chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Nausea, Pain, Vaccination site pain
Clinical narrative: freezing; sweating; body ache; difficulty in breathing; no strength; chills; headache; injection site pain; Nausea; arm muscles ache; This spontaneous case was reported by a consumer and describes the occurrence of FREEZING PHENOMENON (freezing), HYPERHIDROSIS (sweating), PAIN (body ache), DYSPNOEA (difficulty in breathing) and ASTHENIA (no strength) 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.     The patient's past medical history included COVID-19 in October 2020. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced FREEZING PHENOMENON (freezing), HYPERHIDROSIS (sweating), PAIN (body ache), DYSPNOEA (difficulty in breathing), ASTHENIA (no strength), CHILLS (chills), HEADACHE (headache), VACCINATION SITE PAIN (injection site pain), NAUSEA (Nausea) and MYALGIA (arm muscles ache). At the time of the report, FREEZING PHENOMENON (freezing), HYPERHIDROSIS (sweating), PAIN (body ache), DYSPNOEA (difficulty in breathing), ASTHENIA (no strength), CHILLS (chills), HEADACHE (headache), VACCINATION SITE PAIN (injection site pain), NAUSEA (Nausea) and MYALGIA (arm muscles ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking Heart medication, Blood pressure medication, Take some more medication but do not remember right now. Patient treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Injection site pain, chills, nausea, myalgia, and headache  are consistent with the product safety profile
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Eye pruritus, Ocular hyperaemia
Clinical narrative: Both eyes were itchy; red eyes; dry and flaky eyes; This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS (Both eyes were itchy), OCULAR HYPERAEMIA (red eyes) and DRY EYE (dry and flaky eyes) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 EYE PRURITUS (Both eyes were itchy), OCULAR HYPERAEMIA (red eyes) and DRY EYE (dry and flaky eyes). At the time of the report, EYE PRURITUS (Both eyes were itchy), OCULAR HYPERAEMIA (red eyes) and DRY EYE (dry and flaky eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms intensified; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms intensified) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M10A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms intensified). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms intensified) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that side effects had intensified on 7-FEB-2021.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up received on 23 April 2021 Patient Initial corrected.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Paraesthesia, Pruritus
Clinical narrative: tingling in hands and feet; itchiness in hands and feet; can't sleep every night since got vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in hands and feet), PRURITUS (itchiness in hands and feet) and INSOMNIA (can't sleep every night since got vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) and SIMETHICONE for GERD, Amlodipine                                                     for Blood pressure for Hypertension.    On 20-Jan-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PARAESTHESIA (tingling in hands and feet), PRURITUS (itchiness in hands and feet) and INSOMNIA (can't sleep every night since got vaccine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) on 02-Feb-2021 at a dose of 1 dosage form. At the time of the report, PARAESTHESIA (tingling in hands and feet), PRURITUS (itchiness in hands and feet) and INSOMNIA (can't sleep every night since got vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: not feeling well; have a fever like a hundred or a little bit over 100; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well) and PYREXIA (have a fever like a hundred or a little bit over 100) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling well) and PYREXIA (have a fever like a hundred or a little bit over 100). At the time of the report, MALAISE (not feeling well) and PYREXIA (have a fever like a hundred or a little bit over 100) outcome was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: rash near injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash near injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included DENOSUMAB (PROLIA), LISINOPRIL, BETAHISTINE HYDROCHLORIDE (VERTEX [BETAHISTINE HYDROCHLORIDE]), FAMOTIDINE (PEPCID AC) and ESTRIOL for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced INJECTION SITE RASH (rash near injection site). At the time of the report, INJECTION SITE RASH (rash near injection site) 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.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Rash is consistent with the product known safety profile.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID; Cold symptoms; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold symptoms) and SARS-COV-2 TEST POSITIVE (Tested positive for COVID) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced NASOPHARYNGITIS (Cold symptoms). On 11-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID). At the time of the report, NASOPHARYNGITIS (Cold symptoms) and SARS-COV-2 TEST POSITIVE (Tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive. On 20-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.   Concomitant medication not provided.  Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: Follow-up information received on 26-MAR-2021 contains non-significant information. Email Address provided and updated reporter last name..; Sender's Comments: Based on the information provided, the natural history of COVID-19 and the established information about the mRNA-1273 vaccine, a causal association between the event of COVID-19 and the product use is assessed as unlikely.  The patient was most likely exposed to the disease prior to vaccination. Cold symptoms is assessed as due to COVID -19.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Limb discomfort, Nausea, Pain in extremity
