chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Dizziness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and HEADACHE (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 medical history 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 DIZZINESS (Dizziness) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.  Based on MSA comment, events Listedness for USPI is incorrect and should be changed to "Unknown".
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Rash grew largest, double in size - 6 inches diameter; Injection site that was a little itchy; Little pink mark at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site that was a little itchy), VACCINATION SITE ERYTHEMA (Little pink mark at the injection site) and VACCINATION SITE RASH (Rash grew largest, double in size - 6 inches diameter) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SIMVASTATIN, CALCIUM, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D), ACETYLSALICYLIC ACID (BABY ASPIRIN), ASCORBIC ACID (VIT C) and FISH OIL for an unknown indication.   On 10-Feb-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) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site that was a little itchy) and VACCINATION SITE ERYTHEMA (Little pink mark at the injection site). On 14-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash grew largest, double in size - 6 inches diameter). The patient was treated with PARACETAMOL (TYLENOL) for Rash, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PRURITUS (Injection site that was a little itchy), VACCINATION SITE ERYTHEMA (Little pink mark at the injection site) and VACCINATION SITE RASH (Rash grew largest, double in size - 6 inches diameter) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: Patient reported on last page of ADR form "All is well". Outcome of the events updated.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dysphagia, Throat tightness
Clinical narrative: Throat was very tight; Couldn't really swallow; Chest felt tight; A spontaneous report was received from a consumer concerning herself, a 81-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced throat was tight/throat tightness, couldn't really swallow/dysphagia and chest felt tight/chest discomfort.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Feb 2021, approximately 5 days prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 016M20A) Intramuscularly for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced throat was tight, couldn't really swallow and chest felt tight. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, throat was tight, couldn't really swallow and chest felt tight was unknown at the time of this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness of Left side of face around pre-molar area; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (Numbness of Left side of face around pre-molar area) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 030M20N) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy, Cholesterol (Slight cholesterol) and Salmonella since November 2008. Concomitant products included ROSUVASTATIN from 2008 to an unknown date for Cholesterol, DICYCLOMINE [DICYCLOVERINE] from 2012 to an unknown date for Salmonella, MAGNESIUM from 1976 to an unknown date and VITIS VINIFERA SEED (GRAPE SEED EXTRACT [VITIS VINIFERA SEED]) from 1976 to an unknown date for Supplementation therapy.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced HYPOAESTHESIA (Numbness of Left side of face around pre-molar area). At the time of the report, HYPOAESTHESIA (Numbness of Left side of face around pre-molar area) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   other concomitant included fish oil 1000 mg for an unknown indication. Treatment medications were not provided by reporter. Action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: The reporter's contact information was updated (e-mail Address was added). On 08-Jun-2021: Added Patient's demographics, medical history, concomitant medications.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: arm hurt; everything hurt; dizziness; Headache; fever; bone ache; wanted to vomit; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (arm hurt), MYALGIA (everything hurt), DIZZINESS (dizziness), HEADACHE (Headache) and PYREXIA (fever) 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.     No Medical History information was reported.    In January 2021, 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 (arm hurt), MYALGIA (everything hurt), DIZZINESS (dizziness), HEADACHE (Headache), PYREXIA (fever), BONE PAIN (bone ache) and NAUSEA (wanted to vomit). At the time of the report, PAIN IN EXTREMITY (arm hurt), MYALGIA (everything hurt), DIZZINESS (dizziness), HEADACHE (Headache), PYREXIA (fever), BONE PAIN (bone ache) and NAUSEA (wanted to vomit) had resolved.        