chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Decreased appetite, Fatigue, Pain
Clinical narrative: Violent chills after 1st dose; Fever after 1st dose; Shaking after 1st dose; Whole body hurts after 1st dose; No appetite after 1st dose; Armpits hurt after 1st dose; Slightly sore arm after 1st dose; Very tired after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Slightly sore arm after 1st dose), FATIGUE (Very tired after 1st dose), CHILLS (Violent chills after 1st dose), PYREXIA (Fever after 1st dose) and TREMOR (Shaking after 1st dose) in a 68-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.     No Medical History information was reported.    On 11-Mar-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Slightly sore arm after 1st dose) and FATIGUE (Very tired after 1st dose). On an unknown date, the patient experienced CHILLS (Violent chills after 1st dose), PYREXIA (Fever after 1st dose), TREMOR (Shaking after 1st dose), PAIN (Whole body hurts after 1st dose), DECREASED APPETITE (No appetite after 1st dose) and AXILLARY PAIN (Armpits hurt after 1st dose). At the time of the report, PAIN IN EXTREMITY (Slightly sore arm after 1st dose), FATIGUE (Very tired after 1st dose), CHILLS (Violent chills after 1st dose), PYREXIA (Fever after 1st dose), TREMOR (Shaking after 1st dose), PAIN (Whole body hurts after 1st dose), DECREASED APPETITE (No appetite after 1st dose) and AXILLARY PAIN (Armpits hurt after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2019, SARS-CoV-2 test positive: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No Treatments were reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 test positive, Tremor
Clinical narrative: Violent chills after 1st dose; Fever after 1st dose; Shaking after 1st dose; Whole body hurts after 1st dose; No appetite after 1st dose; Armpits hurt after 1st dose; Slightly sore arm after 1st dose; Very tired after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Slightly sore arm after 1st dose), FATIGUE (Very tired after 1st dose), CHILLS (Violent chills after 1st dose), PYREXIA (Fever after 1st dose) and TREMOR (Shaking after 1st dose) in a 68-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.     No Medical History information was reported.    On 11-Mar-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Slightly sore arm after 1st dose) and FATIGUE (Very tired after 1st dose). On an unknown date, the patient experienced CHILLS (Violent chills after 1st dose), PYREXIA (Fever after 1st dose), TREMOR (Shaking after 1st dose), PAIN (Whole body hurts after 1st dose), DECREASED APPETITE (No appetite after 1st dose) and AXILLARY PAIN (Armpits hurt after 1st dose). At the time of the report, PAIN IN EXTREMITY (Slightly sore arm after 1st dose), FATIGUE (Very tired after 1st dose), CHILLS (Violent chills after 1st dose), PYREXIA (Fever after 1st dose), TREMOR (Shaking after 1st dose), PAIN (Whole body hurts after 1st dose), DECREASED APPETITE (No appetite after 1st dose) and AXILLARY PAIN (Armpits hurt after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2019, SARS-CoV-2 test positive: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No Treatments were reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: chills; Low grade fever; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (chills), PYREXIA (Low grade fever) and FATIGUE (fatigue) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Mar-2021, the patient experienced HEADACHE (headache). On 11-Mar-2021, the patient experienced CHILLS (chills), PYREXIA (Low grade fever) and FATIGUE (fatigue). At the time of the report, HEADACHE (headache), CHILLS (chills), PYREXIA (Low grade fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-045117 (Linked Report).; Sender's Comments:  MOD-2021-045117:Wife case
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 years old received 1st dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old received 1st dose of the vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) 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 03-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old received 1st dose of the vaccine). On 03-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old received 1st dose of the vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number 012M20A) with no associated AEs reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: Positive for COVID-19; A little achy; Tired; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), SARS-COV-2 TEST POSITIVE (Positive for COVID-19), PAIN (A little achy) and FATIGUE (Tired) in a 73-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 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), PAIN (A little achy) and FATIGUE (Tired). On 08-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive for COVID-19). On 25-Feb-2021, PAIN IN EXTREMITY (Arm soreness) had resolved. On 27-Feb-2021, PAIN (A little achy) and FATIGUE (Tired) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (Positive for COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD21-054524 (E2B Linked Report). This case was linked to MOD-2021-046345 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2021: Follow-up information received on 15-Mar-2021 included no new information.; Sender's Comments:  MOD21-054524:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever; chills; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (chills) and MYALGIA (muscle aches) 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 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (chills) and MYALGIA (muscle aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 14-Mar-2021, MYALGIA (muscle aches) had resolved. At the time of the report, PYREXIA (Fever) and CHILLS (chills) had not resolved. Not Provided          No relevant concomitant medications were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Itch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itch at injection site) 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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itch at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itch at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow-up received and contains no new information.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Back pain, Myalgia, Pain in extremity
