chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain
Clinical narrative: Arthritis pain, Join pain, Bone pain; Arthritis pain, Join pain, Bone pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BONE PAIN (Arthritis pain, Join pain, Bone pain) and ARTHRALGIA (Arthritis pain, Join pain, Bone pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (doxazosin doxacosin, lisinopril, statin, and ace inhibitors.), Egg allergy and Dairy intolerance. Concomitant products included ACEBUTOLOL HYDROCHLORIDE (SECTRAL), HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE), LOSARTAN, CELECOXIB (CELEXA [CELECOXIB]) and OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced BONE PAIN (Arthritis pain, Join pain, Bone pain) and ARTHRALGIA (Arthritis pain, Join pain, Bone pain). The patient was treated with SULINDAC ongoing from 26-Feb-2021 for Arthritis, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and SULINDAC on 26-Feb-2021 at an unspecified dose and frequency. At the time of the report, BONE PAIN (Arthritis pain, Join pain, Bone pain) and ARTHRALGIA (Arthritis pain, Join pain, Bone pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: feet were warm; rapid test came back positive; felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (feet were warm), SARS-COV-2 TEST POSITIVE (rapid test came back positive) and FATIGUE (felt very tired) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041220A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced FEELING HOT (feet were warm), SARS-COV-2 TEST POSITIVE (rapid test came back positive) and FATIGUE (felt very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Jan-2021, FEELING HOT (feet were warm) and FATIGUE (felt very tired) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (rapid test came back positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.     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 details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain, Vomiting
Clinical narrative: Extreme fatigue; chills; nausea; vomiting; soreness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extreme fatigue), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and PAIN (soreness) 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Extreme fatigue), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and PAIN (soreness). At the time of the report, FATIGUE (Extreme fatigue), CHILLS (chills), NAUSEA (nausea), VOMITING (vomiting) and PAIN (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-057805 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Delayed side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Delayed side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 ADVERSE REACTION (Delayed side effects). At the time of the report, ADVERSE REACTION (Delayed side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided    Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itch at site of injection; Sore arm; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itch at site of injection), MYALGIA (Sore arm) and VACCINATION SITE SWELLING (Swelling at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itch at site of injection), MYALGIA (Sore arm) and VACCINATION SITE SWELLING (Swelling at injection site). On 08-Mar-2021, VACCINATION SITE PRURITUS (Itch at site of injection), MYALGIA (Sore arm) and VACCINATION SITE SWELLING (Swelling at injection site) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: low grade fever of 99.9; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever of 99.9) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included VALSARTAN, LEVOTHYROXINE SODIUM (SYNTHROID) and ALPRAZOLAM for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PYREXIA (low grade fever of 99.9). In March 2021, PYREXIA (low grade fever of 99.9) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: 99.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication details was reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Oxygen saturation, Skin exfoliation, Vaccination site pain
Clinical narrative: headache; sore arm at injection site; severe shortness of breath; skin on her entire left palm was peeling; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (severe shortness of breath), SKIN EXFOLIATION (skin on her entire left palm was peeling), VACCINATION SITE PAIN (sore arm at injection site) and HEADACHE (headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Diabetic. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LISINOPRIL, METFORMIN, GLIPIZIDE, PIOGLITAZONE HYDROCHLORIDE (ACTOS), EZETIMIBE (ZETIA), FAMOTIDINE and ACETYLSALICYLIC ACID (ASPIRIN LOW) for an unknown indication.    On 04-Mar-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore arm at injection site). In March 2021, the patient experienced DYSPNOEA (severe shortness of breath). March 2021, the patient experienced SKIN EXFOLIATION (skin on her entire left palm was peeling). On an unknown date, the patient experienced HEADACHE (headache). In March 2021, DYSPNOEA (severe shortness of breath) had resolved. At the time of the report, SKIN EXFOLIATION (skin on her entire left palm was peeling), VACCINATION SITE PAIN (sore arm at injection site) and HEADACHE (headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Oxygen saturation: 95 (Inconclusive) 95.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       At 10:00 AM the patient felt almost normal from barely breathing, but did end up borrowing her neighbors pulse oximeter where she saw that was at 95%. The patient stated that on the right arm a little spot that was smaller than a pencil eraser that was starting to peel. The patient stated that she did not  know how many layers peeled off but it did not hurt or bleed, and it was just her palm.