chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site swelling
Clinical narrative: Red blotch, the size of half a dollar, like a large the bite of a bee on the injection site; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red blotch, the size of half a dollar, like a large the bite of a bee on the injection site) and VACCINATION SITE SWELLING (Swollen) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 017B21A) for COVID-19 vaccination.     No medical history was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced RASH MACULAR (Red blotch, the size of half a dollar, like a large the bite of a bee on the injection site) and VACCINATION SITE SWELLING (Swollen). At the time of the report, RASH MACULAR (Red blotch, the size of half a dollar, like a large the bite of a bee on the injection site) and VACCINATION SITE SWELLING (Swollen) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 17-Apr-2021, PAIN IN EXTREMITY (sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported.   Treatment information was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: achiness that subsided after 22 hours after 2nd dose; fatigue that comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness that subsided after 22 hours after 2nd dose) and FATIGUE (fatigue that comes and goes) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included VITAMIN D3, VITAMIN C [ASCORBIC ACID] and BIOTIN for an unknown indication.    On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PAIN (achiness that subsided after 22 hours after 2nd dose) and FATIGUE (fatigue that comes and goes). On 07-May-2021, PAIN (achiness that subsided after 22 hours after 2nd dose) had resolved. At the time of the report, FATIGUE (fatigue that comes and goes) outcome was unknown.            Treatment: Tylenol , non drowsy Claritin  Med Info Agent: Gabriella Buffolino  Warm transferred from Moderna Customer Care case number 00164404.  Patient called 13May2021 reporting side effects experienced after the 2nd dose of the Moderna vaccine.   Safety follow up consent granted. Phone was only method of contact patient would provide says "they can call me"   Agent stated no guarantee or timeline of safety follow up, stated it is in the event the safety team needs to follow up with this case.   Healthcare provider follow up consent declined.  Patient reports having fatigue that comes and goes since receiving the 2nd dose of Moderna vaccine and that she experienced achiness that subsided 22 hours after getting the 2nd dose.   1st dose: 8Apr2021 Lot# #032B21A Expiration: not on vaccine card. Patient did not report side effects after the 1st dose.  2nd dose: 6May2021 Lot #014C21A  Expiration: not on vaccine card. States handwriting on vaccine card is "hard to read".   Concomitant medications: "mild blood pressure pill"    This case was linked to MOD-2021-073933 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient received the first dose with the Moderna Covid-19 vaccine and the second dose with the Pfizer vaccine; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the first dose with the Moderna Covid-19 vaccine and the second dose with the Pfizer vaccine) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the first dose with the Moderna Covid-19 vaccine and the second dose with the Pfizer vaccine). On 07-May-2021, WRONG PRODUCT ADMINISTERED (Patient received the first dose with the Moderna Covid-19 vaccine and the second dose with the Pfizer vaccine) had resolved.        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.   This case was linked to US-MODERNATX, INC.-MOD-2021-114483 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114483:Case for patient 1
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Myalgia, Nausea, Paraesthesia
Clinical narrative: Upset stoamch; did not take second shot; hasn't been able to hold down food; diarrhea; left arm had tingling; numbess in left arm and extremeties of fingers of left hand.; dizziness; Queasy feeling in the stomach all the time as if in sides are being chewed out by; soreness in arm; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PRODUCT DOSE OMISSION ISSUE (did not take second shot), FOOD INTOLERANCE (hasn't been able to hold down food), ABDOMINAL DISCOMFORT (Upset stoamch) and PARAESTHESIA (left arm had tingling) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Suspected COVID-19 in March 2020. Concurrent medical conditions included Insomnia since 2007, Polycystic ovaries since 2002, Hypothyroidism since 2010 and Stomach discomfort (Stomach issues for few months) since March 2020. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METFORMIN and TRAZODONE for an unknown indication.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced DIARRHOEA (diarrhea), FOOD INTOLERANCE (hasn't been able to hold down food), PARAESTHESIA (left arm had tingling), HYPOAESTHESIA (numbess in left arm and extremeties of fingers of left hand.), DIZZINESS (dizziness), NAUSEA (Queasy feeling in the stomach all the time as if in sides are being chewed out by), MYALGIA (soreness in arm), HEADACHE (headache) and CHILLS (chills). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not take second shot) and ABDOMINAL DISCOMFORT (Upset stoamch). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Adverse event, at an unspecified dose and frequency; IBUPROFEN for Headache, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Stomach discomfort, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), FOOD INTOLERANCE (hasn't been able to hold down food), ABDOMINAL DISCOMFORT (Upset stoamch) and NAUSEA (Queasy feeling in the stomach all the time as if in sides are being chewed out by) had not resolved and PRODUCT DOSE OMISSION ISSUE (did not take second shot), PARAESTHESIA (left arm had tingling), HYPOAESTHESIA (numbess in left arm and extremeties of fingers of left hand.), DIZZINESS (dizziness), MYALGIA (soreness in arm), HEADACHE (headache) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For treatment patient took a bland diet   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received :  Patient demographics, medical history were added.Concomitant and treatment medications were added. New events added and outcome of all events  was updated.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Upset stoamch; did not take second shot; hasn't been able to hold down food; diarrhea; left arm had tingling; numbess in left arm and extremeties of fingers of left hand.; dizziness; Queasy feeling in the stomach all the time as if in sides are being chewed out by; soreness in arm; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PRODUCT DOSE OMISSION ISSUE (did not take second shot), FOOD INTOLERANCE (hasn't been able to hold down food), ABDOMINAL DISCOMFORT (Upset stoamch) and PARAESTHESIA (left arm had tingling) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Suspected COVID-19 in March 2020. Concurrent medical conditions included Insomnia since 2007, Polycystic ovaries since 2002, Hypothyroidism since 2010 and Stomach discomfort (Stomach issues for few months) since March 2020. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METFORMIN and TRAZODONE for an unknown indication.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced DIARRHOEA (diarrhea), FOOD INTOLERANCE (hasn't been able to hold down food), PARAESTHESIA (left arm had tingling), HYPOAESTHESIA (numbess in left arm and extremeties of fingers of left hand.), DIZZINESS (dizziness), NAUSEA (Queasy feeling in the stomach all the time as if in sides are being chewed out by), MYALGIA (soreness in arm), HEADACHE (headache) and CHILLS (chills). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not take second shot) and ABDOMINAL DISCOMFORT (Upset stoamch). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Adverse event, at an unspecified dose and frequency; IBUPROFEN for Headache, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Stomach discomfort, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), FOOD INTOLERANCE (hasn't been able to hold down food), ABDOMINAL DISCOMFORT (Upset stoamch) and NAUSEA (Queasy feeling in the stomach all the time as if in sides are being chewed out by) had not resolved and PRODUCT DOSE OMISSION ISSUE (did not take second shot), PARAESTHESIA (left arm had tingling), HYPOAESTHESIA (numbess in left arm and extremeties of fingers of left hand.), DIZZINESS (dizziness), MYALGIA (soreness in arm), HEADACHE (headache) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For treatment patient took a bland diet   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received :  Patient demographics, medical history were added.Concomitant and treatment medications were added. New events added and outcome of all events  was updated.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Fatigue, Head discomfort, Illness
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT ("weird feeling in head"), ILLNESS (sick over the weekend for 48 hours), DISCOMFORT ("like a pressure feeling"), PYREXIA (fever) and CHILLS (chills) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Lot 037B21A and 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included VITAMINS NOS for an unknown indication. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced ILLNESS (sick over the weekend for 48 hours), DISCOMFORT ("like a pressure feeling"), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue). On 09-May-2021, the patient experienced HEAD DISCOMFORT ("weird feeling in head"). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-May-2021, PYREXIA (fever) and CHILLS (chills) had resolved. On 12-May-2021, FATIGUE (fatigue) had resolved. At the time of the report, HEAD DISCOMFORT ("weird feeling in head"), ILLNESS (sick over the weekend for 48 hours) and DISCOMFORT ("like a pressure feeling") outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT ("weird feeling in head"), ILLNESS (sick over the weekend for 48 hours), DISCOMFORT ("like a pressure feeling"), PYREXIA (fever) and CHILLS (chills) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Lot 037B21A and 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included VITAMINS NOS for an unknown indication. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced ILLNESS (sick over the weekend for 48 hours), DISCOMFORT ("like a pressure feeling"), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue). On 09-May-2021, the patient experienced HEAD DISCOMFORT ("weird feeling in head"). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-May-2021, PYREXIA (fever) and CHILLS (chills) had resolved. On 12-May-2021, FATIGUE (fatigue) had resolved. At the time of the report, HEAD DISCOMFORT ("weird feeling in head"), ILLNESS (sick over the weekend for 48 hours) and DISCOMFORT ("like a pressure feeling") outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills that was unbelieveable) and PYREXIA (Low grade fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.  No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced CHILLS (Chills that was unbelieveable) and PYREXIA (Low grade fever). On 17-Apr-2021, CHILLS (Chills that was unbelieveable) and PYREXIA (Low grade fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Treatment information provided was that patient tried to take a hot bath but it did not help. Concomitant medications include High Blood Pressure.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Muscle pain) in an 18-year-old male patient who received mRNA-1273 (batch nos. 039B21A and 022C21A) for COVID-19 vaccination.     Patient history is not provided by the reporter.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced MYALGIA (Muscle pain). At the time of the report, MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Unknown Route) and mRNA-1273 (Intramuscular) was unknown.       This case was linked to MOD-2021-127560 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness
Clinical narrative: Arm stiffness/ Legs are stiff and heavy/ muscle stiffness; Joint pain; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 13-May-2021. The most recent information was received on 13-May-2021 and was forwarded to Moderna on 13-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm stiffness/ Legs are stiff and heavy/ muscle stiffness) and ARTHRALGIA (Joint pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Patient's medical history is not provided by the reporter.  The patient's past medical history included COVID-19 in November 2019.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm stiffness/ Legs are stiff and heavy/ muscle stiffness) and ARTHRALGIA (Joint pain). At the time of the report, MUSCULOSKELETAL STIFFNESS (Arm stiffness/ Legs are stiff and heavy/ muscle stiffness) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-127485 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Significant follow up appended; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-127485:husband case
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash under arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash under arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced RASH (Rash under arm). At the time of the report, RASH (Rash under arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Eating disorder, Fatigue, Headache
Clinical narrative: Don't want to eat anymore; Stomach starts to hurt; Loss of appetite; Tired; Headache; Nausea; This spontaneous case was reported by a patient and describes the occurrence of EATING DISORDER (Don't want to eat anymore), ABDOMINAL PAIN UPPER (Stomach starts to hurt), DECREASED APPETITE (Loss of appetite), FATIGUE (Tired) and HEADACHE (Headache) in a patient of an unknown age and gender 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 10-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced EATING DISORDER (Don't want to eat anymore), ABDOMINAL PAIN UPPER (Stomach starts to hurt), DECREASED APPETITE (Loss of appetite), FATIGUE (Tired), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, EATING DISORDER (Don't want to eat anymore), ABDOMINAL PAIN UPPER (Stomach starts to hurt), DECREASED APPETITE (Loss of appetite), FATIGUE (Tired), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications were provided. No treatment details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Don't want to eat anymore; Stomach starts to hurt; Loss of appetite; Tired; Headache; Nausea; This spontaneous case was reported by a patient and describes the occurrence of EATING DISORDER (Don't want to eat anymore), ABDOMINAL PAIN UPPER (Stomach starts to hurt), DECREASED APPETITE (Loss of appetite), FATIGUE (Tired) and HEADACHE (Headache) in a patient of an unknown age and gender 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 10-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced EATING DISORDER (Don't want to eat anymore), ABDOMINAL PAIN UPPER (Stomach starts to hurt), DECREASED APPETITE (Loss of appetite), FATIGUE (Tired), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, EATING DISORDER (Don't want to eat anymore), ABDOMINAL PAIN UPPER (Stomach starts to hurt), DECREASED APPETITE (Loss of appetite), FATIGUE (Tired), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications were provided. No treatment details were provided.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Hyperpyrexia
Clinical narrative: had a hard time breathing about 10% harder than normal; dizziness; fever of 120 degrees Fahrenheit; This spontaneous case was reported by a patient and describes the occurrence of HYPERPYREXIA (fever of 120 degrees Fahrenheit) in a 19-year-old male adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) , while the parent received the product for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient's medical history is not provided by the reporter.     On 12-May-2021, the parent received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 12-May-2021, the adult was diagnosed with DYSPNOEA (had a hard time breathing about 10% harder than normal), DIZZINESS (dizziness) and HYPERPYREXIA (fever of 120 degrees Fahrenheit) (seriousness criterion medically significant). The Adult was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, DYSPNOEA (had a hard time breathing about 10% harder than normal), DIZZINESS (dizziness) and HYPERPYREXIA (fever of 120 degrees Fahrenheit) outcome was unknown.            Concomitant medication were not reported .  Treatment medication were not reported .   This case was linked to MOD-2021-127550 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: found out vaccine was only 22 days apart; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (found out vaccine was only 22 days apart) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (found out vaccine was only 22 days apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (found out vaccine was only 22 days apart) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Initiative, reporter is asking for clarification on which patient to provide FU
