chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Thinking abnormal
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of feeling abnormal (felt loopy), abnormal thinking (couldn't think straight for a day) and pounding headache in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included no adverse event. On Mar 9, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 9, 2021, patient experienced feeling abnormal (felt loopy), abnormal thinking (couldn't think straight for a day) and pounding headache. At the time of the report, feeling abnormal (felt loopy), abnormal thinking (couldn't think straight for a day) and pounding headache outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant products usage and treatment details not included.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 33-year-old female patient (gravida 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 19-Aug-2020 and the estimated date of delivery was 17-Jun-2021. On 07-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) 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.   Patient reported  that she is not under medications.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: sore arm; Body ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (Body ache) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN (Body ache) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN (Body ache) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported ,No treatment medication was reported .
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Coronavirus test, Product dose omission issue, SARS-CoV-2 test positive
Clinical narrative: not received the 2nd vaccine; covid-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (covid-19 virus test positive) and PRODUCT DOSE OMISSION ISSUE (not received the 2nd vaccine) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (covid-19 virus test positive). On 08-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (not received the 2nd vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (covid-19 virus test positive) and PRODUCT DOSE OMISSION ISSUE (not received the 2nd vaccine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Coronavirus test: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment included a monoclonal infusion
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: chills; fever; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), GABAPENTIN, TOPIRAMATE (TOPAMAX), DULOXETINE HYDROCHLORIDE (CYMBALTA), METOPROLOL SUCCINATE, ATORVASTATIN CALCIUM (LIPITOR), Low-Dose Aspirin and ALPRAZOLAM (XANAX) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced CHILLS (chills), PYREXIA (fever) and INFLUENZA LIKE ILLNESS (Flu like symptoms). On 14-Mar-2021, CHILLS (chills), PYREXIA (fever) and INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Norco, Gabapentin, Topamax, Cymbalta,Metoprolol Succinate, Lipitor, Low-Dose Aspirin, Xanax.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash
Clinical narrative: Rash; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and HEADACHE (mild headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included CALCIUM and POTASSIUM for an unknown indication.    On 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced RASH (Rash) and HEADACHE (mild headache). At the time of the report, RASH (Rash) and HEADACHE (mild headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include diabetes medication.  Treatment information not provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nightmare, Peripheral swelling
Clinical narrative: arm is sore; bump on her finger that feels like it's getting worse; nightmares; This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (nightmares), MYALGIA (arm is sore) and PERIPHERAL SWELLING (bump on her finger that feels like it's getting worse) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included SUMATRIPTAN SUCCINATE (IMITREX DF) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced NIGHTMARE (nightmares). On 24-Mar-2021, the patient experienced MYALGIA (arm is sore) and PERIPHERAL SWELLING (bump on her finger that feels like it's getting worse). At the time of the report, NIGHTMARE (nightmares), MYALGIA (arm is sore) and PERIPHERAL SWELLING (bump on her finger that feels like it's getting worse) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported .
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site urticaria
Clinical narrative: Hives; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Hives) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE URTICARIA (Hives) and VACCINATION SITE ERYTHEMA (Injection site redness). At the time of the report, VACCINATION SITE URTICARIA (Hives) and VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She is wondering if she can take the 2nd dose due on 22Apr21. she talk to a pharmacist who advice her to take dexamethasone. She consented to be followed up by the safety department. Concomitant medications were not reported. Treatment details include dexamethasone.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Decreased appetite, Dry mouth, Fatigue
Clinical narrative: loss of appetite; dry mouth; Severe cough; Chills; Fatigue; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), DRY MOUTH (dry mouth), COUGH (Severe cough), CHILLS (Chills) and FATIGUE (Fatigue) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced DECREASED APPETITE (loss of appetite), DRY MOUTH (dry mouth), COUGH (Severe cough), CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (Low grade fever). At the time of the report, DECREASED APPETITE (loss of appetite), DRY MOUTH (dry mouth), COUGH (Severe cough), CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (Low grade fever) outcome was unknown.            No concomitant medication was reported  No treatment medication was reported , Action taken with mRNA-1273 in response to the events was not applicable
