chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Headache, Myalgia, Nausea
Clinical narrative: Really bad body aches; Fever of 100.3; really bad headache; Chills; Vomiting; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Really bad body aches), PYREXIA (Fever of 100.3), HEADACHE (really bad headache), CHILLS (Chills) and VOMITING (Vomiting) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 06-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced MYALGIA (Really bad body aches), PYREXIA (Fever of 100.3), HEADACHE (really bad headache), CHILLS (Chills), VOMITING (Vomiting) and NAUSEA (Nausea). At the time of the report, MYALGIA (Really bad body aches), PYREXIA (Fever of 100.3), HEADACHE (really bad headache), CHILLS (Chills), VOMITING (Vomiting) and NAUSEA (Nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature increased: 100.3f (High) 100.3f.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Really bad body aches; Fever of 100.3; really bad headache; Chills; Vomiting; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Really bad body aches), PYREXIA (Fever of 100.3), HEADACHE (really bad headache), CHILLS (Chills) and VOMITING (Vomiting) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 06-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced MYALGIA (Really bad body aches), PYREXIA (Fever of 100.3), HEADACHE (really bad headache), CHILLS (Chills), VOMITING (Vomiting) and NAUSEA (Nausea). At the time of the report, MYALGIA (Really bad body aches), PYREXIA (Fever of 100.3), HEADACHE (really bad headache), CHILLS (Chills), VOMITING (Vomiting) and NAUSEA (Nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature increased: 100.3f (High) 100.3f.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: Hurting soreness on left side; Redness on the left side; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Hurting soreness on left side) and ERYTHEMA (Redness on the left side) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) 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) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (Hurting soreness on left side) and ERYTHEMA (Redness on the left side). At the time of the report, PAIN IN EXTREMITY (Hurting soreness on left side) and ERYTHEMA (Redness on the left side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Nurse recommended to take paracetamol and ibuprofen.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: soreness at injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3218840) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure fluctuation and Heartburn. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product include unspecified blood pressure medication and heartburn medication.  On 14-FEB-2021, patient experienced injection site soreness and redness and it went away. On 23-FEB-2021, redness and injection site soreness came back.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Headache, Pain
Clinical narrative: Stomach ache; Body ache; Severe Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach ache), PAIN (Body ache), HEADACHE (Severe Headache) and FATIGUE (Fatigue) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache), PAIN (Body ache), HEADACHE (Severe Headache) and FATIGUE (Fatigue). At the time of the report, ABDOMINAL PAIN UPPER (Stomach ache), PAIN (Body ache), HEADACHE (Severe Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Back pain, Chills, Discomfort, Myalgia
Clinical narrative: Arm swelling; Arm hardness; felt sick to my stomach; nausea; injection site itchiness; injection site rash; injection site bumps; injection site red lesion(COVID Arm).; Body aches; FEVER; CHILLS; BACKACHE; SKIN ACHE; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (BACKACHE), PAIN OF SKIN (SKIN ACHE), PERIPHERAL SWELLING (Arm swelling), DISCOMFORT (Arm hardness) and ABDOMINAL DISCOMFORT (felt sick to my stomach) in a 75-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.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced BACK PAIN (BACKACHE), PAIN OF SKIN (SKIN ACHE), VACCINATION SITE PAIN (injection site pain), PYREXIA (FEVER) and CHILLS (CHILLS). On 15-Feb-2021, the patient experienced MYALGIA (Body aches). On 16-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itchiness), VACCINATION SITE RASH (injection site rash), VACCINATION SITE SWELLING (injection site bumps) and VACCINATION SITE ERYTHEMA (injection site red lesion(COVID Arm).). On 21-Feb-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling), DISCOMFORT (Arm hardness), ABDOMINAL DISCOMFORT (felt sick to my stomach) and NAUSEA (nausea). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency and CORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, BACK PAIN (BACKACHE), PAIN OF SKIN (SKIN ACHE), VACCINATION SITE PRURITUS (injection site itchiness), VACCINATION SITE RASH (injection site rash), VACCINATION SITE SWELLING (injection site bumps), VACCINATION SITE ERYTHEMA (injection site red lesion(COVID Arm).), VACCINATION SITE PAIN (injection site pain), PYREXIA (FEVER) and CHILLS (CHILLS) was resolving and PERIPHERAL SWELLING (Arm swelling), DISCOMFORT (Arm hardness), ABDOMINAL DISCOMFORT (felt sick to my stomach), MYALGIA (Body aches) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant products were provided. Ice pack is the other treatment medication reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: followup information received on 25-may-2021, No new information
