chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: (After second dose)she felt very weak.; (After second dose)loss of appetite; (After second dose)had mostly fatigue; (After second dose)headache; (After second dose)chills; (After second dose)fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA ((After second dose)she felt very weak.), DECREASED APPETITE ((After second dose)loss of appetite), FATIGUE ((After second dose)had mostly fatigue), HEADACHE ((After second dose)headache) and CHILLS ((After second dose)chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA ((After second dose)she felt very weak.), DECREASED APPETITE ((After second dose)loss of appetite), FATIGUE ((After second dose)had mostly fatigue), HEADACHE ((After second dose)headache), CHILLS ((After second dose)chills) and PYREXIA ((After second dose)fever). At the time of the report, ASTHENIA ((After second dose)she felt very weak.), DECREASED APPETITE ((After second dose)loss of appetite), FATIGUE ((After second dose)had mostly fatigue), HEADACHE ((After second dose)headache), CHILLS ((After second dose)chills) and PYREXIA ((After second dose)fever) outcome was unknown.            No concomitant medication reported.  No treatment medication reported.   This case was linked to MOD-2021-378262 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: (After second dose)she felt very weak.; (After second dose)loss of appetite; (After second dose)had mostly fatigue; (After second dose)headache; (After second dose)chills; (After second dose)fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA ((After second dose)she felt very weak.), DECREASED APPETITE ((After second dose)loss of appetite), FATIGUE ((After second dose)had mostly fatigue), HEADACHE ((After second dose)headache) and CHILLS ((After second dose)chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA ((After second dose)she felt very weak.), DECREASED APPETITE ((After second dose)loss of appetite), FATIGUE ((After second dose)had mostly fatigue), HEADACHE ((After second dose)headache), CHILLS ((After second dose)chills) and PYREXIA ((After second dose)fever). At the time of the report, ASTHENIA ((After second dose)she felt very weak.), DECREASED APPETITE ((After second dose)loss of appetite), FATIGUE ((After second dose)had mostly fatigue), HEADACHE ((After second dose)headache), CHILLS ((After second dose)chills) and PYREXIA ((After second dose)fever) outcome was unknown.            No concomitant medication reported.  No treatment medication reported.   This case was linked to MOD-2021-378262 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 3 doses administered past the 30 use by date expiration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 doses administered past the 30 use by date expiration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 doses administered past the 30 use by date expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 doses administered past the 30 use by date expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.   This case was linked to MOD-2021-386462, MOD-2021-386455 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This spontaneous case was reported by a physician and describes the occurrence of RASH (rash) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash). At the time of the report, RASH (rash) had resolved.        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.   No Concomitant medications were provided. Treatment medications included antihistamine and steroids.   This case was linked to MOD-2021-378191 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pain, Pyrexia, Vaccination site induration
Clinical narrative: flu like symptoms; injection site is warm; coming over the knot; aches,pain; chills; its hard; itching around the site; swollen; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE WARMTH (injection site is warm), VACCINATION SITE MASS (coming over the knot), PAIN (aches,pain) and CHILLS (chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A, 008621A and 008621A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE WARMTH (injection site is warm), VACCINATION SITE MASS (coming over the knot), PAIN (aches,pain), CHILLS (chills), VACCINATION SITE INDURATION (its hard), VACCINATION SITE PRURITUS (itching around the site), VACCINATION SITE SWELLING (swollen) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE WARMTH (injection site is warm), VACCINATION SITE MASS (coming over the knot), PAIN (aches,pain), CHILLS (chills), VACCINATION SITE INDURATION (its hard), VACCINATION SITE PRURITUS (itching around the site), VACCINATION SITE SWELLING (swollen) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient states the fever and chills come and go.   This case was linked to MOD-2021-066815 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: flu like symptoms; injection site is warm; coming over the knot; aches,pain; chills; its hard; itching around the site; swollen; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE WARMTH (injection site is warm), VACCINATION SITE MASS (coming over the knot), PAIN (aches,pain) and CHILLS (chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A, 008621A and 008621A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE WARMTH (injection site is warm), VACCINATION SITE MASS (coming over the knot), PAIN (aches,pain), CHILLS (chills), VACCINATION SITE INDURATION (its hard), VACCINATION SITE PRURITUS (itching around the site), VACCINATION SITE SWELLING (swollen) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE WARMTH (injection site is warm), VACCINATION SITE MASS (coming over the knot), PAIN (aches,pain), CHILLS (chills), VACCINATION SITE INDURATION (its hard), VACCINATION SITE PRURITUS (itching around the site), VACCINATION SITE SWELLING (swollen) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient states the fever and chills come and go.   This case was linked to MOD-2021-066815 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Nausea, Pyrexia, Rosacea