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: loss of appetite; dry mouth; Severe cough; Chills; Fatigue; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), DRY MOUTH (dry mouth), COUGH (Severe cough), CHILLS (Chills) and FATIGUE (Fatigue) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced DECREASED APPETITE (loss of appetite), DRY MOUTH (dry mouth), COUGH (Severe cough), CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (Low grade fever). At the time of the report, DECREASED APPETITE (loss of appetite), DRY MOUTH (dry mouth), COUGH (Severe cough), CHILLS (Chills), FATIGUE (Fatigue) and PYREXIA (Low grade fever) outcome was unknown.            No concomitant medication was reported  No treatment medication was reported , Action taken with mRNA-1273 in response to the events was not applicable
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: headaches; low-grade fever; chills; Body aches; low-grade fever; chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PYREXIA (low-grade fever), the first episode of CHILLS (chills), the first episode of MYALGIA (Body aches), HEADACHE (headaches) and the second episode of PYREXIA (low-grade fever) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 024MZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (No longer taking medicine, but something fluctuates with weight) since 01-Aug-2017.   On 02-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced the first episode of PYREXIA (low-grade fever), the first episode of CHILLS (chills) and the first episode of MYALGIA (Body aches). On 08-Apr-2021, the patient experienced the second episode of PYREXIA (low-grade fever), the second episode of CHILLS (chills) and the second episode of MYALGIA (Body aches). On 20-Apr-2021, the patient experienced HEADACHE (headaches). On 09-Apr-2021, last episode of PYREXIA (low-grade fever), the last episode of CHILLS (chills) and the last episode of MYALGIA (Body aches) had resolved. On 23-Apr-2021, HEADACHE (headaches) had resolved.            Following the second dose, He had symptoms that have been described as "typical" reactions to the Moderna second dose. While very unpleasant, he recovered in about 12 hours and felt great for a week. About 8 days (08-APR-2021) following that 2nd vaccine shot, he had very similar symptoms at about 70% of the intensity of the initial sickness. The symptoms were the exact same (aches, chills, low-grade fever). He reported the adverse reaction because he had not heard of recurring symptoms after a patient recovered after the 2nd shot. He rarely had headaches, but there was severe weather coupled with high allergy events, so it is possible that was the cause of the headaches.   Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Patient demographics (height,weight,race) was added, additional adverse events were updated, reporter causality was updated
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Having mild fever; Flu like symptoms since last night and slept for almost 16 hours; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms since last night and slept for almost 16 hours) and PYREXIA (Having mild fever) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms since last night and slept for almost 16 hours). On 08-Apr-2021, the patient experienced PYREXIA (Having mild fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms since last night and slept for almost 16 hours) was resolving and PYREXIA (Having mild fever) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspepsia
Clinical narrative: Severe chest pain in left side; Heartburn; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Severe chest pain in left side) and DYSPEPSIA (Heartburn) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced CHEST PAIN (Severe chest pain in left side) and DYSPEPSIA (Heartburn). On 02-Apr-2021 at 2:00 AM, CHEST PAIN (Severe chest pain in left side) and DYSPEPSIA (Heartburn) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hot flush, Influenza like illness, Rash, Rash erythematous
Clinical narrative: Vision issue returned after getting 1st vaccine; Rash all over; Flu-like symptoms; Flushed, cold flushes; Red hot rash developed on upper body and up; Husband is bald and the veins on his head were popping up; Had hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Vision issue returned after getting 1st vaccine), INFLUENZA LIKE ILLNESS (Flu-like symptoms), FLUSHING (Flushed, cold flushes), RASH ERYTHEMATOUS (Red hot rash developed on upper body and up) and VEIN DISORDER (Husband is bald and the veins on his head were popping up) in a 42-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 Temporary vision loss and Eye disorder (History of an eye issue where the fluid builds up in back of retina and results in vision loss).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), FLUSHING (Flushed, cold flushes), RASH ERYTHEMATOUS (Red hot rash developed on upper body and up), VEIN DISORDER (Husband is bald and the veins on his head were popping up) and HOT FLUSH (Had hot flashes). On an unknown date, the patient experienced VISUAL IMPAIRMENT (Vision issue returned after getting 1st vaccine) and RASH (Rash all over). At the time of the report, VISUAL IMPAIRMENT (Vision issue returned after getting 1st vaccine), INFLUENZA LIKE ILLNESS (Flu-like symptoms), FLUSHING (Flushed, cold flushes), RASH ERYTHEMATOUS (Red hot rash developed on upper body and up), VEIN DISORDER (Husband is bald and the veins on his head were popping up), HOT FLUSH (Had hot flashes) and RASH (Rash all over) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was unknown. It was reported that vision issue returned after getting 1st vaccine. As per reporter, the vision issue is caused by blood pressure spikes but the patient's blood pressure was never checked. Side effects are ongoing. No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23-JUN-2021 , contains no significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Vein disorder, Visual impairment