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: Felt cold; Had a temperature; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Felt cold) and PYREXIA (Had a temperature) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013m20a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced NASOPHARYNGITIS (Felt cold) and PYREXIA (Had a temperature). At the time of the report, NASOPHARYNGITIS (Felt cold) and PYREXIA (Had a temperature) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.  Upon internal review on 21-May-2021, the age was corrected to unknown.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Illness, Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 23Jan2021 and 2nd dose on 05 Mar 2021), ILLNESS (felt sick), HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013L20A) 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 LISINOPRIL, HCTZ, FENOFIBRATE, VITAMIN and MAGNESIUM for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 23Jan2021 and 2nd dose on 05 Mar 2021). On 06-Mar-2021, the patient experienced ILLNESS (felt sick), HEADACHE (headache), ARTHRALGIA (joint pain), MYALGIA (muscle pain), NAUSEA (nausea) and FATIGUE (fatigue). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 23Jan2021 and 2nd dose on 05 Mar 2021) outcome was unknown and ILLNESS (felt sick), HEADACHE (headache), ARTHRALGIA (joint pain), MYALGIA (muscle pain), NAUSEA (nausea) and FATIGUE (fatigue) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications include overt the counter cold pills,allergy pill and advised to take Tylenol by doctor. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 23Jan2021 and 2nd dose on 05 Mar 2021), ILLNESS (felt sick), HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013L20A) 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 LISINOPRIL, HCTZ, FENOFIBRATE, VITAMIN and MAGNESIUM for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 23Jan2021 and 2nd dose on 05 Mar 2021). On 06-Mar-2021, the patient experienced ILLNESS (felt sick), HEADACHE (headache), ARTHRALGIA (joint pain), MYALGIA (muscle pain), NAUSEA (nausea) and FATIGUE (fatigue). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 23Jan2021 and 2nd dose on 05 Mar 2021) outcome was unknown and ILLNESS (felt sick), HEADACHE (headache), ARTHRALGIA (joint pain), MYALGIA (muscle pain), NAUSEA (nausea) and FATIGUE (fatigue) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications include overt the counter cold pills,allergy pill and advised to take Tylenol by doctor. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever; body ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and PAIN (body ache) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and PAIN (body ache). At the time of the report, PYREXIA (fever) and PAIN (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Rashes are itchy; Patient started to have rashes that look like blisters all over his body 2 weeks after first dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rashes are itchy) and RASH (Patient started to have rashes that look like blisters all over his body 2 weeks after first dose) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced RASH PRURITIC (Rashes are itchy) and RASH (Patient started to have rashes that look like blisters all over his body 2 weeks after first dose). At the time of the report, RASH PRURITIC (Rashes are itchy) and RASH (Patient started to have rashes that look like blisters all over his body 2 weeks after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Prednisone and a cream
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: salty taste; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (salty taste) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (salty taste). At the time of the report, DYSGEUSIA (salty taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not reported. Treatment medications were not mentioned
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: arm is still red; sore to touch like she just got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm is still red) and VACCINATION SITE PAIN (sore to touch like she just got the shot) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (arm is still red) and VACCINATION SITE PAIN (sore to touch like she just got the shot). At the time of the report, VACCINATION SITE ERYTHEMA (arm is still red) and VACCINATION SITE PAIN (sore to touch like she just got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment information were not reported.  Patient was not on any medications. Lot number was unknown
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Dizziness, Erythema, Eye irritation
Clinical narrative: Burning eyes and head; Dizziness; Swollen arm , tongue and legs; Swollen arm , tongue and legs; Swollen arm , tongue and legs; the head is tender to touch; woke up at night to drink a lot of water because thought that was dehydrated; Sore throat; The arm is really red; Nausea; Headache; Chattering; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Mar-2021 and was forwarded to Moderna on 10-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Burning eyes and head), DIZZINESS (Dizziness), the first episode of PERIPHERAL SWELLING (Swollen arm , tongue and legs), SWOLLEN TONGUE (Swollen arm , tongue and legs) and the second episode of PERIPHERAL SWELLING (Swollen arm , tongue and legs) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced EYE IRRITATION (Burning eyes and head), DIZZINESS (Dizziness), the first episode of PERIPHERAL SWELLING (Swollen arm , tongue