chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Pain over elbow area; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (Pain over elbow area) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Pain over elbow area). At the time of the report, ARTHRALGIA (Pain over elbow area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medicines was not reported by reporter   treatment information was not provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD21-090033, US-MODERNATX, INC.-MOD-2021-128034 (E2B Linked Report).; Sender's Comments:  MOD21-090033: US-MODERNATX, INC.-MOD-2021-128034:Case for patient
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed the time frame for the second dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the time frame for the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the time frame for the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the time frame for the second dose) 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 concomitant and treatment medication information was reported. Patient stated that she has received her first dose in March and was supposed to get her second dose in April but did not get it.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Heart rate increased, Nausea
Clinical narrative: sleeping on and off; pulse is rapid; chills; nausea; headache; fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (sleeping on and off), HEART RATE INCREASED (pulse is rapid), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and PRAVASTATIN for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced SLEEP DISORDER (sleeping on and off), HEART RATE INCREASED (pulse is rapid), CHILLS (chills), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever of 102). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SLEEP DISORDER (sleeping on and off), HEART RATE INCREASED (pulse is rapid), CHILLS (chills), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever of 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Body temperature: 102 (Inconclusive) fever of 102.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: sleeping on and off; pulse is rapid; chills; nausea; headache; fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (sleeping on and off), HEART RATE INCREASED (pulse is rapid), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and PRAVASTATIN for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced SLEEP DISORDER (sleeping on and off), HEART RATE INCREASED (pulse is rapid), CHILLS (chills), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever of 102). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SLEEP DISORDER (sleeping on and off), HEART RATE INCREASED (pulse is rapid), CHILLS (chills), NAUSEA (nausea), HEADACHE (headache) and PYREXIA (fever of 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Body temperature: 102 (Inconclusive) fever of 102.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; little fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (little fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, AMLODIPINE, LOSARTAN, MONTELUKAST, HYDROCODONE, METOPROLOL, LINAGLIPTIN (TRADJENTA) and CLONIDINE for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (little fatigue). On 16-Apr-2021, PAIN IN EXTREMITY (Sore arm) and FATIGUE (little fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information does not provided.   This case was linked to MOD-2021-128053 (Patient Link).
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: has not had second dose and it has been over 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has not had second dose and it has been over 42 days) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not had second dose and it has been over 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not had second dose and it has been over 42 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information and concomitant medications were reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like flu) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21-A and 032M2oA) for COVID-19 vaccination. The patient's past medical history included Crohn's disease. 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 31-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like flu). On 03-Apr-2021, INFLUENZA LIKE ILLNESS (Felt like flu) had resolved. No relevant concomitant medications were reported. No treatment details were reported. This case was linked to US-MODERNATX, INC.-MOD-2021-128189 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Additional information received included no new significant information. On 28-Jul-2021: Additional information received included no new significant information.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-128189:Case for wife
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever of 100.9 F after the 1st dose; Headache after the 1st dose; Chills after 1st dose; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever of 100.9 F after the 1st dose), HEADACHE (Headache after the 1st dose) and CHILLS (Chills after 1st dose) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Food allergy.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced PYREXIA (Fever of 100.9 F after the 1st dose), HEADACHE (Headache after the 1st dose) and CHILLS (Chills after 1st dose). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) at an unspecified dose and frequency. On 13-May-2021, PYREXIA (Fever of 100.9 F after the 1st dose), HEADACHE (Headache after the 1st dose) and CHILLS (Chills after 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient got 2nd dose of vaccine 2 weeks after 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient got 2nd dose of vaccine 2 weeks after 1st dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ARIPIPRAZOLE (ABILIFY), VITAMIN B12 [VITAMIN B12 NOS], IRON, IBUPROFEN, LISINOPRIL, PRAZOSIN, TOPIRAMATE, DULOXETINE HYDROCHLORIDE (CYMBALTA), MONTELUKAST SODIUM (SINGULAIR), DICLOFENAC, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), LIDOCAINE and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for an unknown indication.    On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 26-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient got 2nd dose of vaccine 2 weeks after 1st dose). On 13-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient got 2nd dose of vaccine 2 weeks after 1st dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication: Cordron ointment