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain of skin, Peripheral swelling, Pyrexia, Vaccination site erythema
Clinical narrative: Arm swelling; Arm hardness; felt sick to my stomach; nausea; injection site itchiness; injection site rash; injection site bumps; injection site red lesion(COVID Arm).; Body aches; FEVER; CHILLS; BACKACHE; SKIN ACHE; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (BACKACHE), PAIN OF SKIN (SKIN ACHE), PERIPHERAL SWELLING (Arm swelling), DISCOMFORT (Arm hardness) and ABDOMINAL DISCOMFORT (felt sick to my stomach) in a 75-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.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced BACK PAIN (BACKACHE), PAIN OF SKIN (SKIN ACHE), VACCINATION SITE PAIN (injection site pain), PYREXIA (FEVER) and CHILLS (CHILLS). On 15-Feb-2021, the patient experienced MYALGIA (Body aches). On 16-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itchiness), VACCINATION SITE RASH (injection site rash), VACCINATION SITE SWELLING (injection site bumps) and VACCINATION SITE ERYTHEMA (injection site red lesion(COVID Arm).). On 21-Feb-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling), DISCOMFORT (Arm hardness), ABDOMINAL DISCOMFORT (felt sick to my stomach) and NAUSEA (nausea). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency and CORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, BACK PAIN (BACKACHE), PAIN OF SKIN (SKIN ACHE), VACCINATION SITE PRURITUS (injection site itchiness), VACCINATION SITE RASH (injection site rash), VACCINATION SITE SWELLING (injection site bumps), VACCINATION SITE ERYTHEMA (injection site red lesion(COVID Arm).), VACCINATION SITE PAIN (injection site pain), PYREXIA (FEVER) and CHILLS (CHILLS) was resolving and PERIPHERAL SWELLING (Arm swelling), DISCOMFORT (Arm hardness), ABDOMINAL DISCOMFORT (felt sick to my stomach), MYALGIA (Body aches) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant products were provided. Ice pack is the other treatment medication reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: followup information received on 25-may-2021, No new information
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Arm swelling; Arm hardness; felt sick to my stomach; nausea; injection site itchiness; injection site rash; injection site bumps; injection site red lesion(COVID Arm).; Body aches; FEVER; CHILLS; BACKACHE; SKIN ACHE; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (BACKACHE), PAIN OF SKIN (SKIN ACHE), PERIPHERAL SWELLING (Arm swelling), DISCOMFORT (Arm hardness) and ABDOMINAL DISCOMFORT (felt sick to my stomach) in a 75-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.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced BACK PAIN (BACKACHE), PAIN OF SKIN (SKIN ACHE), VACCINATION SITE PAIN (injection site pain), PYREXIA (FEVER) and CHILLS (CHILLS). On 15-Feb-2021, the patient experienced MYALGIA (Body aches). On 16-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itchiness), VACCINATION SITE RASH (injection site rash), VACCINATION SITE SWELLING (injection site bumps) and VACCINATION SITE ERYTHEMA (injection site red lesion(COVID Arm).). On 21-Feb-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling), DISCOMFORT (Arm hardness), ABDOMINAL DISCOMFORT (felt sick to my stomach) and NAUSEA (nausea). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency and CORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, BACK PAIN (BACKACHE), PAIN OF SKIN (SKIN ACHE), VACCINATION SITE PRURITUS (injection site itchiness), VACCINATION SITE RASH (injection site rash), VACCINATION SITE SWELLING (injection site bumps), VACCINATION SITE ERYTHEMA (injection site red lesion(COVID Arm).), VACCINATION SITE PAIN (injection site pain), PYREXIA (FEVER) and CHILLS (CHILLS) was resolving and PERIPHERAL SWELLING (Arm swelling), DISCOMFORT (Arm hardness), ABDOMINAL DISCOMFORT (felt sick to my stomach), MYALGIA (Body aches) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant products were provided. Ice pack is the other treatment medication reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: followup information received on 25-may-2021, No new information
