chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urinary tract infection
Clinical narrative: developed what she thinks its an UTI; lower back pain; chills; very sore arm (couldn't even lift her arm); low grade fever; body aches; feel very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm (couldn't even lift her arm)), URINARY TRACT INFECTION (developed what she thinks its an UTI), BACK PAIN (lower back pain), PYREXIA (low grade fever) and MYALGIA (body aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (very sore arm (couldn't even lift her arm)), PYREXIA (low grade fever), MYALGIA (body aches) and FATIGUE (feel very tired). On 20-Feb-2021, the patient experienced URINARY TRACT INFECTION (developed what she thinks its an UTI), BACK PAIN (lower back pain) and CHILLS (chills). The patient was treated with CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) (oral) on 20-Feb-2021 for UTI, at a dose of UNK dosage form. On 12-Feb-2021, PAIN IN EXTREMITY (very sore arm (couldn't even lift her arm)), MYALGIA (body aches) and FATIGUE (feel very tired) had resolved. At the time of the report, URINARY TRACT INFECTION (developed what she thinks its an UTI), BACK PAIN (lower back pain) and CHILLS (chills) outcome was unknown and PYREXIA (low grade fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Feeling abnormal, Injection site swelling, Injection site warmth, Limb discomfort
Clinical narrative: doctor told her it was her body's reaction to the vaccine; still warm; injection site looked swollen; felt uncomfortable; discomfort in arm; itchy; hot to the touch; Pain; soreness on arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), PAIN IN EXTREMITY (soreness on arm), LIMB DISCOMFORT (discomfort in arm), PRURITUS (itchy) and INJECTION SITE WARMTH (hot to the touch) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diabetes and Cholesterol. Concurrent medical conditions included Seasonal allergy, Allergy to chemicals, Allergy to chemicals, Drug allergy, Drug allergy and Drug allergy. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN (Pain) and PAIN IN EXTREMITY (soreness on arm). On 08-Feb-2021, the patient experienced LIMB DISCOMFORT (discomfort in arm), PRURITUS (itchy), INJECTION SITE WARMTH (hot to the touch) and FEELING ABNORMAL (felt uncomfortable). On 11-Feb-2021, the patient experienced INJECTION SITE SWELLING (injection site looked swollen) and INJECTION SITE WARMTH (still warm). On an unknown date, the patient experienced ADVERSE REACTION (doctor told her it was her body's reaction to the vaccine). The patient was treated with BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [BACITRACIN ZINC;NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) for Adverse event, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) for Adverse event, at a dose of UNK dosage form. At the time of the report, PAIN (Pain), PAIN IN EXTREMITY (soreness on arm), LIMB DISCOMFORT (discomfort in arm), PRURITUS (itchy), INJECTION SITE WARMTH (hot to the touch), INJECTION SITE SWELLING (injection site looked swollen), INJECTION SITE WARMTH (still warm), ADVERSE REACTION (doctor told her it was her body's reaction to the vaccine) and FEELING ABNORMAL (felt uncomfortable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pruritus
Clinical narrative: doctor told her it was her body's reaction to the vaccine; still warm; injection site looked swollen; felt uncomfortable; discomfort in arm; itchy; hot to the touch; Pain; soreness on arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), PAIN IN EXTREMITY (soreness on arm), LIMB DISCOMFORT (discomfort in arm), PRURITUS (itchy) and INJECTION SITE WARMTH (hot to the touch) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diabetes and Cholesterol. Concurrent medical conditions included Seasonal allergy, Allergy to chemicals, Allergy to chemicals, Drug allergy, Drug allergy and Drug allergy. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN (Pain) and PAIN IN EXTREMITY (soreness on arm). On 08-Feb-2021, the patient experienced LIMB DISCOMFORT (discomfort in arm), PRURITUS (itchy), INJECTION SITE WARMTH (hot to the touch) and FEELING ABNORMAL (felt uncomfortable). On 11-Feb-2021, the patient experienced INJECTION SITE SWELLING (injection site looked swollen) and INJECTION SITE WARMTH (still warm). On an unknown date, the patient experienced ADVERSE REACTION (doctor told her it was her body's reaction to the vaccine). The patient was treated with BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [BACITRACIN ZINC;NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) for Adverse event, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) for Adverse event, at a dose of UNK dosage form. At the time of the report, PAIN (Pain), PAIN IN EXTREMITY (soreness on arm), LIMB DISCOMFORT (discomfort in arm), PRURITUS (itchy), INJECTION SITE WARMTH (hot to the touch), INJECTION SITE SWELLING (injection site looked swollen), INJECTION SITE WARMTH (still warm), ADVERSE REACTION (doctor told her it was her body's reaction to the vaccine) and FEELING ABNORMAL (felt uncomfortable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: oval sized pink area that is 2 1/2 inches long and is warm to the touch; pink area the size of a dime; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE ERYTHEMA (pink area the size of a dime) and VACCINATION SITE WARMTH (oval sized pink area that is 2 1/2 inches long and is warm to the touch) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PARACETAMOL (TYLENOL) for Pain in knee, ATENOLOL, ALOPURINOL, HCTZ, METFORMIN, OLMESARTAN and ATORVASTATIN.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 16-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (pink area the size of a dime). On 20-Feb-2021, the patient experienced VACCINATION SITE WARMTH (oval sized pink area that is 2 1/2 inches long and is warm to the touch). At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINATION SITE ERYTHEMA (pink area the size of a dime) and VACCINATION SITE WARMTH (oval sized pink area that is 2 1/2 inches long and is warm to the touch) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pain in extremity, Pruritus
