chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vaccination site pain
Clinical narrative: pain in injection site right; fatigue; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in injection site right ), FATIGUE (fatigue), NAUSEA (nausea) and HEADACHE (headache) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia. Concurrent medical conditions included Asthma and Arthritis.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced FATIGUE (fatigue), NAUSEA (nausea) and HEADACHE (headache). On 04-May-2021, the patient experienced VACCINATION SITE PAIN (pain in injection site right ). On 04-May-2021, FATIGUE (fatigue), NAUSEA (nausea) and HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE PAIN (pain in injection site right ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided. Patient stated that prior to vaccine, on 13APRIL2021 she consulted her HCP  for evaluation and was approved to receive the Moderna vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2021-148240, US-MODERNATX, INC.-MOD-2021-148880 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-148240:Grand mother case US-MODERNATX, INC.-MOD-2021-148880:
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pfizer's as first dose, then Moderna's as second; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Pfizer's as first dose, then Moderna's as second) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Pfizer's as first dose, then Moderna's as second). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Pfizer's as first dose, then Moderna's as second) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.   No concomitant medications were reported. Treatment information was unknown.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Urinary tract infection
Clinical narrative: UTI; due for her second dose for the vaccine on Friday 21; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) and PRODUCT DOSE OMISSION ISSUE (due for her second dose for the vaccine on Friday 21) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI) and PRODUCT DOSE OMISSION ISSUE (due for her second dose for the vaccine on Friday 21). At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (due for her second dose for the vaccine on Friday 21) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment for the event included antibiotics.    Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose was administered after 15 days of 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered after 15 days of 1st dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-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) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered after 15 days of 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered after 15 days of 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient states she is doing fine and has no complaints  No Treatment and concomitant medicines were reported  Action taken with mRNA-1273 in response to the event was not applicable
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Feeling hot, Headache, Heavy menstrual bleeding
Clinical narrative: Shortened my menstrual cycle; Brought a really heavy period; Had an earlier period, came six days earlier. Period came eight days after second shot; Chest Pain; Headache; Being tired; Cold after vaccine; Pain; wake up hot for six weeks; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (wake up hot for six weeks), NASOPHARYNGITIS (Cold after vaccine), POLYMENORRHOEA (Shortened my menstrual cycle), HEAVY MENSTRUAL BLEEDING (Brought a really heavy period) and MENSTRUATION IRREGULAR (Had an earlier period, came six days earlier. Period came eight days after second shot) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced NASOPHARYNGITIS (Cold after vaccine), PAIN (Pain), HEADACHE (Headache) and FATIGUE (Being tired). On an unknown date, the patient experienced FEELING HOT (wake up hot for six weeks), POLYMENORRHOEA (Shortened my menstrual cycle), HEAVY MENSTRUAL BLEEDING (Brought a really heavy period), MENSTRUATION IRREGULAR (Had an earlier period, came six days earlier. Period came eight days after second shot) and CHEST PAIN (Chest Pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING HOT (wake up hot for six weeks), NASOPHARYNGITIS (Cold after vaccine), POLYMENORRHOEA (Shortened my menstrual cycle), HEAVY MENSTRUAL BLEEDING (Brought a really heavy period), MENSTRUATION IRREGULAR (Had an earlier period, came six days earlier. Period came eight days after second shot), PAIN (Pain), CHEST PAIN (Chest Pain), HEADACHE (Headache) and FATIGUE (Being tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-149251, US-MODERNATX, INC.-MOD-2021-148821, US-MODERNATX, INC.-MOD-2021-149413, US-MODERNATX, INC.-MOD-2021-149360 (E2B Linked Report). This case was linked to MOD-2021-148762 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Added new event Chest pain.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-149413:Cluster case-2nd dose US-MODERNATX, INC.-MOD-2021-149360:Cluster case-1st dose US-MODERNATX, INC.-MOD-2021-148821:unknown female-1st dose US-MODERNATX, INC.-MOD-2021-149251:unknown female-2nd dose
