chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Back started hurting; Clammy; Started getting nauseous; Rash has become much bigger, red, and itchy.; Rash has become much bigger, red, and itchy; She developed a rash at the injection site/rash is bigger; Rash got bigger and hot to the touch; Swelling at the injection site which has gotten bigger\ump at injection site is getting bigger; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE RASH (She developed a rash at the injection site/rash is bigger), VACCINATION SITE WARMTH (Rash got bigger and hot to the touch), BACK PAIN (Back started hurting), COLD SWEAT (Clammy) and NAUSEA (Started getting nauseous) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included Armidex, METFORMIN, LISINOPRIL, LAMOTRIGINE (LAMICTAL), DULOXETINE HYDROCHLORIDE (CYMBALTA) and PROPRANOLOL for an unknown indication.   On 06-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 06-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site which has gotten bigger\ump at injection site is getting bigger). On 07-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Rash got bigger and hot to the touch). On 08-Feb-2021, the patient experienced VACCINATION SITE RASH (She developed a rash at the injection site/rash is bigger), BACK PAIN (Back started hurting), COLD SWEAT (Clammy), NAUSEA (Started getting nauseous), VACCINATION SITE ERYTHEMA (Rash has become much bigger, red, and itchy.) and VACCINATION SITE PRURITUS (Rash has become much bigger, red, and itchy). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at a dose of 1 dosage form and BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE RASH (She developed a rash at the injection site/rash is bigger), VACCINATION SITE WARMTH (Rash got bigger and hot to the touch), BACK PAIN (Back started hurting), COLD SWEAT (Clammy), NAUSEA (Started getting nauseous), VACCINATION SITE ERYTHEMA (Rash has become much bigger, red, and itchy.), VACCINATION SITE PRURITUS (Rash has become much bigger, red, and itchy) and VACCINATION SITE SWELLING (Swelling at the injection site which has gotten bigger\ump at injection site is getting bigger) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (positive for COVID) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) 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 25-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, SARS-CoV-2 test positive: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: Arm soreness; Feels like she ran a race; Felt much more tired than usual; This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), FEELING ABNORMAL (Feels like she ran a race) and FATIGUE (Felt much more tired than usual) 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 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness), FEELING ABNORMAL (Feels like she ran a race) and FATIGUE (Felt much more tired than usual). At the time of the report, PAIN IN EXTREMITY (Arm soreness), FEELING ABNORMAL (Feels like she ran a race) and FATIGUE (Felt much more tired than usual) outcome was unknown.            Concomitant medications were not reported. Treatment information in response to the events was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches; 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 HEADACHE (Headaches) 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 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Myalgia, Nausea, Polymerase chain reaction
Clinical narrative: nausea and vomiting; Nausea; Dizziness; ; Fatigue/worst fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), MYALGIA (Mack truck hit), FATIGUE (Fatigue/worst fatigue), VOMITING (nausea and vomiting) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy and Allergy to antibiotic. Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) from 2020 to an unknown date for Heartburn, EZETIMIBE, SIMVASTATIN (VYTORIN) from 2010 to an unknown date for Hypercholesterolemia.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced DIZZINESS (Dizziness), MYALGIA  and FATIGUE (Fatigue/worst fatigue). On 23-Feb-2021, the patient experienced VOMITING (nausea and vomiting) and NAUSEA (Nausea). On 28-Feb-2021, DIZZINESS (Dizziness) and MYALGIA  had resolved. At the time of the report, FATIGUE (Fatigue/worst fatigue), VOMITING (nausea and vomiting) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, Polymerase chain reaction: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that she felt fatigue, dizziness and myalgia which were similar to her chemotherapy 25 years ago. In concomitant medications patient also reported Claritin 10mg orally for allergy. She started taking it since 2015. Treatment details were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-074321 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: This follow-up was received on 31-MAY-2021 which updated patient demographics, allergic conditions, lab data, re-challenge date, concomitant medications and event outcome.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074321:CROSS LINKED TO DOSE 1
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: nausea and vomiting; Nausea; Dizziness; ; Fatigue/worst fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), MYALGIA (Mack truck hit), FATIGUE (Fatigue/worst fatigue), VOMITING (nausea and vomiting) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy and Allergy to antibiotic. Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) from 2020 to an unknown date for Heartburn, EZETIMIBE, SIMVASTATIN (VYTORIN) from 2010 to an unknown date for Hypercholesterolemia.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced DIZZINESS (Dizziness), MYALGIA  and FATIGUE (Fatigue/worst fatigue). On 23-Feb-2021, the patient experienced VOMITING (nausea and vomiting) and NAUSEA (Nausea). On 28-Feb-2021, DIZZINESS (Dizziness) and MYALGIA  had resolved. At the time of the report, FATIGUE (Fatigue/worst fatigue), VOMITING (nausea and vomiting) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, Polymerase chain reaction: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that she felt fatigue, dizziness and myalgia which were similar to her chemotherapy 25 years ago. In concomitant medications patient also reported Claritin 10mg orally for allergy. She started taking it since 2015. Treatment details were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-074321 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: This follow-up was received on 31-MAY-2021 which updated patient demographics, allergic conditions, lab data, re-challenge date, concomitant medications and event outcome.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074321:CROSS LINKED TO DOSE 1
