wasn't like a heavy period but like something during the last day of period would look like, it was light) and VAGINAL DISCHARGE (when wiped, something pink is still there but not red/it was more like a little discharge) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concomitant products included LEVONORGESTREL (MIRENA) for Birth control, LOSARTAN, AMLODIPINE BESYLATE and VENLAFAXINE for an unknown indication.    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 VAGINAL HAEMORRHAGE (vaginal bleeding/wasn't like a heavy period but like something during the last day of period would look like, it was light) and VAGINAL DISCHARGE (when wiped, something pink is still there but not red/it was more like a little discharge). At the time of the report, VAGINAL HAEMORRHAGE (vaginal bleeding/wasn't like a heavy period but like something during the last day of period would look like, it was light) and VAGINAL DISCHARGE (when wiped, something pink is still there but not red/it was more like a little discharge) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Mirena birth control for an unknown indication.  No treatment medication was reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: headache; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and NAUSEA (nauseous) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 HEADACHE (headache) and NAUSEA (nauseous). At the time of the report, HEADACHE (headache) and NAUSEA (nauseous) outcome was unknown.        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: Vaccination site reaction
Clinical narrative: sensitivity in arm at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (sensitivity in arm at the site of injection) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.    Co-suspect product included non-company product VITAMINS NOS (MULTIVITAMINUM) for an unknown indication.    No Medical History information was reported.   On 22-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 started VITAMINS NOS (MULTIVITAMINUM) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE REACTION (sensitivity in arm at the site of injection). At the time of the report, VACCINATION SITE REACTION (sensitivity in arm at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were added.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: sneezing; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (sneezing) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced SNEEZING (sneezing). At the time of the report, SNEEZING (sneezing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dosing error ( 2nd dose schedule more the recommended dosing interval); This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dosing error ( 2nd dose schedule more the recommended dosing interval)) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dosing error ( 2nd dose schedule more the recommended dosing interval)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dosing error ( 2nd dose schedule more the recommended dosing interval)) 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.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered the vaccine to a patient who is 16 year-old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered the vaccine to a patient who is 16 year-old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered the vaccine to a patient who is 16 year-old). On 11-Jan-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered the vaccine to a patient who is 16 year-old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Batch number of Dose 1 and 2 updated. On 30-Jul-2021: Race information and Ethnic group added
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Chest pain, Chills
Clinical narrative: headache; Pain in arm.; tenderness; neck was hurting; swelling in lymph nodes; confused; fatigue; muscle pain and calf muscles hurting; Joint pain; stomach pain; chills; nausea; dizziness; weakness; chest pain; hiccups; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm.), TENDERNESS (tenderness), NECK PAIN (neck was hurting), VACCINATION SITE LYMPHADENOPATHY (swelling in lymph nodes) and CONFUSIONAL STATE (confused) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm.), TENDERNESS (tenderness), NECK PAIN (neck was hurting), VACCINATION SITE LYMPHADENOPATHY (swelling in lymph nodes), CONFUSIONAL STATE (confused), ARTHRALGIA (Joint pain), ABDOMINAL PAIN UPPER (stomach pain), CHILLS (chills) and HICCUPS (hiccups). 19-Mar-2021, the patient experienced FATIGUE (fatigue), MYALGIA (muscle pain and calf muscles hurting), NAUSEA (nausea), DIZZINESS (dizziness), ASTHENIA (weakness) and CHEST PAIN (chest pain). On 03-Apr-2021, the patient experienced HEADACHE (headache). Not Provided          Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Fatigue, Headache, Hiccups
Clinical narrative: headache; Pain in arm.; tenderness; neck was hurting; swelling in lymph nodes; confused; fatigue; muscle pain and calf muscles hurting; Joint pain; stomach pain; chills; nausea; dizziness; weakness; chest pain; hiccups; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm.), TENDERNESS (tenderness), NECK PAIN (neck was hurting), VACCINATION SITE LYMPHADENOPATHY (swelling in lymph nodes) and CONFUSIONAL STATE (confused) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm.), TENDERNESS (tenderness), NECK PAIN (neck was hurting), VACCINATION SITE LYMPHADENOPATHY (swelling in lymph nodes), CONFUSIONAL STATE (confused), ARTHRALGIA (Joint pain), ABDOMINAL PAIN UPPER (stomach pain), CHILLS (chills) and HICCUPS (hiccups). 19-Mar-2021, the patient experienced FATIGUE (fatigue), MYALGIA (muscle pain and calf muscles hurting), NAUSEA (nausea), DIZZINESS (dizziness), ASTHENIA (weakness) and CHEST PAIN (chest pain). On 03-Apr-2021, the patient experienced HEADACHE (headache). Not Provided          Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Neck pain, Pain in extremity, Tenderness