Clinical narrative: Rosacea/Rash all over her face neck and back/rash was on the nose and cheeks rash; Diarrhea; A sore right arm (her injection arm) and could not move it; A sore right arm (her injection arm); Nausea; A fever of 99.9F; This spontaneous case was reported by a nurse and describes the occurrence of ROSACEA (Rosacea/Rash all over her face neck and back/rash was on the nose and cheeks rash), DIARRHOEA (Diarrhea), VACCINATION SITE MOVEMENT IMPAIRMENT (A sore right arm (her injection arm) and could not move it), VACCINATION SITE PAIN (A sore right arm (her injection arm)) and NAUSEA (Nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Metastatic breast cancer (Metastatic breast cancer survivor .).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), VACCINATION SITE MOVEMENT IMPAIRMENT (A sore right arm (her injection arm) and could not move it), VACCINATION SITE PAIN (A sore right arm (her injection arm)), NAUSEA (Nausea) and PYREXIA (A fever of 99.9F). On an unknown date, the patient experienced ROSACEA (Rosacea/Rash all over her face neck and back/rash was on the nose and cheeks rash). On 25-Mar-2021, DIARRHOEA (Diarrhea), VACCINATION SITE MOVEMENT IMPAIRMENT (A sore right arm (her injection arm) and could not move it), VACCINATION SITE PAIN (A sore right arm (her injection arm)), NAUSEA (Nausea) and PYREXIA (A fever of 99.9F) had resolved. At the time of the report, ROSACEA (Rosacea/Rash all over her face neck and back/rash was on the nose and cheeks rash) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 99.9 (High) 99.9 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided.  They gave her a topical medication that took care of the rash.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Rosacea/Rash all over her face neck and back/rash was on the nose and cheeks rash; Diarrhea; A sore right arm (her injection arm) and could not move it; A sore right arm (her injection arm); Nausea; A fever of 99.9F; This spontaneous case was reported by a nurse and describes the occurrence of ROSACEA (Rosacea/Rash all over her face neck and back/rash was on the nose and cheeks rash), DIARRHOEA (Diarrhea), VACCINATION SITE MOVEMENT IMPAIRMENT (A sore right arm (her injection arm) and could not move it), VACCINATION SITE PAIN (A sore right arm (her injection arm)) and NAUSEA (Nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Metastatic breast cancer (Metastatic breast cancer survivor .).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), VACCINATION SITE MOVEMENT IMPAIRMENT (A sore right arm (her injection arm) and could not move it), VACCINATION SITE PAIN (A sore right arm (her injection arm)), NAUSEA (Nausea) and PYREXIA (A fever of 99.9F). On an unknown date, the patient experienced ROSACEA (Rosacea/Rash all over her face neck and back/rash was on the nose and cheeks rash). On 25-Mar-2021, DIARRHOEA (Diarrhea), VACCINATION SITE MOVEMENT IMPAIRMENT (A sore right arm (her injection arm) and could not move it), VACCINATION SITE PAIN (A sore right arm (her injection arm)), NAUSEA (Nausea) and PYREXIA (A fever of 99.9F) had resolved. At the time of the report, ROSACEA (Rosacea/Rash all over her face neck and back/rash was on the nose and cheeks rash) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 99.9 (High) 99.9 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided.  They gave her a topical medication that took care of the rash.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: urticaria hives / localized hives; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (urticaria hives / localized hives) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (urticaria hives / localized hives). At the time of the report, URTICARIA (urticaria hives / localized hives) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported   Treatment reported includes antihistamine and steroids.   This case was linked to MOD-2021-378187 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: there was a temperature excursion that occurred with Moderna COVID-19 vaccine vials; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (there was a temperature excursion that occurred with Moderna COVID-19 vaccine vials) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (there was a temperature excursion that occurred with Moderna COVID-19 vaccine vials). At the time of the report, PRODUCT STORAGE ERROR (there was a temperature excursion that occurred with Moderna COVID-19 vaccine vials) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  She states that there was a temperature excursion that occurred with Moderna COVID-19 vaccine vials on 1NOV2021. The vaccine was stored in the refrigerator at the time of excursion and was in thawed condition. The maximum temperature reached was 51.2 degrees Fahrenheit and the maximum duration of excursion was 35 minutes. Caller states that the vaccine was administered to employees on 3NOV2021 and 5NOV2021, after the excursion had occurred.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Product administered at inappropriate site, Vaccination site pain, Vaccination site reaction