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Drug specific antibody absent
Clinical narrative: Allergic reaction to PEG in Vaccine; Zero antibodies after first dose of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction to PEG in Vaccine) and DRUG SPECIFIC ANTIBODY ABSENT (Zero antibodies after first dose of Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 immunisation.     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 ALLERGY TO VACCINE (Allergic reaction to PEG in Vaccine) and DRUG SPECIFIC ANTIBODY ABSENT (Zero antibodies after first dose of Moderna vaccine). At the time of the report, ALLERGY TO VACCINE (Allergic reaction to PEG in Vaccine) and DRUG SPECIFIC ANTIBODY ABSENT (Zero antibodies after first dose of Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the Patient received the first dose of the Moderna vaccination (date and lot number not given) and since she was allergic to PEG she got an allergic reaction from it, the HCP advised not take the second dose. Caller did not provide more information for the AE form and said she will call back again. Agent provided caller with case number.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Arm pain; Chills; 102.2°F temperature/100°F temperature/fever; Body aches/muscle aches; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm pain), CHILLS (Chills), PYREXIA (102.2°F temperature/100°F temperature/fever) and MYALGIA (Body aches/muscle aches) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), CHILLS (Chills), PYREXIA (102.2°F temperature/100°F temperature/fever) and MYALGIA (Body aches/muscle aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain), CHILLS (Chills), PYREXIA (102.2°F temperature/100°F temperature/fever) and MYALGIA (Body aches/muscle aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 102.2 f (High) 100 F middle of the night - 102.2 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-020331 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Nasal congestion, Nausea
Clinical narrative: After 1st dose he tested positive for covid; Cough; Nasal congestion; Headache; Nausea/ vomiting; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (After 1st dose he tested positive for covid), COUGH (Cough), NASAL CONGESTION (Nasal congestion), HEADACHE (Headache) and NAUSEA (Nausea/ vomiting) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L204) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 COVID-19 (After 1st dose he tested positive for covid), COUGH (Cough), NASAL CONGESTION (Nasal congestion), HEADACHE (Headache) and NAUSEA (Nausea/ vomiting). At the time of the report, COVID-19 (After 1st dose he tested positive for covid), COUGH (Cough), NASAL CONGESTION (Nasal congestion), HEADACHE (Headache) and NAUSEA (Nausea/ vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive.     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.   Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant  medications were reported.  Treatment medications included antibodies.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received on 15-JUN-2021. All events were resolved before the patient received second dose according to FU source.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test
Clinical narrative: After 1st dose he tested positive for covid; Cough; Nasal congestion; Headache; Nausea/ vomiting; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (After 1st dose he tested positive for covid), COUGH (Cough), NASAL CONGESTION (Nasal congestion), HEADACHE (Headache) and NAUSEA (Nausea/ vomiting) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L204) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 COVID-19 (After 1st dose he tested positive for covid), COUGH (Cough), NASAL CONGESTION (Nasal congestion), HEADACHE (Headache) and NAUSEA (Nausea/ vomiting). At the time of the report, COVID-19 (After 1st dose he tested positive for covid), COUGH (Cough), NASAL CONGESTION (Nasal congestion), HEADACHE (Headache) and NAUSEA (Nausea/ vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive.     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.   Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant  medications were reported.  Treatment medications included antibodies.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received on 15-JUN-2021. All events were resolved before the patient received second dose according to FU source.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: He felt dizzy twice; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (He felt dizzy twice) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced DIZZINESS (He felt dizzy twice). At the time of the report, DIZZINESS (He felt dizzy twice) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: Faulty syringe and some of the vaccine leaked out.; Patient received most of the shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of SYRINGE ISSUE (Faulty syringe and some of the vaccine leaked out.) and UNDERDOSE (Patient received most of the shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 13-May-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 13-May-2021, the patient experienced SYRINGE ISSUE (Faulty syringe and some of the vaccine leaked out.) and UNDERDOSE (Patient received most of the shot). On 13-May-2021, SYRINGE ISSUE (Faulty syringe and some of the vaccine leaked out.) and UNDERDOSE (Patient received most of the shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Pain
Clinical narrative: Numbness in the fingers; Pain from the elbow to shoulder; Joint pain on the left side; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in the fingers), PAIN (Pain from the elbow to shoulder) and ARTHRALGIA (Joint pain on the left side) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 037821A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced HYPOAESTHESIA (Numbness in the fingers), PAIN (Pain from the elbow to shoulder) and ARTHRALGIA (Joint pain on the left side). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbness in the fingers), PAIN (Pain from the elbow to shoulder) and ARTHRALGIA (Joint pain on the left side) had not resolved.            No concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria, Vaccination site reaction
Clinical narrative: small dots around injection site; hives all over her body; itchy bumps all over her body; rashes bumps all over her body; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (small dots around injection site), URTICARIA (hives all over her body), RASH (rashes bumps all over her body) and PRURITUS (itchy bumps all over her body) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for Blood pressure.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (small dots around injection site), URTICARIA (hives all over her body), RASH (rashes bumps all over her body) and PRURITUS (itchy bumps all over her body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (small dots around injection site), URTICARIA (hives all over her body), RASH (rashes bumps all over her body) and PRURITUS (itchy bumps all over her body) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: bad chills/had to put a piece of rubber in my mouth to keep my teeth from chattering; Muscle pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (bad chills/had to put a piece of rubber in my mouth to keep my teeth from chattering), MYALGIA (Muscle pain) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 008C21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, AMLODIPINE, LOSARTAN, MONTELUKAST, HYDROCODONE, METOPROLOL, LINAGLIPTIN (TRADJENTA) and CLONIDINE for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced CHILLS (bad chills/had to put a piece of rubber in my mouth to keep my teeth from chattering), MYALGIA (Muscle pain) and HEADACHE (Headache). On 13-May-2021, CHILLS (bad chills/had to put a piece of rubber in my mouth to keep my teeth from chattering) had resolved. At the time of the report, MYALGIA (Muscle pain) and HEADACHE (Headache) outcome was unknown.            Treatment medication was not reported.   This case was linked to MOD-2021-127970 (Patient Link).
Age: 27.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: on half dose received; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (on half dose received) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (on half dose received). At the time of the report, ACCIDENTAL UNDERDOSE (on half dose received) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea) and FATIGUE (Listlessness/tiredness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high, Hyperlipidaemia and Prediabetes.Concomitant products included METOPROLOL and LISINOPRIL for Blood pressure high, SIMVASTATIN for Hyperlipidaemia, METFORMIN for Prediabetes.On 22-Jan-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea) and FATIGUE (Listlessness/tiredness). On 23-Jan-2021, PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea) and FATIGUE (Listlessness/tiredness) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes:On 18-May-2021: Updated reporter information and patient demographics. Added medical history, vaccine information and concomitant medications. The duration of the event updated.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Tiredness) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 043B21A) for COVID-19 vaccination.No Medical History information was reported. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Tiredness). On 26-Apr-2021, PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Tiredness) had resolved. No relevant concomitant medications were reported. No treatment details were reported. This case was linked to MOD-2021-064397 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (temperature before vaccine and after vaccine went up/temperature 100.4ºF after the first dose) and fatigue (tired) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 00SC21A) for COVID-19 immunization. Concomitant products included hydrochlorothiazide and lisinopril for an unknown indication. On May 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 13, 2021, patient experienced pyrexia (temperature before vaccine and after vaccine went up/temperature 100.4ºF after the first dose) and fatigue (tired). At the time of the report, pyrexia (temperature before vaccine and after vaccine went up/temperature 100.4ºF after the first dose) and fatigue (tired) outcome: unknown. Diagnostic results: On May 13, 2021, body temperature: 100.4ºF (high) after the first dose. On an unknown date, body temperature: 98ºF (high) before the first dose. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Sore Arm; No Energy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and ASTHENIA (No Energy) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm) and ASTHENIA (No Energy). On 15-Apr-2021, PAIN IN EXTREMITY (Sore Arm) and ASTHENIA (No Energy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication, treatment information provided.   This case was linked to MOD-2021-128099 (Patient Link).