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching at trunk of body and around ankles; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching at trunk of body and around ankles) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018m20a) for COVID-19 vaccination.     The patient's past medical history included Blood pressure management (Blood pressure medications) since an unknown date. Concurrent medical conditions included Rheumatoid arthritis (Rheumatoid arthritis medications). Concomitant products included VITAMINS NOS and PROBIOTICS NOS for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PRURITUS (Itching at trunk of body and around ankles). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching at trunk of body and around ankles) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included BLOOD PRESSURE MEDICATIONS, CHOLESTEROL MEDICATIONS and RHEUMATOID ARTHRITIS MEDICATIONS.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Significant Follow-up received on 14-Jul-2021 contains additional information - Event outcome was updated, other relevant history updated
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: Generalize weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Generalize weakness) 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 20-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (Generalize weakness). At the time of the report, ASTHENIA (Generalize weakness) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.    This case was linked to MOD-2021-026102 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Induration, Swelling
Clinical narrative: swelling; hardness; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING (swelling) and INDURATION (hardness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: RESTYLANE.    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 SWELLING (swelling) and INDURATION (hardness). At the time of the report, SWELLING (swelling) and INDURATION (hardness) 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 information was not provided. Concomitant medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Skin warm
Clinical narrative: big red spot on her right arm; itchy; warm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (big red spot on her right arm), PRURITUS (itchy), SKIN WARM (warm) and RASH (Rash) 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 11-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 (big red spot on her right arm), PRURITUS (itchy), SKIN WARM (warm) and RASH (Rash). At the time of the report, ERYTHEMA (big red spot on her right arm), PRURITUS (itchy), SKIN WARM (warm) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  Treatment information included a cream for rash.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Feling something strange; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feling something strange) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feling something strange). At the time of the report, FEELING ABNORMAL (Feling something strange) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Her arm started itching; Rash; A spontaneous report was received from a other healthcare professional concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events her arm started itching,/pruritus and a rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, five minutes after receiving the vaccine, the patient experienced the event her arm started itching. On unknown date, the next day after receiving the vaccine the patient experienced event rash.  Treatment details included diphenhydramine for itching and diphenhydramine cream for rash.  Action taken with mRNA-1273 in response to the events was not reported.   On 8 Feb 2021, the outcome of events her arm started itching, a rash was resolved.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Pain
Clinical narrative: Body aches; Soreness on the chest; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), CHEST PAIN (Soreness on the chest) and CHILLS (Chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN (Body aches), CHEST PAIN (Soreness on the chest) and CHILLS (Chills). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PAIN (Body aches), CHEST PAIN (Soreness on the chest) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: NNI
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: Red patch/rash 2x2in on her arm post 12 days later after vaccination; vaccination site rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red patch/rash 2x2in on her arm post 12 days later after vaccination) and RASH (vaccination site rash) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006MZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced ERYTHEMA (Red patch/rash 2x2in on her arm post 12 days later after vaccination) and RASH (vaccination site rash). At the time of the report, ERYTHEMA (Red patch/rash 2x2in on her arm post 12 days later after vaccination) and RASH (vaccination site rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Nausea, Vomiting
Clinical narrative: hot flashes; vomited 2-3times; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes), VOMITING (vomited 2-3times) and NAUSEA (nauseous) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced HOT FLUSH (hot flashes), VOMITING (vomited 2-3times) and NAUSEA (nauseous). At the time of the report, HOT FLUSH (hot flashes), VOMITING (vomited 2-3times) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle ache in her arm) and PAIN IN EXTREMITY (arm very sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced MYALGIA (muscle ache in her arm) and PAIN IN EXTREMITY (arm very sore). At the time of the report, MYALGIA (muscle ache in her arm) and PAIN IN EXTREMITY (arm very sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the left arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in the left arm). At the time of the report, PAIN IN EXTREMITY (pain in the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Headache, Insomnia, Pain
Clinical narrative: Body ache; Diarrhea; Cannot stay awake; Heavy cough; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), DIARRHOEA (Diarrhea), INSOMNIA (Cannot stay awake), COUGH (Heavy cough) and HEADACHE (Headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-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 PAIN (Body ache), DIARRHOEA (Diarrhea), INSOMNIA (Cannot stay awake), COUGH (Heavy cough) and HEADACHE (Headache). At the time of the report, PAIN (Body ache), DIARRHOEA (Diarrhea), INSOMNIA (Cannot stay awake), COUGH (Heavy cough) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: Congestion; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Congestion). At the time of the report, NASAL CONGESTION (Congestion) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Maternal exposure during pregnancy, Myalgia, Pain in extremity
