chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red bumpy itchy rash on both breasts, belly, back, neck and on upper leg; Red bumpy itchy rash on both breasts, belly, back, neck and on upper leg; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Red bumpy itchy rash on both breasts, belly, back, neck and on upper leg) and RASH ERYTHEMATOUS (Red bumpy itchy rash on both breasts, belly, back, neck and on upper leg) in an 81-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 No adverse event.    On 14-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 RASH PRURITIC (Red bumpy itchy rash on both breasts, belly, back, neck and on upper leg) and RASH ERYTHEMATOUS (Red bumpy itchy rash on both breasts, belly, back, neck and on upper leg). At the time of the report, RASH PRURITIC (Red bumpy itchy rash on both breasts, belly, back, neck and on upper leg) and RASH ERYTHEMATOUS (Red bumpy itchy rash on both breasts, belly, back, neck and on upper leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Red spot after 7 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red spot after 7 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red spot after 7 days). At the time of the report, VACCINATION SITE ERYTHEMA (Red spot after 7 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant medication provided no treatment provided
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Limb discomfort, Pain, Rash, Rash erythematous
Clinical narrative: achy; uncomfortable; red rash on lower side of arm/red dots; itchy rash; oozing rash; arm very uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), INJECTION SITE DISCOMFORT (uncomfortable), RASH ERYTHEMATOUS (red rash on lower side of arm/red dots), RASH PRURITIC (itchy rash) and RASH (oozing rash) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer. Concomitant products included BACITRACIN and HYDROCORTISONE (CORTIZONE 10).    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 PAIN (achy), INJECTION SITE DISCOMFORT (uncomfortable), RASH ERYTHEMATOUS (red rash on lower side of arm/red dots), RASH PRURITIC (itchy rash), RASH (oozing rash) and LIMB DISCOMFORT (arm very uncomfortable). On 05-Feb-2021, PAIN (achy) and INJECTION SITE DISCOMFORT (uncomfortable) had resolved. On 23-Feb-2021, RASH PRURITIC (itchy rash), RASH (oozing rash) and LIMB DISCOMFORT (arm very uncomfortable) had resolved. At the time of the report, RASH ERYTHEMATOUS (red rash on lower side of arm/red dots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: achy; uncomfortable; red rash on lower side of arm/red dots; itchy rash; oozing rash; arm very uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), INJECTION SITE DISCOMFORT (uncomfortable), RASH ERYTHEMATOUS (red rash on lower side of arm/red dots), RASH PRURITIC (itchy rash) and RASH (oozing rash) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer. Concomitant products included BACITRACIN and HYDROCORTISONE (CORTIZONE 10).    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 PAIN (achy), INJECTION SITE DISCOMFORT (uncomfortable), RASH ERYTHEMATOUS (red rash on lower side of arm/red dots), RASH PRURITIC (itchy rash), RASH (oozing rash) and LIMB DISCOMFORT (arm very uncomfortable). On 05-Feb-2021, PAIN (achy) and INJECTION SITE DISCOMFORT (uncomfortable) had resolved. On 23-Feb-2021, RASH PRURITIC (itchy rash), RASH (oozing rash) and LIMB DISCOMFORT (arm very uncomfortable) had resolved. At the time of the report, RASH ERYTHEMATOUS (red rash on lower side of arm/red dots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: I had a big lump in the lymph nodes; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (I had a big lump in the lymph nodes) and FATIGUE (felt tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (I had a big lump in the lymph nodes) and FATIGUE (felt tired). At the time of the report, LYMPHADENOPATHY (I had a big lump in the lymph nodes) and FATIGUE (felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no concomitant medication given no treatment provided
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Night sweats
Clinical narrative: chills and sweating at night; swollen lymph nodes; chills and sweating at night; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (chills and sweating at night), LYMPHADENOPATHY (swollen lymph nodes) and CHILLS (chills and sweating at night) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced CHILLS (chills and sweating at night). On an unknown date, the patient experienced NIGHT SWEATS (chills and sweating at night) and LYMPHADENOPATHY (swollen lymph nodes). At the time of the report, NIGHT SWEATS (chills and sweating at night), LYMPHADENOPATHY (swollen lymph nodes) and CHILLS (chills and sweating at night) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication and treatment provided
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Myalgia
Clinical narrative: itchy at injection site; raised redness at the injection site; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm), INJECTION SITE PRURITUS (itchy at injection site) and INJECTION SITE ERYTHEMA (raised redness at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    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 MYALGIA (sore arm). On 30-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itchy at injection site) and INJECTION SITE ERYTHEMA (raised redness at the injection site). On 23-Jan-2021, MYALGIA (sore arm) had resolved. At the time of the report, INJECTION SITE PRURITUS (itchy at injection site) and INJECTION SITE ERYTHEMA (raised redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medication and treatment provided