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.   The patient  had symptoms like COVID (headache, fever, bone ache, dizziness, wanted to vomit, everything hurt) and it lasted only one day. The patient's arm  hurt for about a week.  No relevant concomitant medications were reported.  Treatment information was not provided.  Based on HA comment, all events ("Unknown" should be captured).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: arm hurt; everything hurt; dizziness; Headache; fever; bone ache; wanted to vomit; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (arm hurt), MYALGIA (everything hurt), DIZZINESS (dizziness), HEADACHE (Headache) and PYREXIA (fever) 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.     No Medical History information was reported.    In January 2021, 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 (arm hurt), MYALGIA (everything hurt), DIZZINESS (dizziness), HEADACHE (Headache), PYREXIA (fever), BONE PAIN (bone ache) and NAUSEA (wanted to vomit). At the time of the report, PAIN IN EXTREMITY (arm hurt), MYALGIA (everything hurt), DIZZINESS (dizziness), HEADACHE (Headache), PYREXIA (fever), BONE PAIN (bone ache) and NAUSEA (wanted to vomit) had resolved.        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.   The patient  had symptoms like COVID (headache, fever, bone ache, dizziness, wanted to vomit, everything hurt) and it lasted only one day. The patient's arm  hurt for about a week.  No relevant concomitant medications were reported.  Treatment information was not provided.  Based on HA comment, all events ("Unknown" should be captured).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: fatigue; low grade fever; headache; body aches; A spontaneous report was received from a type concerning a 51-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events low grade fever/pyrexia, headache, body aches/pain, fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) low grade fever, headache, body aches, fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), low grade fever, headache, body aches, fatigue was unknown.; Sender's Comments:  MOD-2021-029308:Mother case
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Had Covid after first shot; A spontaneous report was received from a reporter like a pharmacist concerning a 61 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and reported events like had Covid after first shot/ Covid-19. The patient's medical history was not provided. Concomitant medications were not provided. On an unknown date, prior to the onset of the events, the patient received first of the two planned doses of mRNA-1273(lot/batch: unknown) intramuscularly in the anatomical position for prophylaxis of COVID-19 infection. On an unknown date, the patient reported of experiencing Covid which was a mild case. Laboratory details were not provided. Treatment information was not provided. The outcome of the event of Covid was resolved. Action taken with mRNA-1273 in response to the events was unknown. At the time of this report, the outcome of the event was resolved.; Sender's Comments:  MOD21-025601: US-MODERNATX, INC.-MOD-2021-029217:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Myalgia, Peripheral swelling, Pruritus, Rash erythematous
Clinical narrative: the rash became pink but it still itched and each day it fades a little bit; severe lower back pain; red rash on the arm that was slightly swollen, itchy and warm to the touch; swellen; sore arm; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, red rash on the arm that was slightly swollen, itchy and warm to the touch, severe lower back pain, the rash became pink but it still itched and each day it fades a little bit.  The patient's medical history was not provided. Concomitant medications reported were Armour Thyroid for drug use for unknown indication.  On 4 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the event(s) sore arm . On 11 Feb 2021, the patient experienced the event(s) red rash on the arm that was slightly swollen . On 11 Feb 2021, the patient experienced the event(s) itchy and warm to the touch . On 12 Feb 2021, the patient experienced the event(s) severe lower back pain . On 15 Feb 2021, the patient experienced the event(s) the rash became pink but it still itched and each day it fades a little bit.  Treatment details included, mRNA-1273 mRNA-1273 Adverse Event Not Applicable.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event(s), sore arm was unknown.The outcome of event(s), red rash on the arm that was slightly swollen was unknown.The outcome of event(s), itchy and warm to the touch was unknown.The outcome of event(s), severe lower back pain was unknown.The outcome of event(s), the rash became pink but it still itched and each day it fades a little bit was unknown..