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient has not receive second dose and way passed by 42 days; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not receive second dose and way passed by 42 days) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not receive second dose and way passed by 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not receive second dose and way passed by 42 days) had resolved.        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.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Feels like crap/sick as a dog/feels worse than when they had covid; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feels like crap/sick as a dog/feels worse than when they had covid) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feels like crap/sick as a dog/feels worse than when they had covid). At the time of the report, MALAISE (Feels like crap/sick as a dog/feels worse than when they had covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported. No laboratory data was reported. No Treatment information was reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (strong headache), MYALGIA (Body aches) and PAIN IN EXTREMITY (sore arm) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. No Medical History information was reported. On 12-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced HEADACHE (strong headache). 13-May-2021, the patient experienced MYALGIA (Body aches) and PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HEADACHE (strong headache) had not resolved and MYALGIA (Body aches) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Patient had her second vaccine shot around 2:00 pm. Patient reported that she was taking rest. No concomitant medications were reported. This case was linked to MOD-2021-127514 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Myalgia, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back Pain), HEADACHE (Headache), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and NAUSEA (Nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ew0150 and ew0169) for COVID-19 vaccination. The patient's past medical history included Hepatitis C and Liver disorder (Subsequent liver issues after Hepatitis C). Concurrent medical conditions included Hypertension.On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced BACK PAIN (Back Pain), HEADACHE (Headache), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and NAUSEA (Nausea). At the time of the report, BACK PAIN (Back Pain), HEADACHE (Headache), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and NAUSEA (Nausea) had not resolved.    The concomitant medications include blood pressure medication. No treatment information was provided.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Rash pruritic, Skin infection
Clinical narrative: Eczema; Skin infection; Little, flat, round, very, very itchy circles that started on her legs, but traveled up her body; This spontaneous case was reported by a patient and describes the occurrence of RASH PRURITIC (Little, flat, round, very, very itchy circles that started on her legs, but traveled up her body), SKIN INFECTION (Skin infection) and ECZEMA (Eczema) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 10A21A) for COVID-19 vaccination.     The patient's past medical history included Keratosis (Patient stated that she had keratosis in the past and she used "used spray" on it and it will go away.).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH PRURITIC (Little, flat, round, very, very itchy circles that started on her legs, but traveled up her body). On 07-Apr-2021, the patient experienced SKIN INFECTION (Skin infection). On 04-May-2021, the patient experienced ECZEMA (Eczema). The patient was treated with HYDROCORTISONE (topical) on 20-Apr-2021 for Skin infection, at an unspecified dose and frequency and TRIAMCINOLONE on 04-May-2021 for Eczema, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Little, flat, round, very, very itchy circles that started on her legs, but traveled up her body), SKIN INFECTION (Skin infection) and ECZEMA (Eczema) outcome was unknown.            No concomitant medicines were reported   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: slight head ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (slight head ache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (No medical history reported.).    On 12-Apr-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 (slight head ache). At the time of the report, HEADACHE (slight head ache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information were reported   This case was linked to MOD-2021-127906 (Patient Link).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) in a 31-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 reaction (No medical history reported.)On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown. No concomitant medicines were reported. No treatment information were reported.Action taken with the drug in response to events was not applicable.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Patient stated that he developed shingles just a couple weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Patient stated that he developed shingles just a couple weeks ago) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Patient stated that he developed shingles just a couple weeks ago). At the time of the report, HERPES ZOSTER (Patient stated that he developed shingles just a couple weeks ago) outcome was unknown.            Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product container issue
Clinical narrative: Doses were giving to 4 patients from a vial that was pierced after 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT CONTAINER ISSUE (Doses were giving to 4 patients from a vial that was pierced after 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced PRODUCT CONTAINER ISSUE (Doses were giving to 4 patients from a vial that was pierced after 12 hours). On 12-May-2021, PRODUCT CONTAINER ISSUE (Doses were giving to 4 patients from a vial that was pierced after 12 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not reported.  Treatment information was not provided.   The reporter stated that she could not provide patient information without consent. Consent given for safety follow up via email.