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Nasopharyngitis, Pain, Polymenorrhoea
Clinical narrative: Shortened my menstrual cycle; Brought a really heavy period; Had an earlier period, came six days earlier. Period came eight days after second shot; Chest Pain; Headache; Being tired; Cold after vaccine; Pain; wake up hot for six weeks; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (wake up hot for six weeks), NASOPHARYNGITIS (Cold after vaccine), POLYMENORRHOEA (Shortened my menstrual cycle), HEAVY MENSTRUAL BLEEDING (Brought a really heavy period) and MENSTRUATION IRREGULAR (Had an earlier period, came six days earlier. Period came eight days after second shot) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced NASOPHARYNGITIS (Cold after vaccine), PAIN (Pain), HEADACHE (Headache) and FATIGUE (Being tired). On an unknown date, the patient experienced FEELING HOT (wake up hot for six weeks), POLYMENORRHOEA (Shortened my menstrual cycle), HEAVY MENSTRUAL BLEEDING (Brought a really heavy period), MENSTRUATION IRREGULAR (Had an earlier period, came six days earlier. Period came eight days after second shot) and CHEST PAIN (Chest Pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING HOT (wake up hot for six weeks), NASOPHARYNGITIS (Cold after vaccine), POLYMENORRHOEA (Shortened my menstrual cycle), HEAVY MENSTRUAL BLEEDING (Brought a really heavy period), MENSTRUATION IRREGULAR (Had an earlier period, came six days earlier. Period came eight days after second shot), PAIN (Pain), CHEST PAIN (Chest Pain), HEADACHE (Headache) and FATIGUE (Being tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-149251, US-MODERNATX, INC.-MOD-2021-148821, US-MODERNATX, INC.-MOD-2021-149413, US-MODERNATX, INC.-MOD-2021-149360 (E2B Linked Report). This case was linked to MOD-2021-148762 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Added new event Chest pain.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-149413:Cluster case-2nd dose US-MODERNATX, INC.-MOD-2021-149360:Cluster case-1st dose US-MODERNATX, INC.-MOD-2021-148821:unknown female-1st dose US-MODERNATX, INC.-MOD-2021-149251:unknown female-2nd dose
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Nasal congestion, Pyrexia, Rhinorrhoea
Clinical narrative: Get a lot out when he blows his  nose; Sinus are blocked out; Congestion; Dry rusty cough; 99.1 degrees Fahrenheit fever; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Get a lot out when he blows his  nose), SINUS CONGESTION (Sinus are blocked out), NASAL CONGESTION (Congestion), COUGH (Dry rusty cough) and PYREXIA (99.1 degrees Fahrenheit fever) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced RHINORRHOEA (Get a lot out when he blows his  nose), SINUS CONGESTION (Sinus are blocked out), NASAL CONGESTION (Congestion), COUGH (Dry rusty cough) and PYREXIA (99.1 degrees Fahrenheit fever). At the time of the report, RHINORRHOEA (Get a lot out when he blows his  nose), SINUS CONGESTION (Sinus are blocked out), NASAL CONGESTION (Congestion), COUGH (Dry rusty cough) and PYREXIA (99.1 degrees Fahrenheit fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2021, Body temperature: 99.1 (High) 99.1 degrees Fahrenheit.         Patient reported that he is taking two new medications which one of them is a hormone for cancer.  No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up received and patient denied further follow up.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus congestion
Clinical narrative: Get a lot out when he blows his  nose; Sinus are blocked out; Congestion; Dry rusty cough; 99.1 degrees Fahrenheit fever; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Get a lot out when he blows his  nose), SINUS CONGESTION (Sinus are blocked out), NASAL CONGESTION (Congestion), COUGH (Dry rusty cough) and PYREXIA (99.1 degrees Fahrenheit fever) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced RHINORRHOEA (Get a lot out when he blows his  nose), SINUS CONGESTION (Sinus are blocked out), NASAL CONGESTION (Congestion), COUGH (Dry rusty cough) and PYREXIA (99.1 degrees Fahrenheit fever). At the time of the report, RHINORRHOEA (Get a lot out when he blows his  nose), SINUS CONGESTION (Sinus are blocked out), NASAL CONGESTION (Congestion), COUGH (Dry rusty cough) and PYREXIA (99.1 degrees Fahrenheit fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2021, Body temperature: 99.1 (High) 99.1 degrees Fahrenheit.         Patient reported that he is taking two new medications which one of them is a hormone for cancer.  No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up received and patient denied further follow up.