chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered dose to 16 years old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered dose to 16 years old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered dose to 16 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered dose to 16 years old) 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.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lactation disorder, Oral pain
Clinical narrative: lactated after 13 months; mouth sore; headache; This spontaneous case was reported by a consumer and describes the occurrence of LACTATION DISORDER (lactated after 13 months), ORAL PAIN (mouth sore) and HEADACHE (headache) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced ORAL PAIN (mouth sore) and HEADACHE (headache). On 14-May-2021, the patient experienced LACTATION DISORDER (lactated after 13 months). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and TENOXICAM (AMIDOL [TENOXICAM]) at an unspecified dose and frequency. At the time of the report, LACTATION DISORDER (lactated after 13 months), ORAL PAIN (mouth sore) and HEADACHE (headache) 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 details was reported.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Eye swelling, Limb discomfort
Clinical narrative: Swollen eye; Itchy eye; itching in the eye lashes; Arm discomfort; This spontaneous case was reported by an other caregiver and describes the occurrence of EYE SWELLING (Swollen eye), EYE PRURITUS (itching in the eye lashes), LIMB DISCOMFORT (Arm discomfort) and EYE PRURITUS (Itchy eye) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced EYE PRURITUS (itching in the eye lashes) and LIMB DISCOMFORT (Arm discomfort). On 15-May-2021, the patient experienced EYE SWELLING (Swollen eye) and EYE PRURITUS (Itchy eye). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at a dose of 1 dosage form. At the time of the report, EYE SWELLING (Swollen eye), EYE PRURITUS (itching in the eye lashes), LIMB DISCOMFORT (Arm discomfort) and EYE PRURITUS (Itchy eye) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Myalgia
Clinical narrative: little bit of cough; little bit of headache; little bit of aches; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (little bit of cough), HEADACHE (little bit of headache) and MYALGIA (little bit of aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-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 COUGH (little bit of cough), HEADACHE (little bit of headache) and MYALGIA (little bit of aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, COUGH (little bit of cough), HEADACHE (little bit of headache) and MYALGIA (little bit of aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness
Clinical narrative: felt off; Chills; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (Chills) and ILLNESS (felt off) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 01-Mar-2021, the patient experienced CHILLS (Chills). On 18-Mar-2021, the patient experienced ILLNESS (felt off). Not Provided      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.   This case was linked to MOD-2021-028367 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Hypersensitivity, Rhinorrhoea
Clinical narrative: I also have allergies; Sometimes I'm short of breath; had the general feeling of coming down with something.; first night I was real tired; I have arunny nose; sinus congestion; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (I also have allergies), DYSPNOEA (Sometimes I'm short of breath), FEELING ABNORMAL (had the general feeling of coming down with something.), FATIGUE (first night I was real tired) and RHINORRHOEA (I have arunny nose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included COVID-19 in January 2021. Concomitant products included AMLODIPINE BESILATE (NORVASC), LITHIUM CARBONATE, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and CLONAZEPAM (KLONOPIN) for an unknown indication.   On 01-May-2021 at 8:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (I also have allergies), DYSPNOEA (Sometimes I'm short of breath), FEELING ABNORMAL (had the general feeling of coming down with something.), FATIGUE (first night I was real tired), RHINORRHOEA (I have arunny nose) and SINUS CONGESTION (sinus congestion). At the time of the report, HYPERSENSITIVITY (I also have allergies), DYSPNOEA (Sometimes I'm short of breath), FEELING ABNORMAL (had the general feeling of coming down with something.), FATIGUE (first night I was real tired), RHINORRHOEA (I have arunny nose) and SINUS CONGESTION (sinus congestion) outcome was unknown.            Treatment was not reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus congestion