Clinical narrative: Sore arm down to her elbow; Painful to lift her arm; Severe tremors; Diarrhea; Couldn't eat; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm down to her elbow), LIMB DISCOMFORT (Painful to lift her arm), TREMOR (Severe tremors), NAUSEA (Nausea) and DIARRHOEA (Diarrhea) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025020A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to sting and Iodine allergy. Concomitant products included MULTIVITAMINS [VITAMINS NOS], ASCORBIC ACID (VIT C) and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm down to her elbow), LIMB DISCOMFORT (Painful to lift her arm), TREMOR (Severe tremors), NAUSEA (Nausea), DIARRHOEA (Diarrhea) and DECREASED APPETITE (Couldn't eat). On 21-Jan-2021, LIMB DISCOMFORT (Painful to lift her arm) had resolved. On 22-Jan-2021, TREMOR (Severe tremors) had resolved. On 23-Jan-2021, DIARRHOEA (Diarrhea) and DECREASED APPETITE (Couldn't eat) had resolved. On 25-Jan-2021, PAIN IN EXTREMITY (Sore arm down to her elbow) had resolved. At the time of the report, NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included pills for high cholesterol, high blood pressure and something for stomach acid.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.  Nausea is consistent with the product known safety profile.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Sore arm down to her elbow; Painful to lift her arm; Severe tremors; Diarrhea; Couldn't eat; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm down to her elbow), LIMB DISCOMFORT (Painful to lift her arm), TREMOR (Severe tremors), NAUSEA (Nausea) and DIARRHOEA (Diarrhea) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025020A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to sting and Iodine allergy. Concomitant products included MULTIVITAMINS [VITAMINS NOS], ASCORBIC ACID (VIT C) and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm down to her elbow), LIMB DISCOMFORT (Painful to lift her arm), TREMOR (Severe tremors), NAUSEA (Nausea), DIARRHOEA (Diarrhea) and DECREASED APPETITE (Couldn't eat). On 21-Jan-2021, LIMB DISCOMFORT (Painful to lift her arm) had resolved. On 22-Jan-2021, TREMOR (Severe tremors) had resolved. On 23-Jan-2021, DIARRHOEA (Diarrhea) and DECREASED APPETITE (Couldn't eat) had resolved. On 25-Jan-2021, PAIN IN EXTREMITY (Sore arm down to her elbow) had resolved. At the time of the report, NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included pills for high cholesterol, high blood pressure and something for stomach acid.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.  Nausea is consistent with the product known safety profile.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Pyrexia
Clinical narrative: various other symptoms; fever; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (various other symptoms) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 ADVERSE EVENT (various other symptoms) and PYREXIA (fever). At the time of the report, ADVERSE EVENT (various other symptoms) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient tested positive for covid-19 after first dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient tested positive for covid-19 after first dose of the vaccine) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced COVID-19 (Patient tested positive for covid-19 after first dose of the vaccine). At the time of the report, COVID-19 (Patient tested positive for covid-19 after first dose of the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient got contact with people with COVID-19 after the vaccination.  No relevant concomitant medications were reported. No treatment information was reported.; Sender's Comments: Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event and the product use is assessed as unlikely.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Having an adverse reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Having an adverse reaction) 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 ADVERSE REACTION (Having an adverse reaction). At the time of the report, ADVERSE REACTION (Having an adverse reaction) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.; Sender's Comments: Very limited information regarding this event has been provided at this time.  No further follow up.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Insomnia, Pain in extremity