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional dose omission, Tremor, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: intentionally missed dose; Arm itches; Very swollen; Arm is still red and hot; Very hot; Shaking uncontrollably; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (Shaking uncontrollably), VACCINATION SITE WARMTH (Very hot), INTENTIONAL DOSE OMISSION (intentionally missed dose), VACCINATION SITE PRURITUS (Arm itches) and VACCINATION SITE SWELLING (Very swollen) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Nausea since 06-Jan-2020, Diarrhea since 06-Jan-2020, Vomiting since 06-Jan-2020 and Upset stomach since 06-Jan-2020. Concomitant products included BIFIDOBACTERIUM INFANTIS (ALIGN) from 11-Mar-2021 to an unknown date for Stomach pain, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) from 11-Mar-2021 to an unknown date for Vitamin D deficiency.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced TREMOR (Shaking uncontrollably). On 14-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Very hot), VACCINATION SITE PRURITUS (Arm itches), VACCINATION SITE SWELLING (Very swollen) and VACCINATION SITE ERYTHEMA (Arm is still red and hot). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (intentionally missed dose). The patient was treated with LORAZEPAM (ATIVAN) for Adverse event, at a dose of .25 milligram. At the time of the report, TREMOR (Shaking uncontrollably), VACCINATION SITE WARMTH (Very hot), INTENTIONAL DOSE OMISSION (intentionally missed dose), VACCINATION SITE PRURITUS (Arm itches), VACCINATION SITE SWELLING (Very swollen) and VACCINATION SITE ERYTHEMA (Arm is still red and hot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: intentionally missed dose; Arm itches; Very swollen; Arm is still red and hot; Very hot; Shaking uncontrollably; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (Shaking uncontrollably), VACCINATION SITE WARMTH (Very hot), INTENTIONAL DOSE OMISSION (intentionally missed dose), VACCINATION SITE PRURITUS (Arm itches) and VACCINATION SITE SWELLING (Very swollen) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Nausea since 06-Jan-2020, Diarrhea since 06-Jan-2020, Vomiting since 06-Jan-2020 and Upset stomach since 06-Jan-2020. Concomitant products included BIFIDOBACTERIUM INFANTIS (ALIGN) from 11-Mar-2021 to an unknown date for Stomach pain, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) from 11-Mar-2021 to an unknown date for Vitamin D deficiency.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced TREMOR (Shaking uncontrollably). On 14-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Very hot), VACCINATION SITE PRURITUS (Arm itches), VACCINATION SITE SWELLING (Very swollen) and VACCINATION SITE ERYTHEMA (Arm is still red and hot). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (intentionally missed dose). The patient was treated with LORAZEPAM (ATIVAN) for Adverse event, at a dose of .25 milligram. At the time of the report, TREMOR (Shaking uncontrollably), VACCINATION SITE WARMTH (Very hot), INTENTIONAL DOSE OMISSION (intentionally missed dose), VACCINATION SITE PRURITUS (Arm itches), VACCINATION SITE SWELLING (Very swollen) and VACCINATION SITE ERYTHEMA (Arm is still red and hot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Muscle swelling, Muscle tightness, Myalgia
Clinical narrative: redness; more tighter; swollen; tender; A spontaneous report  was received from a healthcare professional concerning a 76-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness/erythema, more tighter, swollen/muscle swelling/muscle swollen, tender/myalgia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028720A) intramuscularly for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) redness, more tighter, swollen, tender.  Treatment details included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), redness, more tighter, swollen, tender was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot
Clinical narrative: raised red hot area on arm; raised red hot area on arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (raised red hot area on arm) and FEELING HOT (raised red hot area on arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced ERYTHEMA (raised red hot area on arm) and FEELING HOT (raised red hot area on arm). On 05-Feb-2021, ERYTHEMA (raised red hot area on arm) and FEELING HOT (raised red hot area on arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.     Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Email information added
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain after getting the vaccine) 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 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain after getting the vaccine). At the time of the report, PAIN (Pain after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment medication details not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received. Reporter address updated.
Sex: M
Vaccine: COVID19
Symptoms: Muscle disorder
Clinical narrative: Complete loss of muscular control; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced complete loss of muscular control.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03-Feb-2021, prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 04-Feb-2021, next day after receiving the vaccine, the patient developed a complete loss of muscular control which lasted for eighteen hours. On 5-Feb-2021, forty-eight hours post-vaccination, the patient became fully functional.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable.  The event of complete loss of muscular control was resolved on 05-Feb-2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Vaccination site pain
Clinical narrative: Soreness at injection site; tingling of the tongue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site) and PARAESTHESIA ORAL (tingling of the tongue) in an 83-year-old female patient 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 VACCINATION SITE PAIN (Soreness at injection site) and PARAESTHESIA ORAL (tingling of the tongue). At the time of the report, VACCINATION SITE PAIN (Soreness at injection site) and PARAESTHESIA ORAL (tingling of the tongue) 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 provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Warmness at the injection site; Severe Fatigue; Redness at the injection site; Fever of 103-104°C; A spontaneous report was received from a consumer concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe fatigue, redness at the injection site, warmness at the injection site, fever of 103-104â°c.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the event(s) severe fatigue . On 14 Feb 2021, the patient experienced the event(s) redness at the injection site . On 14 Feb 2021, the patient experienced the event(s) warmness at the injection site . On 14 Feb 2021, the patient experienced the event(s) fever of 103-104â°c.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), severe fatigue was unknown.The outcome of event(s), redness at the injection site was unknown.The outcome of event(s), warmness at the injection site was unknown.The outcome of event(s), fever of 103-104â°c was unknown..
