chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Injection site erythema, Myalgia
Clinical narrative: Arm is swollen / swollen from elbow to shoulder; Red, black and blue at injection site; Red, black and blue at injection site; Feeling funny around 10:30am; Arm is itchy; Temperature of 101 degrees F/temperature kept going up; Bad chills; Body aches; Headaches; Red, black and blue at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Arm is swollen / swollen from elbow to shoulder), VACCINATION SITE DISCOLORATION (Red, black and blue at injection site), VACCINATION SITE BRUISING (Red, black and blue at injection site), FEELING ABNORMAL (Feeling funny around 10:30am) and PYREXIA (Temperature of 101 degrees F/temperature kept going up) in an 81-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.     The patient's past medical history included Knee surgery NOS.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm is swollen / swollen from elbow to shoulder), VACCINATION SITE DISCOLORATION (Red, black and blue at injection site), VACCINATION SITE BRUISING (Red, black and blue at injection site), FEELING ABNORMAL (Feeling funny around 10:30am), PYREXIA (Temperature of 101 degrees F/temperature kept going up), CHILLS (Bad chills), MYALGIA (Body aches), HEADACHE (Headaches), PRURITUS (Arm is itchy) and INJECTION SITE ERYTHEMA (Red, black and blue at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm is swollen / swollen from elbow to shoulder), VACCINATION SITE DISCOLORATION (Red, black and blue at injection site), VACCINATION SITE BRUISING (Red, black and blue at injection site), FEELING ABNORMAL (Feeling funny around 10:30am), PYREXIA (Temperature of 101 degrees F/temperature kept going up), CHILLS (Bad chills), MYALGIA (Body aches) and HEADACHE (Headaches) had resolved and PRURITUS (Arm is itchy) and INJECTION SITE ERYTHEMA (Red, black and blue at injection site) had not resolved. Not Provided          Concomitant product use was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Vaccination site bruising, Vaccination site discolouration
Clinical narrative: Arm is swollen / swollen from elbow to shoulder; Red, black and blue at injection site; Red, black and blue at injection site; Feeling funny around 10:30am; Arm is itchy; Temperature of 101 degrees F/temperature kept going up; Bad chills; Body aches; Headaches; Red, black and blue at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Arm is swollen / swollen from elbow to shoulder), VACCINATION SITE DISCOLORATION (Red, black and blue at injection site), VACCINATION SITE BRUISING (Red, black and blue at injection site), FEELING ABNORMAL (Feeling funny around 10:30am) and PYREXIA (Temperature of 101 degrees F/temperature kept going up) in an 81-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.     The patient's past medical history included Knee surgery NOS.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm is swollen / swollen from elbow to shoulder), VACCINATION SITE DISCOLORATION (Red, black and blue at injection site), VACCINATION SITE BRUISING (Red, black and blue at injection site), FEELING ABNORMAL (Feeling funny around 10:30am), PYREXIA (Temperature of 101 degrees F/temperature kept going up), CHILLS (Bad chills), MYALGIA (Body aches), HEADACHE (Headaches), PRURITUS (Arm is itchy) and INJECTION SITE ERYTHEMA (Red, black and blue at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm is swollen / swollen from elbow to shoulder), VACCINATION SITE DISCOLORATION (Red, black and blue at injection site), VACCINATION SITE BRUISING (Red, black and blue at injection site), FEELING ABNORMAL (Feeling funny around 10:30am), PYREXIA (Temperature of 101 degrees F/temperature kept going up), CHILLS (Bad chills), MYALGIA (Body aches) and HEADACHE (Headaches) had resolved and PRURITUS (Arm is itchy) and INJECTION SITE ERYTHEMA (Red, black and blue at injection site) had not resolved. Not Provided          Concomitant product use was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: light headed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (light headed). At the time of the report, DIZZINESS (light headed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details were not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Low grade fever; Shivers; Achy; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever), CHILLS (Shivers) and MYALGIA (Achy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Low grade fever), CHILLS (Shivers) and MYALGIA (Achy). At the time of the report, PYREXIA (Low grade fever), CHILLS (Shivers) and MYALGIA (Achy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD21-072736 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: F/U received on 17-MAY-2021,Non significant follow up,Contact information updated (Email).; Sender's Comments:  MOD21-072736:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: sore arm; body aches; fever; chills; extreme headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (body aches), PYREXIA (fever), CHILLS (chills) and HEADACHE (extreme headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (body aches), PYREXIA (fever), CHILLS (chills) and HEADACHE (extreme headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (body aches), PYREXIA (fever), CHILLS (chills) and HEADACHE (extreme headache) had not resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-072980 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072980:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; chills; Fever; Extreme headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PAIN IN EXTREMITY (Sore arm), CHILLS (chills), PYREXIA (Fever) and HEADACHE (Extreme headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PAIN (Body aches), CHILLS (chills) and HEADACHE (Extreme headache). 08-Apr-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN (Body aches), PAIN IN EXTREMITY (Sore arm), CHILLS (chills), PYREXIA (Fever) and HEADACHE (Extreme headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medicines was not reported by reporter   treatment information was not provided   The action taken with mRNA-1273 with the events was considered as not applicable     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to US-MODERNATX, INC.-MOD-2021-072968 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072968:
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: chills; sore arm; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (sore arm), PYREXIA (fever) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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), MYALGIA (sore arm), PYREXIA (fever) and HEADACHE (headache). At the time of the report, CHILLS (chills), MYALGIA (sore arm), PYREXIA (fever) and HEADACHE (headache) outcome was unknown. Not Provided          No concomitant and treatment medication information was reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Herpes zoster, Pyrexia
Clinical narrative: SHingles on back and torso; temperature of 101 degrees; Loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles on back and torso), PYREXIA (temperature of 101 degrees) and DECREASED APPETITE (Loss of appetite) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced HERPES ZOSTER (SHingles on back and torso), PYREXIA (temperature of 101 degrees) and DECREASED APPETITE (Loss of appetite). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (SHingles on back and torso), PYREXIA (temperature of 101 degrees) and DECREASED APPETITE (Loss of appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include calamine lotion. No concomitant medication details was reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pain in extremity, Rash, Vaccination site mass
Clinical narrative: lump on left arm; arm sore and puffy; top left side of head feels funny; pink rash; mild headache; arm started hurting right away after shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump on left arm), PAIN IN EXTREMITY (arm sore and puffy), FEELING ABNORMAL (top left side of head feels funny), RASH (pink rash) and VACCINATION SITE PAIN (arm started hurting right away after shot) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm started hurting right away after shot). On 09-Apr-2021, the patient experienced VACCINATION SITE MASS (lump on left arm), PAIN IN EXTREMITY (arm sore and puffy), FEELING ABNORMAL (top left side of head feels funny), RASH (pink rash) and HEADACHE (mild headache). At the time of the report, VACCINATION SITE MASS (lump on left arm), PAIN IN EXTREMITY (arm sore and puffy), FEELING ABNORMAL (top left side of head feels funny), RASH (pink rash), VACCINATION SITE PAIN (arm started hurting right away after shot) and HEADACHE (mild headache) outcome was unknown.            No relevant Concomitant Medications were reported. No Treatment Information Provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-057714 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-057714:1st dose
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: lump on left arm; arm sore and puffy; top left side of head feels funny; pink rash; mild headache; arm started hurting right away after shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump on left arm), PAIN IN EXTREMITY (arm sore and puffy), FEELING ABNORMAL (top left side of head feels funny), RASH (pink rash) and VACCINATION SITE PAIN (arm started hurting right away after shot) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm started hurting right away after shot). On 09-Apr-2021, the patient experienced VACCINATION SITE MASS (lump on left arm), PAIN IN EXTREMITY (arm sore and puffy), FEELING ABNORMAL (top left side of head feels funny), RASH (pink rash) and HEADACHE (mild headache). At the time of the report, VACCINATION SITE MASS (lump on left arm), PAIN IN EXTREMITY (arm sore and puffy), FEELING ABNORMAL (top left side of head feels funny), RASH (pink rash), VACCINATION SITE PAIN (arm started hurting right away after shot) and HEADACHE (mild headache) outcome was unknown.            No relevant Concomitant Medications were reported. No Treatment Information Provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-057714 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-057714:1st dose