and legs), SWOLLEN TONGUE (Swollen arm , tongue and legs), the second episode of PERIPHERAL SWELLING (Swollen arm , tongue and legs), TENDERNESS (the head is tender to touch), DEHYDRATION (woke up at night to drink a lot of water because thought that was dehydrated), OROPHARYNGEAL PAIN (Sore throat), ERYTHEMA (The arm is really red), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chattering). At the time of the report, EYE IRRITATION (Burning eyes and head), DIZZINESS (Dizziness), SWOLLEN TONGUE (Swollen arm , tongue and legs), the last episode of PERIPHERAL SWELLING (Swollen arm , tongue and legs), TENDERNESS (the head is tender to touch), DEHYDRATION (woke up at night to drink a lot of water because thought that was dehydrated), OROPHARYNGEAL PAIN (Sore throat), ERYTHEMA (The arm is really red), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chattering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Oropharyngeal pain, Peripheral swelling, Swollen tongue
Clinical narrative: Burning eyes and head; Dizziness; Swollen arm , tongue and legs; Swollen arm , tongue and legs; Swollen arm , tongue and legs; the head is tender to touch; woke up at night to drink a lot of water because thought that was dehydrated; Sore throat; The arm is really red; Nausea; Headache; Chattering; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Mar-2021 and was forwarded to Moderna on 10-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Burning eyes and head), DIZZINESS (Dizziness), the first episode of PERIPHERAL SWELLING (Swollen arm , tongue and legs), SWOLLEN TONGUE (Swollen arm , tongue and legs) and the second episode of PERIPHERAL SWELLING (Swollen arm , tongue and legs) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced EYE IRRITATION (Burning eyes and head), DIZZINESS (Dizziness), the first episode of PERIPHERAL SWELLING (Swollen arm , tongue and legs), SWOLLEN TONGUE (Swollen arm , tongue and legs), the second episode of PERIPHERAL SWELLING (Swollen arm , tongue and legs), TENDERNESS (the head is tender to touch), DEHYDRATION (woke up at night to drink a lot of water because thought that was dehydrated), OROPHARYNGEAL PAIN (Sore throat), ERYTHEMA (The arm is really red), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chattering). At the time of the report, EYE IRRITATION (Burning eyes and head), DIZZINESS (Dizziness), SWOLLEN TONGUE (Swollen arm , tongue and legs), the last episode of PERIPHERAL SWELLING (Swollen arm , tongue and legs), TENDERNESS (the head is tender to touch), DEHYDRATION (woke up at night to drink a lot of water because thought that was dehydrated), OROPHARYNGEAL PAIN (Sore throat), ERYTHEMA (The arm is really red), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chattering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Burning eyes and head; Dizziness; Swollen arm , tongue and legs; Swollen arm , tongue and legs; Swollen arm , tongue and legs; the head is tender to touch; woke up at night to drink a lot of water because thought that was dehydrated; Sore throat; The arm is really red; Nausea; Headache; Chattering; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Mar-2021 and was forwarded to Moderna on 10-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Burning eyes and head), DIZZINESS (Dizziness), the first episode of PERIPHERAL SWELLING (Swollen arm , tongue and legs), SWOLLEN TONGUE (Swollen arm , tongue and legs) and the second episode of PERIPHERAL SWELLING (Swollen arm , tongue and legs) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced EYE IRRITATION (Burning eyes and head), DIZZINESS (Dizziness), the first episode of PERIPHERAL SWELLING (Swollen arm , tongue and legs), SWOLLEN TONGUE (Swollen arm , tongue and legs), the second episode of PERIPHERAL SWELLING (Swollen arm , tongue and legs), TENDERNESS (the head is tender to touch), DEHYDRATION (woke up at night to drink a lot of water because thought that was dehydrated), OROPHARYNGEAL PAIN (Sore throat), ERYTHEMA (The arm is really red), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chattering). At the time of the report, EYE IRRITATION (Burning eyes and head), DIZZINESS (Dizziness), SWOLLEN TONGUE (Swollen arm , tongue and legs), the last episode of PERIPHERAL SWELLING (Swollen arm , tongue and legs), TENDERNESS (the head is tender to touch), DEHYDRATION (woke up at night to drink a lot of water because thought that was dehydrated), OROPHARYNGEAL PAIN (Sore throat), ERYTHEMA (The arm is really red), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (Chattering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (felt tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (felt tired). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Drug interaction, Erythema, Eye swelling, Pruritus, Swelling face
Clinical narrative: Not allergic to shrimp or the vaccination but I'm allergic to both of them together, combo allergy; Eyes and face started to swell up; Swelling under my eye; Welts on my face; Redness; Face was itching; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of DRUG INTERACTION (Not allergic to shrimp or the vaccination but I'm allergic to both of them together, combo allergy), SWELLING FACE (Eyes and face started to swell up), EYE SWELLING (Swelling under my eye), PRURITUS (Face was itching) and URTICARIA (Welts on my face) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No past relevant history was given.  