Clinical narrative: headache; Pain in arm.; tenderness; neck was hurting; swelling in lymph nodes; confused; fatigue; muscle pain and calf muscles hurting; Joint pain; stomach pain; chills; nausea; dizziness; weakness; chest pain; hiccups; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm.), TENDERNESS (tenderness), NECK PAIN (neck was hurting), VACCINATION SITE LYMPHADENOPATHY (swelling in lymph nodes) and CONFUSIONAL STATE (confused) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm.), TENDERNESS (tenderness), NECK PAIN (neck was hurting), VACCINATION SITE LYMPHADENOPATHY (swelling in lymph nodes), CONFUSIONAL STATE (confused), ARTHRALGIA (Joint pain), ABDOMINAL PAIN UPPER (stomach pain), CHILLS (chills) and HICCUPS (hiccups). 19-Mar-2021, the patient experienced FATIGUE (fatigue), MYALGIA (muscle pain and calf muscles hurting), NAUSEA (nausea), DIZZINESS (dizziness), ASTHENIA (weakness) and CHEST PAIN (chest pain). On 03-Apr-2021, the patient experienced HEADACHE (headache). Not Provided          Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: headache; Pain in arm.; tenderness; neck was hurting; swelling in lymph nodes; confused; fatigue; muscle pain and calf muscles hurting; Joint pain; stomach pain; chills; nausea; dizziness; weakness; chest pain; hiccups; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm.), TENDERNESS (tenderness), NECK PAIN (neck was hurting), VACCINATION SITE LYMPHADENOPATHY (swelling in lymph nodes) and CONFUSIONAL STATE (confused) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm.), TENDERNESS (tenderness), NECK PAIN (neck was hurting), VACCINATION SITE LYMPHADENOPATHY (swelling in lymph nodes), CONFUSIONAL STATE (confused), ARTHRALGIA (Joint pain), ABDOMINAL PAIN UPPER (stomach pain), CHILLS (chills) and HICCUPS (hiccups). 19-Mar-2021, the patient experienced FATIGUE (fatigue), MYALGIA (muscle pain and calf muscles hurting), NAUSEA (nausea), DIZZINESS (dizziness), ASTHENIA (weakness) and CHEST PAIN (chest pain). On 03-Apr-2021, the patient experienced HEADACHE (headache). Not Provided          Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Illness, Rash
Clinical narrative: pretting sick tonight; rashes in her armpit; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (pretting sick tonight) and RASH (rashes in her armpit) 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 Autoimmune disorder (Overactive Immune System).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (pretting sick tonight) and RASH (rashes in her armpit). At the time of the report, ILLNESS (pretting sick tonight) and RASH (rashes in her armpit) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) in a 33-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.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 02-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea, Pain in extremity, Somnolence
Clinical narrative: down and out; couldn't wake up for a while/ sleepy; sore arm; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (down and out), SOMNOLENCE (couldn't wake up for a while/ sleepy), PAIN IN EXTREMITY (sore arm) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (down and out), SOMNOLENCE (couldn't wake up for a while/ sleepy), PAIN IN EXTREMITY (sore arm) and NAUSEA (nausea). At the time of the report, FEELING ABNORMAL (down and out), SOMNOLENCE (couldn't wake up for a while/ sleepy), PAIN IN EXTREMITY (sore arm) and NAUSEA (nausea) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was unknown Concomitant product is not provided. treatment is not provided.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: severe headaches; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headaches) and ARTHRALGIA (joint pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-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 HEADACHE (severe headaches) and ARTHRALGIA (joint pain). At the time of the report, HEADACHE (severe headaches) and ARTHRALGIA (joint pain) 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.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash over the lower part of both legs, near ankle; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash over the lower part of both legs, near ankle) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash over the lower part of both legs, near ankle). At the time of the report, RASH (rash over the lower part of both legs, near ankle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: TCR received on 7-JUL-2021, added second dose without any event, updated event outcome for first dose.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Fatigue, Headache, Heart rate
Clinical narrative: dizziness; headache; nausea; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (dizziness), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021 at 3:52 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced DIZZINESS (dizziness), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) on 02-Apr-2021 at a dose of 25 milligram. At the time of the report, DIZZINESS (dizziness), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood pressure measurement: 136/69 mmHg (abnormal) 136/69. On 02-Apr-2021, Heart rate: 70 (normal) 70 per minute. On 02-Apr-2021, Oxygen saturation: 97 (normal) 97 percent.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After experiencing the events, the  patient laid down on a cot and was monitored by one of the registered nurses. The patient sat up for 10-15 minutes and felt better.  No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21 May 2021 included no new information.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Oxygen saturation
Clinical narrative: dizziness; headache; nausea; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (dizziness), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021 at 3:52 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced DIZZINESS (dizziness), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) on 02-Apr-2021 at a dose of 25 milligram. At the time of the report, DIZZINESS (dizziness), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood pressure measurement: 136/69 mmHg (abnormal) 136/69. On 02-Apr-2021, Heart rate: 70 (normal) 70 per minute. On 02-Apr-2021, Oxygen saturation: 97 (normal) 97 percent.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After experiencing the events, the  patient laid down on a cot and was monitored by one of the registered nurses. The patient sat up for 10-15 minutes and felt better.  No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21 May 2021 included no new information.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: My temperature is 100.2°F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (My temperature is 100.2°F) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PYREXIA (My temperature is 100.2°F). At the time of the report, PYREXIA (My temperature is 100.2°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 (High) the patient had a temperature of 100.2.         Concomitant products included Lots of prescription medications for an unknown indication.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurt after the vaccination for just that day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt after the vaccination for just that day) 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 No adverse event.