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Rash erythematous
Clinical narrative: A big red patch on her left arm; Warm; Had a tiny bit of arm soreness / little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Had a tiny bit of arm soreness / little sore), RASH ERYTHEMATOUS (A big red patch on her left arm) and FEELING HOT (Warm) 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 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Had a tiny bit of arm soreness / little sore). On 22-Feb-2021, the patient experienced RASH ERYTHEMATOUS (A big red patch on her left arm) and FEELING HOT (Warm). On 14-Feb-2021, PAIN IN EXTREMITY (Had a tiny bit of arm soreness / little sore) had resolved. At the time of the report, RASH ERYTHEMATOUS (A big red patch on her left arm) and FEELING HOT (Warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up was received on 25may2021,  no new information.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Vaccination site pruritus
Clinical narrative: itching at injection site; warm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of   in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Illness, Pain
Clinical narrative: Extremely ILL; Fever; Chills; Body aches; Headache; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Extremely ILL), PYREXIA (Fever), CHILLS (Chills), PAIN (Body aches) and HEADACHE (Headache) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ILLNESS (Extremely ILL), PYREXIA (Fever), CHILLS (Chills), PAIN (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, ILLNESS (Extremely ILL), PYREXIA (Fever), CHILLS (Chills), PAIN (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Extremely ILL; Fever; Chills; Body aches; Headache; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Extremely ILL), PYREXIA (Fever), CHILLS (Chills), PAIN (Body aches) and HEADACHE (Headache) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ILLNESS (Extremely ILL), PYREXIA (Fever), CHILLS (Chills), PAIN (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, ILLNESS (Extremely ILL), PYREXIA (Fever), CHILLS (Chills), PAIN (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: neck pain; light reaction (little pain) he had on his shoulder; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jan-2021 and was forwarded to Moderna on 29-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain) and ARTHRALGIA (light reaction (little pain) he had on his shoulder) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027420A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced NECK PAIN (neck pain) and ARTHRALGIA (light reaction (little pain) he had on his shoulder). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NECK PAIN (neck pain) and ARTHRALGIA (light reaction (little pain) he had on his shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: Achiness; Fever; Fatigue; Nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 06-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achiness), PYREXIA (Fever), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Achiness), PYREXIA (Fever), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, MYALGIA (Achiness), PYREXIA (Fever), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.            No concomitant medication information was mentioned  No treatment medication information was mentioned  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the event was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received including no new information
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Vomiting
Clinical narrative: chills; bad fatigue; vomiting and nausea; vomiting and nausea; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (chills), FATIGUE (bad fatigue), VOMITING (vomiting and nausea) and NAUSEA (vomiting and nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19.     No Medical History information was reported.   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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), FATIGUE (bad fatigue), VOMITING (vomiting and nausea) and NAUSEA (vomiting and nausea). At the time of the report, CHILLS (chills), FATIGUE (bad fatigue), VOMITING (vomiting and nausea) and NAUSEA (vomiting and nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: uncomfortable feeling on her arm; itchy arm; like a long rectangle 3-4 inches and 2,5-3 inches wide; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (uncomfortable feeling on her arm), VACCINATION SITE PRURITUS (itchy arm) and VACCINATION SITE SWELLING (like a long rectangle 3-4 inches and 2,5-3 inches wide) 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 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 21-Feb-2021, the patient experienced VACCINATION SITE DISCOMFORT (uncomfortable feeling on her arm), VACCINATION SITE PRURITUS (itchy arm) and VACCINATION SITE SWELLING (like a long rectangle 3-4 inches and 2,5-3 inches wide). At the time of the report, VACCINATION SITE DISCOMFORT (uncomfortable feeling on her arm), VACCINATION SITE PRURITUS (itchy arm) and VACCINATION SITE SWELLING (like a long rectangle 3-4 inches and 2,5-3 inches wide) had not resolved.            Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by reporter  No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received on 02 July 2021 ,Email address provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Sore arm; Muscle pain; A spontaneous report was received from a consumer concerning a  73-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sore arm/vaccination site pain and muscle pain/myalgia.  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.  On 19 Jan 2021,  the same day as the onset of symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch# not provided) intramuscularly in the left non-dominant arm for prophylaxis of COVID-19 infection.  On 19 Jan 2021, the patient reported a sore arm and muscle pain after the injection. Treatment information was not provided.   On 16 Feb 2021, the patient received the second dose of of mRNA-1273 (Batch# not provided) intramuscularly for prophylaxis of COVID-19 infection.   The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, sore arm and muscle pain, was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: severe joint pains; sharp muscle pains; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (severe joint pains) and MYALGIA (sharp muscle pains) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) 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) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced ARTHRALGIA (severe joint pains) and MYALGIA (sharp muscle pains). The patient was treated with HYDROCODONE at an unspecified dose and frequency; Bed rest (Bedridden for 3 days) for Arthralgia and Bed rest (Bedridden for 3 days) for Myalgia. On 09-Feb-2021, ARTHRALGIA (severe joint pains) and MYALGIA (sharp muscle pains) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypokinesia, Injection site pain, Swelling
Clinical narrative: she could not move her arm; whole upper shoulder is swollen and red; whole upper shoulder is swollen and red; severe pain on the shoulder of the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (she could not move her arm), SWELLING (whole upper shoulder is swollen and red), ERYTHEMA (whole upper shoulder is swollen and red) and INJECTION SITE PAIN (severe pain on the shoulder of the injection arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced HYPOKINESIA (she could not move her arm), SWELLING (whole upper shoulder is swollen and red), ERYTHEMA (whole upper shoulder is swollen and red) and INJECTION SITE PAIN (severe pain on the shoulder of the injection arm). At the time of the report, HYPOKINESIA (she could not move her arm) was resolving and SWELLING (whole upper shoulder is swollen and red), ERYTHEMA (whole upper shoulder is swollen and red) and INJECTION SITE PAIN (severe pain on the shoulder of the injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: upset stomach; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach) and DIARRHOEA (diarrhea) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach) and DIARRHOEA (diarrhea). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach) and DIARRHOEA (diarrhea) outcome was unknown.            No concomitant medications reported by reporter. No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Additional information received and Reporter details updated. On 14-Jul-2021: Follow up information received on 14 Jul 2021 and patient's demographics were updated,Dose 1 batch number 029L20A was added.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise
Clinical narrative: COVID postive; Feeling sick; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MALAISE (Feeling sick) and COVID-19 (COVID postive) 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 16-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 MALAISE (Feeling sick). On 19-Jan-2021, the patient experienced COVID-19 (COVID postive). The patient was treated with MONOCLONAL ANTIBODIES at an unspecified dose and frequency. At the time of the report, MALAISE (Feeling sick) and COVID-19 (COVID postive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, COVID-19: tested positive..     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.   This case was linked to MOD-2021-017944 (Patient Link).