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itching like crazy at injection site; 3 inch redness at injection site; Itchy at injection site; Quarter size redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE ERYTHEMA (Quarter size redness at injection site), VACCINATION SITE PRURITUS (Itching like crazy at injection site) and VACCINATION SITE ERYTHEMA (3 inch redness at injection site) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE ERYTHEMA (Quarter size redness at injection site). On 10-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching like crazy at injection site) and VACCINATION SITE ERYTHEMA (3 inch redness at injection site). On 29-Jan-2021, VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE ERYTHEMA (Quarter size redness at injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itching like crazy at injection site) and VACCINATION SITE ERYTHEMA (3 inch redness at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication and treatment provided
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site sore; injection site red; injection site big,hot; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (injection site red), INJECTION SITE WARMTH (injection site big,hot) and INJECTION SITE SWELLING (Injection site sore) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historic conditions reported.).   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site red) and INJECTION SITE WARMTH (injection site big,hot). On an unknown date, the patient experienced INJECTION SITE SWELLING (Injection site sore). At the time of the report, INJECTION SITE ERYTHEMA (injection site red), INJECTION SITE WARMTH (injection site big,hot) and INJECTION SITE SWELLING (Injection site sore) outcome was unknown.            no concomitant medication and treatment provided   This case was linked to US-MODERNATX, INC.-MOD-2021-024646, US-MODERNATX, INC.-MOD-2021-024767 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-024767: US-MODERNATX, INC.-MOD-2021-024646:MOD21-023085
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: patient experienced: hives; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (patient experienced: hives) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     Concomitant products included OMALIZUMAB (XOLAIR).    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 URTICARIA (patient experienced: hives). At the time of the report, URTICARIA (patient experienced: hives) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment information were not provided by the reporter.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product availability issue
Clinical narrative: Was scheduled to receive the second dose, but the sight was closed; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT AVAILABILITY ISSUE (Was scheduled to receive the second dose, but the sight was closed) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history.).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PRODUCT AVAILABILITY ISSUE (Was scheduled to receive the second dose, but the sight was closed). On 13-Feb-2021, PRODUCT AVAILABILITY ISSUE (Was scheduled to receive the second dose, but the sight was closed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was provided.  No treatment details were provided.    This case was linked to MOD-2021-023438 (E2B Linked Report).; Sender's Comments:  MOD-2021-023438:Same reporter
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: experienced Covid-19 like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experienced Covid-19 like symptoms) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse drug effect (no medical history found).    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (experienced Covid-19 like symptoms). At the time of the report, VACCINATION COMPLICATION (experienced Covid-19 like symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   no concomitant medication and treatment provided
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood pressure increased, Blood pressure measurement, Body temperature, Heart rate
Clinical narrative: Stomach Ache on the right side; Fever 101F; Injection Site Pain; Blood Pressure was increased 140/96; High Pulse 101; Body Pain all over the body; This spontaneous case was reported by a nurse and describes the occurrence of BLOOD PRESSURE INCREASED (Blood Pressure was increased 140/96), HEART RATE INCREASED (High Pulse 101), PAIN (Body Pain all over the body), ABDOMINAL PAIN UPPER (Stomach Ache on the right side) and PYREXIA (Fever 101F) in a 67-year-old female patient 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 Blood pressure high. Concomitant products included AMLODIPINE for Blood pressure high.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood Pressure was increased 140/96), HEART RATE INCREASED (High Pulse 101), PAIN (Body Pain all over the body), PYREXIA (Fever 101F) and VACCINATION SITE PAIN (Injection Site Pain). On 07-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach Ache on the right side). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain and Fever, at an unspecified dose and frequency. At the time of the report, BLOOD PRESSURE INCREASED (Blood Pressure was increased 140/96), HEART RATE INCREASED (High Pulse 101), PAIN (Body Pain all over the body), ABDOMINAL PAIN UPPER (Stomach Ache on the right side), PYREXIA (Fever 101F) and VACCINATION SITE PAIN (Injection Site Pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Blood pressure measurement: increase (High) 140/96. On 05-Feb-2021, Body temperature: high (High) Fever 101F. On 05-Feb-2021, Heart rate: high (High) pulse rate 101. On 06-Feb-2021, Body temperature: high (High) went up again Fever 99.6 F.     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.   patient has applied heat on the stomach and taken 2 advil tablets   This case was linked to MOD-2021-022908, MOD-2021-022912 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Stomach Ache on the right side; Fever 101F; Injection Site Pain; Blood Pressure was increased 140/96; High Pulse 101; Body Pain all over the body; This spontaneous case was reported by a nurse and describes the occurrence of BLOOD PRESSURE INCREASED (Blood Pressure was increased 140/96), HEART RATE INCREASED (High Pulse 101), PAIN (Body Pain all over the body), ABDOMINAL PAIN UPPER (Stomach Ache on the right side) and PYREXIA (Fever 101F) in a 67-year-old female patient 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 Blood pressure high. Concomitant products included AMLODIPINE for Blood pressure high.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood Pressure was increased 140/96), HEART RATE INCREASED (High Pulse 101), PAIN (Body Pain all over the body), PYREXIA (Fever 101F) and VACCINATION SITE PAIN (Injection Site Pain). On 07-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach Ache on the right side). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain and Fever, at an unspecified dose and frequency. At the time of the report, BLOOD PRESSURE INCREASED (Blood Pressure was increased 140/96), HEART RATE INCREASED (High Pulse 101), PAIN (Body Pain all over the body), ABDOMINAL PAIN UPPER (Stomach Ache on the right side), PYREXIA (Fever 101F) and VACCINATION SITE PAIN (Injection Site Pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Blood pressure measurement: increase (High) 140/96. On 05-Feb-2021, Body temperature: high (High) Fever 101F. On 05-Feb-2021, Heart rate: high (High) pulse rate 101. On 06-Feb-2021, Body temperature: high (High) went up again Fever 99.6 F.     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.   patient has applied heat on the stomach and taken 2 advil tablets   This case was linked to MOD-2021-022908, MOD-2021-022912 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 78-year-old male 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.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: sore arm; Didn't sleep well; Wasn't feeling well; bodyaches; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), SLEEP DISORDER (Didn't sleep well), MALAISE (Wasn't feeling well), MYALGIA (bodyaches) and PYREXIA (Fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypothyroidism and Acid reflux (esophageal). Concurrent medical conditions included Penicillin allergy, Zinc sulfate turbidity abnormal and Drug allergy (Allergy to Zofran drug.). Concomitant products included PANTOPRAZOLE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), SLEEP DISORDER (Didn't sleep well), MALAISE (Wasn't feeling well), MYALGIA (bodyaches), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (sore arm), SLEEP DISORDER (Didn't sleep well), MALAISE (Wasn't feeling well), MYALGIA (bodyaches), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.            Treatment information was unknown. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-024239, MOD-2021-053240 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: sore arm; Didn't sleep well; Wasn't feeling well; bodyaches; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), SLEEP DISORDER (Didn't sleep well), MALAISE (Wasn't feeling well), MYALGIA (bodyaches) and PYREXIA (Fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypothyroidism and Acid reflux (esophageal). Concurrent medical conditions included Penicillin allergy, Zinc sulfate turbidity abnormal and Drug allergy (Allergy to Zofran drug.). Concomitant products included PANTOPRAZOLE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), SLEEP DISORDER (Didn't sleep well), MALAISE (Wasn't feeling well), MYALGIA (bodyaches), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (sore arm), SLEEP DISORDER (Didn't sleep well), MALAISE (Wasn't feeling well), MYALGIA (bodyaches), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.            Treatment information was unknown. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-024239, MOD-2021-053240 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site erythema
Clinical narrative: injection site looked black and blue; injection site looks pink spot as big as quarter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (injection site looked black and blue) and VACCINATION SITE ERYTHEMA (injection site looks pink spot as big as quarter) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for an unknown indication.     No medical history was provided by reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ATORVASTATIN for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site looks pink spot as big as quarter). On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (injection site looked black and blue). On 07-Feb-2021, VACCINATION SITE DISCOLOURATION (injection site looked black and blue) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (injection site looks pink spot as big as quarter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: warmth at injection site; hardness at injection site; swollen at injection site; soreness in injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warmth at injection site), VACCINATION SITE INDURATION (hardness at injection site), VACCINATION SITE PAIN (soreness in injection site) and VACCINATION SITE SWELLING (swollen at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness in injection site). On 17-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warmth at injection site), VACCINATION SITE INDURATION (hardness at injection site) and VACCINATION SITE SWELLING (swollen at injection site). On 13-Feb-2021, VACCINATION SITE PAIN (soreness in injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (warmth at injection site), VACCINATION SITE INDURATION (hardness at injection site) and VACCINATION SITE SWELLING (swollen at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity
Clinical narrative: Sore arm; Muscle pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle pain) and HEADACHE (Headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history.).    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle pain) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle pain) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication and treatment provided
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site rash
Clinical narrative: rash on the right arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and VACCINATION SITE RASH (rash on the right arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021L20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced FATIGUE (fatigue). On 11-Jan-2021, the patient experienced VACCINATION SITE RASH (rash on the right arm). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, FATIGUE (fatigue) and VACCINATION SITE RASH (rash on the right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication provided   This case was linked to MOD-2021-024119 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 06-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication and treatment provided
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Muscle spasms, Muscular weakness, Vaccination site pain
Clinical narrative: left leg is totally weak; could hardly walk; leg cramped up; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (left leg is totally weak), GAIT DISTURBANCE (could hardly walk), VACCINATION SITE PAIN (sore arm) and MUSCLE SPASMS (leg cramped up) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Lung nodule and Environmental allergy. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), VITAMINS NOS and HYDROCHLOROTHIAZIDE, TRIAMTERENE (MAXZIDE) for an unknown indication, CHLORPHENAMINE MALEATE (ALLERGY tablet [CHLORPHENAMINE MALEATE]).    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 24-Feb-2021, the patient experienced MUSCULAR WEAKNESS (left leg is totally weak), GAIT DISTURBANCE (could hardly walk) and MUSCLE SPASMS (leg cramped up). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency and PARACETAMOL (TYNELOL (might take next)) at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (left leg is totally weak), GAIT DISTURBANCE (could hardly walk), VACCINATION SITE PAIN (sore arm) and MUSCLE SPASMS (leg cramped up) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: arm is little swollen; redness in moving down on arm; upper back is itching; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is little swollen), ERYTHEMA (redness in moving down on arm) and PRURITUS (upper back is itching) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided). Concomitant products included LEVOTHYROXINE and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm is little swollen), ERYTHEMA (redness in moving down on arm) and PRURITUS (upper back is itching). At the time of the report, PERIPHERAL SWELLING (arm is little swollen), ERYTHEMA (redness in moving down on arm) and PRURITUS (upper back is itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication and treatment provided
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Vaccination site reaction
Clinical narrative: rash on arm; covid arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on arm) and VACCINATION SITE REACTION (covid arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced RASH (rash on arm) and VACCINATION SITE REACTION (covid arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ITCH STOPPING CREAM) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (rash on arm) and VACCINATION SITE REACTION (covid arm) outcome was unknown.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Fast heart rates; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart rates) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no 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 HEART RATE INCREASED (Fast heart rates). At the time of the report, HEART RATE INCREASED (Fast heart rates) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication and treatment provided
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives all over the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over the body) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced URTICARIA (hives all over the body). At the time of the report, URTICARIA (hives all over the body) outcome was unknown.            No concomitant medication was provided.  No treatment details were provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: had a red spot on her collar bone that is migrating towards her chest; rash on her arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on her arm) and RASH MACULAR (had a red spot on her collar bone that is migrating towards her chest) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided). Concomitant products included USTEKINUMAB (STELARA) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced RASH (rash on her arm) and RASH MACULAR (had a red spot on her collar bone that is migrating towards her chest). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (rash on her arm) and RASH MACULAR (had a red spot on her collar bone that is migrating towards her chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: severe itchiness; severe rash; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (severe itchiness), RASH (severe rash) and PYREXIA (fever) 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 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced PYREXIA (fever). On 22-Feb-2021, the patient experienced PRURITUS (severe itchiness) and RASH (severe rash). On 21-Feb-2021, PYREXIA (fever) had resolved. At the time of the report, PRURITUS (severe itchiness) and RASH (severe rash) outcome was unknown.            Treatment details included allergy medicine, not specified. no concomitant medication provided