Clinical narrative: From shoulder to arm and on upper leg; Sometimes back would hurt; Concerned; has a pull like something is "pulling" her muscles on opposite arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (has a pull like something is "pulling" her muscles on opposite arm of the injection), PAIN IN EXTREMITY (From shoulder to arm and on upper leg), BACK PAIN (Sometimes back would hurt) and ANXIETY (Concerned) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced MYALGIA (has a pull like something is "pulling" her muscles on opposite arm of the injection), PAIN IN EXTREMITY (From shoulder to arm and on upper leg), BACK PAIN (Sometimes back would hurt) and ANXIETY (Concerned). At the time of the report, MYALGIA (has a pull like something is "pulling" her muscles on opposite arm of the injection), PAIN IN EXTREMITY (From shoulder to arm and on upper leg), BACK PAIN (Sometimes back would hurt) and ANXIETY (Concerned) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue
Clinical narrative: Severe shortness of breath and has been progressively worse/walked outside to take the trash out, about 50feet from the door and was huffing and puffing; The fatigue is really bad; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Severe shortness of breath and has been progressively worse/walked outside to take the trash out, about 50feet from the door and was huffing and puffing) and FATIGUE (The fatigue is really bad) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced DYSPNOEA (Severe shortness of breath and has been progressively worse/walked outside to take the trash out, about 50feet from the door and was huffing and puffing) and FATIGUE (The fatigue is really bad). At the time of the report, DYSPNOEA (Severe shortness of breath and has been progressively worse/walked outside to take the trash out, about 50feet from the door and was huffing and puffing) and FATIGUE (The fatigue is really bad) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient has undergone countless blood test, x-rays, pulmonary function test, cardiac catherization test. patient used cpap machine and it still doesn't help.  Concomitant medications were not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Event outcome is updated
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Myalgia
Clinical narrative: fogginess; headache; muscle ache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (muscle ache), FATIGUE (fatigue) and FEELING ABNORMAL (fogginess) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HEADACHE (headache), MYALGIA (muscle ache), FATIGUE (fatigue) and FEELING ABNORMAL (fogginess). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, HEADACHE (headache), MYALGIA (muscle ache), FATIGUE (fatigue) and FEELING ABNORMAL (fogginess) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 15 March the symptoms diminished but are still present off and on.   No concomitant medications were reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Fatigue, Vaccination site pain
Clinical narrative: Became pregnant; Tired and lazy; Pain in left arm for 2 days after vaccination; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Became pregnant), FATIGUE (Tired and lazy) and VACCINATION SITE PAIN (Pain in left arm for 2 days after vaccination) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Q11A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Feb-2021 and the estimated date of delivery was 12-Nov-2021. On 26-Feb-2021, the patient experienced FATIGUE (Tired and lazy) and VACCINATION SITE PAIN (Pain in left arm for 2 days after vaccination). On 13-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Became pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 28-Feb-2021, VACCINATION SITE PAIN (Pain in left arm for 2 days after vaccination) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (Became pregnant) and FATIGUE (Tired and lazy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter.; Sender's Comments: This is a case of product exposure during pregnancy for this female patient who experienced tired and lazy and pain in the left arm. 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. The patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Heart rate, Nausea, Oxygen saturation, Respiratory rate