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: sore arm; Chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHILLS (Chills), PYREXIA (fever) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 PAIN IN EXTREMITY (sore arm), CHILLS (Chills), PYREXIA (fever) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), CHILLS (Chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.            The action taken with the drug was not applicable. Concomitant medications are not provided Treatment information does not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pain
Clinical narrative: yesterday itchy rash but not severe; The soreness at the injection site did not bother her at first; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (yesterday itchy rash but not severe) and VACCINATION SITE PAIN (The soreness at the injection site did not bother her at first) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE PAIN (The soreness at the injection site did not bother her at first). On 08-Apr-2021, the patient experienced PRURITUS (yesterday itchy rash but not severe). At the time of the report, PRURITUS (yesterday itchy rash but not severe) and VACCINATION SITE PAIN (The soreness at the injection site did not bother her at first) outcome was unknown.            No concomitant medications and treatment information were reported. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: red slightly raised rash from top of legs about 4-5 inches down; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red slightly raised rash from top of legs about 4-5 inches down) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced RASH ERYTHEMATOUS (red slightly raised rash from top of legs about 4-5 inches down). At the time of the report, RASH ERYTHEMATOUS (red slightly raised rash from top of legs about 4-5 inches down) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: reaction a week after receiving the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (reaction a week after receiving the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERSENSITIVITY (reaction a week after receiving the vaccine). At the time of the report, HYPERSENSITIVITY (reaction a week after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.No treatment information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: arm was a little warm around the injection site; arm was reddish around the injection site; arm was itchy around the injection site; arm was slightly swollen around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm was a little warm around the injection site), VACCINATION SITE ERYTHEMA (arm was reddish around the injection site), VACCINATION SITE PRURITUS (arm was itchy around the injection site) and VACCINATION SITE SWELLING (arm was slightly swollen around the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE WARMTH (arm was a little warm around the injection site), VACCINATION SITE ERYTHEMA (arm was reddish around the injection site), VACCINATION SITE PRURITUS (arm was itchy around the injection site) and VACCINATION SITE SWELLING (arm was slightly swollen around the injection site). At the time of the report, VACCINATION SITE WARMTH (arm was a little warm around the injection site), VACCINATION SITE ERYTHEMA (arm was reddish around the injection site), VACCINATION SITE PRURITUS (arm was itchy around the injection site) and VACCINATION SITE SWELLING (arm was slightly swollen around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported Treatment medications was not provided
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash macular, Vaccination site reaction
Clinical narrative: 2 big blotches; very Itchy; breakout on stomach above waist; Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), RASH (breakout on stomach above waist), RASH MACULAR (2 big blotches) and PRURITUS (very Itchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.  No Medical History information was reported.  On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), RASH (breakout on stomach above waist), RASH MACULAR (2 big blotches) and PRURITUS (very Itchy). The patient was treated with CORTISONE (topical) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Covid arm), RASH (breakout on stomach above waist), RASH MACULAR (2 big blotches) and PRURITUS (very Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. Treatment also includes Ice.