chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Gait disturbance, Headache
Clinical narrative: Difficult walking around; every bone on my body hurts from toes to hat; Chills like freezing cold; Headache; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Difficult walking around), BONE PAIN (every bone on my body hurts from toes to hat), CHILLS (Chills like freezing cold) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical history was reported by reporter.  Concomitant products included LISINOPRIL, ATORVASTATIN, DICLOFENAC, ACETYLSALICYLIC ACID (BABY ASPIRIN), CALCIUM, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced CHILLS (Chills like freezing cold) and HEADACHE (Headache). On an unknown date, the patient experienced GAIT DISTURBANCE (Difficult walking around) and BONE PAIN (every bone on my body hurts from toes to hat). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 10-Jan-2021, CHILLS (Chills like freezing cold) and HEADACHE (Headache) had resolved. At the time of the report, GAIT DISTURBANCE (Difficult walking around) and BONE PAIN (every bone on my body hurts from toes to hat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patients reactions to the first dose settled down after few days   Most recent FOLLOW-UP information incorporated above includes: On 06-Feb-2021: No specific follow-up information recorded. On 10-Jul-2021: Events outcome updated from unknow to recovered resolved
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: When I rub my fingers over it, it feels very rough; It is warm; Injection site was very red and swollen; Injection site was very red and swollen; Rash underneath the red and swollen area; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (When I rub my fingers over it, it feels very rough), INJECTION SITE WARMTH (It is warm), INJECTION SITE ERYTHEMA (Injection site was very red and swollen), INJECTION SITE SWELLING (Injection site was very red and swollen) and INJECTION SITE RASH (Rash underneath the red and swollen area) 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 17-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 DRY SKIN (When I rub my fingers over it, it feels very rough), INJECTION SITE WARMTH (It is warm), INJECTION SITE ERYTHEMA (Injection site was very red and swollen), INJECTION SITE SWELLING (Injection site was very red and swollen) and INJECTION SITE RASH (Rash underneath the red and swollen area). At the time of the report, DRY SKIN (When I rub my fingers over it, it feels very rough), INJECTION SITE WARMTH (It is warm), INJECTION SITE ERYTHEMA (Injection site was very red and swollen), INJECTION SITE SWELLING (Injection site was very red and swollen) and INJECTION SITE RASH (Rash underneath the red and swollen area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: No new information provided. On 15-Apr-2021: No new information provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: arm was  red and warm; Low grade fever for a few days; arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever for a few days), VACCINATION SITE PAIN (arm sore) and VACCINATION SITE ERYTHEMA (arm was  red and warm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced PYREXIA (Low grade fever for a few days) and VACCINATION SITE PAIN (arm sore). On 21-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm was  red and warm). In January 2021, PYREXIA (Low grade fever for a few days) had resolved. At the time of the report, VACCINATION SITE PAIN (arm sore) and VACCINATION SITE ERYTHEMA (arm was  red and warm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-013724 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site movement impairment, Vaccination site pain, Vaccination site pruritus
Clinical narrative: arm stiffness; itching; red circle approximately 2 inches in size right across the injection site; arm soreness; little redness on the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (arm stiffness), VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (arm soreness), VACCINATION SITE ERYTHEMA (little redness on the site) and VACCINATION SITE ERYTHEMA (red circle approximately 2 inches in size right across the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     Concomitant products included CALCIUM CITRATE (CITRACAL [CALCIUM CITRATE]) for Calcium supplementation, ROSUVASTATIN for Cholesterol high, LEVOTHYROXINE for Thyroid disorder, MULTIVITAMINS [VITAMINS NOS] for Vitamin supplementation.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm soreness) and VACCINATION SITE ERYTHEMA (little redness on the site). On 23-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (arm stiffness), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (red circle approximately 2 inches in size right across the injection site). The patient was treated with PARAFFIN (VASELINE [PARAFFIN]) at a dose of 1 dosage form. On 18-Jan-2021, VACCINATION SITE PAIN (arm soreness) and VACCINATION SITE ERYTHEMA (little redness on the site) had resolved. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (arm stiffness), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (red circle approximately 2 inches in size right across the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Significant Follow-up received on 02-Jul-2021: Outcome of events updated, and dose number reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: around injection site hot; a red spot which is painful, raised, hot, warm, this happened again 1 week later; around injection site painfull; around injection site raised; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (around injection site hot), VACCINATION SITE ERYTHEMA (a red spot which is painful, raised, hot, warm, this happened again 1 week later), VACCINATION SITE PAIN (around injection site painfull) and VACCINATION SITE SWELLING (around injection site raised) 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 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE WARMTH (around injection site hot), VACCINATION SITE ERYTHEMA (a red spot which is painful, raised, hot, warm, this happened again 1 week later), VACCINATION SITE PAIN (around injection site painfull) and VACCINATION SITE SWELLING (around injection site raised). On 17-Jan-2021, VACCINATION SITE WARMTH (around injection site hot), VACCINATION SITE ERYTHEMA (a red spot which is painful, raised, hot, warm, this happened again 1 week later), VACCINATION SITE PAIN (around injection site painfull) and VACCINATION SITE SWELLING (around injection site raised) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.5 (High) Patient had fever of 103.5 F after receiving Moderna COVID 19 vaccine.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: rash all over the body; mild arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (mild arm soreness) and RASH (rash all over the body) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (mild arm soreness). On 15-Jan-2021, the patient experienced RASH (rash all over the body). On 14-Jan-2021, PAIN IN EXTREMITY (mild arm soreness) outcome was unknown. At the time of the report, RASH (rash all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced NAUSEA (Nauseous). At the time of the report, NAUSEA (Nauseous) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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 event, a causal relationship cannot be excluded.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nausea, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Nausea; Joint pain; Itchy Sensation - Near Injection Site; Swelling - Near Injection Site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site), NAUSEA (Nausea) and ARTHRALGIA (Joint pain) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site). On 23-Jan-2021, the patient experienced NAUSEA (Nausea) and ARTHRALGIA (Joint pain). At the time of the report, VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site), NAUSEA (Nausea) and ARTHRALGIA (Joint pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pruritus, Rash, Vaccination site pruritus, Vaccination site rash
Clinical narrative: today its relatively itchy; had a rash that got pretty large about 3 inches long and 2 inches wide, going up and down her; At the injection site, it was excessively itching; has like a rash all around on the arm; spot where it was injected started to get a little bit itchy; It was really uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (spot where it was injected started to get a little bit itchy), MALAISE (It was really uncomfortable), PRURITUS (today its relatively itchy), RASH (had a rash that got pretty large about 3 inches long and 2 inches wide, going up and down her) and VACCINATION SITE PRURITUS (At the injection site, it was excessively itching) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced PRURITUS (spot where it was injected started to get a little bit itchy), MALAISE (It was really uncomfortable), RASH (had a rash that got pretty large about 3 inches long and 2 inches wide, going up and down her), VACCINATION SITE PRURITUS (At the injection site, it was excessively itching) and VACCINATION SITE RASH (has like a rash all around on the arm). On 22-Jan-2021, the patient experienced PRURITUS (today its relatively itchy). At the time of the report, PRURITUS (spot where it was injected started to get a little bit itchy), MALAISE (It was really uncomfortable), PRURITUS (today its relatively itchy), RASH (had a rash that got pretty large about 3 inches long and 2 inches wide, going up and down her), VACCINATION SITE PRURITUS (At the injection site, it was excessively itching) and VACCINATION SITE RASH (has like a rash all around on the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information include Cortisone cream.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2021: Informations added.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) had resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive - 2 days. In 2021, SARS-CoV-2 test: negative (Negative) Negative - 2 tests.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    The patient reported she tested negative after 2 days of testing positive. She took the test again, it was negative for COVID-19.  No concomitant medication and treatment information was provided.  Reporter did not allow further contact  Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Additional information was received from the patient and processed with initial report. Event outcome was updated.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 antibody test
Clinical narrative: Diagnosed with COVID; Felt Unwell; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Diagnosed with COVID) and MALAISE (Felt Unwell) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included ASCORBIC ACID (VITAMIN C ACID) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000).   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Jan-2021, the patient experienced MALAISE (Felt Unwell). On 18-Jan-2021, the patient experienced COVID-19 (Diagnosed with COVID). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (CITRAMAX FORTE) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, COVID-19 (Diagnosed with COVID) and MALAISE (Felt Unwell) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. Treatment medications included isolation, antibiotics, citramax and aspirins   This case was linked to US-MODERNATX, INC.-MOD-2021-014845 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: Additional information received On 26-Jan-2021: Additional information received; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-014845:Patient's Wife case (reporter and patient are same)
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: vaccination site warmth; red, itchy, warm spot; red, itchy, warm spot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (red, itchy, warm spot) and VACCINATION SITE ERYTHEMA (red, itchy, warm spot) 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 15-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 VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (red, itchy, warm spot) and VACCINATION SITE ERYTHEMA (red, itchy, warm spot). At the time of the report, VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (red, itchy, warm spot) and VACCINATION SITE ERYTHEMA (red, itchy, warm spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Swelling in injection area of arm; Redness in injection area of arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (Swelling in injection area of arm) and VACCINATION SITE ERYTHEMA (Redness in injection area of arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN (ZOCOR), TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), LEVOTHYROXINE SODIUM (SYNTHROID), ASPIRIN [ACETYLSALICYLIC ACID], CINNAMON [CINNAMOMUM VERUM] and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    On 23-Jan-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 VACCINATION SITE SWELLING (Swelling in injection area of arm) and VACCINATION SITE ERYTHEMA (Redness in injection area of arm). At the time of the report, VACCINATION SITE SWELLING (Swelling in injection area of arm) and VACCINATION SITE ERYTHEMA (Redness in injection area of arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pain, Pain in extremity
Clinical narrative: weakness; arm soreness; body aches; Fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PAIN IN EXTREMITY (arm soreness), PAIN (body aches), PYREXIA (Fever) and CHILLS (chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced ASTHENIA (weakness), PAIN IN EXTREMITY (arm soreness), PAIN (body aches), PYREXIA (Fever), CHILLS (chills) and HEADACHE (headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness), PAIN IN EXTREMITY (arm soreness), PAIN (body aches), PYREXIA (Fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.         Concomitant medications were not reported.Treatment information included ibuprofen.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: weakness; arm soreness; body aches; Fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PAIN IN EXTREMITY (arm soreness), PAIN (body aches), PYREXIA (Fever) and CHILLS (chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced ASTHENIA (weakness), PAIN IN EXTREMITY (arm soreness), PAIN (body aches), PYREXIA (Fever), CHILLS (chills) and HEADACHE (headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness), PAIN IN EXTREMITY (arm soreness), PAIN (body aches), PYREXIA (Fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.         Concomitant medications were not reported.Treatment information included ibuprofen.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: The injection site is still red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (The injection site is still red) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 15-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (The injection site is still red). At the time of the report, VACCINATION SITE ERYTHEMA (The injection site is still red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment details are not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: itching; couple of raised, red spots, redness on her shoulders and back; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and URTICARIA (couple of raised, red spots, redness on her shoulders and back) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Autoimmune disorder.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PRURITUS (itching) and URTICARIA (couple of raised, red spots, redness on her shoulders and back). At the time of the report, PRURITUS (itching) and URTICARIA (couple of raised, red spots, redness on her shoulders and back) outcome was unknown.            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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itching on and off; Red big circle; Itchy; sore arm; Case reference number MOD-2021-013765 is a spontaneous case report sent by a Other on 25-JAN-2021 00:00:00 , which refers to a Female aged 77 Years The following drugs are known to have been taken by the patient prior to the event: GABAPENTIN[] ,CARBAMAZEPIN  The patient got the 1st dose of the moderna covid-19 vaccine on 16jan2021 and afterwards it was really sore, then itchy for fewdays that stopped on 20th Jan 2021. Over a period of the next 5 days, the patient also developed Itching on and off, and red big circle has developed.   The patient was treated for the event with CORTISONE Cream.    The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.  .   Terse Narrative (for PSUR narratives and signal review) Brief 3 line summary of above for CIOMS listing: Report Source- Other,  Age- 77 Years,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment- CORTISONE  Diagnosis\Outcome- Red big circle - Unknown,Itching on and off - Unknown,Itchy - Recovered/Resolved,sore arm - Recovered/Resolved.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Injection site itching; Injection site tender/Delayed injection site tenderness; Arm was very sore; Chills/Fever (101.5)/Fever all day; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Arm was very sore), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE PAIN (Injection site tender/Delayed injection site tenderness) and PYREXIA (Chills/Fever (101.5)/Fever all day) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021 at 7:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021 at 6:00 PM, the patient experienced PYREXIA (Chills/Fever (101.5)/Fever all day). On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was very sore). On 15-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE PAIN (Injection site tender/Delayed injection site tenderness). On 10-Jan-2021, PAIN IN EXTREMITY (Arm was very sore) and PYREXIA (Chills/Fever (101.5)/Fever all day) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE PAIN (Injection site tender/Delayed injection site tenderness) 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.   Treatment included antihistamines.  Concomitant medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) 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) at an unspecified dose. On an unknown date, the patient experienced RASH (rash). At the time of the report, RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment informations were provided.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Skin tightness, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: hot to touch; tight; itch a little; rash around the area; Rash is a bit redder; pain; Soreness around the muschle; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (hot to touch), SKIN TIGHTNESS (tight), VACCINATION SITE PRURITUS (itch a little), MYALGIA (Soreness around the muschle) and VACCINATION SITE RASH (rash around the area) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced MYALGIA (Soreness around the muschle) and VACCINATION SITE PAIN (pain). On 21-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch), SKIN TIGHTNESS (tight), VACCINATION SITE PRURITUS (itch a little), VACCINATION SITE RASH (rash around the area) and VACCINATION SITE ERYTHEMA (Rash is a bit redder). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (hot to touch), SKIN TIGHTNESS (tight), VACCINATION SITE PRURITUS (itch a little), MYALGIA (Soreness around the muschle), VACCINATION SITE RASH (rash around the area), VACCINATION SITE ERYTHEMA (Rash is a bit redder) and VACCINATION SITE PAIN (pain) 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 relevant concomitant medications were reported.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: hot to touch; tight; itch a little; rash around the area; Rash is a bit redder; pain; Soreness around the muschle; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (hot to touch), SKIN TIGHTNESS (tight), VACCINATION SITE PRURITUS (itch a little), MYALGIA (Soreness around the muschle) and VACCINATION SITE RASH (rash around the area) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced MYALGIA (Soreness around the muschle) and VACCINATION SITE PAIN (pain). On 21-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch), SKIN TIGHTNESS (tight), VACCINATION SITE PRURITUS (itch a little), VACCINATION SITE RASH (rash around the area) and VACCINATION SITE ERYTHEMA (Rash is a bit redder). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (hot to touch), SKIN TIGHTNESS (tight), VACCINATION SITE PRURITUS (itch a little), MYALGIA (Soreness around the muschle), VACCINATION SITE RASH (rash around the area), VACCINATION SITE ERYTHEMA (Rash is a bit redder) and VACCINATION SITE PAIN (pain) 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 relevant concomitant medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity, Rash, Urticaria
Clinical narrative: More hives in the axillary zone; Rash all over the body; Severe headache; Dizziness; Pain in the arm of the injection; This spontaneous case was reported by a non-health professional and describes the occurrence of URTICARIA (More hives in the axillary zone), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Pain in the arm of the injection), RASH (Rash all over the body) and HEADACHE (Severe headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Allergy. Concomitant products included LEVOTHYROXINE and MINERALS NOS, VITAMINS NOS (MULTIVITAMIN AND MINERAL SUPPLEMENT) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DIZZINESS (Dizziness), PAIN IN EXTREMITY (Pain in the arm of the injection) and HEADACHE (Severe headache). On 24-Jan-2021, the patient experienced URTICARIA (More hives in the axillary zone) and RASH (Rash all over the body). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 22-Jan-2021, DIZZINESS (Dizziness), PAIN IN EXTREMITY (Pain in the arm of the injection) and HEADACHE (Severe headache) had resolved. On 24-Jan-2021, URTICARIA (More hives in the axillary zone) and RASH (Rash all over the body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment for the event included diphenhydramine and fexofenadine.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dyspnoea, Fatigue, Pyrexia
Clinical narrative: Chest was burning/Chest pain; Body temperature was warm; Chills; Fatigue; Breathing issues got worse/More shrotness of breath; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest was burning/Chest pain), DYSPNOEA (Breathing issues got worse/More shrotness of breath), PYREXIA (Body temperature was warm), CHILLS (Chills) and FATIGUE (Fatigue) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Shortness of breath. Concomitant products included BROMELAINS (BROMELAIN) and CHONDROITIN SULFATE, GLUCOSAMINE SULFATE, METHYLSULFONYLMETHANE (GLUCOSAMINE CHONDROITIN & MSM) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 22-Jan-2021, the patient experienced DYSPNOEA (Breathing issues got worse/More shrotness of breath), CHILLS (Chills) and FATIGUE (Fatigue). On an unknown date, the patient experienced CHEST PAIN (Chest was burning/Chest pain) and PYREXIA (Body temperature was warm). At the time of the report, CHEST PAIN (Chest was burning/Chest pain) had not resolved and DYSPNOEA (Breathing issues got worse/More shrotness of breath), PYREXIA (Body temperature was warm), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include Fish oils.  Treatment information provided was Homeopathic Remedy.Patient had to increase the use of  Bromelain and Glucosamine/Chondroitin to help breath better. Exercise and walking also seemed to help. Cold air helps.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination complication, Vaccination site pain
Clinical narrative: Felt like he was hit by a truck; vaccination site pain; Aches all over the body; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt like he was hit by a truck), VACCINATION SITE PAIN (vaccination site pain) and MYALGIA (Aches all over the body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (March 2020). Concomitant products included METOPROLOL for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION COMPLICATION (Felt like he was hit by a truck), VACCINATION SITE PAIN (vaccination site pain) and MYALGIA (Aches all over the body). On 14-Jan-2021, VACCINATION SITE PAIN (vaccination site pain) had resolved. At the time of the report, VACCINATION COMPLICATION (Felt like he was hit by a truck) and MYALGIA (Aches all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Rash erythematous, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Irritated; Swolen; Hot; Little rash; Itchy; Red; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE RASH (Little rash), VACCINATION SITE PRURITUS (Itchy), RASH ERYTHEMATOUS (Red) and RASH (Irritated) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pain in arm from 14-Jan-2021 to 15-Jan-2021, Rash on 17-Jan-2021, Vaccination site pruritus on 17-Jan-2021, Red rash (Not able to code "sort of largen than the injection site") on 17-Jan-2021, Rash aggravated, Vaccination site swelling, Vaccination site joint warmth and Facial swelling (Facial swelling in the past (before the vaccine).). Concurrent medical conditions included Vaccination site rash (the shape and size of rash have moved) since 26-Jan-2021.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 17-Jan-2021, the patient experienced VACCINATION SITE RASH (Little rash), VACCINATION SITE PRURITUS (Itchy) and RASH ERYTHEMATOUS (Red). On an unknown date, the patient experienced RASH (Irritated), VACCINATION SITE SWELLING (Swolen) and VACCINATION SITE WARMTH (Hot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. On 15-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, VACCINATION SITE RASH (Little rash), VACCINATION SITE PRURITUS (Itchy) and RASH ERYTHEMATOUS (Red) had not resolved, RASH (Irritated) and VACCINATION SITE WARMTH (Hot) outcome was unknown and VACCINATION SITE SWELLING (Swolen) had resolved. Not Provided
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Irritated; Swolen; Hot; Little rash; Itchy; Red; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE RASH (Little rash), VACCINATION SITE PRURITUS (Itchy), RASH ERYTHEMATOUS (Red) and RASH (Irritated) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pain in arm from 14-Jan-2021 to 15-Jan-2021, Rash on 17-Jan-2021, Vaccination site pruritus on 17-Jan-2021, Red rash (Not able to code "sort of largen than the injection site") on 17-Jan-2021, Rash aggravated, Vaccination site swelling, Vaccination site joint warmth and Facial swelling (Facial swelling in the past (before the vaccine).). Concurrent medical conditions included Vaccination site rash (the shape and size of rash have moved) since 26-Jan-2021.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 17-Jan-2021, the patient experienced VACCINATION SITE RASH (Little rash), VACCINATION SITE PRURITUS (Itchy) and RASH ERYTHEMATOUS (Red). On an unknown date, the patient experienced RASH (Irritated), VACCINATION SITE SWELLING (Swolen) and VACCINATION SITE WARMTH (Hot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. On 15-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, VACCINATION SITE RASH (Little rash), VACCINATION SITE PRURITUS (Itchy) and RASH ERYTHEMATOUS (Red) had not resolved, RASH (Irritated) and VACCINATION SITE WARMTH (Hot) outcome was unknown and VACCINATION SITE SWELLING (Swolen) had resolved. Not Provided
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Pain in extremity
Clinical narrative: Woke up every night with bloody left nostril; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Woke up every night with bloody left nostril) and PAIN IN EXTREMITY (Arm soreness) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN from 22-May-2020 to an unknown date for Hypercholesterolemia, METOPROLOL for Hypertension, DOXEPIN HCL from 16-Mar-2021 to an unknown date for Sleep disorder, LEVOTHYROXINE from 31-Mar-2021 to an unknown date for Thyroid function decreased, MULTIVITAMIN [VITAMINS NOS], OMEGA-3 NOS, CALCIUM, ACETYLSALICYLIC ACID (ASPIRIN 81) and SERTRALINE HCL from 31-Mar-2021 to an unknown date for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced EPISTAXIS (Woke up every night with bloody left nostril) and PAIN IN EXTREMITY (Arm soreness). In January 2021, EPISTAXIS (Woke up every night with bloody left nostril) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for event epistaxis was humidifier.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Additional information was received and processed with initial report. Patient demographics and concomitant product used were updated. Second dose information was provided. Event outcome for epistaxis was updated.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Vaccination site reaction
Clinical narrative: Covid-arm; delayed reaction red spot; delayed reaction itching; delayed reaction swelling; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (Covid-arm), INJECTION SITE RASH (delayed reaction red spot), INJECTION SITE PRURITUS (delayed reaction itching) and INJECTION SITE SWELLING (delayed reaction swelling) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 11-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 VACCINATION SITE REACTION (Covid-arm), INJECTION SITE RASH (delayed reaction red spot), INJECTION SITE PRURITUS (delayed reaction itching) and INJECTION SITE SWELLING (delayed reaction swelling). At the time of the report, VACCINATION SITE REACTION (Covid-arm), INJECTION SITE RASH (delayed reaction red spot), INJECTION SITE PRURITUS (delayed reaction itching) and INJECTION SITE SWELLING (delayed reaction swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Teatment included Benadryl and Hydrocortisone cream.. It was reported that it was a case of Covid-arm which came on day 10 and after taking Benadryl, it cleared up in 3-4 days.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Follow up was received on 29 mar 2021 included, outcome of events changed to resolved, additional event of Covid-arm added; 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