Clinical narrative: Drug exposure during pregnancy; sore arm; facial numbness; headache; muscle ache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy), PAIN IN EXTREMITY (sore arm), HYPOAESTHESIA (facial numbness), HEADACHE (headache) and MYALGIA (muscle ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy), PAIN IN EXTREMITY (sore arm), HYPOAESTHESIA (facial numbness), HEADACHE (headache) and MYALGIA (muscle ache). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) had resolved and PAIN IN EXTREMITY (sore arm), HYPOAESTHESIA (facial numbness), HEADACHE (headache) and MYALGIA (muscle ache) outcome was unknown. 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 21-Jul-2021: Non-significant Follow up added. Reporter contact details updated.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant patient received the moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received the moderna vaccine) in a 34-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 2014. Concomitant products included LEVOTHYROXINE for Hypothyroidism, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Jan-2021 and the estimated date of delivery was 12-Oct-2021. On 24-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received the moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventh week of the pregnancy.  On 24-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received the moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got sick). At the time of the report, ILLNESS (Got sick) outcome was unknown. 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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Received second vaccine outside dosing interval day 43; Redness and swelling at injection site (left) arm; Redness and swelling at injection site (left) arm; A spontaneous report was received from a consumer (patient's husband), concerning a 67-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and received second vaccine outside dosing interval day 43 (Inappropriate schedule of vaccine administered), experienced redness and swelling at injection site (left) arm (Vaccination site erythema), redness and swelling at injection site (left) arm (Vaccination site swelling).  The patient's medical history included liver transplant. Current condition included autoimmune disorder. No concomitant medications were reported.  On 12 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) and on 24 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 012A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced redness and swelling at injection site (left) arm. The patient received second vaccine outside dosing interval day 43. The patient also had possible polyethylene glycol (PEG) reaction from Moderna vaccine ingredient.  Treatment information for the events was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the event(s) is not applicable.   The events of redness and swelling at injection site (left) arm (Vaccination site erythema), redness and swelling at injection site (left) arm (Vaccination site swelling) resolved on 19 Jan 2021 while the event of received second vaccine outside dosing interval day 43 (Inappropriate schedule of vaccine administered) was considered resolved on an unknown date.  The reporter did not provide an assessment for the events redness and swelling at injection site (left) arm (Vaccination site erythema), redness and swelling at injection site (left) arm (Vaccination site swelling) and received second vaccine outside dosing interval day 43 (Inappropriate schedule of vaccine administered).; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273 (Lot #: 041L20A). Based on the current available information and temporal association between the use of the product and the start date of the events other events (Vaccination site erythema and Vaccination site swelling), a causal relationship cannot be excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Swollen tongue, Tongue discolouration, Tongue discomfort, Tongue dry
Clinical narrative: dry tongue; white spots in the tongue; burning, tingling sensation in the tongue; burning, tingling sensation in the tongue; swelling of the tongue; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of TONGUE DISCOMFORT (burning, tingling sensation in the tongue), PARAESTHESIA ORAL (burning, tingling sensation in the tongue), SWOLLEN TONGUE (swelling of the tongue), TONGUE DISCOLOURATION (white spots in the tongue) and TONGUE DRY (dry tongue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 029L20A) for COVID-19 vaccination.     Medical history was not provided by the reporter.  The patient's past medical history included No adverse event. Concomitant products included LORATADINE (CLARITINE), LEVOTHYROXINE and VITAMINS NOS for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced TONGUE DISCOMFORT (burning, tingling sensation in the tongue), PARAESTHESIA ORAL (burning, tingling sensation in the tongue) and SWOLLEN TONGUE (swelling of the tongue). On 21-Feb-2021, the patient experienced TONGUE DISCOLOURATION (white spots in the tongue). On 25-Feb-2021, the patient experienced TONGUE DRY (dry tongue). At the time of the report, TONGUE DISCOMFORT (burning, tingling sensation in the tongue), PARAESTHESIA ORAL (burning, tingling sensation in the tongue), SWOLLEN TONGUE (swelling of the tongue), TONGUE DISCOLOURATION (white spots in the tongue) and TONGUE DRY (dry tongue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: light headedness; A spontaneous report was received from a consumer concerning a 58-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events light headedness/dizziness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  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: 012L20A) intramuscularly in unknown for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the event light headedness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 8 Feb 2021, the outcome of event light headedness was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Chills; Fever; Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body aches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included NAPROXEN SODIUM (ALEVE) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body aches). At the time of the report, CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) 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 24-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 PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Right arm huritng; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm huritng) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-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 PAIN IN EXTREMITY (Right arm huritng). At the time of the report, PAIN IN EXTREMITY (Right arm huritng) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Non-significant follow-up