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Crying, Eye pain, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in arm), PARAESTHESIA (tingling in arm), CHEST DISCOMFORT (muscle pull / tightness in her chest), EYE PAIN (pain in her right eye) and PAIN (achy) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced HYPOAESTHESIA (numbness in arm), PARAESTHESIA (tingling in arm), EYE PAIN (pain in her right eye), RASH (rash), HEADACHE (headache) and VACCINATION SITE PAIN (vaccination site pain). On 08-Apr-2021, the patient experienced CHEST DISCOMFORT (muscle pull / tightness in her chest), MYALGIA (body aches), PYREXIA (100.5 fever) and CHILLS (chills). On an unknown date, the patient experienced PAIN (achy), PAIN IN EXTREMITY (sore arm/achy limbs), CRYING (crying) and RASH (a big rash on her forehead). At the time of the report, HYPOAESTHESIA (numbness in arm), PARAESTHESIA (tingling in arm), CHEST DISCOMFORT (muscle pull / tightness in her chest), EYE PAIN (pain in her right eye), PAIN (achy), PAIN IN EXTREMITY (sore arm/achy limbs), CRYING (crying), RASH (a big rash on her forehead), RASH (rash), HEADACHE (headache), MYALGIA (body aches), PYREXIA (100.5 fever), CHILLS (chills) and VACCINATION SITE PAIN (vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Heart rate: (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.Treatment for the events included ice pack.    Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Follow-up information received on 09 Apr 2021. Added new events.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Hypoaesthesia, Myalgia, Pain, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in arm), PARAESTHESIA (tingling in arm), CHEST DISCOMFORT (muscle pull / tightness in her chest), EYE PAIN (pain in her right eye) and PAIN (achy) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced HYPOAESTHESIA (numbness in arm), PARAESTHESIA (tingling in arm), EYE PAIN (pain in her right eye), RASH (rash), HEADACHE (headache) and VACCINATION SITE PAIN (vaccination site pain). On 08-Apr-2021, the patient experienced CHEST DISCOMFORT (muscle pull / tightness in her chest), MYALGIA (body aches), PYREXIA (100.5 fever) and CHILLS (chills). On an unknown date, the patient experienced PAIN (achy), PAIN IN EXTREMITY (sore arm/achy limbs), CRYING (crying) and RASH (a big rash on her forehead). At the time of the report, HYPOAESTHESIA (numbness in arm), PARAESTHESIA (tingling in arm), CHEST DISCOMFORT (muscle pull / tightness in her chest), EYE PAIN (pain in her right eye), PAIN (achy), PAIN IN EXTREMITY (sore arm/achy limbs), CRYING (crying), RASH (a big rash on her forehead), RASH (rash), HEADACHE (headache), MYALGIA (body aches), PYREXIA (100.5 fever), CHILLS (chills) and VACCINATION SITE PAIN (vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Heart rate: (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.Treatment for the events included ice pack.    Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Follow-up information received on 09 Apr 2021. Added new events.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Rash, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in arm), PARAESTHESIA (tingling in arm), CHEST DISCOMFORT (muscle pull / tightness in her chest), EYE PAIN (pain in her right eye) and PAIN (achy) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced HYPOAESTHESIA (numbness in arm), PARAESTHESIA (tingling in arm), EYE PAIN (pain in her right eye), RASH (rash), HEADACHE (headache) and VACCINATION SITE PAIN (vaccination site pain). On 08-Apr-2021, the patient experienced CHEST DISCOMFORT (muscle pull / tightness in her chest), MYALGIA (body aches), PYREXIA (100.5 fever) and CHILLS (chills). On an unknown date, the patient experienced PAIN (achy), PAIN IN EXTREMITY (sore arm/achy limbs), CRYING (crying) and RASH (a big rash on her forehead). At the time of the report, HYPOAESTHESIA (numbness in arm), PARAESTHESIA (tingling in arm), CHEST DISCOMFORT (muscle pull / tightness in her chest), EYE PAIN (pain in her right eye), PAIN (achy), PAIN IN EXTREMITY (sore arm/achy limbs), CRYING (crying), RASH (a big rash on her forehead), RASH (rash), HEADACHE (headache), MYALGIA (body aches), PYREXIA (100.5 fever), CHILLS (chills) and VACCINATION SITE PAIN (vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Heart rate: (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.Treatment for the events included ice pack.    Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Follow-up information received on 09 Apr 2021. Added new events.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus
Clinical narrative: Itchy all over; Really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy all over) and HEADACHE (Really bad headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 at an unspecified dose. On an unknown date, the patient experienced PRURITUS (Itchy all over) and HEADACHE (Really bad headache). At the time of the report, PRURITUS (Itchy all over) had resolved and HEADACHE (Really bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-073015 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Fatigue, Hypertension, Illness