Clinical narrative: pain in back; pain in arm; difficulty sleeping; pain in head; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain in back), PAIN IN EXTREMITY (pain in arm), INSOMNIA (difficulty sleeping) and HEADACHE (pain in head) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included IBUPROFEN for an unknown indication.    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 BACK PAIN (pain in back), PAIN IN EXTREMITY (pain in arm), INSOMNIA (difficulty sleeping) and HEADACHE (pain in head). At the time of the report, BACK PAIN (pain in back), PAIN IN EXTREMITY (pain in arm), INSOMNIA (difficulty sleeping) and HEADACHE (pain in head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  Other concomitant medication included anti-inflammatory medications.  Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Rhinorrhoea, Vaccination site inflammation, Vaccination site pain
Clinical narrative: Head cold; Running nose; Cough that has continued until today; Very painful; Inflamed; Itch a little; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Head cold), RHINORRHOEA (Running nose), COUGH (Cough that has continued until today), VACCINATION SITE PAIN (Very painful) and VACCINATION SITE INFLAMMATION (Inflamed) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (Very painful), VACCINATION SITE INFLAMMATION (Inflamed) and VACCINATION SITE PRURITUS (Itch a little). On 18-Feb-2021, the patient experienced NASOPHARYNGITIS (Head cold), RHINORRHOEA (Running nose) and COUGH (Cough that has continued until today). The patient was treated with PARACETAMOL (TYLENOL) on 09-Feb-2021 at an unspecified dose and frequency. On 22-Feb-2021, VACCINATION SITE PAIN (Very painful), VACCINATION SITE INFLAMMATION (Inflamed) and VACCINATION SITE PRURITUS (Itch a little) had resolved. At the time of the report, NASOPHARYNGITIS (Head cold), RHINORRHOEA (Running nose) and COUGH (Cough that has continued until today) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  No concomitant medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Head cold; Running nose; Cough that has continued until today; Very painful; Inflamed; Itch a little; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Head cold), RHINORRHOEA (Running nose), COUGH (Cough that has continued until today), VACCINATION SITE PAIN (Very painful) and VACCINATION SITE INFLAMMATION (Inflamed) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (Very painful), VACCINATION SITE INFLAMMATION (Inflamed) and VACCINATION SITE PRURITUS (Itch a little). On 18-Feb-2021, the patient experienced NASOPHARYNGITIS (Head cold), RHINORRHOEA (Running nose) and COUGH (Cough that has continued until today). The patient was treated with PARACETAMOL (TYLENOL) on 09-Feb-2021 at an unspecified dose and frequency. On 22-Feb-2021, VACCINATION SITE PAIN (Very painful), VACCINATION SITE INFLAMMATION (Inflamed) and VACCINATION SITE PRURITUS (Itch a little) had resolved. At the time of the report, NASOPHARYNGITIS (Head cold), RHINORRHOEA (Running nose) and COUGH (Cough that has continued until today) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  No concomitant medications were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site lymphadenopathy
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Dull headache) and VACCINATION SITE LYMPHADENOPATHY (Lymph node on the left under arm, the same where received shot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced HEADACHE (Dull headache). On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Lymph node on the left under arm, the same where received shot). On 24-Feb-2021, HEADACHE (Dull headache) had resolved. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Lymph node on the left under arm, the same where received shot) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient is also on a heart medication she can't remember. No treatment medications provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: Follow up received on 01MAR2021, Updated reporter details, Anatomical location of vaccine, vaccination facility details, concomitant medication Eliquis and additional event vaccination site lymphadenopathy.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.  The reported events are consistent with the product known safety profile.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Rash
Clinical narrative: red, non-itchy rashes over his chest and arms; fever; chills; fatigue; This spontaneous case was reported by a physician and describes the occurrence of RASH (red, non-itchy rashes over his chest and arms), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue). On 17-Feb-2021, the patient experienced RASH (red, non-itchy rashes over his chest and arms). On 17-Feb-2021, PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) had resolved. On 20-Feb-2021, RASH (red, non-itchy rashes over his chest and arms) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.     No concomitant medications were reported.  Treatment information was not provided.   This case was linked.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Neck pain