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was accidently given on 5-19-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was accidently given on 5-19-2021) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-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-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was accidently given on 5-19-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was accidently given on 5-19-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Pharmacist states a dose of Moderna vaccine was drawn at 9am on 5-18-2021. The dose was left out at room temperature for about 24 hours and dose was accidently given on 5-19-2021.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patients receiving second dose after more than 6 weeks of getting first dose; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patients receiving second dose after more than 6 weeks of getting first dose) 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patients receiving second dose after more than 6 weeks of getting first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patients receiving second dose after more than 6 weeks of getting first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Burning sensation, Fatigue, Hypoaesthesia, Testicular pain
Clinical narrative: Bottom of spine feels like someone is squeezing it and has a burning sensation; Bottom of spine feels like someone is squeezing it and has a burning sensation; Experiencing the same thing in testicles; Legs numb for 5 minutes/could move his legs but not toes.; Tired, had body fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Legs numb for 5 minutes/could move his legs but not toes.), BACK PAIN (Bottom of spine feels like someone is squeezing it and has a burning sensation), BURNING SENSATION (Bottom of spine feels like someone is squeezing it and has a burning sensation), TESTICULAR PAIN (Experiencing the same thing in testicles) and FATIGUE (Tired, had body fatigue) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced FATIGUE (Tired, had body fatigue). On 19-May-2021, the patient experienced HYPOAESTHESIA (Legs numb for 5 minutes/could move his legs but not toes.). On 20-May-2021, the patient experienced BACK PAIN (Bottom of spine feels like someone is squeezing it and has a burning sensation), BURNING SENSATION (Bottom of spine feels like someone is squeezing it and has a burning sensation) and TESTICULAR PAIN (Experiencing the same thing in testicles). At the time of the report, HYPOAESTHESIA (Legs numb for 5 minutes/could move his legs but not toes.), BACK PAIN (Bottom of spine feels like someone is squeezing it and has a burning sensation), BURNING SENSATION (Bottom of spine feels like someone is squeezing it and has a burning sensation), TESTICULAR PAIN (Experiencing the same thing in testicles) and FATIGUE (Tired, had body fatigue) 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.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up was received on 20 May 2021 included additional events. Updated events are bottom of spine feels like someone is squeezing it and has a burning sensation, experiencing the same thing in testicles.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: nausea; started throwing up late last night, starting to feel like he needs to throw up again.; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and VOMITING (started throwing up late last night, starting to feel like he needs to throw up again.) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced NAUSEA (nausea) and VOMITING (started throwing up late last night, starting to feel like he needs to throw up again.). On 18-May-2021, NAUSEA (nausea) had resolved. At the time of the report, VOMITING (started throwing up late last night, starting to feel like he needs to throw up again.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Relevant concomitant product usage were not reported by the reporter. No treatment details were added.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Rash
Clinical narrative: eyes were swollen; rash mostly around eyes, rash on buttock area; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (eyes were swollen) and RASH (rash mostly around eyes, rash on buttock area) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-May-2021, the patient experienced RASH (rash mostly around eyes, rash on buttock area). On 18-May-2021, the patient experienced EYE SWELLING (eyes were swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, EYE SWELLING (eyes were swollen) and RASH (rash mostly around eyes, rash on buttock area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concominant medications were not reported.  On 18 May 2021, the patient went to the Emergency Room (ER) and was prescribed a steroid for the swelling. The patient believes this is an allergic reaction to the vaccine.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in injection site left arm) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Fibromyalgia and Arthritis.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Pain in injection site left arm). At the time of the report, VACCINATION SITE PAIN (Pain in injection site left arm) outcome was unknown.            No concomitant products were reported.  No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-148240 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-148240:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Sinus pain