Clinical narrative: I also have allergies; Sometimes I'm short of breath; had the general feeling of coming down with something.; first night I was real tired; I have arunny nose; sinus congestion; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (I also have allergies), DYSPNOEA (Sometimes I'm short of breath), FEELING ABNORMAL (had the general feeling of coming down with something.), FATIGUE (first night I was real tired) and RHINORRHOEA (I have arunny nose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included COVID-19 in January 2021. Concomitant products included AMLODIPINE BESILATE (NORVASC), LITHIUM CARBONATE, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and CLONAZEPAM (KLONOPIN) for an unknown indication.   On 01-May-2021 at 8:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (I also have allergies), DYSPNOEA (Sometimes I'm short of breath), FEELING ABNORMAL (had the general feeling of coming down with something.), FATIGUE (first night I was real tired), RHINORRHOEA (I have arunny nose) and SINUS CONGESTION (sinus congestion). At the time of the report, HYPERSENSITIVITY (I also have allergies), DYSPNOEA (Sometimes I'm short of breath), FEELING ABNORMAL (had the general feeling of coming down with something.), FATIGUE (first night I was real tired), RHINORRHOEA (I have arunny nose) and SINUS CONGESTION (sinus congestion) outcome was unknown.            Treatment was not reported.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: a moderna shot was mistakenly administered in place of a PPSV23 shot; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (a moderna shot was mistakenly administered in place of a PPSV23 shot) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced EXTRA DOSE ADMINISTERED (a moderna shot was mistakenly administered in place of a PPSV23 shot). At the time of the report, EXTRA DOSE ADMINISTERED (a moderna shot was mistakenly administered in place of a PPSV23 shot) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 42 days have passed since first dose, still didn't get second dose; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 42 days have passed since first dose, still didn't get second dose) 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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 42 days have passed since first dose, still didn't get second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 42 days have passed since first dose, still didn't get second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 23 May 2021 does not contain any new information. On 14-May-2021: Follow up received on 30 May 2021 does not contain any new information.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever) and headache in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 025C21A) for COVID-19 immunization. No medical history reported. On May 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On May 2, 2021, patient experienced pyrexia (fever). On May 4, 2021, patient experienced headache. The patient treated with Tylenol (paracetamol), at an unspecified dose and frequency. At the time of the report, pyrexia (fever) and headache: unresolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: "It seems like not all of the vaccine went into the patient"; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE ("It seems like not all of the vaccine went into the patient") in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE ("It seems like not all of the vaccine went into the patient"). On 14-May-2021, ACCIDENTAL UNDERDOSE ("It seems like not all of the vaccine went into the patient") had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment history was reported .
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseated) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) 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 NAUSEA (Nauseated). At the time of the report, NAUSEA (Nauseated) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she has not taken any medication to help with the symptom. She reported that she was not on any medication. She reported that nausea lasted for 3-4 days and she did not threw up. She stated that she was nauseated as she was terrified of needles.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Corrected patient initials and updated event outcome.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Gait disturbance, Malaise