Clinical narrative: warm face; Nausea/vomiting; Nausea/vomiting; Chills; tachycardia; This spontaneous case was reported by a nurse and describes the occurrence of TACHYCARDIA (tachycardia), NAUSEA (Nausea/vomiting), SKIN WARM (warm face), VOMITING (Nausea/vomiting) and CHILLS (Chills) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced TACHYCARDIA (tachycardia), NAUSEA (Nausea/vomiting), VOMITING (Nausea/vomiting) and CHILLS (Chills). On an unknown date, the patient experienced SKIN WARM (warm face). At the time of the report, TACHYCARDIA (tachycardia), NAUSEA (Nausea/vomiting), SKIN WARM (warm face), VOMITING (Nausea/vomiting) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Heart rate: 115-120 (High) 115-120. On 14-Mar-2021, Oxygen saturation: 98 percent (Inconclusive) 98%. On 14-Mar-2021, Respiratory rate: 16 (Inconclusive) 16.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was monitored for 30 minutes by the onsite nurse.  No concomitant medications were reported.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: This follow-up was received on 24-MAY-2021 which updated historical condition, lab data, dosage details and new events.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Skin warm, Tachycardia, Vomiting
Clinical narrative: warm face; Nausea/vomiting; Nausea/vomiting; Chills; tachycardia; This spontaneous case was reported by a nurse and describes the occurrence of TACHYCARDIA (tachycardia), NAUSEA (Nausea/vomiting), SKIN WARM (warm face), VOMITING (Nausea/vomiting) and CHILLS (Chills) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced TACHYCARDIA (tachycardia), NAUSEA (Nausea/vomiting), VOMITING (Nausea/vomiting) and CHILLS (Chills). On an unknown date, the patient experienced SKIN WARM (warm face). At the time of the report, TACHYCARDIA (tachycardia), NAUSEA (Nausea/vomiting), SKIN WARM (warm face), VOMITING (Nausea/vomiting) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Heart rate: 115-120 (High) 115-120. On 14-Mar-2021, Oxygen saturation: 98 percent (Inconclusive) 98%. On 14-Mar-2021, Respiratory rate: 16 (Inconclusive) 16.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was monitored for 30 minutes by the onsite nurse.  No concomitant medications were reported.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: This follow-up was received on 24-MAY-2021 which updated historical condition, lab data, dosage details and new events.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: "Kicked her ass" after the second dose; Felt nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE ("Kicked her ass" after the second dose) and NAUSEA (Felt nausea) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE ("Kicked her ass" after the second dose) and NAUSEA (Felt nausea). At the time of the report, MALAISE ("Kicked her ass" after the second dose) and NAUSEA (Felt nausea) outcome was unknown.            Concomitant product details was not provided by the reporter.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: TCR Received : Contains No New Information
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product used was not provided by the reporter.  Treatment information was not reported.   Reporter did not allow further contact
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain
Clinical narrative: vaccination site pain; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Mar-2021 and was forwarded to Moderna on 15-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain) and CHILLS (Chills) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 31-Mar-2020, Neuropathy (Patient  was hospitalized.) on 31-Mar-2020 and Hospitalization. Concurrent medical conditions included Lung disorder NOS since 31-Mar-2020.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain) and CHILLS (Chills). At the time of the report, VACCINATION SITE PAIN (vaccination site pain) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Other relevant concomitant medication was reported as treatment for lung damage.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up information received on 13 Jul- 021 contains non-significant information.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 10-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: past 42 day mark for her first vaccine; A spontaneous report was received from a consumer concerning herself ,female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced missed dose.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 037A20A) on 28 Jan 2021 for the prophylaxis of COVID-19 infection.   The patient had past 42 day mark for her first vaccination and had missed the second dose.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event(s) was unknown.  The outcome of the event missed dose was unknown.; Reporter's Comments: This report refers to a case of Product dose omission issue(missed second dose) for mRNA-1273, lot # 037A20A  with no associated Adverse Events.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: arm itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm itching) 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, the patient experienced PRURITUS (arm itching). At the time of the report, PRURITUS (arm itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25 May 2021 and contains no new information
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported.   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash, Vaccination site reaction