Clinical narrative: All of a sudden my sinuses were killing me; very achy/muscles were very sore from waist down for day and half/My arm was hurting for day and half; This spontaneous case was reported by a consumer and describes the occurrence of SINUS PAIN (All of a sudden my sinuses were killing me) and MYALGIA (very achy/muscles were very sore from waist down for day and half/My arm was hurting for day and half) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced SINUS PAIN (All of a sudden my sinuses were killing me) and MYALGIA (very achy/muscles were very sore from waist down for day and half/My arm was hurting for day and half). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SINUS PAIN (All of a sudden my sinuses were killing me) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not Applicable   This case was linked to MOD-2021-068773 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Musculoskeletal discomfort, Myalgia, Vaccination site discolouration, Vaccination site rash
Clinical narrative: quarter or half-dollar sized spot on his arm where he got the shot; looks like a brown birthmark, color so the spot wasn't red.; arm is sore when he moves it a certain way; feels discomfort in his shoulder; feels like he bumped into something and it is bruised; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (quarter or half-dollar sized spot on his arm where he got the shot), VACCINATION SITE DISCOLOURATION (looks like a brown birthmark, color so the spot wasn't red.), MYALGIA (arm is sore when he moves it a certain way), MUSCULOSKELETAL DISCOMFORT (feels discomfort in his shoulder) and CONTUSION (feels like he bumped into something and it is bruised) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     Concomitant products included GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORINE) for an unknown indication.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced VACCINATION SITE RASH (quarter or half-dollar sized spot on his arm where he got the shot), VACCINATION SITE DISCOLOURATION (looks like a brown birthmark, color so the spot wasn't red.), MYALGIA (arm is sore when he moves it a certain way), MUSCULOSKELETAL DISCOMFORT (feels discomfort in his shoulder) and CONTUSION (feels like he bumped into something and it is bruised). At the time of the report, VACCINATION SITE RASH (quarter or half-dollar sized spot on his arm where he got the shot), VACCINATION SITE DISCOLOURATION (looks like a brown birthmark, color so the spot wasn't red.), MYALGIA (arm is sore when he moves it a certain way), MUSCULOSKELETAL DISCOMFORT (feels discomfort in his shoulder) and CONTUSION (feels like he bumped into something and it is bruised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD21-091826 (E2B Linked Report).; Sender's Comments:  MOD21-091826:crosslinked
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Intertrigo, Rash
Clinical narrative: progressed to pimple all over his chest; temporary diagnosed with intertrigo; rash under his arm, back of his head; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (progressed to pimple all over his chest), INTERTRIGO (temporary diagnosed with intertrigo) and RASH (rash under his arm, back of his head) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 021B21A) for COVID-19 immunisation.     Concomitant products included VITAMINS NOS and SIMVASTATIN for an unknown indication.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced ACNE (progressed to pimple all over his chest), INTERTRIGO (temporary diagnosed with intertrigo) and RASH (rash under his arm, back of his head). The patient was treated with HYDROCORTISONE (topical) for Rash, at a dose of 2.5 %; MUPIROCIN (topical) for Rash, at a dose of 2 %; DOXYCYCLINE for Rash, at a dose of 100 milligram and KETOCONAZOLE (topical) for Rash, at a dose of 2 %. At the time of the report, ACNE (progressed to pimple all over his chest), INTERTRIGO (temporary diagnosed with intertrigo) and RASH (rash under his arm, back of his head) outcome was unknown.            Concomitant medicines include vitamins and Simvastatin Treatment drugs Concomitant medicines include hydrocortisone cream 2.5%, mupirocin 2%,doxycycline 100mg,ketoconazole 2% The action taken with mRNA-1273 (Moderna COVID-19 vaccine ) was not applicable   This case was linked to MOD21-091922, US-MODERNATX, INC.-MOD-2021-148669 (E2B Linked Report).; Sender's Comments:  MOD21-091922: US-MODERNATX, INC.-MOD-2021-148669:
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Myalgia, Pain in extremity