Clinical narrative: felt weak; Congested; Coughing; could not walk for 3 days; Felt very sick; High fever; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (felt weak), NASAL CONGESTION (Congested), COUGH (Coughing), GAIT DISTURBANCE (could not walk for 3 days) and MALAISE (Felt very sick) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included OMEPRAZOLE for Acid reflux (esophageal).   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced ASTHENIA (felt weak), NASAL CONGESTION (Congested), COUGH (Coughing), GAIT DISTURBANCE (could not walk for 3 days), MALAISE (Felt very sick), PYREXIA (High fever) and CHILLS (Chills). On 05-May-2021, MALAISE (Felt very sick) and PYREXIA (High fever) had resolved. At the time of the report, ASTHENIA (felt weak), NASAL CONGESTION (Congested), COUGH (Coughing) and CHILLS (Chills) had not resolved and GAIT DISTURBANCE (could not walk for 3 days) had resolved.            The action taken with mRNA-1273 in response to the event was not applicable. Patient reported that a few hours after second dose of vaccination she experienced high fever, felt weak, could not walk for 3 days and had to visit the emergency room. Patient's congestion with coughing, weakness and chills was not resolved.  Patient has taken Tylenol and Tylenol PM for the treatment.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pyrexia
Clinical narrative: felt weak; Congested; Coughing; could not walk for 3 days; Felt very sick; High fever; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (felt weak), NASAL CONGESTION (Congested), COUGH (Coughing), GAIT DISTURBANCE (could not walk for 3 days) and MALAISE (Felt very sick) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included OMEPRAZOLE for Acid reflux (esophageal).   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced ASTHENIA (felt weak), NASAL CONGESTION (Congested), COUGH (Coughing), GAIT DISTURBANCE (could not walk for 3 days), MALAISE (Felt very sick), PYREXIA (High fever) and CHILLS (Chills). On 05-May-2021, MALAISE (Felt very sick) and PYREXIA (High fever) had resolved. At the time of the report, ASTHENIA (felt weak), NASAL CONGESTION (Congested), COUGH (Coughing) and CHILLS (Chills) had not resolved and GAIT DISTURBANCE (could not walk for 3 days) had resolved.            The action taken with mRNA-1273 in response to the event was not applicable. Patient reported that a few hours after second dose of vaccination she experienced high fever, felt weak, could not walk for 3 days and had to visit the emergency room. Patient's congestion with coughing, weakness and chills was not resolved.  Patient has taken Tylenol and Tylenol PM for the treatment.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: "For the last 2-3 weeks, I have had pain in my shoulder down to my fingers, sometimes its hard to; "For the last 2-3 weeks, I have had pain in my shoulder down to my fingers, sometimes its hard to; "For the last 2-3 weeks, I have had pain in my shoulder down to my fingers, sometimes its hard to; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY ("For the last 2-3 weeks, I have had pain in my shoulder down to my fingers, sometimes its hard to), MOBILITY DECREASED ("For the last 2-3 weeks, I have had pain in my shoulder down to my fingers, sometimes its hard to) and ARTHRALGIA ("For the last 2-3 weeks, I have had pain in my shoulder down to my fingers, sometimes its hard to) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced PAIN IN EXTREMITY ("For the last 2-3 weeks, I have had pain in my shoulder down to my fingers, sometimes its hard to), MOBILITY DECREASED ("For the last 2-3 weeks, I have had pain in my shoulder down to my fingers, sometimes its hard to) and ARTHRALGIA ("For the last 2-3 weeks, I have had pain in my shoulder down to my fingers, sometimes its hard to). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and CORTISONE at a dose of shot. At the time of the report, PAIN IN EXTREMITY ("For the last 2-3 weeks, I have had pain in my shoulder down to my fingers, sometimes its hard to) and ARTHRALGIA ("For the last 2-3 weeks, I have had pain in my shoulder down to my fingers, sometimes its hard to) was resolving and MOBILITY DECREASED ("For the last 2-3 weeks, I have had pain in my shoulder down to my fingers, sometimes its hard to) had not resolved.            No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Added treatment medication[Cortisone]. Updated events outcome:  pain in fingers and shoulder pain from unknown to recovering and mobility decreased from unknown to not recovered.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Face oedema, Feeling hot, Illness, Peripheral swelling
Clinical narrative: Stung on the leg and now has a 3-inch diameter of swelling; Stung on the left cheek and it "took out half my face" and the sting spread to the jaw and neck; Felt heat like any inflammation and moved down to the throat; Sick for a day and a half on the couch; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for a day and a half on the couch), FACE OEDEMA (Stung on the left cheek and it "took out half my face" and the sting spread to the jaw and neck), FEELING HOT (Felt heat like any inflammation and moved down to the throat) and PERIPHERAL SWELLING (Stung on the leg and now has a 3-inch diameter of swelling) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 031B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergic reaction to wasp sting. Concomitant products included PRAVASTATIN for Cholesterol, SERTRALINE for Depression, LEVOTHYROXINE for Thyroid disorder.