Clinical narrative: Vision issue returned after getting 1st vaccine; Rash all over; Flu-like symptoms; Flushed, cold flushes; Red hot rash developed on upper body and up; Husband is bald and the veins on his head were popping up; Had hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Vision issue returned after getting 1st vaccine), INFLUENZA LIKE ILLNESS (Flu-like symptoms), FLUSHING (Flushed, cold flushes), RASH ERYTHEMATOUS (Red hot rash developed on upper body and up) and VEIN DISORDER (Husband is bald and the veins on his head were popping up) in a 42-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 Temporary vision loss and Eye disorder (History of an eye issue where the fluid builds up in back of retina and results in vision loss).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), FLUSHING (Flushed, cold flushes), RASH ERYTHEMATOUS (Red hot rash developed on upper body and up), VEIN DISORDER (Husband is bald and the veins on his head were popping up) and HOT FLUSH (Had hot flashes). On an unknown date, the patient experienced VISUAL IMPAIRMENT (Vision issue returned after getting 1st vaccine) and RASH (Rash all over). At the time of the report, VISUAL IMPAIRMENT (Vision issue returned after getting 1st vaccine), INFLUENZA LIKE ILLNESS (Flu-like symptoms), FLUSHING (Flushed, cold flushes), RASH ERYTHEMATOUS (Red hot rash developed on upper body and up), VEIN DISORDER (Husband is bald and the veins on his head were popping up), HOT FLUSH (Had hot flashes) and RASH (Rash all over) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was unknown. It was reported that vision issue returned after getting 1st vaccine. As per reporter, the vision issue is caused by blood pressure spikes but the patient's blood pressure was never checked. Side effects are ongoing. No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23-JUN-2021 , contains no significant information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: Fever 101 degree F; Chills; Bodyaches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 101 degree F), CHILLS (Chills) and MYALGIA (Bodyaches) 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 (No reported medical history).    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PYREXIA (Fever 101 degree F), CHILLS (Chills) and MYALGIA (Bodyaches). At the time of the report, PYREXIA (Fever 101 degree F), CHILLS (Chills) and MYALGIA (Bodyaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 101 °F (Inconclusive) 101 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Arthralgia, Decreased appetite, Insomnia, X-ray
Clinical narrative: pain on left side from hip down to knee; appetite has changed; feels bloated; doesn't sleep at night; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain on left side from hip down to knee), DECREASED APPETITE (appetite has changed), ABDOMINAL DISTENSION (feels bloated) and INSOMNIA (doesn't sleep at night) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (pain on left side from hip down to knee), DECREASED APPETITE (appetite has changed), ABDOMINAL DISTENSION (feels bloated) and INSOMNIA (doesn't sleep at night). At the time of the report, ARTHRALGIA (pain on left side from hip down to knee), DECREASED APPETITE (appetite has changed), ABDOMINAL DISTENSION (feels bloated) and INSOMNIA (doesn't sleep at night) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, X-ray: (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications provided. Doctor started consumer  on Tramadol but it made her sick and cut off her breathing .She took two extra strength Tylenol, which helped . She also puts ice pack and heat on her legs.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity
Clinical narrative: sore arm; Headache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (Headache) and MYALGIA (Body ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), HEADACHE (Headache) and MYALGIA (Body ache). At the time of the report, PAIN IN EXTREMITY (sore arm), HEADACHE (Headache) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication was reported . no treatment medication was reported .   