Clinical narrative: bone pain in arm where shot was done in my deltoid; arm pain; muscle aches; This spontaneous case was reported by a patient and describes the occurrence of BONE PAIN (bone pain in arm where shot was done in my deltoid), PAIN IN EXTREMITY (arm pain) and MYALGIA (muscle aches) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced BONE PAIN (bone pain in arm where shot was done in my deltoid), PAIN IN EXTREMITY (arm pain) and MYALGIA (muscle aches). At the time of the report, BONE PAIN (bone pain in arm where shot was done in my deltoid), PAIN IN EXTREMITY (arm pain) and MYALGIA (muscle aches) 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.   No Concomitant Medication was provided. No treatment  was provided.    Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Non-Significant follow up
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Slight headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L21A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for an unknown indication.    On 14-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 HEADACHE (Slight headache). At the time of the report, HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided by the reporter.   This case was linked to MOD-2021-148611 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Magnetic resonance imaging, Muscle contracture, Pain in extremity
Clinical narrative: can not raise my arm; terrible pain in arm; the arm is contracted; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (can not raise my arm), PAIN IN EXTREMITY (terrible pain in arm) and MUSCLE CONTRACTURE (the arm is contracted) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced HYPOKINESIA (can not raise my arm), PAIN IN EXTREMITY (terrible pain in arm) and MUSCLE CONTRACTURE (the arm is contracted). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, HYPOKINESIA (can not raise my arm), PAIN IN EXTREMITY (terrible pain in arm) and MUSCLE CONTRACTURE (the arm is contracted) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) degenerative changes in the muscle from before the vaccine.         No concomitant medications were reported.  Based on current available information and the temporal association between product use and the start date of the events a causal cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: TCR - outcome updated; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Injection site pruritus, Palpitations
Clinical narrative: Palpitation of heart; Injection site was little bit itchy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitation of heart), INJECTION SITE PRURITUS (Injection site was little bit itchy) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Palpitation of heart), INJECTION SITE PRURITUS (Injection site was little bit itchy) and HEADACHE (Headache). At the time of the report, PALPITATIONS (Palpitation of heart), INJECTION SITE PRURITUS (Injection site was little bit itchy) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate increased: increased incresed.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-070295 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Feeding disorder, Loss of personal independence in daily activities
Clinical narrative: Activities of daily living impaired; sharp stabbing pain in right hand then same happened in her left hand, then pain started in her right and left legs one after another; Fever; felt tired; sleepy; Stomach pain; Mobility decreased; Feeding disorder; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy), ABDOMINAL PAIN UPPER (Stomach pain), MOBILITY DECREASED (Mobility decreased), FEEDING DISORDER (Feeding disorder) and DIZZINESS (dizzy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced SOMNOLENCE (sleepy), ABDOMINAL PAIN UPPER (Stomach pain), MOBILITY DECREASED (Mobility decreased), FEEDING DISORDER (Feeding disorder), DIZZINESS (dizzy), MYALGIA (sharp stabbing pain in right hand then same happened in her left hand, then pain started in her right and left legs one after another), PYREXIA (Fever) and FATIGUE (felt tired). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired). At the time of the report, SOMNOLENCE (sleepy), ABDOMINAL PAIN UPPER (Stomach pain), MOBILITY DECREASED (Mobility decreased), FEEDING DISORDER (Feeding disorder), DIZZINESS (dizzy), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired), MYALGIA (sharp stabbing pain in right hand then same happened in her left hand, then pain started in her right and left legs one after another), PYREXIA (Fever) and FATIGUE (felt tired) outcome was unknown.            No treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable.   This case was linked to MOD-2021-148590 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Pyrexia, Somnolence