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: getting COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (getting COVID) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced COVID-19 (getting COVID). At the time of the report, COVID-19 (getting COVID) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.   It was reported that on 10-Jan-2021, the patient had the bam infusion done. Reportedly, the patient's second dose was scheduled on 28-Jan-2021.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI-TCR (reporter provided email address)
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: upper arm was itchy at the site of injection; red,the size of a large coin; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (upper arm was itchy at the site of injection) and INJECTION SITE ERYTHEMA (red,the size of a large coin) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced INJECTION SITE PRURITUS (upper arm was itchy at the site of injection) and INJECTION SITE ERYTHEMA (red,the size of a large coin). On 23-Feb-2021, INJECTION SITE ERYTHEMA (red,the size of a large coin) had resolved. At the time of the report, INJECTION SITE PRURITUS (upper arm was itchy at the site of injection) 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: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) 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 VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14-JUL-2021 and contains no new significant information
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Redness around injection; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jan-2021 and was forwarded to Moderna on 30-Jan-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jan-2021 and was forwarded to Moderna on 30-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness around injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 25-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 VACCINATION SITE ERYTHEMA (Redness around injection). At the time of the report, VACCINATION SITE ERYTHEMA (Redness around injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Chest pain, Diarrhoea, Pruritus, Rash erythematous
Clinical narrative: she had really bad chest pain; she is not hypoglycemic and doesn't have diabetes but her her blood sugar kept dropping; had diarrhea; vomiting; red patch on her arm; still very itchy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red patch on her arm), CHEST PAIN (she had really bad chest pain), BLOOD GLUCOSE DECREASED (she is not hypoglycemic and doesn't have diabetes but her her blood sugar kept dropping), DIARRHOEA (had diarrhea) and PRURITUS (still very itchy) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypoglycemia.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced RASH ERYTHEMATOUS (red patch on her arm) and PRURITUS (still very itchy). On an unknown date, the patient experienced CHEST PAIN (she had really bad chest pain), BLOOD GLUCOSE DECREASED (she is not hypoglycemic and doesn't have diabetes but her her blood sugar kept dropping), DIARRHOEA (had diarrhea) and VOMITING (vomiting). At the time of the report, RASH ERYTHEMATOUS (red patch on her arm), CHEST PAIN (she had really bad chest pain), BLOOD GLUCOSE DECREASED (she is not hypoglycemic and doesn't have diabetes but her her blood sugar kept dropping), DIARRHOEA (had diarrhea), PRURITUS (still very itchy) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: she had really bad chest pain; she is not hypoglycemic and doesn't have diabetes but her her blood sugar kept dropping; had diarrhea; vomiting; red patch on her arm; still very itchy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red patch on her arm), CHEST PAIN (she had really bad chest pain), BLOOD GLUCOSE DECREASED (she is not hypoglycemic and doesn't have diabetes but her her blood sugar kept dropping), DIARRHOEA (had diarrhea) and PRURITUS (still very itchy) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypoglycemia.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced RASH ERYTHEMATOUS (red patch on her arm) and PRURITUS (still very itchy). On an unknown date, the patient experienced CHEST PAIN (she had really bad chest pain), BLOOD GLUCOSE DECREASED (she is not hypoglycemic and doesn't have diabetes but her her blood sugar kept dropping), DIARRHOEA (had diarrhea) and VOMITING (vomiting). At the time of the report, RASH ERYTHEMATOUS (red patch on her arm), CHEST PAIN (she had really bad chest pain), BLOOD GLUCOSE DECREASED (she is not hypoglycemic and doesn't have diabetes but her her blood sugar kept dropping), DIARRHOEA (had diarrhea), PRURITUS (still very itchy) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest discomfort, Feeling abnormal, Heart rate