Clinical narrative: Itching all over my body; Blisters; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), BLISTER (Blisters) and PRURITUS (Itching all over my body) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 15-Feb-2021, the patient experienced BLISTER (Blisters). On an unknown date, the patient experienced PRURITUS (Itching all over my body). The patient was treated with CORTISONE for Adverse event, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm), BLISTER (Blisters) and PRURITUS (Itching all over my body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: High fever 101; chills; fatigue; body joint pain; This spontaneous case was reported by a physical therapist and describes the occurrence of PYREXIA (High fever 101), CHILLS (chills), FATIGUE (fatigue) and ARTHRALGIA (body joint pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced PYREXIA (High fever 101), CHILLS (chills), FATIGUE (fatigue) and ARTHRALGIA (body joint pain). At the time of the report, PYREXIA (High fever 101), CHILLS (chills), FATIGUE (fatigue) and ARTHRALGIA (body joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, Body temperature: 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pain in extremity, Throat irritation, Vaccination site pain
Clinical narrative: Arm sore at injection site; Felt pain when moving injected arm forward or backward; Low grade cough; Feels like a tickle in the throat; A spontaneous report was received from a consumer concerning a 77-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm sore at injection site, felt pain when moving injected arm forward or backward, low grade cough, feels like a tickle in the throat.  The patient's medical history was not provided. Concomitant medications reported were Vitamin D, Vitamin B Complex, Calcium, Levothyroxine, Melatonin, Biotin for drug use for unknown indication.  On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown)unknown route for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced the events arm sore at injection site, felt pain when moving injected arm forward or backward, low grade cough, feels like a tickle in the throat.  Treatment details included Zinc, Steam.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, arm sore at injection site, felt pain when moving injected arm forward or backward, low grade cough, feels like a tickle in the throat was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Vaccination site pain
Clinical narrative: Pinky rash upper breast; Itchy rash upper breast; Tenderness in right arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Pinky rash upper breast), RASH PRURITIC (Itchy rash upper breast) and VACCINATION SITE PAIN (Tenderness in right arm of injection) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038k20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer, Hypertension, Diabetes and Alcohol allergy (Allergy: alcohol when drinking).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Pinky rash upper breast), RASH PRURITIC (Itchy rash upper breast) and VACCINATION SITE PAIN (Tenderness in right arm of injection). At the time of the report, RASH ERYTHEMATOUS (Pinky rash upper breast), RASH PRURITIC (Itchy rash upper breast) and VACCINATION SITE PAIN (Tenderness in right arm of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient uses unspecified medication for breast  cancer survivor, blood pressure, diabetes as concomitant medications.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: flu-like symptoms; temperature 101; body aches; tiredness; nausea; a really bad headache; a bruise of 5 inches diameter; it stayed there for a long time; she also got bruises in her legs; big; unexplained; one of 6-7 inches diameter; took a long time to resolve; A spontaneous report was received from a healthcare professional concerning a 49-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nausea, a really bad headache, a bruise of 5 inches diameter, it stayed there for a long time, she also got bruises in her legs, big, unexplained, one of 6-7 inches diameter, took a long time to resolve, flu-like symptoms, temperature 101, body aches, tiredness.  The patient's medical history was not provided. Concomitant medications reported were Multivitamins for drug use for unknown indication.  On 30 Dec 2020, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) nausea, a really bad headache, a bruise of 5 inches diameter, it stayed there for a long time, she also got bruises in her legs, big, unexplained. One of 6-7 inches diameter, took a long time to resolve, flu-like symptoms, temperature 101, body aches, tiredness.  Treatment details included Ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), nausea, a really bad headache, a bruise of 5 inches diameter, it stayed there for a long time, she also got bruises in her legs, big, unexplained, one of 6-7 inches diameter, took a long time to resolve, flu-like symptoms, temperature 101, body aches, tiredness was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: flu-like symptoms; temperature 101; body aches; tiredness; nausea; a really bad headache; a bruise of 5 inches diameter; it stayed there for a long time; she also got bruises in her legs; big; unexplained; one of 6-7 inches diameter; took a long time to resolve; A spontaneous report was received from a healthcare professional concerning a 49-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nausea, a really bad headache, a bruise of 5 inches diameter, it stayed there for a long time, she also got bruises in her legs, big, unexplained, one of 6-7 inches diameter, took a long time to resolve, flu-like symptoms, temperature 101, body aches, tiredness.  The patient's medical history was not provided. Concomitant medications reported were Multivitamins for drug use for unknown indication.  On 30 Dec 2020, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) nausea, a really bad headache, a bruise of 5 inches diameter, it stayed there for a long time, she also got bruises in her legs, big, unexplained. One of 6-7 inches diameter, took a long time to resolve, flu-like symptoms, temperature 101, body aches, tiredness.  Treatment details included Ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), nausea, a really bad headache, a bruise of 5 inches diameter, it stayed there for a long time, she also got bruises in her legs, big, unexplained, one of 6-7 inches diameter, took a long time to resolve, flu-like symptoms, temperature 101, body aches, tiredness was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: She had a 100.5 F temperature for a couple of days; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (She had a 100.5 F temperature for a couple of days) and VACCINATION SITE PAIN (Soreness at the injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PYREXIA (She had a 100.5 F temperature for a couple of days) and VACCINATION SITE PAIN (Soreness at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (She had a 100.5 F temperature for a couple of days) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Body temperature: 100.5 (High) 100.5 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.; 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. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: adverse event; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ADVERSE EVENT (adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (adverse event). At the time of the report, ADVERSE EVENT (adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment drugs were reported
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Large rash around the injection site; Injection site tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Large rash around the injection site) and VACCINATION SITE PAIN (Injection site tender) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-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 (Large rash around the injection site) and VACCINATION SITE PAIN (Injection site tender). At the time of the report, VACCINATION SITE RASH (Large rash around the injection site) and VACCINATION SITE PAIN (Injection site tender) 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
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pregnant.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 07-Jul-2021. On 07-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications was provided by the reporter.  No Treatment medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2021: Internal review on 23-Jul-2021 resulted in updates to the pregnancy details.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Headache
Clinical narrative: Red arm; Swollen arm; Swollen lymph nodes at the arm of the injection; Pain at the injection site; Fever; Chills; Headache; Joint pain; Fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of ERYTHEMA (Red arm), PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes at the arm of the injection), VACCINATION SITE PAIN (Pain at the injection site) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Allergy Aspirin), Drug allergy (Toradol), Drug allergy (Maclodent), Drug allergy (Anaprox), Contrast media allergy (Contrast), Drug allergy (Ensids) and Drug allergy (Retromicin).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced ERYTHEMA (Red arm), PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes at the arm of the injection), VACCINATION SITE PAIN (Pain at the injection site), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Red arm), PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes at the arm of the injection), VACCINATION SITE PAIN (Pain at the injection site), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) 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.   Concomitant product use was not reported.  Treatment : Steroids   This case was linked to MOD-2021-022482 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: Red arm; Swollen arm; Swollen lymph nodes at the arm of the injection; Pain at the injection site; Fever; Chills; Headache; Joint pain; Fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of ERYTHEMA (Red arm), PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes at the arm of the injection), VACCINATION SITE PAIN (Pain at the injection site) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Allergy Aspirin), Drug allergy (Toradol), Drug allergy (Maclodent), Drug allergy (Anaprox), Contrast media allergy (Contrast), Drug allergy (Ensids) and Drug allergy (Retromicin).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced ERYTHEMA (Red arm), PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes at the arm of the injection), VACCINATION SITE PAIN (Pain at the injection site), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Red arm), PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes at the arm of the injection), VACCINATION SITE PAIN (Pain at the injection site), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) 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.   Concomitant product use was not reported.  Treatment : Steroids   This case was linked to MOD-2021-022482 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Little red spots on injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Little red spots on injection site) in a male 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 provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Little red spots on injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Little red spots on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication and treatment provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Pain
Clinical narrative: Uable to move due to fatigue; Aches all over; She woke up in the middle of the night with fever102.6; Head hurting; Joint pain that is really bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches all over), PYREXIA (She woke up in the middle of the night with fever102.6), HEADACHE (Head hurting), ARTHRALGIA (Joint pain that is really bad) and FATIGUE (Uable to move due to fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN (Aches all over), PYREXIA (She woke up in the middle of the night with fever102.6), HEADACHE (Head hurting) and ARTHRALGIA (Joint pain that is really bad). On 05-Feb-2021, the patient experienced FATIGUE (Uable to move due to fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Aches all over), PYREXIA (She woke up in the middle of the night with fever102.6), HEADACHE (Head hurting), ARTHRALGIA (Joint pain that is really bad) and FATIGUE (Uable to move due to fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 102.6 (High) body temperature 102.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Uable to move due to fatigue; Aches all over; She woke up in the middle of the night with fever102.6; Head hurting; Joint pain that is really bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches all over), PYREXIA (She woke up in the middle of the night with fever102.6), HEADACHE (Head hurting), ARTHRALGIA (Joint pain that is really bad) and FATIGUE (Uable to move due to fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN (Aches all over), PYREXIA (She woke up in the middle of the night with fever102.6), HEADACHE (Head hurting) and ARTHRALGIA (Joint pain that is really bad). On 05-Feb-2021, the patient experienced FATIGUE (Uable to move due to fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Aches all over), PYREXIA (She woke up in the middle of the night with fever102.6), HEADACHE (Head hurting), ARTHRALGIA (Joint pain that is really bad) and FATIGUE (Uable to move due to fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 102.6 (High) body temperature 102.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Oral herpes, Pyrexia
Clinical narrative: started having diarrhea; cold sore lip; fever; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore arm), PYREXIA (fever), DIARRHOEA (started having diarrhea) and ORAL HERPES (cold sore lip) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced ARTHRALGIA (sore arm). On 20-Feb-2021, the patient experienced PYREXIA (fever). On 22-Feb-2021, the patient experienced DIARRHOEA (started having diarrhea) and ORAL HERPES (cold sore lip). On 21-Feb-2021, PYREXIA (fever) had resolved. On 22-Feb-2021, ARTHRALGIA (sore arm) had resolved. At the time of the report, DIARRHOEA (started having diarrhea) and ORAL HERPES (cold sore lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Rhinorrhoea, Sinus congestion
Clinical narrative: Sinus Congestion; Runny nose; Felt miserable; This spontaneous case was reported by a consumer and describes the occurrence of SINUS CONGESTION (Sinus Congestion), RHINORRHOEA (Runny nose) and FEELING ABNORMAL (Felt miserable) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced SINUS CONGESTION (Sinus Congestion), RHINORRHOEA (Runny nose) and FEELING ABNORMAL (Felt miserable). At the time of the report, SINUS CONGESTION (Sinus Congestion), RHINORRHOEA (Runny nose) and FEELING ABNORMAL (Felt miserable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Adverse reaction; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Adverse reaction) 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 reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse reaction). At the time of the report, VACCINATION COMPLICATION (Adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Skin bacterial infection, Vaccination site erythema, Vaccination site pain
Clinical narrative: Red ring surrounding the area; Bacterial skin infection; Slight pain for few hours after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BACTERIAL INFECTION (Bacterial skin infection), VACCINATION SITE ERYTHEMA (Red ring surrounding the area) and VACCINATION SITE PAIN (Slight pain for few hours after the vaccination) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 032M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CLOBETASOL for Vaginal irritation, CLONAZEPAM for an unknown indication.   On 08-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) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (Slight pain for few hours after the vaccination). On 22-Feb-2021, the patient experienced SKIN BACTERIAL INFECTION (Bacterial skin infection). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red ring surrounding the area). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) on 23-Feb-2021 for Skin infection, at a dose of 500 mg twice a day. On 08-Feb-2021, VACCINATION SITE PAIN (Slight pain for few hours after the vaccination) had resolved. At the time of the report, SKIN BACTERIAL INFECTION (Bacterial skin infection) outcome was unknown and VACCINATION SITE ERYTHEMA (Red ring surrounding the area) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient stated that the doctor said her to take antibiotics for 5 days instead of 7 if she wishes to do so.   This case was linked to MOD-2021-187387 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Added concomitant medication, Added event, added dosage information On 27-May-2021: NNI