Clinical narrative: Activities of daily living impaired; sharp stabbing pain in right hand then same happened in her left hand, then pain started in her right and left legs one after another; Fever; felt tired; sleepy; Stomach pain; Mobility decreased; Feeding disorder; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy), ABDOMINAL PAIN UPPER (Stomach pain), MOBILITY DECREASED (Mobility decreased), FEEDING DISORDER (Feeding disorder) and DIZZINESS (dizzy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced SOMNOLENCE (sleepy), ABDOMINAL PAIN UPPER (Stomach pain), MOBILITY DECREASED (Mobility decreased), FEEDING DISORDER (Feeding disorder), DIZZINESS (dizzy), MYALGIA (sharp stabbing pain in right hand then same happened in her left hand, then pain started in her right and left legs one after another), PYREXIA (Fever) and FATIGUE (felt tired). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired). At the time of the report, SOMNOLENCE (sleepy), ABDOMINAL PAIN UPPER (Stomach pain), MOBILITY DECREASED (Mobility decreased), FEEDING DISORDER (Feeding disorder), DIZZINESS (dizzy), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired), MYALGIA (sharp stabbing pain in right hand then same happened in her left hand, then pain started in her right and left legs one after another), PYREXIA (Fever) and FATIGUE (felt tired) outcome was unknown.            No treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable.   This case was linked to MOD-2021-148590 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Myalgia, Pain in extremity
Clinical narrative: Chills; Dull headache; body aches, worst was the body aches; sore arm; Brain fog; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-May-2021 and was forwarded to the company on 19-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Dull headache), MYALGIA (body aches, worst was the body aches), PAIN IN EXTREMITY (sore arm) and FEELING ABNORMAL (Brain fog) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 047B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Nasal allergy.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced CHILLS (Chills), HEADACHE (Dull headache), MYALGIA (body aches, worst was the body aches), PAIN IN EXTREMITY (sore arm) and FEELING ABNORMAL (Brain fog). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Ache, at a dose of 1 dosage form and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for Ache, at a dose of 1 dosage form. On 19-May-2021, CHILLS (Chills), HEADACHE (Dull headache), MYALGIA (body aches, worst was the body aches), PAIN IN EXTREMITY (sore arm) and FEELING ABNORMAL (Brain fog) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-080323 (Patient Link).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling sensation on the left leg/ Tingling sensation on the right leg; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation on the left leg/ Tingling sensation on the right leg) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced PARAESTHESIA (Tingling sensation on the left leg/ Tingling sensation on the right leg). At the time of the report, PARAESTHESIA (Tingling sensation on the left leg/ Tingling sensation on the right leg) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: 15 patients received a dose from vials that have a light orange tinge; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (15 patients received a dose from vials that have a light orange tinge) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-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-May-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (15 patients received a dose from vials that have a light orange tinge). On 19-May-2021, POOR QUALITY PRODUCT ADMINISTERED (15 patients received a dose from vials that have a light orange tinge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Non-Significant Follow up
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Rash macular, Sleep disorder, Urticaria
Clinical narrative: hardly got any sleep; hives all over their body; really red, really high and hard nut on the left arm; left ear ache; headaches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-May-2021 and was forwarded to Moderna on 19-May-2021.    This spontaneous case was reported by a patient and describes the occurrence of RASH MACULAR (really red, really high and hard nut on the left arm), EAR PAIN (left ear ache), HEADACHE (headaches), SLEEP DISORDER (hardly got any sleep) and URTICARIA (hives all over their body) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 14-May-2021, the patient experienced RASH MACULAR (really red, really high and hard nut on the left arm), EAR PAIN (left ear ache) and HEADACHE (headaches). On 19-May-2021, the patient experienced SLEEP DISORDER (hardly got any sleep) and URTICARIA (hives all over their body). At the time of the report, RASH MACULAR (really red, really high and hard nut on the left arm), EAR PAIN (left ear ache), HEADACHE (headaches), SLEEP DISORDER (hardly got any sleep) and URTICARIA (hives all over their body) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact