chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Too busy to receive 2nd dose on due date; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Too busy to receive 2nd dose on due date) 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 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Too busy to receive 2nd dose on due date). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Too busy to receive 2nd dose on due date) 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.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: like the ear ringing; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (like the ear ringing) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (like the ear ringing). At the time of the report, TINNITUS (like the ear ringing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were reported  No concomitant medication were reported   This case was linked to MOD-2021-092646 (E2B Linked Report).; Sender's Comments:  MOD-2021-092646:Same reporter, for himself
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Vaccination site pain
Clinical narrative: soreness at injection site; Chills; Fatigue; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALPRAZOLAM for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (soreness at injection site), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment include ice pack
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: "hurt arm"; fever; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY ("hurt arm"), PYREXIA (fever) and FATIGUE (felt tired) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PAIN IN EXTREMITY ("hurt arm"), PYREXIA (fever) and FATIGUE (felt tired). At the time of the report, PAIN IN EXTREMITY ("hurt arm"), PYREXIA (fever) and FATIGUE (felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Magnetic resonance imaging, Pyrexia, Therapeutic response unexpected, Vaccination site pain
Clinical narrative: Pain at injection site left arm; Fever 101.6; Reduced size of Lipoma right armpit; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Reduced size of Lipoma right armpit), VACCINATION SITE PAIN (Pain at injection site left arm) and PYREXIA (Fever 101.6) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Lipoma (finding a fatty lymph node under her right arm,size was 4.5 x 4.5 cm.).   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) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Reduced size of Lipoma right armpit). On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site left arm) and PYREXIA (Fever 101.6). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Reduced size of Lipoma right armpit), VACCINATION SITE PAIN (Pain at injection site left arm) and PYREXIA (Fever 101.6) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 101.6 (High) 101.6. On 01-Apr-2021, Magnetic resonance imaging: normal (normal) confirmed size of Lipoma was greatly reduced.         No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided          No concomitant medication provided. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-091772, US-MODERNATX, INC.-MOD-2021-092231 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-091772:case for daughter US-MODERNATX, INC.-MOD-2021-092231:case for mother
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Dizziness, Fatigue, Insomnia, Lymphadenopathy
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS ("on and off again" dizziness,dizziness when turning head), LYMPHADENOPATHY (lymph node swelling (left breast area),lymph node swelling (center left armpit)), INSOMNIA (difficulty sleeping), AXILLARY PAIN (feeling uncomfortable due to lymph node swelling) and FATIGUE (fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No medical history was not provided by reporter.  Concomitant products included IBUPROFEN and VITAMINS NOS for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced DIZZINESS ("on and off again" dizziness,dizziness when turning head) and FATIGUE (fatigue). On 05-Apr-2021, the patient experienced LYMPHADENOPATHY (lymph node swelling (left breast area),lymph node swelling (center left armpit)), INSOMNIA (difficulty sleeping) and AXILLARY PAIN (feeling uncomfortable due to lymph node swelling). At the time of the report, DIZZINESS ("on and off again" dizziness,dizziness when turning head), LYMPHADENOPATHY (lymph node swelling (left breast area),lymph node swelling (center left armpit)), INSOMNIA (difficulty sleeping), AXILLARY PAIN (feeling uncomfortable due to lymph node swelling) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include Ibuprofen,Ultrasound .   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Vision blurred
Clinical narrative: vision has been very blurred for about an hour now; Feeling a little run down; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (vision has been very blurred for about an hour now) and ASTHENIA (Feeling a little run down) 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 26-Apr-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 26-Apr-2021, the patient experienced ASTHENIA (Feeling a little run down). On 27-Apr-2021, the patient experienced VISION BLURRED (vision has been very blurred for about an hour now). At the time of the report, VISION BLURRED (vision has been very blurred for about an hour now) and ASTHENIA (Feeling a little run down) outcome was unknown. Not Provided          No Concomitant medications was reported No Treatment medication was reported.     Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up was received and Updated Reporter contact information.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment:The doctor is prescribing monoclonal antibodies infusion for treatment of the infection and has cautioned that she can take only take the second dose of the Moderna vaccine 90 days after the infusion.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: given shingles vaccine at same time as COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (given shingles vaccine at same time as COVID-19 vaccine) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0031321A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (given shingles vaccine at same time as COVID-19 vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (given shingles vaccine at same time as COVID-19 vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Additional information included second dose date, batch and lot number for both doses and an updated narrative
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH PRURITIC (Itchy rash). At the time of the report, RASH PRURITIC (Itchy rash) outcome was unknown. Not Provided          No concomitant medications were provided. No treatment details were provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pruritus, Urticaria
Clinical narrative: Welts itch really bad/itching is on the inside; Welts all over the body/welts on butt, arm and ankles/welts go away and pop up somewhere else; Patient took 2nd dose of moderna after 37 days of 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Welts itch really bad/itching is on the inside), URTICARIA (Welts all over the body/welts on butt, arm and ankles/welts go away and pop up somewhere else) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 2nd dose of moderna after 37 days of 1st dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 025L20A) for COVID-19 vaccination.     The patient's past medical history included Hypersensitivity reaction and Urticaria. Concurrent medical conditions included Diabetes (Condition improvement) since 17-Dec-1985, Hypertension (Condition at goal) on 18-Oct-2019 and Drug allergy (Hives) in 1988. Concomitant products included INSULIN HUMAN (INSULIN [INSULIN HUMAN]) for Diabetes, METFORMIN HYDROCHLORIDE (METFORMIN ER) and ATORVASTATIN for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 2nd dose of moderna after 37 days of 1st dose). On an unknown date, the patient experienced PRURITUS (Welts itch really bad/itching is on the inside) and URTICARIA (Welts all over the body/welts on butt, arm and ankles/welts go away and pop up somewhere else). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL LOTION N) (topical) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEK) (oral) at an unspecified dose and frequency. At the time of the report, PRURITUS (Welts itch really bad/itching is on the inside) and URTICARIA (Welts all over the body/welts on butt, arm and ankles/welts go away and pop up somewhere else) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took 2nd dose of moderna after 37 days of 1st dose) had resolved. Not Provided          The patient was taking high blood pressure medicine concomitantly.   This case was linked to MOD-2021-092419 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant Follow up received on 20-jul-2021, updated patient demographic, suspect drug taken date was updated, New event added, clinical course of the events updated
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: second dose of vaccine missed; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (second dose of vaccine missed) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (second dose of vaccine missed). At the time of the report, PRODUCT DOSE OMISSION ISSUE (second dose of vaccine missed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm soreness at injection site ) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concomitant products included VORTIOXETINE HYDROBROMIDE (TRINTELLIX) for Antidepressant therapy.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm soreness at injection site ). At the time of the report, VACCINATION SITE PAIN (arm soreness at injection site ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported   This case was linked to MOD-2021-092565 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis
Clinical narrative: Coughing a lot; Cold like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing a lot) and NASOPHARYNGITIS (Cold like symptoms) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Coughing a lot) and NASOPHARYNGITIS (Cold like symptoms). At the time of the report, COUGH (Coughing a lot) and NASOPHARYNGITIS (Cold like symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took cough syrup for the treatment of symptoms.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Guttate psoriasis, Peripheral swelling
Clinical narrative: psoriasis eruption all over his body; Swollen hands, especially on the left hand; This spontaneous case was reported by a consumer and describes the occurrence of GUTTATE PSORIASIS (psoriasis eruption all over his body) and PERIPHERAL SWELLING (Swollen hands, especially on the left hand) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced GUTTATE PSORIASIS (psoriasis eruption all over his body) and PERIPHERAL SWELLING (Swollen hands, especially on the left hand). At the time of the report, GUTTATE PSORIASIS (psoriasis eruption all over his body) and PERIPHERAL SWELLING (Swollen hands, especially on the left hand) outcome was unknown.            The reporter stated that he has taken Otezta in the past. No treatment medication were reported. no concomitant product was reported