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Soreness at injection arm) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Previously administered products included for Flu vaccination: flu vaccine (5 years ago she had an allergic reaction to a flu vaccine which caused severe swelling and approximately 1 year ago she experienced a less severe version of this reaction.).Past adverse reactions to the above products included Swelling with flu vaccine. Concomitant products included WARFARIN, AMLODIPINE, POTASSIUM CHLORIDE (POTASSIUM [POTASSIUM CHLORIDE]), FUROSEMIDE and PARACETAMOL (TYLENOL) for an unknown indication.   On 13-May-2021 at 6:30 PM, 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 13-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Soreness at injection arm). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Soreness at injection arm) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Treatment was not reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Heart rate, Myalgia, Pyrexia
Clinical narrative: Low grade Fever 99.9 F (After Second Shot); Body Aches (After Second Shot); Pounding Headache (After Second Shot); This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade Fever 99.9 F (After Second Shot)), MYALGIA (Body Aches (After Second Shot)) and HEADACHE (Pounding Headache (After Second Shot)) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02K21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced PYREXIA (Low grade Fever 99.9 F (After Second Shot)), MYALGIA (Body Aches (After Second Shot)) and HEADACHE (Pounding Headache (After Second Shot)). At the time of the report, PYREXIA (Low grade Fever 99.9 F (After Second Shot)), MYALGIA (Body Aches (After Second Shot)) and HEADACHE (Pounding Headache (After Second Shot)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Blood pressure measurement: 127/93 mmHg. On 13-May-2021, Heart rate: 110 BPM. On 13-May-2021, Pyrexia: 99.9 F.         Treatment medications were not reported. Concomitant medications were not reported.   This case was linked to MOD-2021-128082 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on both arms/rash is patches like/rash is spreading) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. No Medical History information was reported. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced RASH (rash on both arms/rash is patches like/rash is spreading). At the time of the report, RASH (rash on both arms/rash is patches like/rash is spreading) outcome was unknown. No relevant concomitant medications were reported. No treatment details were reported. This case was linked to MOD-2021-022193 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Fall, Fatigue, Groin pain, Pain in extremity
Clinical narrative: swelled up from head to toe; your groin hurts on both sides; took 3 steps and fell down; balance is all messed up/unstable on her feet; left arm hurts; too tired; This spontaneous case was reported by a non-health professional and describes the occurrence of SWELLING (swelled up from head to toe), GROIN PAIN (your groin hurts on both sides), FALL (took 3 steps and fell down), BALANCE DISORDER (balance is all messed up/unstable on her feet) and PAIN IN EXTREMITY (left arm hurts) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C2IA and 001C2IA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sleep apnea (reported history) and Hemiplegic migraine (reported history). Concurrent medical conditions included Diabetes (reported history).   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced SWELLING (swelled up from head to toe), GROIN PAIN (your groin hurts on both sides), FALL (took 3 steps and fell down), BALANCE DISORDER (balance is all messed up/unstable on her feet), PAIN IN EXTREMITY (left arm hurts) and FATIGUE (too tired). At the time of the report, SWELLING (swelled up from head to toe), GROIN PAIN (your groin hurts on both sides), FALL (took 3 steps and fell down), BALANCE DISORDER (balance is all messed up/unstable on her feet), PAIN IN EXTREMITY (left arm hurts) and FATIGUE (too tired) outcome was unknown.            The patient reported she takes a 'cocktail" of medications on a daily basis but she was too tired to give the list.  The patient reported her experience felt like a big truck hit her. She reported she was not hurt after the fall. No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: swelled up from head to toe; your groin hurts on both sides; took 3 steps and fell down; balance is all messed up/unstable on her feet; left arm hurts; too tired; This spontaneous case was reported by a non-health professional and describes the occurrence of SWELLING (swelled up from head to toe), GROIN PAIN (your groin hurts on both sides), FALL (took 3 steps and fell down), BALANCE DISORDER (balance is all messed up/unstable on her feet) and PAIN IN EXTREMITY (left arm hurts) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C2IA and 001C2IA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sleep apnea (reported history) and Hemiplegic migraine (reported history). Concurrent medical conditions included Diabetes (reported history).   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced SWELLING (swelled up from head to toe), GROIN PAIN (your groin hurts on both sides), FALL (took 3 steps and fell down), BALANCE DISORDER (balance is all messed up/unstable on her feet), PAIN IN EXTREMITY (left arm hurts) and FATIGUE (too tired). At the time of the report, SWELLING (swelled up from head to toe), GROIN PAIN (your groin hurts on both sides), FALL (took 3 steps and fell down), BALANCE DISORDER (balance is all messed up/unstable on her feet), PAIN IN EXTREMITY (left arm hurts) and FATIGUE (too tired) outcome was unknown.            The patient reported she takes a 'cocktail" of medications on a daily basis but she was too tired to give the list.  The patient reported her experience felt like a big truck hit her. She reported she was not hurt after the fall. No treatment information was provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: soreness in injection arm; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in injection arm) and HEADACHE (slight headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) 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) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness in injection arm) and HEADACHE (slight headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Pain in arm, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (soreness in injection arm) and HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-128137, US-MODERNATX, INC.-MOD-2021-128138 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-128138:created for dose 2