Clinical narrative: received 2nd injection into his thigh muscle; having "little side effects"; hang-over that lasted one day; thigh area "a little tender"; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (received 2nd injection into his thigh muscle), VACCINATION SITE REACTION (having "little side effects"), FEELING ABNORMAL (hang-over that lasted one day) and VACCINATION SITE PAIN (thigh area "a little tender") in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Rotator cuff repair (Have left rotator cuff surgery in his upper left arm and there is remaining subcutaneous fluid there).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (received 2nd injection into his thigh muscle), VACCINATION SITE REACTION (having "little side effects"), FEELING ABNORMAL (hang-over that lasted one day) and VACCINATION SITE PAIN (thigh area "a little tender"). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (received 2nd injection into his thigh muscle) had resolved and VACCINATION SITE REACTION (having "little side effects"), FEELING ABNORMAL (hang-over that lasted one day) and VACCINATION SITE PAIN (thigh area "a little tender") outcome was unknown.            Concomitant  medications were not reported. Treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I felt tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I felt tired) 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 Heart valve replacement (have an artificial heart valve).    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced FATIGUE (I felt tired). At the time of the report, FATIGUE (I felt tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-379333 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left arm day after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm day after the vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   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 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore left arm day after the vaccine). At the time of the report, VACCINATION SITE PAIN (Sore left arm day after the vaccine) outcome was unknown.            No concomitant medication information was provided. No treatment medication were provided. No adverse event for both dose 1 and 2.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow-up received and contains no new information.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Inappropriate schedule of product administration, Influenza, Myalgia, Pyrexia
Clinical narrative: Fever over 104; Like I had the flu; Really sore; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Like I had the flu), MYALGIA (Really sore), PYREXIA (Fever over 104) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Birth defects (Birth problems). Concurrent medical conditions included Autism.   On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 05-Nov-2021, the patient experienced INFLUENZA (Like I had the flu). 05-Nov-2021, the patient experienced MYALGIA (Really sore). On 05-Nov-2021 at 7:30 PM, the patient experienced PYREXIA (Fever over 104). On 05-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. On 07-Nov-2021, INFLUENZA (Like I had the flu), MYALGIA (Really sore) and PYREXIA (Fever over 104) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Nov-2021, Body temperature: high (High) High,fever over 104.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided.  It was reported that was At 7:30 PM on 05-Nov-2021, patient had a fever over 104, felt really sore, and like he had a flu. This lasted for 2 days before resolving. He did not take any medications or treatments. He was considering calling 911, but did not. He has not spoken to a HCP about his symptoms.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Limb injury
Clinical narrative: sore arm; little fuzzy; little tired; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (sore arm), FEELING ABNORMAL (little fuzzy) and FATIGUE (little tired) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL and LEVOTHYROXINE for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced LIMB INJURY (sore arm), FEELING ABNORMAL (little fuzzy) and FATIGUE (little tired). On 05-Mar-2021, LIMB INJURY (sore arm), FEELING ABNORMAL (little fuzzy) and FATIGUE (little tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included over the counter allergy pills. No treatment information provided.   This case was linked to MOD-2021-378215, MOD-2021-378216 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site lymphadenopathy
Clinical narrative: He is uncomfortable when he moves the left arm; Swollen Lymph node under left armpit and it is getting worst. The lymph node swelling is getting worst and it became significant on 07NOV2021; This spontaneous case was reported by a nurse and describes the occurrence of LIMB DISCOMFORT (He is uncomfortable when he moves the left arm) and VACCINATION SITE LYMPHADENOPATHY (Swollen Lymph node under left armpit and it is getting worst. The lymph node swelling is getting worst and it became significant on 07NOV2021) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024F21A, 012L20A and 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swollen Lymph node under left armpit and it is getting worst. The lymph node swelling is getting worst and it became significant on 07NOV2021). On 08-Nov-2021, the patient experienced LIMB DISCOMFORT (He is uncomfortable when he moves the left arm). At the time of the report, LIMB DISCOMFORT (He is uncomfortable when he moves the left arm) and VACCINATION SITE LYMPHADENOPATHY (Swollen Lymph node under left armpit and it is getting worst. The lymph node swelling is getting worst and it became significant on 07NOV2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Therapeutic response unexpected