Clinical narrative: Sore throuh neck; Extremely tired; Sore through shoulder; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Sore throuh neck), FATIGUE (Extremely tired) and ARTHRALGIA (Sore through shoulder) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 842L28A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Sore throuh neck), FATIGUE (Extremely tired) and ARTHRALGIA (Sore through shoulder). At the time of the report, NECK PAIN (Sore throuh neck), FATIGUE (Extremely tired) and ARTHRALGIA (Sore through shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  No treatment details were provided   This case was linked to MOD-2021-065997 (Patient Link).; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.  Arthralgia and fatigue are consistent with the product known safety profile.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Red, red large; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red, red large) and PRURITUS (Itchy) 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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red, red large) and PRURITUS (Itchy). At the time of the report, ERYTHEMA (Red, red large) and PRURITUS (Itchy) 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 assessment.  No concomitant medications were reported.  Treatment information was not provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: pruritic; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (pruritic) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (pruritic). At the time of the report, PRURITUS (pruritic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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.   Reporter did not allow further contact; 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Pain in right heel; Sore Left Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in right heel) and VACCINATION SITE PAIN (Sore Left Arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Bursitis.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in right heel) and VACCINATION SITE PAIN (Sore Left Arm). On 03-Feb-2021, VACCINATION SITE PAIN (Sore Left Arm) had resolved. On 18-Feb-2021, PAIN IN EXTREMITY (Pain in right heel) 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 assessment.  About three weeks after the first vaccine, on 18-FEB-2021, patient had a cortisone shot in the heel of her right foot.  No concomitant medications were reported. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: itching; with round red rash at the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (with round red rash at the injection site) in a 46-year-old male 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (with round red rash at the injection site). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency and TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (with round red rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the event included cetirizine (Zyrtec) and triamcinolone cream.  No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.  The reported events are consistent with the product known safety profile.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Dizzyness; Body Ache; Fatigue; Chills; Head ache; Fever; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizzyness), PAIN (Body Ache), FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Head ache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced DIZZINESS (Dizzyness), PAIN (Body Ache), FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Head ache) and PYREXIA (Fever). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzyness), PAIN (Body Ache), FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Head ache) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, Body temperature: 101.5 (High) 101.5. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.  Fever, chills, fatigue and headache are consistent with the product known safety profile.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Dizzyness; Body Ache; Fatigue; Chills; Head ache; Fever; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizzyness), PAIN (Body Ache), FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Head ache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced DIZZINESS (Dizzyness), PAIN (Body Ache), FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Head ache) and PYREXIA (Fever). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzyness), PAIN (Body Ache), FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Head ache) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, Body temperature: 101.5 (High) 101.5. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.  Fever, chills, fatigue and headache are consistent with the product known safety profile.
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pruritus, Injection site warmth, Vaccination site erythema
Clinical narrative: heat at injection site; itching around injection site; redness around injection site; hardness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (heat at injection site), INJECTION SITE PRURITUS (itching around injection site), VACCINATION SITE ERYTHEMA (redness around injection site) and INJECTION SITE INDURATION (hardness around 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 21-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 INJECTION SITE PRURITUS (itching around injection site), VACCINATION SITE ERYTHEMA (redness around injection site) and INJECTION SITE INDURATION (hardness around injection site). On an unknown date, the patient experienced INJECTION SITE WARMTH (heat at injection site). At the time of the report, INJECTION SITE WARMTH (heat at injection site), INJECTION SITE PRURITUS (itching around injection site), VACCINATION SITE ERYTHEMA (redness around injection site) and INJECTION SITE INDURATION (hardness around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded. Injection site induration, injection site erythema, and injection site itching are consistent with the product known safety profile.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chest pain, Fatigue, Headache, Lymphadenopathy