Clinical narrative: COVID arm; itching; redness; swelling in arm; larger rash on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), PRURITUS (itching), ERYTHEMA (redness), PERIPHERAL SWELLING (swelling in arm) and RASH (larger rash on arm) in a 62-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 06-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 VACCINATION SITE REACTION (COVID arm), PRURITUS (itching), ERYTHEMA (redness), PERIPHERAL SWELLING (swelling in arm) and RASH (larger rash on arm). At the time of the report, VACCINATION SITE REACTION (COVID arm) had resolved and PRURITUS (itching), ERYTHEMA (redness), PERIPHERAL SWELLING (swelling in arm) and RASH (larger rash on arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment included topical steroid NOS.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Had a severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Had a severe headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Had a severe headache). At the time of the report, HEADACHE (Had a severe headache) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: warm to touch; arm itchy; arm red, redness got bigger and extended down to elbow; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm itchy), ERYTHEMA (arm red, redness got bigger and extended down to elbow) and FEELING HOT (warm to touch) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0C1A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PRURITUS (arm itchy) and ERYTHEMA (arm red, redness got bigger and extended down to elbow). On 15-Mar-2021, the patient experienced FEELING HOT (warm to touch). At the time of the report, PRURITUS (arm itchy), ERYTHEMA (arm red, redness got bigger and extended down to elbow) and FEELING HOT (warm to touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.   Patient was prescribed an unspecified steroid and antihistamine for the treatment of the events.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Herpes zoster
Clinical narrative: Broke out in shingles; Body aches; Chills; Headache; Joint aches; Real fatigue; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Broke out in shingles), PAIN IN EXTREMITY (Sore Arm), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 25-Feb-2021, the patient experienced MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Joint aches) and FATIGUE (Real fatigue). On 28-Feb-2021, the patient experienced HERPES ZOSTER (Broke out in shingles). At the time of the report, HERPES ZOSTER (Broke out in shingles), PAIN IN EXTREMITY (Sore Arm), MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Joint aches) and FATIGUE (Real fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Broke out in shingles; Body aches; Chills; Headache; Joint aches; Real fatigue; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Broke out in shingles), PAIN IN EXTREMITY (Sore Arm), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 25-Feb-2021, the patient experienced MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Joint aches) and FATIGUE (Real fatigue). On 28-Feb-2021, the patient experienced HERPES ZOSTER (Broke out in shingles). At the time of the report, HERPES ZOSTER (Broke out in shingles), PAIN IN EXTREMITY (Sore Arm), MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Joint aches) and FATIGUE (Real fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Some redness at the injection site after the 2nd dose; A spontaneous report  was received from a consumer concerning a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events some redness at the injection site after the 2nd dose/ vaccination site erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: not have the card) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event some redness at the injection site after the 2nd dose.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.  The outcome of event, some redness at the injection site after the 2nd dose was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Incorrect dose administered
Clinical narrative: Big blue bruise; Did not receive the full second dose/warm fluid running down her arm; A spontaneous report (United States), was received from a consumer (patient), concerning herself, a 69 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced big blue bruise (contusion) and did not receive the full second dose/warm fluid running down her arm (incorrect dose administration).   The patient's medical history was not provided. Concomitant medications were ibuprofen and cefixime.  On 13 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch N0: 011M201A), intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 13 Mar 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Batch N0: 048A21A) intramuscularly in the right arm for prophylaxis of COBID-19 infection.  On 13 Mar 2021, same day, the patient noticed that warm fluid was running down her arm. The person giving the injection soaked it up with a cotton swab and told her that she was okay. The patient was concerned that she didn't receive the full second dose as her arm was not sore this time, although it did have a big blue bruise. The patient went to a pharmacy and asked someone about it and was told that maybe they didn't hit her muscle but rather hit below the muscle. Treatment information not provided.  Action taken with second dose of mRNA-1273 in response to the events was not applicable.   The outcome of event, big blue bruise was not reported and that of event, did not receive the full second dose/warm fluid running down her arm was considered as resolved on 13 Mar 2021.; Reporter's Comments: This case concerns a 69 years-old female patient who was experienced did not receive the full second dose/warm fluid running down her arm (incomplete dose administration) mRNA-1273 (Batch #; 048A21A) and experienced big blue bruise.  Based on temporal association, a causal association between the event if big bruise and product use cannot be excluded.  The event of incomplete dose administered is considered not applicable.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema
Clinical narrative: Feels feverish; Redness at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Feels feverish) and VACCINATION SITE ERYTHEMA (Redness at site of injection) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Feels feverish) and VACCINATION SITE ERYTHEMA (Redness at site of injection). At the time of the report, PYREXIA (Feels feverish) and VACCINATION SITE ERYTHEMA (Redness at site of injection) outcome was unknown.            No concomitant medications were reported.  The patient had not yet undergone any treatment for the events.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in her 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in her arm). At the time of the report, PAIN IN EXTREMITY (Pain in her arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Eye symptom
Clinical narrative: Eye reactions; This spontaneous case was reported by a consumer and describes the occurrence of EYE SYMPTOM (Eye reactions) 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 EYE SYMPTOM (Eye reactions). At the time of the report, EYE SYMPTOM (Eye reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were reported. Concomitant product use was not provided by the reporter.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Fall, Fatigue
Clinical narrative: Fell on left side; Joint and hips ache; Tired; Overall weakness; Couldn't walk; Legs were like jello; Legs were like rubber; Achy; Felt unwell; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Overall weakness), FALL (Fell on left side), GAIT DISTURBANCE (Couldn't walk), FEELING ABNORMAL (Legs were like jello) and RESTLESS LEGS SYNDROME (Legs were like rubber) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 05-Nov-2020 and Throat cancer (patient was on a feeding tube following cancer surgery).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ASTHENIA (Overall weakness), GAIT DISTURBANCE (Couldn't walk), FEELING ABNORMAL (Legs were like jello), RESTLESS LEGS SYNDROME (Legs were like rubber), PAIN (Achy), MALAISE (Felt unwell) and FATIGUE (Tired). On 15-Mar-2021, the patient experienced ARTHRALGIA (Joint and hips ache). On an unknown date, the patient experienced FALL (Fell on left side). The patient was treated with PARACETAMOL (TYLENOL) for Body temperature increased, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Overall weakness), FALL (Fell on left side), GAIT DISTURBANCE (Couldn't walk), FEELING ABNORMAL (Legs were like jello), RESTLESS LEGS SYNDROME (Legs were like rubber), PAIN (Achy), MALAISE (Felt unwell), ARTHRALGIA (Joint and hips ache) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 101.8 101.8 degree Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Malaise, Pain, Restless legs syndrome
Clinical narrative: Fell on left side; Joint and hips ache; Tired; Overall weakness; Couldn't walk; Legs were like jello; Legs were like rubber; Achy; Felt unwell; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Overall weakness), FALL (Fell on left side), GAIT DISTURBANCE (Couldn't walk), FEELING ABNORMAL (Legs were like jello) and RESTLESS LEGS SYNDROME (Legs were like rubber) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 05-Nov-2020 and Throat cancer (patient was on a feeding tube following cancer surgery).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ASTHENIA (Overall weakness), GAIT DISTURBANCE (Couldn't walk), FEELING ABNORMAL (Legs were like jello), RESTLESS LEGS SYNDROME (Legs were like rubber), PAIN (Achy), MALAISE (Felt unwell) and FATIGUE (Tired). On 15-Mar-2021, the patient experienced ARTHRALGIA (Joint and hips ache). On an unknown date, the patient experienced FALL (Fell on left side). The patient was treated with PARACETAMOL (TYLENOL) for Body temperature increased, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Overall weakness), FALL (Fell on left side), GAIT DISTURBANCE (Couldn't walk), FEELING ABNORMAL (Legs were like jello), RESTLESS LEGS SYNDROME (Legs were like rubber), PAIN (Achy), MALAISE (Felt unwell), ARTHRALGIA (Joint and hips ache) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 101.8 101.8 degree Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral nerve neurostimulation, Pruritus, Rash, Skin mass
Clinical narrative: it felt like her nerve endings in her arms and legs were pulsating; Hard lumps; Hard lumps and very bumpy feel and also extremely itchy; Painful Rash; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL NERVE NEUROSTIMULATION (it felt like her nerve endings in her arms and legs were pulsating), SKIN MASS (Hard lumps), PRURITUS (Hard lumps and very bumpy feel and also extremely itchy) and RASH (Painful Rash) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Painful Rash). On an unknown date, the patient experienced PERIPHERAL NERVE NEUROSTIMULATION (it felt like her nerve endings in her arms and legs were pulsating), SKIN MASS (Hard lumps) and PRURITUS (Hard lumps and very bumpy feel and also extremely itchy). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, PERIPHERAL NERVE NEUROSTIMULATION (it felt like her nerve endings in her arms and legs were pulsating), SKIN MASS (Hard lumps) and PRURITUS (Hard lumps and very bumpy feel and also extremely itchy) outcome was unknown and RASH (Painful Rash) was resolving.            Concomitant product use was not provided by the reporter.  The patient experienced arms and legs felt like gravel roads, there were Hard lumps and very bumpy feel. The rash was extremely painful as well and it felt like her nerve endings in arms and legs were pulsating.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.