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Whelps all over; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No medical history information reported .     On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced URTICARIA. The patient was treated with BENADRYL for Urticaria, at an unspecified dose and frequency and ZYRTEC for Urticaria, at an unspecified dose and frequency. At the time of the report, URTICARIA had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported  In the follow up it was reported that patient had 2nd dose, still on Benadryl. PCP recommended reporter to see an allergist and needs a list of ingredients.    Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Second dose details updated, event outcome updated
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever which continued overnight rising to 104F this morning.; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever which continued overnight rising to 104F this morning.) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced PYREXIA (fever which continued overnight rising to 104F this morning.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever which continued overnight rising to 104F this morning.) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103F and 104 (High) 104F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter stated that the fever improved for 1-2 hours after the patient took Tylenol but again returned to 103-104 F.   This case was linked to US-MODERNATX, INC.-MOD-2021-092506 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092506:Same reporter
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-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 26-Apr-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.  For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.     This case was linked to US-MODERNATX, INC.-MOD-2021-092175 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092175:wife case
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was a little sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and SALBUTAMOL SULFATE (INHALERIN) for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced VACCINATION SITE PAIN (Arm was a little sore). At the time of the report, VACCINATION SITE PAIN (Arm was a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Other concomitant medication included unspecified Ace Inhibitor, once a day.  No treatment information was reported.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-024834 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Fatigue, Nausea, Vitamin D
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DYSSTASIA (Difficulty in standing), FATIGUE (Tiredness/ She can't stand up to cook) and NAUSEA (Nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced DIZZINESS (Dizziness), DYSSTASIA (Difficulty in standing) and FATIGUE (Tiredness/ She can't stand up to cook). On 17-Mar-2021, the patient experienced NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness), DYSSTASIA (Difficulty in standing), FATIGUE (Tiredness/ She can't stand up to cook) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vitamin D: 18 (Low) Decreased.         No relevant concomitant medication was reported.  Treatment information was not provided.   This case was linked to MOD-2021-092285 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Renal disorder
Clinical narrative: Elevated kidney levels; shoulder was sore for 4-5 days; Bruise, it was elongated; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruise, it was elongated), RENAL DISORDER (Elevated kidney levels) and ARTHRALGIA (shoulder was sore for 4-5 days) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included Cirrhosis of liver.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced CONTUSION (Bruise, it was elongated) and ARTHRALGIA (shoulder was sore for 4-5 days). On an unknown date, the patient experienced RENAL DISORDER (Elevated kidney levels). At the time of the report, CONTUSION (Bruise, it was elongated) had resolved and RENAL DISORDER (Elevated kidney levels) and ARTHRALGIA (shoulder was sore for 4-5 days) outcome was unknown.            No concomitant medications were provided.  No treatment information provided.   This case was linked to MODERNATX, INC.-MOD-2021-092229 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Significant Follow up received. TCR attached. Patient relevant medical history and event Arthralgia were updated.; Sender's Comments:  MODERNATX, INC.-MOD-2021-092229:Same reporter, different patient
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Vision blurred
Clinical narrative: Brain fog; blurry vision; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), VISION BLURRED (blurry vision), FATIGUE (Fatigue) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced FEELING ABNORMAL (Brain fog), VISION BLURRED (blurry vision), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, FEELING ABNORMAL (Brain fog), VISION BLURRED (blurry vision), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Concomitant medications were not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low grade fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (Low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Low grade fever). At the time of the report, PYREXIA (Low grade fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details not provided. concomitant products details not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-092475 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092475:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Vaccination site paraesthesia