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt after the vaccination for just that day). On 17-Mar-2021, PAIN IN EXTREMITY (arm hurt after the vaccination for just that day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Intense Vertigo episodes lasting 5 seconds at a time After the FIRST Shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (Intense Vertigo episodes lasting 5 seconds at a time After the FIRST Shot) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant product use was not provided.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced VERTIGO (Intense Vertigo episodes lasting 5 seconds at a time After the FIRST Shot). On 06-Feb-2021, VERTIGO (Intense Vertigo episodes lasting 5 seconds at a time After the FIRST Shot) outcome was unknown.            This case was linked to MOD-2021-066581 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Nasopharyngitis, Nausea, Somnolence
Clinical narrative: down and out; couldn't wake up for a while; sleepy; nausea; did not feel right; felt cold; felt weak; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (did not feel right), NASOPHARYNGITIS (felt cold), ASTHENIA (felt weak), FEELING ABNORMAL (down and out) and ASTHENIA (couldn't wake up for a while) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-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 19-Mar-2021, the patient experienced FEELING ABNORMAL (did not feel right), NASOPHARYNGITIS (felt cold) and ASTHENIA (felt weak). On an unknown date, the patient experienced FEELING ABNORMAL (down and out), ASTHENIA (couldn't wake up for a while), SOMNOLENCE (sleepy) and NAUSEA (nausea). At the time of the report, FEELING ABNORMAL (did not feel right), NASOPHARYNGITIS (felt cold), ASTHENIA (felt weak), FEELING ABNORMAL (down and out), ASTHENIA (couldn't wake up for a while), SOMNOLENCE (sleepy) and NAUSEA (nausea) outcome was unknown.            No concomitant was provided. Patient treatment information was not provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Product dose omission issue
Clinical narrative: Not able to receive the second vaccine dose as scheduled; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Not able to receive the second vaccine dose as scheduled) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for an unknown indication.     The patient's past medical history included Carotid artery repair on 26-Feb-2021.    On 30-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 PRODUCT DOSE OMISSION ISSUE (Not able to receive the second vaccine dose as scheduled). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Not able to receive the second vaccine dose as scheduled) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Computerised tomogram: abnormal (abnormal) abnormal scan of carotid artery.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Doctor performed surgery for carotid artery on 26-Feb-2021. Patient was scheduled to receive second vaccine dose on 27-Feb-2021.  This report refers to a case of product dose omission issue for mRNA-1273, with no associated AEs. Further information has been requested.; Sender's Comments: This report refers to a case of product dose omission issue for mRNA-1273, with no associated AEs. Further information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: fever; Chills; muscle pain; joint pain; headache; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (Chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and HEADACHE (headache) in a 63-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 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 PYREXIA (fever), CHILLS (Chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (tiredness). At the time of the report, PYREXIA (fever), CHILLS (Chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; Chills; muscle pain; joint pain; headache; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (Chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and HEADACHE (headache) in a 63-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 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 PYREXIA (fever), CHILLS (Chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (tiredness). At the time of the report, PYREXIA (fever), CHILLS (Chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Influenza like illness, Myalgia
Clinical narrative: felt crappy; feels like the flu; arm hurts; nauseous to stomach; chills; body was achy; headachy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt crappy), INFLUENZA LIKE ILLNESS (feels like the flu), PAIN (arm hurts), NAUSEA (nauseous to stomach) and CHILLS (chills) in a 61-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 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced FEELING ABNORMAL (felt crappy), PAIN (arm hurts), NAUSEA (nauseous to stomach) and HEADACHE (headachy). 01-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (feels like the flu), CHILLS (chills) and MYALGIA (body was achy). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN LOW) for Headache, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (felt crappy), INFLUENZA LIKE ILLNESS (feels like the flu), PAIN (arm hurts), NAUSEA (nauseous to stomach), CHILLS (chills), MYALGIA (body was achy) and HEADACHE (headachy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. The reporter does not provide any causal relationship with  mRNA-1273 .
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: felt crappy; feels like the flu; arm hurts; nauseous to stomach; chills; body was achy; headachy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt crappy), INFLUENZA LIKE ILLNESS (feels like the flu), PAIN (arm hurts), NAUSEA (nauseous to stomach) and CHILLS (chills) in a 61-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 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced FEELING ABNORMAL (felt crappy), PAIN (arm hurts), NAUSEA (nauseous to stomach) and HEADACHE (headachy). 01-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (feels like the flu), CHILLS (chills) and MYALGIA (body was achy). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN LOW) for Headache, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (felt crappy), INFLUENZA LIKE ILLNESS (feels like the flu), PAIN (arm hurts), NAUSEA (nauseous to stomach), CHILLS (chills), MYALGIA (body was achy) and HEADACHE (headachy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. The reporter does not provide any causal relationship with  mRNA-1273 .