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Experienced sore arm after first dose and again after second dose; Patient had a little fever of 100°F, did not have motivation; Tired; Head was kind of hurting but it wasn't headache, it was from the fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Experienced sore arm after first dose and again after second dose), PYREXIA (Patient had a little fever of 100°F, did not have motivation), FATIGUE (Tired) and HEADACHE (Head was kind of hurting but it wasn't headache, it was from the fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history). Concomitant products included MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] and MELATONIN for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Experienced sore arm after first dose and again after second dose), PYREXIA (Patient had a little fever of 100°F, did not have motivation), FATIGUE (Tired) and HEADACHE (Head was kind of hurting but it wasn't headache, it was from the fever). On 03-Apr-2021, PAIN IN EXTREMITY (Experienced sore arm after first dose and again after second dose), PYREXIA (Patient had a little fever of 100°F, did not have motivation), FATIGUE (Tired) and HEADACHE (Head was kind of hurting but it wasn't headache, it was from the fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 100 °F (Inconclusive) 100 °F.         Treatment for the event included ibuprofen.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: swelling; Experienced fever; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling) and PYREXIA (Experienced 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 (No recorded medical history).    On 07-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced SWELLING (swelling) and PYREXIA (Experienced fever). At the time of the report, SWELLING (swelling) and PYREXIA (Experienced fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives all over face; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over face) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives all over face). At the time of the report, URTICARIA (hives all over face) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported . No treatment medication was reported .   Reporter did not allow further contact
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid-19) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced COVID-19 (Tested positive for Covid-19). At the time of the report, COVID-19 (Tested positive for Covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-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 product use was not provided by the reporter.  Treatment for the event included monoclonal antibody therapy.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: covid-19 virus test positive; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (covid-19 virus test positive) and PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 24-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (covid-19 virus test positive). At the time of the report, SARS-COV-2 TEST POSITIVE (covid-19 virus test positive) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: She felt a bit dizzy; Felt weak these lasted a day or two; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (She felt a bit dizzy) and ASTHENIA (Felt weak these lasted a day or two) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007521A and 015A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (She felt a bit dizzy) and ASTHENIA (Felt weak these lasted a day or two). On 06-Mar-2021, DIZZINESS (She felt a bit dizzy) and ASTHENIA (Felt weak these lasted a day or two) had resolved.            Concomitant medication information was not reported. Treatment information as not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.   This case was linked to MOD-2021-071043 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Illness, Influenza
Clinical narrative: Felt like she was getting the flu; dizzy; problems with her tummy; diarrhea from hell; Sick for two days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for two days after the first dose), INFLUENZA (Felt like she was getting the flu), DIZZINESS (dizzy), DIARRHOEA (diarrhea from hell) and ABDOMINAL PAIN (problems with her tummy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced ILLNESS (Sick for two days after the first dose). On 08-Apr-2021, the patient experienced DIARRHOEA (diarrhea from hell). On an unknown date, the patient experienced INFLUENZA (Felt like she was getting the flu), DIZZINESS (dizzy) and ABDOMINAL PAIN (problems with her tummy). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. On 07-Mar-2021, ILLNESS (Sick for two days after the first dose) had resolved. At the time of the report, INFLUENZA (Felt like she was getting the flu) had resolved and DIZZINESS (dizzy), DIARRHOEA (diarrhea from hell) and ABDOMINAL PAIN (problems with her tummy) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient had reports taking two tablets of Imodium after the first episode, then two tablets of Imodium after the second episode, and then just drank water after that. She states that the Imodium did not help.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Husband had a cough at back of throat after Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Husband had a cough at back of throat after Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    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 COUGH (Husband had a cough at back of throat after Moderna vaccine). At the time of the report, COUGH (Husband had a cough at back of throat after Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Rhinorrhoea, Sinusitis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Flaring up of Sinuses), LACRIMATION INCREASED (Watering of eyes) and RHINORRHOEA (Runny nose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Sinusitis. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced SINUSITIS (Flaring up of Sinuses), LACRIMATION INCREASED (Watering of eyes) and RHINORRHOEA (Runny nose). At the time of the report, SINUSITIS (Flaring up of Sinuses), LACRIMATION INCREASED (Watering of eyes) and RHINORRHOEA (Runny nose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Rash, Rash pruritic