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination site pain
Clinical narrative: Soreness around the injection site, pain in the area of the arm where the shots were applied; 17 yr old Pediatric Patient received the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 yr old Pediatric Patient received the first dose) and VACCINATION SITE PAIN (Soreness around the injection site, pain in the area of the arm where the shots were applied) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 017C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 yr old Pediatric Patient received the first dose). On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness around the injection site, pain in the area of the arm where the shots were applied). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 yr old Pediatric Patient received the first dose) had resolved and VACCINATION SITE PAIN (Soreness around the injection site, pain in the area of the arm where the shots were applied) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications reported include Multivitamin Gummies Kirkland and Probiotic Gummies Schiff.  Treatment information was not provided   This case was linked to MOD-2021-132637 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow up received  contain significant follow up information included patient demographic details- race updated, Product information updated for both doses, 1st dose start date updated. On 20-Jul-2021: Non Significant Follow up: Patient demographics again changed. Product information 1st dose date changed back to 14-4-2021
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Mobility decreased, Pain in extremity
Clinical narrative: woke up with a weird sensation; could not move her left arm/cannot raise her arm at all; arm hurts/arm pain was horrible; cannot get comfortable; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (woke up with a weird sensation), MOBILITY DECREASED (could not move her left arm/cannot raise her arm at all), PAIN IN EXTREMITY (arm hurts/arm pain was horrible) and DISCOMFORT (cannot get comfortable) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 028A21A) 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) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced FEELING ABNORMAL (woke up with a weird sensation), MOBILITY DECREASED (could not move her left arm/cannot raise her arm at all), PAIN IN EXTREMITY (arm hurts/arm pain was horrible) and DISCOMFORT (cannot get comfortable). The patient was treated with MENTHOL, METHYL SALICYLATE (BENGAY [MENTHOL;METHYL SALICYLATE]) for Pain in arm, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain in arm, at a dose of 600 mg every six hours. At the time of the report, FEELING ABNORMAL (woke up with a weird sensation), MOBILITY DECREASED (could not move her left arm/cannot raise her arm at all), PAIN IN EXTREMITY (arm hurts/arm pain was horrible) and DISCOMFORT (cannot get comfortable) outcome was unknown.            No concomitant product was reported.  Patient used ice and heating pads on her arm as treatment.    This case was linked to US-MODERNATX, INC.-MOD-2021-128128 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-128128:created for dose 1
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Diarrhoea, Feeling abnormal, Illness
Clinical narrative: its positive effect and it would be great if this vaccine works for IBS people; started feeling better; I thought I would be very sick after vaccine; my bloating went away for 2 to 3 days; my diarrhea went away for 2 to 3 days; my stomach pain went away for 2 to 3 days; My IBS problem completely gone for 2 and 3 days; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (started feeling better), ILLNESS (I thought I would be very sick after vaccine), ABDOMINAL DISTENSION (my bloating went away for 2 to 3 days), DIARRHEA (my diarrhea went away for 2 to 3 days) and ABDOMINAL PAIN UPPER (my stomach pain went away for 2 to 3 days) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Irritable bowel syndrome and Hysterectomy (I had hysterectomy couple of years ago). Concomitant products included MOMETASONE FUROATE (NASONEX), CETIRIZINE, OMEPRAZOLE, METOPROLOL, DICYCLOMINE [DICYCLOVERINE], FLUOXETINE and ALPRAZOLAM (XANAX) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 30-Apr-2021, the patient experienced FEELING ABNORMAL (started feeling better), ILLNESS (I thought I would be very sick after vaccine), ABDOMINAL DISTENSION (my bloating went away for 2 to 3 days), DIARRHEA (my diarrhea went away for 2 to 3 days), ABDOMINAL PAIN UPPER (my stomach pain went away for 2 to 3 days) and IRRITABLE BOWEL SYNDROME (My IBS problem completely gone for 2 and 3 days). On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (its positive effect and it would be great if this vaccine works for IBS people). At the time of the report, FEELING ABNORMAL (started feeling better), ILLNESS (I thought I would be very sick after vaccine), ABDOMINAL DISTENSION (my bloating went away for 2 to 3 days), DIARRHEA (my diarrhea went away for 2 to 3 days), ABDOMINAL PAIN UPPER (my stomach pain went away for 2 to 3 days), IRRITABLE BOWEL SYNDROME (My IBS problem completely gone for 2 and 3 days) and IRRITABLE BOWEL SYNDROME (its positive effect and it would be great if this vaccine works for IBS people) outcome was unknown.            Treatment information was not provided.