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced ILLNESS (Sick for a day and a half on the couch). On 11-May-2021, the patient experienced FACE OEDEMA (Stung on the left cheek and it "took out half my face" and the sting spread to the jaw and neck) and FEELING HOT (Felt heat like any inflammation and moved down to the throat). On 16-May-2021, the patient experienced PERIPHERAL SWELLING (Stung on the leg and now has a 3-inch diameter of swelling). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 12-May-2021, FACE OEDEMA (Stung on the left cheek and it "took out half my face" and the sting spread to the jaw and neck) and FEELING HOT (Felt heat like any inflammation and moved down to the throat) had resolved. At the time of the report, ILLNESS (Sick for a day and a half on the couch) and PERIPHERAL SWELLING (Stung on the leg and now has a 3-inch diameter of swelling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After receiving second dose, patient was sick for a day and a half and was on the couch. Patient is a beekeeper and have no allergies to bees. Patient noticed an allergic reaction about 2 weeks after the vaccination. And on 11 May 2021, the patient was stung by the bee and there was a reaction and it took half patient's face, later it spread to the jaw, neck and throat. Patient also felt heat and inflammation over there. Then on 16 May 2021, patient got stung on the leg and developed a swelling of 3 inch. The patient was wondering whether her histamine response has changed after getting the vaccine.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given vaccine out of a vial given 24 hours after puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given vaccine out of a vial given 24 hours after puncture) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-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 EXPIRED PRODUCT ADMINISTERED (Patient given vaccine out of a vial given 24 hours after puncture). On 13-May-2021, EXPIRED PRODUCT ADMINISTERED (Patient given vaccine out of a vial given 24 hours after puncture) had resolved. Not Provided      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.   Relevant concomitant product usage were not reported by the reporter. No treatment details were added.    This case was linked to US-MODERNATX, INC.-MOD-2021-132785 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132785:Crosslink
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: diagnosed with covid 19 less than 1 week later; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (diagnosed with covid 19 less than 1 week later) 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 09-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 COVID-19 (diagnosed with covid 19 less than 1 week later). At the time of the report, COVID-19 (diagnosed with covid 19 less than 1 week later) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test: positive (Positive) Positive.     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 reported  no treatment medication was reported
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; Low grade fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PYREXIA (Low grade fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: MONOCLONAL ANTIBODIES. Past adverse reactions to the above products included No adverse event with MONOCLONAL ANTIBODIES.    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 PAIN IN EXTREMITY (sore arm) and PYREXIA (Low grade fever). At the time of the report, PAIN IN EXTREMITY (sore arm) and PYREXIA (Low grade fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was unknown.  Reporter stated that the patient was given the first dose of vaccine 14 days after the Monoclonal antibody infusion.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: after the 2nd dose injection blood started running down on her arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE HAEMORRHAGE (after the 2nd dose injection blood started running down on her arm) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, LOSARTAN and HYDROCHLOROTHIAZIDE for an unknown indication.    On 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (after the 2nd dose injection blood started running down on her arm). On 14-May-2021, VACCINATION SITE HAEMORRHAGE (after the 2nd dose injection blood started running down on her arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment of events was reported as none.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Given 24 hours after being drawn up.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given 24 hours after being drawn up.) 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 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given 24 hours after being drawn up.). On 14-May-2021, EXPIRED PRODUCT ADMINISTERED (Given 24 hours after being drawn up.) had resolved. Not Provided      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 medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow-up information received on 19-May-2021, contains non-significant information.