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Knot on injection site; itching at injection site; hurts at injection site; swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Knot on injection site), VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE PAIN (hurts at injection site) and VACCINATION SITE SWELLING (swollen 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 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Knot on injection site), VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE PAIN (hurts at injection site) and VACCINATION SITE SWELLING (swollen at injection site). At the time of the report, VACCINATION SITE INDURATION (Knot on injection site), VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE PAIN (hurts at injection site) and VACCINATION SITE SWELLING (swollen at injection site) 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 reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: As per TCR attached, patient declined further followups
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Contusion, Diarrhoea, Pyrexia
Clinical narrative: Some bruising; Sore arm; Fever from 100-101; Diarrhea; Energy is not completely back; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Some bruising), DIARRHOEA (Diarrhea), ASTHENIA (Energy is not completely back), VACCINATION SITE PAIN (Sore arm) and PYREXIA (Fever from 100-101) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced CONTUSION (Some bruising) and VACCINATION SITE PAIN (Sore arm). In February 2021, the patient experienced DIARRHOEA (Diarrhea), ASTHENIA (Energy is not completely back) and PYREXIA (Fever from 100-101). On 09-Feb-2021, CONTUSION (Some bruising), DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Sore arm) and PYREXIA (Fever from 100-101) had resolved. At the time of the report, ASTHENIA (Energy is not completely back) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100-101 (High) Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. Treatment information for the events was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-028867 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-028867:husband case
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Some bruising; Sore arm; Fever from 100-101; Diarrhea; Energy is not completely back; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Some bruising), DIARRHOEA (Diarrhea), ASTHENIA (Energy is not completely back), VACCINATION SITE PAIN (Sore arm) and PYREXIA (Fever from 100-101) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced CONTUSION (Some bruising) and VACCINATION SITE PAIN (Sore arm). In February 2021, the patient experienced DIARRHOEA (Diarrhea), ASTHENIA (Energy is not completely back) and PYREXIA (Fever from 100-101). On 09-Feb-2021, CONTUSION (Some bruising), DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Sore arm) and PYREXIA (Fever from 100-101) had resolved. At the time of the report, ASTHENIA (Energy is not completely back) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100-101 (High) Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. Treatment information for the events was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-028867 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-028867:husband case
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: Increasingly Nauseous; Arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Increasingly Nauseous) and VACCINATION SITE PAIN (Arm hurts) 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-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 10-Feb-2021, the patient experienced NAUSEA (Increasingly Nauseous) and VACCINATION SITE PAIN (Arm hurts). At the time of the report, NAUSEA (Increasingly Nauseous) and VACCINATION SITE PAIN (Arm hurts) outcome was unknown. 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.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chest pain, Chills, Decreased appetite
Clinical narrative: Blood pressure went up to 201; Strange feeling in the tongue; Not having appetite; Diarrhea; Chest pain; Temperature 98.2; Chills; Nausea; Little soreness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure went up to 201), PARAESTHESIA ORAL (Strange feeling in the tongue), DECREASED APPETITE (Not having appetite), DIARRHOEA (Diarrhea) and CHEST PAIN (Chest pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN (Little soreness). On 07-Feb-2021, the patient experienced HYPERTENSION (Blood pressure went up to 201), PARAESTHESIA ORAL (Strange feeling in the tongue), DECREASED APPETITE (Not having appetite), DIARRHOEA (Diarrhea), CHEST PAIN (Chest pain), PYREXIA (Temperature 98.2), CHILLS (Chills) and NAUSEA (Nausea). On 04-Feb-2021, PAIN (Little soreness) had resolved. At the time of the report, HYPERTENSION (Blood pressure went up to 201), PARAESTHESIA ORAL (Strange feeling in the tongue), DECREASED APPETITE (Not having appetite), DIARRHOEA (Diarrhea), CHEST PAIN (Chest pain), PYREXIA (Temperature 98.2), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Blood pressure measurement: 201 High. On 07-Feb-2021, Body temperature: 98.2 Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hypertension, Nausea, Pain, Paraesthesia oral
