chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Headache, Vaccination site pain, Vomiting
Clinical narrative: massive headache at center of her forehead; threw up; pain at injection site; felt dehydrated more than normal; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site), DEHYDRATION (felt dehydrated more than normal), HEADACHE (massive headache at center of her forehead) and VOMITING (threw up) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Migraine. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site) and DEHYDRATION (felt dehydrated more than normal). On 15-Apr-2021, the patient experienced HEADACHE (massive headache at center of her forehead) and VOMITING (threw up). At the time of the report, VACCINATION SITE PAIN (pain at injection site), DEHYDRATION (felt dehydrated more than normal), HEADACHE (massive headache at center of her forehead) and VOMITING (threw up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications listed.
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: received Moderna vaccine instead of Pfizer 2nd dose; This spontaneous case was reported by a physician and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (received Moderna vaccine instead of Pfizer 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE for COVID-19 vaccination.    No medical history was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and first dose of COVID-19 VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (received Moderna vaccine instead of Pfizer 2nd dose). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (received Moderna vaccine instead of Pfizer 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported    This case was linked to US-MODERNATX, INC.-MOD-2021-081486 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081486:Crosslinked
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 01-Mar-2021 and the estimated date of delivery was 06-Dec-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dizziness, Fatigue, Feeling hot
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), ABDOMINAL DISCOMFORT (upset stomach), DIZZINESS (dizziness), PERIPHERAL SWELLING (Arm is swollen) and FEELING HOT (Head feels hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036_21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Vertigo. Concomitant products included MECLIZINE [MECLOZINE] for Dizziness. On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), ABDOMINAL DISCOMFORT (upset stomach) and NAUSEA (Nausea). On 15-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm is swollen), FEELING HOT (Head feels hot) and MYALGIA (Body Aches). On 16-Apr-2021, the patient experienced HEADACHE (headache) and FATIGUE (tiredness). On 22-Apr-2021, the patient experienced DIZZINESS (dizziness). On 13-May-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced VERTIGO (Vertigo, off balanced), INFLUENZA (flu) and SOMNOLENCE (Sleepy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) at a dose of UNK, bid and ASPIRIN [ACETYLSALICYLIC ACID] at a dose of UNK, bid. At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), ABDOMINAL DISCOMFORT (upset stomach), DIZZINESS (dizziness), PERIPHERAL SWELLING (Arm is swollen), FEELING HOT (Head feels hot), INFLUENZA (flu), SOMNOLENCE (Sleepy), HEADACHE (headache), NAUSEA (Nausea), MYALGIA (Body Aches) and FATIGUE (tiredness) outcome was unknown and VERTIGO (Vertigo, off balanced) and CHILLS (Chills) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to US-MODERNATX, INC.-MOD-2021-054733 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up received on 22 Apr 2021 included information of additional events after second dose. The events experienced were headache, dizziness, vertigo, fatigue, influenza and somnolence. On 22-May-2021: Additional information included event outcome and concomitant medication was updated.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-054733:For First dose
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Headache, Influenza, Myalgia, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), ABDOMINAL DISCOMFORT (upset stomach), DIZZINESS (dizziness), PERIPHERAL SWELLING (Arm is swollen) and FEELING HOT (Head feels hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036_21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Vertigo. Concomitant products included MECLIZINE [MECLOZINE] for Dizziness. On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), ABDOMINAL DISCOMFORT (upset stomach) and NAUSEA (Nausea). On 15-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm is swollen), FEELING HOT (Head feels hot) and MYALGIA (Body Aches). On 16-Apr-2021, the patient experienced HEADACHE (headache) and FATIGUE (tiredness). On 22-Apr-2021, the patient experienced DIZZINESS (dizziness). On 13-May-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced VERTIGO (Vertigo, off balanced), INFLUENZA (flu) and SOMNOLENCE (Sleepy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) at a dose of UNK, bid and ASPIRIN [ACETYLSALICYLIC ACID] at a dose of UNK, bid. At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), ABDOMINAL DISCOMFORT (upset stomach), DIZZINESS (dizziness), PERIPHERAL SWELLING (Arm is swollen), FEELING HOT (Head feels hot), INFLUENZA (flu), SOMNOLENCE (Sleepy), HEADACHE (headache), NAUSEA (Nausea), MYALGIA (Body Aches) and FATIGUE (tiredness) outcome was unknown and VERTIGO (Vertigo, off balanced) and CHILLS (Chills) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to US-MODERNATX, INC.-MOD-2021-054733 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up received on 22 Apr 2021 included information of additional events after second dose. The events experienced were headache, dizziness, vertigo, fatigue, influenza and somnolence. On 22-May-2021: Additional information included event outcome and concomitant medication was updated.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-054733:For First dose
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Somnolence, Vertigo
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), ABDOMINAL DISCOMFORT (upset stomach), DIZZINESS (dizziness), PERIPHERAL SWELLING (Arm is swollen) and FEELING HOT (Head feels hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036_21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Vertigo. Concomitant products included MECLIZINE [MECLOZINE] for Dizziness. On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), ABDOMINAL DISCOMFORT (upset stomach) and NAUSEA (Nausea). On 15-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm is swollen), FEELING HOT (Head feels hot) and MYALGIA (Body Aches). On 16-Apr-2021, the patient experienced HEADACHE (headache) and FATIGUE (tiredness). On 22-Apr-2021, the patient experienced DIZZINESS (dizziness). On 13-May-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced VERTIGO (Vertigo, off balanced), INFLUENZA (flu) and SOMNOLENCE (Sleepy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) at a dose of UNK, bid and ASPIRIN [ACETYLSALICYLIC ACID] at a dose of UNK, bid. At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), ABDOMINAL DISCOMFORT (upset stomach), DIZZINESS (dizziness), PERIPHERAL SWELLING (Arm is swollen), FEELING HOT (Head feels hot), INFLUENZA (flu), SOMNOLENCE (Sleepy), HEADACHE (headache), NAUSEA (Nausea), MYALGIA (Body Aches) and FATIGUE (tiredness) outcome was unknown and VERTIGO (Vertigo, off balanced) and CHILLS (Chills) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to US-MODERNATX, INC.-MOD-2021-054733 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up received on 22 Apr 2021 included information of additional events after second dose. The events experienced were headache, dizziness, vertigo, fatigue, influenza and somnolence. On 22-May-2021: Additional information included event outcome and concomitant medication was updated.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-054733:For First dose
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Rush of Metallic Taste in the Mouth; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSGEUSIA (Rush of Metallic Taste in the Mouth) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced DYSGEUSIA (Rush of Metallic Taste in the Mouth). At the time of the report, DYSGEUSIA (Rush of Metallic Taste in the Mouth) 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 concomitant medications reported. No treatment reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Dizziness, Fall
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (been having dizzy spells), FALL (He's been finding himself on the floor and he doesn't know how he got on the floor) and BLOOD PRESSURE DECREASED (blood pressure drops) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The patient's past medical history included Dialysis (Patient stated he had been on dialysis for 4 years and sees the nurse every other day.) since an unknown date. On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (been having dizzy spells), FALL (He's been finding himself on the floor and he doesn't know how he got on the floor) and BLOOD PRESSURE DECREASED (blood pressure drops). At the time of the report, DIZZINESS (been having dizzy spells) and FALL (He's been finding himself on the floor and he doesn't know how he got on the floor) had not resolved and BLOOD PRESSURE DECREASED (blood pressure drops) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. No concomitant medications reported. No treatment reported. This case was linked to US-MODERNATX, INC.-MOD-2021-081591 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081591:CROSSLINKED WITH DOSE 1
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Overdue 2nd dose of Moderna COVID-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 01-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 PRODUCT DOSE OMISSION ISSUE (Overdue 2nd dose of Moderna COVID-19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Overdue 2nd dose of Moderna COVID-19 vaccine) 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 drugs and treatment medications were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Rash pruritic
Clinical narrative: A rash developed all over her body where the itching is unbearable; Her legs are hot to touch; This spontaneous case was reported by a patient and describes the occurrence of RASH PRURITIC (A rash developed all over her body where the itching is unbearable) and FEELING HOT (Her legs are hot to touch) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced RASH PRURITIC (A rash developed all over her body where the itching is unbearable) and FEELING HOT (Her legs are hot to touch). The patient was treated with MUPIROCIN at a dose of UNK dosage form, qd and TRIAMCINOLONE at a dose of UNK dosage form, qd. At the time of the report, RASH PRURITIC (A rash developed all over her body where the itching is unbearable) and FEELING HOT (Her legs are hot to touch) had not resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  Concomitant product used was not provided by the reporter. .   This case was linked to MOD-2021-081504 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced FATIGUE (tired). At the time of the report, FATIGUE (tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment medications was provided.   This case was linked to, INC.-MOD-2021-081741 (E2B Linked Report).; Sender's Comments:, INC.-MOD-2021-081741:Cross-Linked to wife case