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Less than recommended dose level vaccine was adminbsitered; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Less than recommended dose level vaccine was adminbsitered) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced ACCIDENTAL UNDERDOSE (Less than recommended dose level vaccine was adminbsitered). At the time of the report, ACCIDENTAL UNDERDOSE (Less than recommended dose level vaccine was adminbsitered) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Rash erythematous, Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash around the injection site approximately 3 inches in diameter although not a complete circle; Red bumps; Slightly itchy; Immediately sore arm at the injection site; Immediately swelling at the injection site; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Immediately sore arm at the injection site), VACCINATION SITE SWELLING (Immediately swelling at the injection site), VACCINATION SITE RASH (Rash around the injection site approximately 3 inches in diameter although not a complete circle), RASH ERYTHEMATOUS (Red bumps) and PRURITUS (Slightly itchy) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced MYALGIA (Immediately sore arm at the injection site) and VACCINATION SITE SWELLING (Immediately swelling at the injection site). On 14-May-2021, the patient experienced VACCINATION SITE RASH (Rash around the injection site approximately 3 inches in diameter although not a complete circle), RASH ERYTHEMATOUS (Red bumps) and PRURITUS (Slightly itchy). On 10-May-2021, MYALGIA (Immediately sore arm at the injection site) and VACCINATION SITE SWELLING (Immediately swelling at the injection site) outcome was unknown. At the time of the report, VACCINATION SITE RASH (Rash around the injection site approximately 3 inches in diameter although not a complete circle) and RASH ERYTHEMATOUS (Red bumps) outcome was unknown. Not Provided      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 treatment and concomitant medication information were provided   Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ears started ringing loudly; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ears started ringing loudly) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Tinnitus (mild ,for the past 18 years).    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 TINNITUS (Ears started ringing loudly). At the time of the report, TINNITUS (Ears started ringing loudly) outcome was unknown. Not Provided          concomitant product details not provided. patient decided not to take the second dose of Moderna COVID-19 vaccine
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccine administered to 15 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to 15 year old) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to 15 year old). On 14-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to 15 year old) outcome was unknown. Not Provided      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 medication use was unknown.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Influenza like illness, Nausea, Pain
Clinical narrative: flu- like symptoms; no energy at all; Nausea (thrown up once); very achy; fatigue; on and off fever; Nausea (thrown up once); This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy at all), PAIN (very achy), INFLUENZA LIKE ILLNESS (flu- like symptoms), FATIGUE (fatigue) and PYREXIA (on and off fever) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AZITHROMYCIN for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PAIN (very achy), FATIGUE (fatigue), PYREXIA (on and off fever) and NAUSEA (Nausea (thrown up once)). On an unknown date, the patient experienced ASTHENIA (no energy at all), INFLUENZA LIKE ILLNESS (flu- like symptoms) and VOMITING (Nausea (thrown up once)). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN (very achy), INFLUENZA LIKE ILLNESS (flu- like symptoms), FATIGUE (fatigue), PYREXIA (on and off fever), NAUSEA (Nausea (thrown up once)) and VOMITING (Nausea (thrown up once)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: flu- like symptoms; no energy at all; Nausea (thrown up once); very achy; fatigue; on and off fever; Nausea (thrown up once); This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy at all), PAIN (very achy), INFLUENZA LIKE ILLNESS (flu- like symptoms), FATIGUE (fatigue) and PYREXIA (on and off fever) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AZITHROMYCIN for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PAIN (very achy), FATIGUE (fatigue), PYREXIA (on and off fever) and NAUSEA (Nausea (thrown up once)). On an unknown date, the patient experienced ASTHENIA (no energy at all), INFLUENZA LIKE ILLNESS (flu- like symptoms) and VOMITING (Nausea (thrown up once)). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN (very achy), INFLUENZA LIKE ILLNESS (flu- like symptoms), FATIGUE (fatigue), PYREXIA (on and off fever), NAUSEA (Nausea (thrown up once)) and VOMITING (Nausea (thrown up once)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Chills, Fatigue, Myalgia, Pain in extremity