Clinical narrative: Blood pressure went up to 201; Strange feeling in the tongue; Not having appetite; Diarrhea; Chest pain; Temperature 98.2; Chills; Nausea; Little soreness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure went up to 201), PARAESTHESIA ORAL (Strange feeling in the tongue), DECREASED APPETITE (Not having appetite), DIARRHOEA (Diarrhea) and CHEST PAIN (Chest pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN (Little soreness). On 07-Feb-2021, the patient experienced HYPERTENSION (Blood pressure went up to 201), PARAESTHESIA ORAL (Strange feeling in the tongue), DECREASED APPETITE (Not having appetite), DIARRHOEA (Diarrhea), CHEST PAIN (Chest pain), PYREXIA (Temperature 98.2), CHILLS (Chills) and NAUSEA (Nausea). On 04-Feb-2021, PAIN (Little soreness) had resolved. At the time of the report, HYPERTENSION (Blood pressure went up to 201), PARAESTHESIA ORAL (Strange feeling in the tongue), DECREASED APPETITE (Not having appetite), DIARRHOEA (Diarrhea), CHEST PAIN (Chest pain), PYREXIA (Temperature 98.2), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Blood pressure measurement: 201 High. On 07-Feb-2021, Body temperature: 98.2 Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Blood pressure went up to 201; Strange feeling in the tongue; Not having appetite; Diarrhea; Chest pain; Temperature 98.2; Chills; Nausea; Little soreness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure went up to 201), PARAESTHESIA ORAL (Strange feeling in the tongue), DECREASED APPETITE (Not having appetite), DIARRHOEA (Diarrhea) and CHEST PAIN (Chest pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN (Little soreness). On 07-Feb-2021, the patient experienced HYPERTENSION (Blood pressure went up to 201), PARAESTHESIA ORAL (Strange feeling in the tongue), DECREASED APPETITE (Not having appetite), DIARRHOEA (Diarrhea), CHEST PAIN (Chest pain), PYREXIA (Temperature 98.2), CHILLS (Chills) and NAUSEA (Nausea). On 04-Feb-2021, PAIN (Little soreness) had resolved. At the time of the report, HYPERTENSION (Blood pressure went up to 201), PARAESTHESIA ORAL (Strange feeling in the tongue), DECREASED APPETITE (Not having appetite), DIARRHOEA (Diarrhea), CHEST PAIN (Chest pain), PYREXIA (Temperature 98.2), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Blood pressure measurement: 201 High. On 07-Feb-2021, Body temperature: 98.2 Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: "a very unusual side effect"; This spontaneous case was reported by a consumer and describes the occurrence of   in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant Medications were not provided by the reporter.  Treatment Medications were not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Hypoaesthesia, Hypokinesia, Limb discomfort, Pain in extremity
Clinical narrative: Numbness in thumb; Legs felt heavy; Balance was off; Could barely move; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Balance was off), HYPOKINESIA (Could barely move), HYPOAESTHESIA (Numbness in thumb), LIMB DISCOMFORT (Legs felt heavy) and PAIN IN EXTREMITY (Sore arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 09-Feb-2021, the patient experienced BALANCE DISORDER (Balance was off), HYPOKINESIA (Could barely move) and LIMB DISCOMFORT (Legs felt heavy). On 10-Feb-2021, the patient experienced HYPOAESTHESIA (Numbness in thumb). On 06-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, BALANCE DISORDER (Balance was off), HYPOKINESIA (Could barely move), HYPOAESTHESIA (Numbness in thumb) and LIMB DISCOMFORT (Legs felt heavy) 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 provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Arthralgia, Body temperature, Headache, Myalgia