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 years old received the first dose of the moderna covid-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old received the first dose of the moderna covid-19 vaccine) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old received the first dose of the moderna covid-19 vaccine). On 25-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old received the first dose of the moderna covid-19 vaccine) 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.   This report refers to a case of Product administered to patient of Inappropriate age for mRNA-1273, lot #  044A21A, with no associated AEs.; Sender's Comments: This report refers to a case of Product administered to patient of Inappropriate age for mRNA-1273, lot #  044A21A, with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Localised infection, Myalgia
Clinical narrative: arm was infected; severe pain; pain in THE shoulder; first shot of the Moderna COVID-19 Vaccine on 5Feb2021; This spontaneous case was reported by a consumer and describes the occurrence of LOCALISED INFECTION (arm was infected), MYALGIA (severe pain), ARTHRALGIA (pain in THE shoulder) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first shot of the Moderna COVID-19 Vaccine on 5Feb2021) 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 05-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 LOCALISED INFECTION (arm was infected), MYALGIA (severe pain), ARTHRALGIA (pain in THE shoulder) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first shot of the Moderna COVID-19 Vaccine on 5Feb2021). At the time of the report, LOCALISED INFECTION (arm was infected), MYALGIA (severe pain), ARTHRALGIA (pain in THE shoulder) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first shot of the Moderna COVID-19 Vaccine on 5Feb2021) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Antibiotics were prescribed for the patient to treat symptoms.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical  History information was provided by the reporter.  Concomitant products included THYROID for Thyroid cold nodule.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VISION BLURRED (Blurred vision). At the time of the report, VISION BLURRED (Blurred vision) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Myalgia, Pain in extremity
Clinical narrative: muscle pain; fatigue; dizziness (room is spinning at different degrees.); weakness; arm hurts; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm hurts), MYALGIA (muscle pain), FATIGUE (fatigue), DIZZINESS (dizziness (room is spinning at different degrees.)) and ASTHENIA (weakness) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurts), MYALGIA (muscle pain), FATIGUE (fatigue), DIZZINESS (dizziness (room is spinning at different degrees.)) and ASTHENIA (weakness). At the time of the report, PAIN IN EXTREMITY (arm hurts), MYALGIA (muscle pain), FATIGUE (fatigue), DIZZINESS (dizziness (room is spinning at different degrees.)) and ASTHENIA (weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications listed. No treatment medications listed.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Lichen sclerosus, Pain
Clinical narrative: I've had a terrible breakout since I got the 1st dose; Condition aggravated; It's the most painful thing I've ever experienced; This spontaneous case was reported by a consumer and describes the occurrence of LICHEN SCLEROSUS (I've had a terrible breakout since I got the 1st dose), CONDITION AGGRAVATED (Condition aggravated) and PAIN (It's the most painful thing I've ever experienced) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Lichen sclerosus.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced LICHEN SCLEROSUS (I've had a terrible breakout since I got the 1st dose), CONDITION AGGRAVATED (Condition aggravated) and PAIN (It's the most painful thing I've ever experienced). At the time of the report, LICHEN SCLEROSUS (I've had a terrible breakout since I got the 1st dose), CONDITION AGGRAVATED (Condition aggravated) and PAIN (It's the most painful thing I've ever experienced) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications listed.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dyschromatopsia, Eye inflammation, Photophobia, Visual impairment
Clinical narrative: inflammmed retina/Optic nerve inflammation; color vision problems; Light sensitivity; vision dim; This spontaneous case was reported by a consumer and describes the occurrence of DYSCHROMATOPSIA (color vision problems), PHOTOPHOBIA (Light sensitivity), VISUAL IMPAIRMENT (vision dim) and EYE INFLAMMATION (inflammmed retina/Optic nerve inflammation) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy, Polycythemia vera since August 2000 and Thyroid nodule. Concomitant products included THYROID for Thyroid nodule, LEVOTHYROXINE SODIUM (SYNTHROID) from 1993 to an unknown date and FAMOTIDINE from January 2021 to an unknown date for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced DYSCHROMATOPSIA (color vision problems), PHOTOPHOBIA (Light sensitivity) and VISUAL IMPAIRMENT (vision dim). On 13-Mar-2021, the patient experienced EYE INFLAMMATION (inflammmed retina/Optic nerve inflammation). At the time of the report, DYSCHROMATOPSIA (color vision problems), PHOTOPHOBIA (Light sensitivity) and VISUAL IMPAIRMENT (vision dim) outcome was unknown and EYE INFLAMMATION (inflammmed retina/Optic nerve inflammation) had not resolved.            Patient being treated with steroids for 3 weeks. Action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-081612 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Email and ADR received, added patient demographics, concomitant drugs, past medical history, allergies, additional AE , start date and outcome of an event updated from unknown to not recovered.; Sender's Comments:  MOD-2021-081612:first dose case
Sex: M
Vaccine: COVID19