Clinical narrative: did not get 2nd dose; bad headache stopped after Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (bad headache stopped after Moderna vaccine) and PRODUCT DOSE OMISSION ISSUE (did not get 2nd dose   ) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020 and Headache (After experiencing covid-19, patient continued having headaches.).    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (bad headache stopped after Moderna vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get 2nd dose   ). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (bad headache stopped after Moderna vaccine) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not get 2nd dose   ) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was provided by the reporter.  Patient had COVID-19, after it patient continued having headaches. But a week following vaccination headaches subsided. Patient did not get second dose.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Feeling hot, Incorrect route of product administration
Clinical narrative: Started to feel bad; Left side of their chest was red and warm; Left side of their chest was red and warm; subcutaneous injections instead of intramuscular one; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (Started to feel bad), ERYTHEMA (Left side of their chest was red and warm), FEELING HOT (Left side of their chest was red and warm) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (subcutaneous injections instead of intramuscular one) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 022M20A and 007M20A) for COVID-19 vaccination.     Concomitant products included METOPROLOL and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (subcutaneous injections instead of intramuscular one). On 06-Nov-2021, the patient experienced FEELING ABNORMAL (Started to feel bad), ERYTHEMA (Left side of their chest was red and warm) and FEELING HOT (Left side of their chest was red and warm). The patient was treated with IBUPROFEN for Adverse event, at a dose of 200 mg twice a day. On 05-Nov-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (subcutaneous injections instead of intramuscular one) had resolved. At the time of the report, FEELING ABNORMAL (Started to feel bad), ERYTHEMA (Left side of their chest was red and warm) and FEELING HOT (Left side of their chest was red and warm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that injection site was not at the deltoid muscle but more in the middle triceps area
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Mobility decreased
Clinical narrative: She spent a whole day in bed with her second shot; sick after having no problems in a year; Fatigue; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (She spent a whole day in bed with her second shot), ILLNESS (sick after having no problems in a year), FATIGUE (Fatigue) and HEADACHE (Headaches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced MOBILITY DECREASED (She spent a whole day in bed with her second shot), ILLNESS (sick after having no problems in a year), FATIGUE (Fatigue) and HEADACHE (Headaches). On 04-Feb-2021, MOBILITY DECREASED (She spent a whole day in bed with her second shot), ILLNESS (sick after having no problems in a year), FATIGUE (Fatigue) and HEADACHE (Headaches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MOD-2021-378233 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Injection site pain
Clinical narrative: (felt) very hot; Could feel his blood pressure going up; Felt the injection going into his arm/It was painful/Hurt as the needle was being withdrawn/Every time the weather changes he feels the pain in the muscle at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT ((felt) very hot), FEELING ABNORMAL (Could feel his blood pressure going up) and INJECTION SITE PAIN (Felt the injection going into his arm/It was painful/Hurt as the needle was being withdrawn/Every time the weather changes he feels the pain in the muscle at the injection site) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 033B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced FEELING HOT ((felt) very hot), FEELING ABNORMAL (Could feel his blood pressure going up) and INJECTION SITE PAIN (Felt the injection going into his arm/It was painful/Hurt as the needle was being withdrawn/Every time the weather changes he feels the pain in the muscle at the injection site). On 11-Jun-2021, INJECTION SITE PAIN (Felt the injection going into his arm/It was painful/Hurt as the needle was being withdrawn/Every time the weather changes he feels the pain in the muscle at the injection site) had resolved. At the time of the report, FEELING HOT ((felt) very hot) and FEELING ABNORMAL (Could feel his blood pressure going up) outcome was unknown.            No relevant concomitant medication was reported. Treatment information were not provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: patient received dose from a vial punctured more than 20 times; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (patient received dose from a vial punctured more than 20 times) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, the patient experienced UNDERDOSE (patient received dose from a vial punctured more than 20 times). On 08-Nov-2021, UNDERDOSE (patient received dose from a vial punctured more than 20 times) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore left arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm) and FATIGUE (fatigue) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore left arm) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (sore left arm) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment reported.   This case was linked to MOD-2021-378237, MOD-2021-378238 (Patient Link).