Sex: F
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: Patient has not received 2nd dose yet; This spontaneous case was reported by a patient and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Patient has not received 2nd dose yet) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 INTENTIONAL PRODUCT USE ISSUE (Patient has not received 2nd dose yet). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Patient has not received 2nd dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were unknown.  Patient has not received 2nd dose which was scheduled on 13May2021.   No treatment nor AE was reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in his arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. No Medical History information was reported. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in his arm). On 17-Feb-2021, PAIN IN EXTREMITY (soreness in his arm) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication was not provided. Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received, included significant information patient demographic.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia, Vaccination site erythema
Clinical narrative: Site of injection is hot to touch; Body achiness; Fever up to 102 degrees and is going down; chills/cold; Site of injection is bright red taking up the whole shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Site of injection is hot to touch), MYALGIA (Body achiness), PYREXIA (Fever up to 102 degrees and is going down), CHILLS (chills/cold) and VACCINATION SITE ERYTHEMA (Site of injection is bright red taking up the whole shoulder) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced VACCINATION SITE WARMTH (Site of injection is hot to touch), MYALGIA (Body achiness), PYREXIA (Fever up to 102 degrees and is going down), CHILLS (chills/cold) and VACCINATION SITE ERYTHEMA (Site of injection is bright red taking up the whole shoulder). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Site of injection is hot to touch), MYALGIA (Body achiness), PYREXIA (Fever up to 102 degrees and is going down), CHILLS (chills/cold) and VACCINATION SITE ERYTHEMA (Site of injection is bright red taking up the whole shoulder) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Body temperature: 102 (High) Unknown.         No concomitant medication was reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Site of injection is hot to touch; Body achiness; Fever up to 102 degrees and is going down; chills/cold; Site of injection is bright red taking up the whole shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Site of injection is hot to touch), MYALGIA (Body achiness), PYREXIA (Fever up to 102 degrees and is going down), CHILLS (chills/cold) and VACCINATION SITE ERYTHEMA (Site of injection is bright red taking up the whole shoulder) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced VACCINATION SITE WARMTH (Site of injection is hot to touch), MYALGIA (Body achiness), PYREXIA (Fever up to 102 degrees and is going down), CHILLS (chills/cold) and VACCINATION SITE ERYTHEMA (Site of injection is bright red taking up the whole shoulder). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Site of injection is hot to touch), MYALGIA (Body achiness), PYREXIA (Fever up to 102 degrees and is going down), CHILLS (chills/cold) and VACCINATION SITE ERYTHEMA (Site of injection is bright red taking up the whole shoulder) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Body temperature: 102 (High) Unknown.         No concomitant medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient is receiving second Moderna vaccine after six week period.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is receiving second Moderna vaccine after six week period.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is receiving second Moderna vaccine after six week period.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is receiving second Moderna vaccine after six week period.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Hot flush, Off label use, Pyrexia
Clinical narrative: Upper body area and feels cold; Mini 30-60 minute episodes like a hot flash; Fever; chills/still experiencing chills for more than a month; Received her second dose one week late; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Received her second dose one week late), FEELING COLD (Upper body area and feels cold), HOT FLUSH (Mini 30-60 minute episodes like a hot flash), PYREXIA (Fever) and CHILLS (chills/still experiencing chills for more than a month) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 025A21A) for COVID-19 vaccination.     Concomitant products included CICLOSPORIN (RESTASIS) for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (Received her second dose one week late). On 10-Apr-2021, the patient experienced FEELING COLD (Upper body area and feels cold), HOT FLUSH (Mini 30-60 minute episodes like a hot flash), PYREXIA (Fever) and CHILLS (chills/still experiencing chills for more than a month). On 07-Apr-2021, OFF LABEL USE (Received her second dose one week late) had resolved. At the time of the report, FEELING COLD (Upper body area and feels cold), HOT FLUSH (Mini 30-60 minute episodes like a hot flash), PYREXIA (Fever) and CHILLS (chills/still experiencing chills for more than a month) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information reported included heat pads.   This case was linked to MOD-2021-062367 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Fatigue; Chills; Nausea; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Body aches). At the time of the report, FATIGUE (Fatigue), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Body aches) 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.   Reporter did not allow further contact
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: Flu-like symptoms; Stuffed nose; Sore throat; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), NASAL CONGESTION (Stuffed nose), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and PYREXIA (Fever) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), NASAL CONGESTION (Stuffed nose), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), NASAL CONGESTION (Stuffed nose), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment drug information was not given.   This case was linked to US-MODERNATX, INC.-MOD-2021-127329 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-127329:fiancé case (female)