Symptoms: Eye pruritus, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: runny nose; itchy eyes; fever; body pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body pain), RHINORRHOEA (runny nose), EYE PRURITUS (itchy eyes) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PAIN (body pain) and PYREXIA (fever). On 19-Apr-2021, the patient experienced RHINORRHOEA (runny nose) and EYE PRURITUS (itchy eyes). On 16-Apr-2021, PAIN (body pain) and PYREXIA (fever) had resolved. At the time of the report, RHINORRHOEA (runny nose) and EYE PRURITUS (itchy eyes) outcome was unknown.            Treatment information not reported. No concomitant medications reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Fatigue; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and MYALGIA (Muscle ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced FATIGUE (Fatigue) and MYALGIA (Muscle ache). At the time of the report, FATIGUE (Fatigue) and MYALGIA (Muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.  No treatment information reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID after vaccination; trouble breathing; cough; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID after vaccination), DYSPNOEA (trouble breathing) and COUGH (cough) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-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 SARS-COV-2 TEST POSITIVE (tested positive for COVID after vaccination), DYSPNOEA (trouble breathing) and COUGH (cough). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID after vaccination), DYSPNOEA (trouble breathing) and COUGH (cough) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not reported. No concomitant medications reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the second dose 3 months after the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose 3 months after the first dose) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose 3 months after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second dose 3 months after the first dose) outcome was unknown. Not Provided          Treatment reported as none. No concomitant medications reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first dose given in FEB, can second dose be given or repeat both doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose given in FEB, can second dose be given or repeat both doses) in a patient of an unknown age and gender 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.).    In February 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 (first dose given in FEB, can second dose be given or repeat both doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose given in FEB, can second dose be given or repeat both doses) 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.   Treatment information not reported. No concomitant medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Decreased appetite, Feeling abnormal, Heart rate increased, Myalgia
Clinical narrative: throwing up; vomiting started today; no appetite; pain in the legs; feel like muscle pain but not whole muscle; feeling nasty; nauseated the last couple of days; shaking real bad; heart rate went up; blood pressure went up; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (no appetite), PAIN IN EXTREMITY (pain in the legs), MYALGIA (feel like muscle pain but not whole muscle), FEELING ABNORMAL (feeling nasty) and NAUSEA (nauseated the last couple of days) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Pyrexia, BUPRENORPHINE HYDROCHLORIDE (SUBUTEX) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced TREMOR (shaking real bad), HEART RATE INCREASED (heart rate went up) and BLOOD PRESSURE INCREASED (blood pressure went up). On 15-Apr-2021, the patient experienced DECREASED APPETITE (no appetite), PAIN IN EXTREMITY (pain in the legs), MYALGIA (feel like muscle pain but not whole muscle), FEELING ABNORMAL (feeling nasty) and NAUSEA (nauseated the last couple of days). On 20-Apr-2021, the patient experienced VOMITING (throwing up; vomiting started today). At the time of the report, DECREASED APPETITE (no appetite), PAIN IN EXTREMITY (pain in the legs), MYALGIA (feel like muscle pain but not whole muscle), FEELING ABNORMAL (feeling nasty), NAUSEA (nauseated the last couple of days), VOMITING (throwing up; vomiting started today), TREMOR (shaking real bad), HEART RATE INCREASED (heart rate went up) and BLOOD PRESSURE INCREASED (blood pressure went up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Aspirin she took the night before last (18Apr)
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Tremor, Vomiting
Clinical narrative: throwing up; vomiting started today; no appetite; pain in the legs; feel like muscle pain but not whole muscle; feeling nasty; nauseated the last couple of days; shaking real bad; heart rate went up; blood pressure went up; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (no appetite), PAIN IN EXTREMITY (pain in the legs), MYALGIA (feel like muscle pain but not whole muscle), FEELING ABNORMAL (feeling nasty) and NAUSEA (nauseated the last couple of days) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Pyrexia, BUPRENORPHINE HYDROCHLORIDE (SUBUTEX) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced TREMOR (shaking real bad), HEART RATE INCREASED (heart rate went up) and BLOOD PRESSURE INCREASED (blood pressure went up). On 15-Apr-2021, the patient experienced DECREASED APPETITE (no appetite), PAIN IN EXTREMITY (pain in the legs), MYALGIA (feel like muscle pain but not whole muscle), FEELING ABNORMAL (feeling nasty) and NAUSEA (nauseated the last couple of days). On 20-Apr-2021, the patient experienced VOMITING (throwing up; vomiting started today). At the time of the report, DECREASED APPETITE (no appetite), PAIN IN EXTREMITY (pain in the legs), MYALGIA (feel like muscle pain but not whole muscle), FEELING ABNORMAL (feeling nasty), NAUSEA (nauseated the last couple of days), VOMITING (throwing up; vomiting started today), TREMOR (shaking real bad), HEART RATE INCREASED (heart rate went up) and BLOOD PRESSURE INCREASED (blood pressure went up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Aspirin she took the night before last (18Apr)