Concomitant products included HCTZ, SIMVASTATIN, SAW PALMETTO [SERENOA REPENS], CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]), COLECALCIFEROL (VITAMIN D 3), MAGNESIUM, METFORMIN, TAMSULOSIN and ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (Face was itching). On 09-Mar-2021, the patient experienced DRUG INTERACTION (Not allergic to shrimp or the vaccination but I'm allergic to both of them together, combo allergy), SWELLING FACE (Eyes and face started to swell up), EYE SWELLING (Swelling under my eye), URTICARIA (Welts on my face) and ERYTHEMA (Redness). On 08-Mar-2021, PRURITUS (Face was itching) had resolved. On 10-Mar-2021, SWELLING FACE (Eyes and face started to swell up), URTICARIA (Welts on my face) and ERYTHEMA (Redness) had resolved. At the time of the report, DRUG INTERACTION (Not allergic to shrimp or the vaccination but I'm allergic to both of them together, combo allergy) outcome was unknown and EYE SWELLING (Swelling under my eye) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Shot in his hip (doesn't know the name).    Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up information received on 22-jun-2021 contains no new information.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Not allergic to shrimp or the vaccination but I'm allergic to both of them together, combo allergy; Eyes and face started to swell up; Swelling under my eye; Welts on my face; Redness; Face was itching; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of DRUG INTERACTION (Not allergic to shrimp or the vaccination but I'm allergic to both of them together, combo allergy), SWELLING FACE (Eyes and face started to swell up), EYE SWELLING (Swelling under my eye), PRURITUS (Face was itching) and URTICARIA (Welts on my face) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No past relevant history was given.  Concomitant products included HCTZ, SIMVASTATIN, SAW PALMETTO [SERENOA REPENS], CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]), COLECALCIFEROL (VITAMIN D 3), MAGNESIUM, METFORMIN, TAMSULOSIN and ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (Face was itching). On 09-Mar-2021, the patient experienced DRUG INTERACTION (Not allergic to shrimp or the vaccination but I'm allergic to both of them together, combo allergy), SWELLING FACE (Eyes and face started to swell up), EYE SWELLING (Swelling under my eye), URTICARIA (Welts on my face) and ERYTHEMA (Redness). On 08-Mar-2021, PRURITUS (Face was itching) had resolved. On 10-Mar-2021, SWELLING FACE (Eyes and face started to swell up), URTICARIA (Welts on my face) and ERYTHEMA (Redness) had resolved. At the time of the report, DRUG INTERACTION (Not allergic to shrimp or the vaccination but I'm allergic to both of them together, combo allergy) outcome was unknown and EYE SWELLING (Swelling under my eye) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Shot in his hip (doesn't know the name).    Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up information received on 22-jun-2021 contains no new information.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Vaccination site pain
Clinical narrative: nauseated; Body aches; Sore arm at injection site; very persistent headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (very persistent headache), NAUSEA (nauseated), MYALGIA (Body aches) and VACCINATION SITE PAIN (Sore arm at injection site) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced MYALGIA (Body aches) and VACCINATION SITE PAIN (Sore arm at injection site). On 10-Mar-2021, the patient experienced NAUSEA (nauseated). In March 2021, the patient experienced HEADACHE (very persistent headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 07-Mar-2021, MYALGIA (Body aches) and VACCINATION SITE PAIN (Sore arm at injection site) had resolved. At the time of the report, HEADACHE (very persistent headache) and NAUSEA (nauseated) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient was given 2nd dose of the vaccine 14 days after the 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient was given 2nd dose of the vaccine 14 days after the 1st dose) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient was given 2nd dose of the vaccine 14 days after the 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient was given 2nd dose of the vaccine 14 days after the 1st dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test false positive, SARS-CoV-2 test positive
Clinical narrative: test was false positive; tested positive from a rapid PCR test; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive from a rapid PCR test) and SARS-COV-2 TEST FALSE POSITIVE (test was false positive) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 11-Nov-2020.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive from a rapid PCR test). On an unknown date, the patient experienced SARS-COV-2 TEST FALSE POSITIVE (test was false positive). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive from a rapid PCR test) and SARS-COV-2 TEST FALSE POSITIVE (test was false positive) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.         No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up information received on 21-JUN-2021 and event (SARS COV-2 test false positive) is updated
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fall, Headache
Clinical narrative: Fall with injury to the face requiring one stitch; Headache; Light headed/Dizzy; More off balance than usual; Caller is calling to update contact information