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: received Moderna COVID-19 vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (received Moderna COVID-19 vaccine while pregnant) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 13-Oct-2020 and the estimated date of delivery was 27-Jul-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (received Moderna COVID-19 vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twelfth week of the pregnancy.  On 08-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (received Moderna COVID-19 vaccine while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided by the reporter.  No treatment information was provided by the reporter.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 infection just after the first dose; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19 infection just after the first dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jan-2021, the patient experienced COVID-19 (COVID-19 infection just after the first dose). At the time of the report, COVID-19 (COVID-19 infection just after the first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Based on the current available information, the mRNA-1723 does not contain a virus and with the occurrence of Covid-19 infection after vaccination, this event is assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the current available information, the mRNA-1723 does not contain a virus and with the occurrence of Covid-19 infection after vaccination, this event is assessed as unlikely related to mRNA-1273.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Chills; headache; nausea; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (headache), NAUSEA (nausea), PYREXIA (fever) and FATIGUE (fatigue) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Dyslipidemia.    On 21-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 CHILLS (Chills), HEADACHE (headache), NAUSEA (nausea), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, CHILLS (Chills), HEADACHE (headache), NAUSEA (nausea), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided; 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site mass, Vaccination site swelling
Clinical narrative: Big lump; Numbness in arm; Swelling in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Big lump), HYPOAESTHESIA (Numbness in arm) and VACCINATION SITE SWELLING (Swelling in arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031l20A) for COVID-19 vaccination.     Concomitant products included Blood Pressure for Blood pressure, INSULIN DETEMIR (LEVEMIR), INSULIN and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE MASS (Big lump), HYPOAESTHESIA (Numbness in arm) and VACCINATION SITE SWELLING (Swelling in arm). At the time of the report, VACCINATION SITE MASS (Big lump), HYPOAESTHESIA (Numbness in arm) and VACCINATION SITE SWELLING (Swelling in arm) 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 treatment information was provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site discolouration, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: lump on the injection site/tumor like; Injection site lump was described by patient as dark; Injection site lump was described by patient as hard; headache; Injection site lump was described by patient as swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE MASS (lump on the injection site/tumor like), INJECTION SITE DISCOLOURATION (Injection site lump was described by patient as dark), INJECTION SITE INDURATION (Injection site lump was described by patient as hard), HEADACHE (headache) and INJECTION SITE SWELLING (Injection site lump was described by patient as swollen) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     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 an unknown date, the patient experienced INJECTION SITE MASS (lump on the injection site/tumor like), INJECTION SITE DISCOLOURATION (Injection site lump was described by patient as dark), INJECTION SITE INDURATION (Injection site lump was described by patient as hard), HEADACHE (headache) and INJECTION SITE SWELLING (Injection site lump was described by patient as swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE MASS (lump on the injection site/tumor like), INJECTION SITE DISCOLOURATION (Injection site lump was described by patient as dark), INJECTION SITE INDURATION (Injection site lump was described by patient as hard), HEADACHE (headache) and INJECTION SITE SWELLING (Injection site lump was described by patient as swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Soreness in arm which lasted a few days; Rash at injection site which lasted a few days; Very itchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm which lasted a few days), VACCINATION SITE RASH (Rash at injection site which lasted a few days) and VACCINATION SITE PRURITUS (Very itchy at injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Asthma since an unknown date and COPD since an unknown date. Concomitant products included LEVOTHYROXINE, POTASSIUM and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 12-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 PAIN IN EXTREMITY (Soreness in arm which lasted a few days), VACCINATION SITE RASH (Rash at injection site which lasted a few days) and VACCINATION SITE PRURITUS (Very itchy at injection site). At the time of the report, PAIN IN EXTREMITY (Soreness in arm which lasted a few days), VACCINATION SITE RASH (Rash at injection site which lasted a few days) and VACCINATION SITE PRURITUS (Very itchy at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.    This case was linked to MOD-2021-098781 (Patient Link).