Clinical narrative: like tingling feeling in the body/ happens 3-4 times a day or even more/ just comes and goes; regular soreness in the left arm after the shot; radiates form my injection spot to the shoulder to around that part but nowhere else in the body; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (like tingling feeling in the body/ happens 3-4 times a day or even more/ just comes and goes), PAIN IN EXTREMITY (regular soreness in the left arm after the shot) and VACCINATION SITE PARAESTHESIA (radiates form my injection spot to the shoulder to around that part but nowhere else in the body) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PARAESTHESIA (like tingling feeling in the body/ happens 3-4 times a day or even more/ just comes and goes), PAIN IN EXTREMITY (regular soreness in the left arm after the shot) and VACCINATION SITE PARAESTHESIA (radiates form my injection spot to the shoulder to around that part but nowhere else in the body). At the time of the report, PARAESTHESIA (like tingling feeling in the body/ happens 3-4 times a day or even more/ just comes and goes), PAIN IN EXTREMITY (regular soreness in the left arm after the shot) and VACCINATION SITE PARAESTHESIA (radiates form my injection spot to the shoulder to around that part but nowhere else in the body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Rash, Vaccination complication
Clinical narrative: other side effects; Chills; fever; rash on legs,arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (other side effects), CHILLS (Chills), PYREXIA (fever) and RASH (rash on legs,arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-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 VACCINATION COMPLICATION (other side effects), CHILLS (Chills), PYREXIA (fever) and RASH (rash on legs,arm). At the time of the report, VACCINATION COMPLICATION (other side effects), CHILLS (Chills), PYREXIA (fever) and RASH (rash on legs,arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: follow-up was received on 27-APR-2021, contain no significant information.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus
Clinical narrative: itching like I have lice; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching like I have lice) and MYALGIA (Sore arm) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced MYALGIA (Sore arm). On 26-Apr-2021, the patient experienced PRURITUS (itching like I have lice). On 25-Apr-2021, MYALGIA (Sore arm) had resolved. At the time of the report, PRURITUS (itching like I have lice) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Arthralgia, Asthenia, Chills, Dyspnoea
Clinical narrative: No strength; Shakes; Shortness of breath; Hair loss; Where she is in space feels screwed up; Joint pain; chills; Muscle pain; Absolutely debilitating fatigue; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No strength), TREMOR (Shakes), DYSPNOEA (Shortness of breath), ALOPECIA (Hair loss) and FEELING ABNORMAL (Where she is in space feels screwed up) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced ASTHENIA (No strength), TREMOR (Shakes), DYSPNOEA (Shortness of breath), ALOPECIA (Hair loss), FEELING ABNORMAL (Where she is in space feels screwed up), ARTHRALGIA (Joint pain), CHILLS (chills), MYALGIA (Muscle pain), FATIGUE (Absolutely debilitating fatigue) and FATIGUE (Tired). At the time of the report, ASTHENIA (No strength), TREMOR (Shakes), DYSPNOEA (Shortness of breath), ALOPECIA (Hair loss), FEELING ABNORMAL (Where she is in space feels screwed up), ARTHRALGIA (Joint pain), CHILLS (chills), MYALGIA (Muscle pain), FATIGUE (Absolutely debilitating fatigue) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment The consumer is taking Tylenol for these symptoms.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Myalgia, Tremor
Clinical narrative: No strength; Shakes; Shortness of breath; Hair loss; Where she is in space feels screwed up; Joint pain; chills; Muscle pain; Absolutely debilitating fatigue; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No strength), TREMOR (Shakes), DYSPNOEA (Shortness of breath), ALOPECIA (Hair loss) and FEELING ABNORMAL (Where she is in space feels screwed up) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced ASTHENIA (No strength), TREMOR (Shakes), DYSPNOEA (Shortness of breath), ALOPECIA (Hair loss), FEELING ABNORMAL (Where she is in space feels screwed up), ARTHRALGIA (Joint pain), CHILLS (chills), MYALGIA (Muscle pain), FATIGUE (Absolutely debilitating fatigue) and FATIGUE (Tired). At the time of the report, ASTHENIA (No strength), TREMOR (Shakes), DYSPNOEA (Shortness of breath), ALOPECIA (Hair loss), FEELING ABNORMAL (Where she is in space feels screwed up), ARTHRALGIA (Joint pain), CHILLS (chills), MYALGIA (Muscle pain), FATIGUE (Absolutely debilitating fatigue) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment The consumer is taking Tylenol for these symptoms.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Feeling abnormal, Feeling cold