Clinical narrative: blood pressure was up; heart rate went up; periodic chest pressure; felt tingling down to her arm and it went over to her chest and to her groin; felt like she was coming out of anesthesia; felt as if she was about to pass out; Chest tingling; Groin tingling; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jan-2021 and was forwarded to Moderna on 30-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (blood pressure was up), HEART RATE INCREASED (heart rate went up), CHEST DISCOMFORT (periodic chest pressure), PARAESTHESIA (felt tingling down to her arm and it went over to her chest and to her groin) and FEELING ABNORMAL (felt like she was coming out of anesthesia) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune thyroid disorder (Patient has autoimmune thyroid disease.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (blood pressure was up), HEART RATE INCREASED (heart rate went up), CHEST DISCOMFORT (periodic chest pressure), PARAESTHESIA (felt tingling down to her arm and it went over to her chest and to her groin), FEELING ABNORMAL (felt like she was coming out of anesthesia), PRESYNCOPE (felt as if she was about to pass out), CHEST DISCOMFORT (Chest tingling) and MUSCULOSKELETAL DISCOMFORT (Groin tingling). At the time of the report, BLOOD PRESSURE INCREASED (blood pressure was up), HEART RATE INCREASED (heart rate went up), CHEST DISCOMFORT (periodic chest pressure), PARAESTHESIA (felt tingling down to her arm and it went over to her chest and to her groin), FEELING ABNORMAL (felt like she was coming out of anesthesia), PRESYNCOPE (felt as if she was about to pass out), CHEST DISCOMFORT (Chest tingling) and MUSCULOSKELETAL DISCOMFORT (Groin tingling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Blood pressure measurement: 156/90 mmHg (High) At vaccine site-156/90 Recheked before leaving the vaccine site 136/85. rechecked on reaching home- normal  with a 110/80. On 25-Jan-2021, Heart rate: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication provided were Benadryl and advil.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Reporter contact details (fax number) added.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Musculoskeletal discomfort, Paraesthesia, Presyncope
Clinical narrative: blood pressure was up; heart rate went up; periodic chest pressure; felt tingling down to her arm and it went over to her chest and to her groin; felt like she was coming out of anesthesia; felt as if she was about to pass out; Chest tingling; Groin tingling; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jan-2021 and was forwarded to Moderna on 30-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (blood pressure was up), HEART RATE INCREASED (heart rate went up), CHEST DISCOMFORT (periodic chest pressure), PARAESTHESIA (felt tingling down to her arm and it went over to her chest and to her groin) and FEELING ABNORMAL (felt like she was coming out of anesthesia) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune thyroid disorder (Patient has autoimmune thyroid disease.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (blood pressure was up), HEART RATE INCREASED (heart rate went up), CHEST DISCOMFORT (periodic chest pressure), PARAESTHESIA (felt tingling down to her arm and it went over to her chest and to her groin), FEELING ABNORMAL (felt like she was coming out of anesthesia), PRESYNCOPE (felt as if she was about to pass out), CHEST DISCOMFORT (Chest tingling) and MUSCULOSKELETAL DISCOMFORT (Groin tingling). At the time of the report, BLOOD PRESSURE INCREASED (blood pressure was up), HEART RATE INCREASED (heart rate went up), CHEST DISCOMFORT (periodic chest pressure), PARAESTHESIA (felt tingling down to her arm and it went over to her chest and to her groin), FEELING ABNORMAL (felt like she was coming out of anesthesia), PRESYNCOPE (felt as if she was about to pass out), CHEST DISCOMFORT (Chest tingling) and MUSCULOSKELETAL DISCOMFORT (Groin tingling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Blood pressure measurement: 156/90 mmHg (High) At vaccine site-156/90 Recheked before leaving the vaccine site 136/85. rechecked on reaching home- normal  with a 110/80. On 25-Jan-2021, Heart rate: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication provided were Benadryl and advil.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Reporter contact details (fax number) added.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Peripheral coldness, Pyrexia
Clinical narrative: pain in upper arm; coldness in extremeties; soreness; Achiness; Low grade Fever; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in upper arm), PERIPHERAL COLDNESS (coldness in extremeties), PAIN (soreness), PAIN (Achiness) and PYREXIA (Low grade Fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in upper arm), PERIPHERAL COLDNESS (coldness in extremeties), PAIN (soreness), PAIN (Achiness), PYREXIA (Low grade Fever) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (pain in upper arm), PERIPHERAL COLDNESS (coldness in extremeties), PAIN (soreness), PAIN (Achiness), PYREXIA (Low grade Fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.