Clinical narrative: fatigue; had trouble getting her breath; blood pressure was all over the place; sick; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (had trouble getting her breath), HYPERTENSION (blood pressure was all over the place), ILLNESS (sick), NAUSEA (nausea) and FATIGUE (fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017821A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic kidney disease stage 4, Congestive heart failure and Drug allergy (allergy to pain killers).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced DYSPNOEA (had trouble getting her breath), HYPERTENSION (blood pressure was all over the place), ILLNESS (sick) and NAUSEA (nausea). On an unknown date, the patient experienced FATIGUE (fatigue). The patient was treated with FUROSEMIDE for Hypertension, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (had trouble getting her breath), HYPERTENSION (blood pressure was all over the place), ILLNESS (sick), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood pressure measurement: 265/210 (High) high.         No concomitant medications were reported.Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-073042 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: fatigue; had trouble getting her breath; blood pressure was all over the place; sick; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (had trouble getting her breath), HYPERTENSION (blood pressure was all over the place), ILLNESS (sick), NAUSEA (nausea) and FATIGUE (fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017821A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic kidney disease stage 4, Congestive heart failure and Drug allergy (allergy to pain killers).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced DYSPNOEA (had trouble getting her breath), HYPERTENSION (blood pressure was all over the place), ILLNESS (sick) and NAUSEA (nausea). On an unknown date, the patient experienced FATIGUE (fatigue). The patient was treated with FUROSEMIDE for Hypertension, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (had trouble getting her breath), HYPERTENSION (blood pressure was all over the place), ILLNESS (sick), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood pressure measurement: 265/210 (High) high.         No concomitant medications were reported.Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-073042 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Rash erythematous, Skin swelling
Clinical narrative: looked like sunburn; skin is bumpy; Reddish spots appeared at injection site; COVID Arm; red arm; swollen arm/bumpy arm; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID Arm), PAIN IN EXTREMITY (arm was sore), RASH ERYTHEMATOUS (looked like sunburn), SKIN SWELLING (skin is bumpy) and ERYTHEMA (red arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypercholesterolemia and Hypertension. Concomitant products included ATORVASTATIN for Hypercholesterolemia, METOPROLOL for Hypertension, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 07-Apr-2021, the patient experienced VACCINATION SITE REACTION (COVID Arm), ERYTHEMA (red arm) and PERIPHERAL SWELLING (swollen arm/bumpy arm). On an unknown date, the patient experienced RASH ERYTHEMATOUS (looked like sunburn), SKIN SWELLING (skin is bumpy) and VACCINATION SITE ERYTHEMA (Reddish spots appeared at injection site). On 14-Apr-2021, VACCINATION SITE REACTION (COVID Arm), ERYTHEMA (red arm) and PERIPHERAL SWELLING (swollen arm/bumpy arm) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was sore), RASH ERYTHEMATOUS (looked like sunburn), SKIN SWELLING (skin is bumpy) and VACCINATION SITE ERYTHEMA (Reddish spots appeared at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included ice packs several times a day.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Additional information received on 14-May-2021 added medical history, concomitant medications,new events and second dose details
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site reaction
Clinical narrative: looked like sunburn; skin is bumpy; Reddish spots appeared at injection site; COVID Arm; red arm; swollen arm/bumpy arm; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID Arm), PAIN IN EXTREMITY (arm was sore), RASH ERYTHEMATOUS (looked like sunburn), SKIN SWELLING (skin is bumpy) and ERYTHEMA (red arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypercholesterolemia and Hypertension. Concomitant products included ATORVASTATIN for Hypercholesterolemia, METOPROLOL for Hypertension, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 07-Apr-2021, the patient experienced VACCINATION SITE REACTION (COVID Arm), ERYTHEMA (red arm) and PERIPHERAL SWELLING (swollen arm/bumpy arm). On an unknown date, the patient experienced RASH ERYTHEMATOUS (looked like sunburn), SKIN SWELLING (skin is bumpy) and VACCINATION SITE ERYTHEMA (Reddish spots appeared at injection site). On 14-Apr-2021, VACCINATION SITE REACTION (COVID Arm), ERYTHEMA (red arm) and PERIPHERAL SWELLING (swollen arm/bumpy arm) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was sore), RASH ERYTHEMATOUS (looked like sunburn), SKIN SWELLING (skin is bumpy) and VACCINATION SITE ERYTHEMA (Reddish spots appeared at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included ice packs several times a day.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Additional information received on 14-May-2021 added medical history, concomitant medications,new events and second dose details