Clinical narrative: Missed her second shot; headache; her left shoulder started hurting whenever she would use it, she could not move her arm; diarrhea; felt really bad; arm hurt so bad that it woke her up every night.; low sodium; temperature of 99.8F which went up to 101F; left shoulder started hurting; felt cold; bad chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (felt cold), DIARRHOEA (diarrhea), FEELING ABNORMAL (felt really bad), PAIN IN EXTREMITY (arm hurt so bad that it woke her up every night.) and HYPONATRAEMIA (low sodium) in a 66-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 Arthritis (Patient had arthritis in her left arm/shoulder at baseline.) and Colonoscopy on 16-Mar-2021. Family history included Colon cancer. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), TOCOPHERYL ACETATE (VITAMIN E [TOCOPHERYL ACETATE]), ROSUVASTATIN CALCIUM (CRESTOR), MONTELUKAST SODIUM (SINGULAIR), OXYBUTYNIN and UBIDECARENONE (COQ-10) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced FEELING COLD (felt cold) and CHILLS (bad chills). On 22-Mar-2021, the patient experienced DIARRHOEA (diarrhea), FEELING ABNORMAL (felt really bad), PAIN IN EXTREMITY (arm hurt so bad that it woke her up every night.), HYPONATRAEMIA (low sodium), HEADACHE (headache), ARTHRALGIA (her left shoulder started hurting whenever she would use it, she could not move her arm), PYREXIA (temperature of 99.8F which went up to 101F) and ARTHRALGIA (left shoulder started hurting). On 03-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed her second shot). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, FEELING COLD (felt cold), DIARRHOEA (diarrhea), FEELING ABNORMAL (felt really bad), PAIN IN EXTREMITY (arm hurt so bad that it woke her up every night.), HYPONATRAEMIA (low sodium), PRODUCT DOSE OMISSION ISSUE (Missed her second shot), HEADACHE (headache), ARTHRALGIA (her left shoulder started hurting whenever she would use it, she could not move her arm), CHILLS (bad chills), PYREXIA (temperature of 99.8F which went up to 101F) and ARTHRALGIA (left shoulder started hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included Cortisone shot.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyponatraemia, Pain in extremity, Product dose omission issue, Pyrexia
Clinical narrative: Missed her second shot; headache; her left shoulder started hurting whenever she would use it, she could not move her arm; diarrhea; felt really bad; arm hurt so bad that it woke her up every night.; low sodium; temperature of 99.8F which went up to 101F; left shoulder started hurting; felt cold; bad chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (felt cold), DIARRHOEA (diarrhea), FEELING ABNORMAL (felt really bad), PAIN IN EXTREMITY (arm hurt so bad that it woke her up every night.) and HYPONATRAEMIA (low sodium) in a 66-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 Arthritis (Patient had arthritis in her left arm/shoulder at baseline.) and Colonoscopy on 16-Mar-2021. Family history included Colon cancer. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), TOCOPHERYL ACETATE (VITAMIN E [TOCOPHERYL ACETATE]), ROSUVASTATIN CALCIUM (CRESTOR), MONTELUKAST SODIUM (SINGULAIR), OXYBUTYNIN and UBIDECARENONE (COQ-10) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced FEELING COLD (felt cold) and CHILLS (bad chills). On 22-Mar-2021, the patient experienced DIARRHOEA (diarrhea), FEELING ABNORMAL (felt really bad), PAIN IN EXTREMITY (arm hurt so bad that it woke her up every night.), HYPONATRAEMIA (low sodium), HEADACHE (headache), ARTHRALGIA (her left shoulder started hurting whenever she would use it, she could not move her arm), PYREXIA (temperature of 99.8F which went up to 101F) and ARTHRALGIA (left shoulder started hurting). On 03-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed her second shot). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, FEELING COLD (felt cold), DIARRHOEA (diarrhea), FEELING ABNORMAL (felt really bad), PAIN IN EXTREMITY (arm hurt so bad that it woke her up every night.), HYPONATRAEMIA (low sodium), PRODUCT DOSE OMISSION ISSUE (Missed her second shot), HEADACHE (headache), ARTHRALGIA (her left shoulder started hurting whenever she would use it, she could not move her arm), CHILLS (bad chills), PYREXIA (temperature of 99.8F which went up to 101F) and ARTHRALGIA (left shoulder started hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included Cortisone shot.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Facial pain
Clinical narrative: pain in the face on left side lower jaw; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (pain in the face on left side lower jaw) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No  Medical History was reported.     On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced FACIAL PAIN (pain in the face on left side lower jaw). At the time of the report, FACIAL PAIN (pain in the face on left side lower jaw) outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Eosinophil count, Eosinophilia, Fatigue
Clinical narrative: eosinophilia; diarrhea; extreme fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of EOSINOPHILIA, DIARRHOEA, and FATIGUE in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced DIARRHOEA and FATIGUE. On 26-Apr-2021, the patient experienced EOSINOPHILIA. At the time of the report, EOSINOPHILIA, DIARRHOEA, and FATIGUE  outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, Eosinophil count: 18.5 (High).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EOSINOPHILIA to be related. No further causality assessments were provided for DIARRHOEA and FATIGUE.    Concomitant medication included ACE Inhibitors.  No treatment information provided.  Action taken with mRNA-1273 in response to the events was not Applicable.