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal discomfort, Product dose omission issue
Clinical narrative: Patient has not received 2nd dose of Moderna vaccine; Perpetual need to cough; Like having a bunch of cotton balls or socks on their throat; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Perpetual need to cough), OROPHARYNGEAL DISCOMFORT (Like having a bunch of cotton balls or socks on their throat) and PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose of Moderna vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL (ESTROGEN), PROGESTERONE and VITAMINS NOS for an unknown indication.    On 20-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 COUGH (Perpetual need to cough) and OROPHARYNGEAL DISCOMFORT (Like having a bunch of cotton balls or socks on their throat). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose of Moderna vaccine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Cough, at an unspecified dose and frequency. On 21-Jan-2021, COUGH (Perpetual need to cough) and OROPHARYNGEAL DISCOMFORT (Like having a bunch of cotton balls or socks on their throat) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose of Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: No new information reported On 16-Jun-2021: Reporter contact details and event information updated
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Coronavirus test
Clinical narrative: Contracted COVID after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted COVID after first dose) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced COVID-19 (Contracted COVID after first dose). At the time of the report, COVID-19 (Contracted COVID after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Coronavirus test: (Inconclusive) Covid.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Nasopharyngitis, Pain
Clinical narrative: Cold; Loss of Appetite; Soreness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), DECREASED APPETITE (Loss of Appetite), PAIN (Soreness) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold), DECREASED APPETITE (Loss of Appetite), PAIN (Soreness) and FATIGUE (Fatigue). At the time of the report, NASOPHARYNGITIS (Cold), DECREASED APPETITE (Loss of Appetite), PAIN (Soreness) and FATIGUE (Fatigue) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Nausea, Pain in extremity
Clinical narrative: No energy; Little nauseated; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No energy), NAUSEA (Little nauseated) and PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (No energy), NAUSEA (Little nauseated) and PAIN IN EXTREMITY (Sore arm). At the time of the report, ASTHENIA (No energy), NAUSEA (Little nauseated) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Migraine, Neck pain, Paraesthesia
Clinical narrative: 2 full periods after being menopause for 9 years; migraines; tingling pain all over the body; Headache; face completely numb; neck pain; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (2 full periods after being menopause for 9 years), MIGRAINE (migraines) and PARAESTHESIA (tingling pain all over the body) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hay fever, Drug allergy (reacted to a sulfa drug) and Menopause. Concomitant products included LEVOTHYROXINE for Thyroid disorder.    On 17-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 POSTMENOPAUSAL HAEMORRHAGE (2 full periods after being menopause for 9 years), MIGRAINE (migraines) and PARAESTHESIA (tingling pain all over the body). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (2 full periods after being menopause for 9 years), MIGRAINE (migraines) and PARAESTHESIA (tingling pain all over the body) 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.   No treatment medications were reported.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Additional events and outcome updated.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: 2 full periods after being menopause for 9 years; migraines; tingling pain all over the body; Headache; face completely numb; neck pain; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (2 full periods after being menopause for 9 years), MIGRAINE (migraines) and PARAESTHESIA (tingling pain all over the body) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hay fever, Drug allergy (reacted to a sulfa drug) and Menopause. Concomitant products included LEVOTHYROXINE for Thyroid disorder.    On 17-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 POSTMENOPAUSAL HAEMORRHAGE (2 full periods after being menopause for 9 years), MIGRAINE (migraines) and PARAESTHESIA (tingling pain all over the body). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (2 full periods after being menopause for 9 years), MIGRAINE (migraines) and PARAESTHESIA (tingling pain all over the body) 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.   No treatment medications were reported.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Additional events and outcome updated.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (I have developed an itching, rashy kind of thing on various parts of my body) and RASH in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (I have developed an itching, rash kind of thing on various parts of my body) and RASH. At the time of the report, PRURITUS and RASH outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication reported. No treatment was provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia, Vaccination complication
Clinical narrative: Feeling crappy; Tiredness; Fatigue; Headache; Fever of 102 degrees; A spontaneous report was received from a consumer concerning a 49-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tiredness, fatigue, headache, fever of 102 degrees and feeling bad.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 02M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the event(s) tiredness, fatigue, headache, fever of 102 degrees, feeling bad.  Treatment details included tylenol, motrin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), tiredness, fatigue, headache, fever of 102 degrees, feeling bad was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm; Head ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (Head ache) 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 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Head ache). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Head ache) 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.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-026644 (E2B Linked Report).; Sender's Comments:  MOD-2021-026644:Crosslinked to MOD21-038768, Same reporter