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: a lot worse and heavier than her normal periods; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (a lot worse and heavier than her normal periods) 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-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MENSTRUAL DISORDER (a lot worse and heavier than her normal periods). At the time of the report, MENSTRUAL DISORDER (a lot worse and heavier than her normal periods) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Warmth of skin at injection site in the left upper arm; Itching at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmth of skin at injection site in the left upper arm) and VACCINATION SITE PRURITUS (Itching at injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN and VITAMINS NOS for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warmth of skin at injection site in the left upper arm) and VACCINATION SITE PRURITUS (Itching at injection site). At the time of the report, VACCINATION SITE WARMTH (Warmth of skin at injection site in the left upper arm) and VACCINATION SITE PRURITUS (Itching at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication details was reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: sleeplessness; This spontaneous case was reported by a health care professional and describes the occurrence of INSOMNIA (sleeplessness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Irritable bowel syndrome.    On 09-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 INSOMNIA (sleeplessness). At the time of the report, INSOMNIA (sleeplessness) outcome was unknown.        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 details was reported.   This case was linked to MOD21-050421 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash on arm at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on arm at the vaccination site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash on arm at the vaccination site). At the time of the report, VACCINATION SITE RASH (rash on arm at the vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Pharyngeal swelling, Swollen tongue
Clinical narrative: Tongue is swollen; Throat is swollen; Tongue feels numb; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Tongue is swollen), PHARYNGEAL SWELLING (Throat is swollen) and HYPOAESTHESIA ORAL (Tongue feels numb) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 127721A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced SWOLLEN TONGUE (Tongue is swollen), PHARYNGEAL SWELLING (Throat is swollen) and HYPOAESTHESIA ORAL (Tongue feels numb). At the time of the report, SWOLLEN TONGUE (Tongue is swollen), PHARYNGEAL SWELLING (Throat is swollen) and HYPOAESTHESIA ORAL (Tongue feels numb) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included diabetic medication and blood pressure medication.  No treatment medication was reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: itching; pain at injection site left arm; rash; heat; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat), VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (pain at injection site left arm) and VACCINATION SITE RASH (rash) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE WARMTH (heat) and VACCINATION SITE RASH (rash). On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching) and VACCINATION SITE PAIN (pain at injection site left arm). At the time of the report, VACCINATION SITE WARMTH (heat), VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (pain at injection site left arm) and VACCINATION SITE RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. The treatment medication included patient applied cream twice.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: soreness under her arm pit; Huge swollen lymph node; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (soreness under her arm pit) and LYMPHADENOPATHY (Huge swollen lymph node) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-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 AXILLARY PAIN (soreness under her arm pit) and LYMPHADENOPATHY (Huge swollen lymph node). At the time of the report, AXILLARY PAIN (soreness under her arm pit) and LYMPHADENOPATHY (Huge swollen lymph node) 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. No treatment medication details was reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Erythema, Fatigue, Inappropriate schedule of product administration, Pain
Clinical narrative: Sore arm; fatigue; little tired; feeling achy; Covid arm; a rash that is warm ,red, and itchy; a rash that is warm ,red, and itchy; a rash that is warm ,red, and itchy; second dose on 4Mar2021 in my right arm which is a 34 days difference.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), SKIN WARM (a rash that is warm ,red, and itchy), FATIGUE (fatigue), ERYTHEMA (a rash that is warm ,red, and itchy) and FATIGUE (little tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on 4Mar2021 in my right arm which is a 34 days difference.). On 09-Mar-2021, the patient experienced SKIN WARM (a rash that is warm ,red, and itchy), ERYTHEMA (a rash that is warm ,red, and itchy), COVID-19 (Covid arm) and PRURITUS (a rash that is warm ,red, and itchy). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). an unknown date, the patient experienced FATIGUE (fatigue), FATIGUE (little tired) and PAIN (feeling achy). On 04-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on 4Mar2021 in my right arm which is a 34 days difference.) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), SKIN WARM (a rash that is warm ,red, and itchy), FATIGUE (fatigue), ERYTHEMA (a rash that is warm ,red, and itchy), FATIGUE (little tired), PAIN (feeling achy), COVID-19 (Covid arm) and PRURITUS (a rash that is warm ,red, and itchy) outcome was unknown. Not Provided          No relevant concomitant medications provided. No relevant Treatment information provided. Action taken with mRNA-1273 in response to the events was not applicable.