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Lymphadenopathy, Peripheral swelling, Pruritus
Clinical narrative: itchy; Arm is swollen; Redness; Lymph nodes swollen; headache; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (itchy), PERIPHERAL SWELLING (Arm is swollen), ERYTHEMA (Redness), LYMPHADENOPATHY (Lymph nodes swollen) and HEADACHE (headache) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. CX4M20a) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PRURITUS (itchy), PERIPHERAL SWELLING (Arm is swollen), ERYTHEMA (Redness), LYMPHADENOPATHY (Lymph nodes swollen) and HEADACHE (headache). At the time of the report, PRURITUS (itchy), PERIPHERAL SWELLING (Arm is swollen), ERYTHEMA (Redness), LYMPHADENOPATHY (Lymph nodes swollen) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Vaccination site erythema, Vaccination site induration
Clinical narrative: hard above and below injection site; itching at injection site; red at injection site; the injection site is tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hard above and below injection site), INJECTION SITE PRURITUS (itching at injection site), VACCINATION SITE ERYTHEMA (red at injection site) and INJECTION SITE PAIN (the injection site is tender) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE INDURATION (hard above and below injection site), INJECTION SITE PRURITUS (itching at injection site), VACCINATION SITE ERYTHEMA (red at injection site) and INJECTION SITE PAIN (the injection site is tender). At the time of the report, VACCINATION SITE INDURATION (hard above and below injection site), INJECTION SITE PRURITUS (itching at injection site), VACCINATION SITE ERYTHEMA (red at injection site) and INJECTION SITE PAIN (the injection site is tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Malaise, Oropharyngeal pain, Pyrexia
Clinical narrative: loss of appetite; sore throat; not feeling well; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), OROPHARYNGEAL PAIN (sore throat), MALAISE (not feeling well) and PYREXIA (low grade fever) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced DECREASED APPETITE (loss of appetite), OROPHARYNGEAL PAIN (sore throat), MALAISE (not feeling well) and PYREXIA (low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (loss of appetite), OROPHARYNGEAL PAIN (sore throat), MALAISE (not feeling well) and PYREXIA (low grade fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were Provided by the reporter.   This case was linked to MOD-2021-257403 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Significant follow up received and Updated Events start date and outcome of the events as Resolved.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: bad rash, that is extremely itchy, red and hot on the site of injection; bad rash, that is extremely itchy, red and hot on the site of injection; bad rash, that is extremely itchy, red and hot on the site of injection; bad rash, that is extremely itchy, red and hot on the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (bad rash, that is extremely itchy, red and hot on the site of injection), INJECTION SITE PRURITUS (bad rash, that is extremely itchy, red and hot on the site of injection), INJECTION SITE RASH (bad rash, that is extremely itchy, red and hot on the site of injection) and INJECTION SITE ERYTHEMA (bad rash, that is extremely itchy, red and hot on the site of injection) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer. Concurrent medical conditions included Blood pressure. Concomitant products included LETROZOLE for Breast cancer, high blood pressure medication, ATORVASTATIN and ALIROCUMAB (PRALUENT) for an unknown indication.  On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INJECTION SITE WARMTH (bad rash, that is extremely itchy, red and hot on the site of injection), INJECTION SITE PRURITUS (bad rash, that is extremely itchy, red and hot on the site of injection), INJECTION SITE RASH (bad rash, that is extremely itchy, red and hot on the site of injection) and INJECTION SITE ERYTHEMA (bad rash, that is extremely itchy, red and hot on the site of injection). The patient was treated with AVENA SATIVA FLUID EXTRACT (AVEENO) (topical) for Itching, at a dose of Cream. At the time of the report, INJECTION SITE WARMTH (bad rash, that is extremely itchy, red and hot on the site of injection), INJECTION SITE PRURITUS (bad rash, that is extremely itchy, red and hot on the site of injection), INJECTION SITE RASH (bad rash, that is extremely itchy, red and hot on the site of injection) and INJECTION SITE ERYTHEMA (bad rash, that is extremely itchy, red and hot on the site of injection) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Arm red; Arm swollen; Arm warm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Arm red), INJECTION SITE SWELLING (Arm swollen) and INJECTION SITE WARMTH (Arm warm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Arm red), INJECTION SITE SWELLING (Arm swollen) and INJECTION SITE WARMTH (Arm warm). At the time of the report, INJECTION SITE ERYTHEMA (Arm red), INJECTION SITE SWELLING (Arm swollen) and INJECTION SITE WARMTH (Arm warm) outcome was unknown. Not Provided   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   Concomitant medications were not reported.  No treatment information provided.