Clinical narrative: Muscle ache (not severe); Pain at ankle; pain at hip; Headache; Has side effects; fever at 99.0F, 99.5F, 99.6F, 98F, 99.3F and 100F twice; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Has side effects), PYREXIA (fever at 99.0F, 99.5F, 99.6F, 98F, 99.3F and 100F twice), MYALGIA (Muscle ache (not severe)), ARTHRALGIA (Pain at ankle) and ARTHRALGIA (pain at hip) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis (mild case of arthritis).   On 12-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced ADVERSE REACTION (Has side effects), PYREXIA (fever at 99.0F, 99.5F, 99.6F, 98F, 99.3F and 100F twice) and HEADACHE (Headache). On an unknown date, the patient experienced MYALGIA (Muscle ache (not severe)), ARTHRALGIA (Pain at ankle) and ARTHRALGIA (pain at hip). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ADVERSE REACTION (Has side effects), PYREXIA (fever at 99.0F, 99.5F, 99.6F, 98F, 99.3F and 100F twice), MYALGIA (Muscle ache (not severe)), ARTHRALGIA (Pain at ankle), ARTHRALGIA (pain at hip) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 99.6f 99.0F, 99.5F, 99.6F, 98F, 99.3F and 100F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient reported that he took 1 acetaminophen this morning and it went back to normal.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Muscle ache (not severe); Pain at ankle; pain at hip; Headache; Has side effects; fever at 99.0F, 99.5F, 99.6F, 98F, 99.3F and 100F twice; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Has side effects), PYREXIA (fever at 99.0F, 99.5F, 99.6F, 98F, 99.3F and 100F twice), MYALGIA (Muscle ache (not severe)), ARTHRALGIA (Pain at ankle) and ARTHRALGIA (pain at hip) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis (mild case of arthritis).   On 12-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced ADVERSE REACTION (Has side effects), PYREXIA (fever at 99.0F, 99.5F, 99.6F, 98F, 99.3F and 100F twice) and HEADACHE (Headache). On an unknown date, the patient experienced MYALGIA (Muscle ache (not severe)), ARTHRALGIA (Pain at ankle) and ARTHRALGIA (pain at hip). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ADVERSE REACTION (Has side effects), PYREXIA (fever at 99.0F, 99.5F, 99.6F, 98F, 99.3F and 100F twice), MYALGIA (Muscle ache (not severe)), ARTHRALGIA (Pain at ankle), ARTHRALGIA (pain at hip) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 99.6f 99.0F, 99.5F, 99.6F, 98F, 99.3F and 100F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient reported that he took 1 acetaminophen this morning and it went back to normal.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: lightheadedness; fatigue (sleeps a lot, he is too tired and does not have energy); This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness) and FATIGUE (fatigue (sleeps a lot, he is too tired and does not have energy)) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013S20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced FATIGUE (fatigue (sleeps a lot, he is too tired and does not have energy)). On an unknown date, the patient experienced DIZZINESS (lightheadedness). At the time of the report, DIZZINESS (lightheadedness) and FATIGUE (fatigue (sleeps a lot, he is too tired and does not have energy)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: NNI FU - No new information was provided
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Rash
Clinical narrative: swelling on the inside of her knee that was big like a hand; rash on both legs, from her knees up; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on both legs, from her knees up) and JOINT SWELLING (swelling on the inside of her knee that was big like a hand) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced RASH (rash on both legs, from her knees up). On 03-Feb-2021, the patient experienced JOINT SWELLING (swelling on the inside of her knee that was big like a hand). On 04-Feb-2021, RASH (rash on both legs, from her knees up) and JOINT SWELLING (swelling on the inside of her knee that was big like a hand) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included For the symptoms: cream on her skin., Other: blood pressure medicine.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Cough, Nasal congestion, Pain in extremity
Clinical narrative: back pain; Congestion; Coughing; legs became achey; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), NASAL CONGESTION (Congestion), COUGH (Coughing) and PAIN IN EXTREMITY (legs became achey) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (legs became achey). On 07-Feb-2021, the patient experienced NASAL CONGESTION (Congestion) and COUGH (Coughing). On an unknown date, the patient experienced BACK PAIN (back pain). The patient was treated with TRAMADOL at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, BACK PAIN (back pain), NASAL CONGESTION (Congestion), COUGH (Coughing) and PAIN IN EXTREMITY (legs became achey) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.