Clinical narrative: slept a lot; whole rainbow of symptoms; fever; chills; exhausted; body aches; sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm), SOMNOLENCE (slept a lot), ADVERSE REACTION (whole rainbow of symptoms), PYREXIA (fever) and CHILLS (chills) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 30-Mar-2021, the patient experienced SOMNOLENCE (slept a lot), ADVERSE REACTION (whole rainbow of symptoms), PYREXIA (fever), CHILLS (chills), FATIGUE (exhausted) and MYALGIA (body aches). At the time of the report, PAIN IN EXTREMITY (sore arm), SOMNOLENCE (slept a lot), ADVERSE REACTION (whole rainbow of symptoms), PYREXIA (fever), CHILLS (chills), FATIGUE (exhausted) and MYALGIA (body aches) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided. Events recovered in 3-4 days.   This case was linked to US-MODERNATX, INC.-MOD-2021-132183 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132183:Dose 2
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: slept a lot; whole rainbow of symptoms; fever; chills; exhausted; body aches; sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm), SOMNOLENCE (slept a lot), ADVERSE REACTION (whole rainbow of symptoms), PYREXIA (fever) and CHILLS (chills) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 30-Mar-2021, the patient experienced SOMNOLENCE (slept a lot), ADVERSE REACTION (whole rainbow of symptoms), PYREXIA (fever), CHILLS (chills), FATIGUE (exhausted) and MYALGIA (body aches). At the time of the report, PAIN IN EXTREMITY (sore arm), SOMNOLENCE (slept a lot), ADVERSE REACTION (whole rainbow of symptoms), PYREXIA (fever), CHILLS (chills), FATIGUE (exhausted) and MYALGIA (body aches) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided. Events recovered in 3-4 days.   This case was linked to US-MODERNATX, INC.-MOD-2021-132183 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132183:Dose 2
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Insomnia, Myalgia
Clinical narrative: significant rash at injection site; muscle ache; fever; no sleep; sore arm; joint ache; chills; Tiredness; This spontaneous case was reported by a pharmacist and describes the occurrence of INSOMNIA (no sleep), PAIN IN EXTREMITY (sore arm), ARTHRALGIA (joint ache), CHILLS (chills) and FATIGUE (Tiredness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included VERAPAMIL, AMLODIPINE, HYDROCHLOROTHIAZIDE and PANTOPRAZOLE for an unknown indication.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced INSOMNIA (no sleep), PAIN IN EXTREMITY (sore arm), ARTHRALGIA (joint ache), CHILLS (chills), FATIGUE (Tiredness), MYALGIA (muscle ache) and PYREXIA (fever). On 14-May-2021, the patient experienced VACCINATION SITE RASH (significant rash at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) for Rash, at an unspecified dose and frequency. On 13-May-2021, INSOMNIA (no sleep), ARTHRALGIA (joint ache), CHILLS (chills), FATIGUE (Tiredness), MYALGIA (muscle ache) and PYREXIA (fever) had resolved, PAIN IN EXTREMITY (sore arm) outcome was unknown. At the time of the report, VACCINATION SITE RASH (significant rash at injection site) 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.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site rash
Clinical narrative: significant rash at injection site; muscle ache; fever; no sleep; sore arm; joint ache; chills; Tiredness; This spontaneous case was reported by a pharmacist and describes the occurrence of INSOMNIA (no sleep), PAIN IN EXTREMITY (sore arm), ARTHRALGIA (joint ache), CHILLS (chills) and FATIGUE (Tiredness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included VERAPAMIL, AMLODIPINE, HYDROCHLOROTHIAZIDE and PANTOPRAZOLE for an unknown indication.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced INSOMNIA (no sleep), PAIN IN EXTREMITY (sore arm), ARTHRALGIA (joint ache), CHILLS (chills), FATIGUE (Tiredness), MYALGIA (muscle ache) and PYREXIA (fever). On 14-May-2021, the patient experienced VACCINATION SITE RASH (significant rash at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) for Rash, at an unspecified dose and frequency. On 13-May-2021, INSOMNIA (no sleep), ARTHRALGIA (joint ache), CHILLS (chills), FATIGUE (Tiredness), MYALGIA (muscle ache) and PYREXIA (fever) had resolved, PAIN IN EXTREMITY (sore arm) outcome was unknown. At the time of the report, VACCINATION SITE RASH (significant rash at injection site) 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.