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Rash
Clinical narrative: Palpitations; Full body rash; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations) and RASH (Full body rash) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 immunization.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PALPITATIONS (Palpitations) and RASH (Full body rash). On 18-Apr-2021, PALPITATIONS (Palpitations) and RASH (Full body rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment reported as Benadryl.  Based on the current available information and temporal association between the use of the product and the start date of the events, 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 events, a causal relationship cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Dyspnoea, Dysstasia, Tremor
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA, DYSPNEA, CHEST PAIN, TREMOR and DYSTASIA in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included LEVOTHYROXINE and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 20-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 ASTHENIA, DYSPNEA, CHEST PAIN, TREMOR and DYSTASIA. At the time of the report, ASTHENIA, DYSPNEA, CHEST PAIN, TREMOR and DYSTASIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment reported as none.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Hypokinesia, Illness
Clinical narrative: Has no energy; Is very sick; Can hardly move; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Has no energy), ILLNESS (Is very sick) and HYPOKINESIA (Can hardly move) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced ASTHENIA (Has no energy), ILLNESS (Is very sick) and HYPOKINESIA (Can hardly move). At the time of the report, ASTHENIA (Has no energy), ILLNESS (Is very sick) and HYPOKINESIA (Can hardly move) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient only wanted to report the adverse events and did not want to provide further information. Patient did mention something regarding cancer treatment, but did not state specifics.  No concomitant medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore injection site arm) 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 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore injection site arm). At the time of the report, PAIN IN EXTREMITY (sore injection site arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drug was reported. No concomitant medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-081642, US-MODERNATX, INC.-MOD-2021-081770 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081642:Same patient, 2nd dose US-MODERNATX, INC.-MOD-2021-081770:This case is for the reporter's husband
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Numbness lips and tongue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numbness lips and tongue) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (Numbness lips and tongue). On 23-Mar-2021, HYPOAESTHESIA ORAL (Numbness lips and tongue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. Not treatment was reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Peripheral swelling, Pruritus, Rash, Vaccination site pain
Clinical narrative: injection site feverish; hard; left arm swollen; itches; injection site itches; injection site hurt; injection site swollen; left arm broke out; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site feverish), INDURATION (hard), PERIPHERAL SWELLING (left arm swollen), PRURITUS (itches) and VACCINATION SITE PRURITUS (injection site itches) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in September 2020.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE WARMTH (injection site feverish), INDURATION (hard), PERIPHERAL SWELLING (left arm swollen), PRURITUS (itches), VACCINATION SITE PRURITUS (injection site itches), VACCINATION SITE PAIN (injection site hurt), VACCINATION SITE SWELLING (injection site swollen) and RASH (left arm broke out). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (injection site feverish), INDURATION (hard), PERIPHERAL SWELLING (left arm swollen), PRURITUS (itches), VACCINATION SITE PRURITUS (injection site itches), VACCINATION SITE PAIN (injection site hurt), VACCINATION SITE SWELLING (injection site swollen) and RASH (left arm broke out) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient wanted to know if she should go to her doctor or give it a couple days.  No concomitant mediations reported. Treatment reported as Ibuprofen.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site feverish; hard; left arm swollen; itches; injection site itches; injection site hurt; injection site swollen; left arm broke out; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site feverish), INDURATION (hard), PERIPHERAL SWELLING (left arm swollen), PRURITUS (itches) and VACCINATION SITE PRURITUS (injection site itches) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in September 2020.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE WARMTH (injection site feverish), INDURATION (hard), PERIPHERAL SWELLING (left arm swollen), PRURITUS (itches), VACCINATION SITE PRURITUS (injection site itches), VACCINATION SITE PAIN (injection site hurt), VACCINATION SITE SWELLING (injection site swollen) and RASH (left arm broke out). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (injection site feverish), INDURATION (hard), PERIPHERAL SWELLING (left arm swollen), PRURITUS (itches), VACCINATION SITE PRURITUS (injection site itches), VACCINATION SITE PAIN (injection site hurt), VACCINATION SITE SWELLING (injection site swollen) and RASH (left arm broke out) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient wanted to know if she should go to her doctor or give it a couple days.  No concomitant mediations reported. Treatment reported as Ibuprofen.