Clinical narrative: Covid arm (Red itchy rash); Rash; Headache; Chills; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Covid arm (Red itchy rash)), RASH (Rash), HEADACHE (Headache), CHILLS (Chills) and LYMPHADENOPATHY (Swollen lymph nodes) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Covid arm (Red itchy rash)), RASH (Rash), HEADACHE (Headache), CHILLS (Chills) and LYMPHADENOPATHY (Swollen lymph nodes). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form; CETIRIZINE HYDROCHLORIDE (ZYRTEC R) at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form; TRIAMCINOLONE at a dose of 1 dosage form and ACETONIDE DE FLUCLOROLONE at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (Covid arm (Red itchy rash)), RASH (Rash), HEADACHE (Headache), CHILLS (Chills) and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's Concomitant Meds also include: Birth control pill and vitamins   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: No specific follow-up information recorded. This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Covid arm (Red itchy rash)), RASH (Rash), HEADACHE (Headache), CHILLS (Chills) and LYMPHADENOPATHY (Swollen lymph nodes) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Covid arm (Red itchy rash)), RASH (Rash), HEADACHE (Headache), CHILLS (Chills) and LYMPHADENOPATHY (Swollen lymph nodes). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form; CETIRIZINE HYDROCHLORIDE (ZYRTEC R) at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form; TRIAMCINOLONE at a dose of 1 dosage form and ACETONIDE DE FLUCLOROLONE at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (Covid arm (Red itchy rash)), RASH (Rash), HEADACHE (Headache), CHILLS (Chills) and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's Concomitant Meds also include: Birth control pill and vitamins
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Lymphadenopathy, Pain in extremity
Clinical narrative: headache; lymph nodes were swollen under her arm (left)/lymph nodes by breast were swollen (left); opposing arm also has swollen lymph nodes; lymph nodes by breast were swollen (left); soreness; dizzy; felt weak; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness), DIZZINESS (dizzy), ASTHENIA (felt weak), HEADACHE (headache) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes were swollen under her arm (left)/lymph nodes by breast were swollen (left)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007521A and 015A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (dizzy) and ASTHENIA (felt weak). On 02-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (soreness), HEADACHE (headache), VACCINATION SITE LYMPHADENOPATHY (lymph nodes were swollen under her arm (left)/lymph nodes by breast were swollen (left)), LYMPHADENOPATHY (opposing arm also has swollen lymph nodes) and LYMPHADENOPATHY (lymph nodes by breast were swollen (left)). On 06-Mar-2021, DIZZINESS (dizzy) and ASTHENIA (felt weak) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (soreness), HEADACHE (headache), VACCINATION SITE LYMPHADENOPATHY (lymph nodes were swollen under her arm (left)/lymph nodes by breast were swollen (left)), LYMPHADENOPATHY (opposing arm also has swollen lymph nodes) and LYMPHADENOPATHY (lymph nodes by breast were swollen (left)) outcome was unknown.            There was no concomitant medications provided. No treatment information provided.   This case was linked to MOD-2021-071037 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: headache; lymph nodes were swollen under her arm (left)/lymph nodes by breast were swollen (left); opposing arm also has swollen lymph nodes; lymph nodes by breast were swollen (left); soreness; dizzy; felt weak; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness), DIZZINESS (dizzy), ASTHENIA (felt weak), HEADACHE (headache) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes were swollen under her arm (left)/lymph nodes by breast were swollen (left)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007521A and 015A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (dizzy) and ASTHENIA (felt weak). On 02-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (soreness), HEADACHE (headache), VACCINATION SITE LYMPHADENOPATHY (lymph nodes were swollen under her arm (left)/lymph nodes by breast were swollen (left)), LYMPHADENOPATHY (opposing arm also has swollen lymph nodes) and LYMPHADENOPATHY (lymph nodes by breast were swollen (left)). On 06-Mar-2021, DIZZINESS (dizzy) and ASTHENIA (felt weak) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (soreness), HEADACHE (headache), VACCINATION SITE LYMPHADENOPATHY (lymph nodes were swollen under her arm (left)/lymph nodes by breast were swollen (left)), LYMPHADENOPATHY (opposing arm also has swollen lymph nodes) and LYMPHADENOPATHY (lymph nodes by breast were swollen (left)) outcome was unknown.            There was no concomitant medications provided. No treatment information provided.   This case was linked to MOD-2021-071037 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Apr-2021 and was forwarded to Moderna on 08-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-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 DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Document received on 16-Jun-2021 and it contains Patient denies having access to Fax/email. States that diarrhea was due to the flu and not from the vaccine.Requested to be removed from call list.