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Temperature of 101°F; Sore arm; Not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MALAISE (Not feeling well) and PYREXIA (Temperature of 101°F) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and MALAISE (Not feeling well). On an unknown date, the patient experienced PYREXIA (Temperature of 101°F). At the time of the report, PAIN IN EXTREMITY (Sore arm), MALAISE (Not feeling well) and PYREXIA (Temperature of 101°F) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Body temperature: 101°f (High) 101°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include migraine medication, No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in February 2021 and the estimated date of delivery was on an unknown date. On 30-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 30-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       she just found out last week that she was pregnant, and no prenatal care has been established. She currently does not have a doctor. Her last menstrual period was in Feb 2021, but she was not sure the day.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Eye pruritus, Lacrimation increased, Peripheral swelling, Rhinorrhoea
Clinical narrative: sneezing; runny nose; itchy eyes; watery eyes; Cough; wheezy; arm was hot; arm was swollen; skin has a stain from shot; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (sneezing), RHINORRHOEA (runny nose), EYE PRURITUS (itchy eyes), LACRIMATION INCREASED (watery eyes) and COUGH (Cough) in a 58-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.     The patient's past medical history included Asthma since an unknown date.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced SNEEZING (sneezing) and RHINORRHOEA (runny nose). an unknown date, the patient experienced EYE PRURITUS (itchy eyes), LACRIMATION INCREASED (watery eyes), COUGH (Cough), WHEEZING (wheezy), SENSITIVE SKIN (arm was hot), PERIPHERAL SWELLING (arm was swollen) and VACCINATION SITE ERYTHEMA (skin has a stain from shot). At the time of the report, SNEEZING (sneezing), RHINORRHOEA (runny nose), EYE PRURITUS (itchy eyes), LACRIMATION INCREASED (watery eyes), COUGH (Cough), WHEEZING (wheezy), SENSITIVE SKIN (arm was hot), PERIPHERAL SWELLING (arm was swollen) and VACCINATION SITE ERYTHEMA (skin has a stain from shot) 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.
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin, Sneezing, Vaccination site erythema, Wheezing
Clinical narrative: sneezing; runny nose; itchy eyes; watery eyes; Cough; wheezy; arm was hot; arm was swollen; skin has a stain from shot; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (sneezing), RHINORRHOEA (runny nose), EYE PRURITUS (itchy eyes), LACRIMATION INCREASED (watery eyes) and COUGH (Cough) in a 58-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.     The patient's past medical history included Asthma since an unknown date.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced SNEEZING (sneezing) and RHINORRHOEA (runny nose). an unknown date, the patient experienced EYE PRURITUS (itchy eyes), LACRIMATION INCREASED (watery eyes), COUGH (Cough), WHEEZING (wheezy), SENSITIVE SKIN (arm was hot), PERIPHERAL SWELLING (arm was swollen) and VACCINATION SITE ERYTHEMA (skin has a stain from shot). At the time of the report, SNEEZING (sneezing), RHINORRHOEA (runny nose), EYE PRURITUS (itchy eyes), LACRIMATION INCREASED (watery eyes), COUGH (Cough), WHEEZING (wheezy), SENSITIVE SKIN (arm was hot), PERIPHERAL SWELLING (arm was swollen) and VACCINATION SITE ERYTHEMA (skin has a stain from shot) 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.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Fatigue, Pain of skin, Skin mass
Clinical narrative: bump on the back of calf; Bump is painful; bump is red; Tiredness; Diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea), SKIN MASS (bump on the back of calf), PAIN OF SKIN (Bump is painful), ERYTHEMA (bump is red) and FATIGUE (Tiredness) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Congestive heart failure (on blood thinners).   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced DIARRHOEA (Diarrhoea) and FATIGUE (Tiredness). On 08-Apr-2021, the patient experienced SKIN MASS (bump on the back of calf), PAIN OF SKIN (Bump is painful) and ERYTHEMA (bump is red). At the time of the report, DIARRHOEA (Diarrhoea) and FATIGUE (Tiredness) had not resolved and SKIN MASS (bump on the back of calf), PAIN OF SKIN (Bump is painful) and ERYTHEMA (bump is red) outcome was unknown.            The patient was also concerned about it being a blood clot as she has congestive heart failure and was on blood thinners.Action taken with mRNA-1273 in response to the events was not applicable.No treatment information was provided.