Clinical narrative: pain right in the middle of the chest; little sharp pain right under breast in the chest; Delayed Reaction; injection site itch; headache; fever; lymph node swelling; fatigue; injection site redness; mild reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (mild reaction), CHEST PAIN (pain right in the middle of the chest), BREAST PAIN (little sharp pain right under breast in the chest), TYPE IV HYPERSENSITIVITY REACTION (Delayed Reaction) and VACCINATION SITE PRURITUS (injection site itch) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION COMPLICATION (mild reaction). On 06-Feb-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Delayed Reaction), VACCINATION SITE PRURITUS (injection site itch), HEADACHE (headache), PYREXIA (fever), LYMPHADENOPATHY (lymph node swelling), FATIGUE (fatigue) and VACCINATION SITE ERYTHEMA (injection site redness). On 10-Feb-2021, the patient experienced CHEST PAIN (pain right in the middle of the chest) and BREAST PAIN (little sharp pain right under breast in the chest). On 03-Feb-2021, VACCINATION COMPLICATION (mild reaction) had resolved. On 16-Feb-2021, TYPE IV HYPERSENSITIVITY REACTION (Delayed Reaction), VACCINATION SITE PRURITUS (injection site itch), HEADACHE (headache), PYREXIA (fever), LYMPHADENOPATHY (lymph node swelling) and VACCINATION SITE ERYTHEMA (injection site redness) had resolved. On 21-Feb-2021, FATIGUE (fatigue) had resolved. At the time of the report, CHEST PAIN (pain right in the middle of the chest) and BREAST PAIN (little sharp pain right under breast in the chest) 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.   No concomitant medications were reported. Treatment information was not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Type IV hypersensitivity reaction, Vaccination complication, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: pain right in the middle of the chest; little sharp pain right under breast in the chest; Delayed Reaction; injection site itch; headache; fever; lymph node swelling; fatigue; injection site redness; mild reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (mild reaction), CHEST PAIN (pain right in the middle of the chest), BREAST PAIN (little sharp pain right under breast in the chest), TYPE IV HYPERSENSITIVITY REACTION (Delayed Reaction) and VACCINATION SITE PRURITUS (injection site itch) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION COMPLICATION (mild reaction). On 06-Feb-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Delayed Reaction), VACCINATION SITE PRURITUS (injection site itch), HEADACHE (headache), PYREXIA (fever), LYMPHADENOPATHY (lymph node swelling), FATIGUE (fatigue) and VACCINATION SITE ERYTHEMA (injection site redness). On 10-Feb-2021, the patient experienced CHEST PAIN (pain right in the middle of the chest) and BREAST PAIN (little sharp pain right under breast in the chest). On 03-Feb-2021, VACCINATION COMPLICATION (mild reaction) had resolved. On 16-Feb-2021, TYPE IV HYPERSENSITIVITY REACTION (Delayed Reaction), VACCINATION SITE PRURITUS (injection site itch), HEADACHE (headache), PYREXIA (fever), LYMPHADENOPATHY (lymph node swelling) and VACCINATION SITE ERYTHEMA (injection site redness) had resolved. On 21-Feb-2021, FATIGUE (fatigue) had resolved. At the time of the report, CHEST PAIN (pain right in the middle of the chest) and BREAST PAIN (little sharp pain right under breast in the chest) 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.   No concomitant medications were reported. Treatment information was not provided.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded. Some vaccines have been known to exacerbate latent herpes zoster,
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: Chills; Nausea; Vomiting; Fatigue; Joint pain; Headache; Fever of 101.5; This spontaneous case was reported by an other and describes the occurrence of CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 an unknown date, the patient experienced CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), HEADACHE (Headache) and PYREXIA (Fever of 101.5). At the time of the report, CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), HEADACHE (Headache) and PYREXIA (Fever of 101.5) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported No treatment information was provided; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.  The reported events are consistent with the product known safety profile
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Chills; Nausea; Vomiting; Fatigue; Joint pain; Headache; Fever of 101.5; This spontaneous case was reported by an other and describes the occurrence of CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 an unknown date, the patient experienced CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), HEADACHE (Headache) and PYREXIA (Fever of 101.5). At the time of the report, CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), HEADACHE (Headache) and PYREXIA (Fever of 101.5) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported No treatment information was provided; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the other events, a causal relationship cannot be excluded.  The reported events are consistent with the product known safety profile