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Vaccination site pain, Vomiting
Clinical narrative: they were sick to their stomach; uncontrollable diarrhea; chills; their arm was sore; threw up last night; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (they were sick to their stomach), DIARRHOEA (uncontrollable diarrhea), CHILLS (chills), VACCINATION SITE PAIN (their arm was sore) and VOMITING (threw up last night) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced ABDOMINAL DISCOMFORT (they were sick to their stomach), DIARRHOEA (uncontrollable diarrhea), CHILLS (chills), VACCINATION SITE PAIN (their arm was sore) and VOMITING (threw up last night). At the time of the report, ABDOMINAL DISCOMFORT (they were sick to their stomach), DIARRHOEA (uncontrollable diarrhea), CHILLS (chills), VACCINATION SITE PAIN (their arm was sore) and VOMITING (threw up last night) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-378313 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Nausea; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Fatigue) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medications were reported No treatment medications were reported.   This case was linked to MOD-2021-378227, MOD-2021-378238 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Fatigue, Vaccination site pain
Clinical narrative: Sore left injection site arm; Patient was fatigued; Expired vaccine provided to the patient as a booster dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm), FATIGUE (Patient was fatigued) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine provided to the patient as a booster dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm), FATIGUE (Patient was fatigued) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine provided to the patient as a booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine provided to the patient as a booster dose) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) and FATIGUE (Patient was fatigued) outcome was unknown.            No concomitant and treatment medication were reported.   This case was linked to MOD-2021-378237, MOD-2021-378227 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: ongoing dizziness; really bad vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (ongoing dizziness) and VERTIGO (really bad vertigo) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (ongoing dizziness) and VERTIGO (really bad vertigo). At the time of the report, DIZZINESS (ongoing dizziness) and VERTIGO (really bad vertigo) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Heart rate, Hypertension, Tachycardia
Clinical narrative: tachycardia/pulse rate was 135; blood pressure was 150/110; felt very lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (tachycardia/pulse rate was 135), HYPERTENSION (blood pressure was 150/110) and DIZZINESS (felt very lightheaded) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 040B21A and 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Postural orthostatic tachycardia syndrome (POTS). Concomitant products included METOPROLOL for Blood pressure abnormal, ALPRAZOLAM (XANAX), QUETIAPINE FUMARATE (SEROQUEL) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced TACHYCARDIA (tachycardia/pulse rate was 135), HYPERTENSION (blood pressure was 150/110) and DIZZINESS (felt very lightheaded). The patient was treated with METOPROLOL for Adverse event, at a dose of 0.25 mg. At the time of the report, TACHYCARDIA (tachycardia/pulse rate was 135), HYPERTENSION (blood pressure was 150/110) and DIZZINESS (felt very lightheaded) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2021, Blood pressure measurement: 150/110 (High) 150/110. On 04-Nov-2021, Heart rate: 135 (High) 135.         The patient reported possible adverse events after her booster. On the evening of 04-Nov-2021, she experienced tachycardia, blood pressure was 150/110, pulse rate was 135, and felt very lightheaded. The patient immediately called emergency medical services and was transported to the local hospital. She stated the wait time was long therefore she left prior to being admitted and evaluated by HCP. She had reached out to her HCP twice regarding the event, once was on the evening of events and once on 05-Nov-2021. Her HCP had suggested that booster dose may be exacerbated her condition. She was advised by HCP not to take another dose of booster if needed in future. No previous diagnosis of COVID. No previous history of pericarditis or myocarditis.  For her events she took another dose of her blood pressure medication (self-treated with 0.25 mg metoprolol).
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: This spontaneous case reported by a consumer (subsequently medically confirmed), describes the occurrence of pruritus (itchy back) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included patchy rash (dry patches on his back from before the vaccine). On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pruritus (itchy back). At the time of the report, pruritus (itchy back) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medications and treatment information not provided. Patient had an itchy back that did not come from the shot according to his doctor, since he had dry patches on his back from before the vaccine. This case linked to MOD-2021-379265, MOD-2021-379259 (patient link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: extremely cold for 1 day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (extremely cold for 1 day) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced FEELING COLD (extremely cold for 1 day). At the time of the report, FEELING COLD (extremely cold for 1 day) outcome was unknown.            No Treatment information was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: (after booster dose)loss of appetite; (after booster dose)she felt very weak.; (after booster dose)mostly fatigue; (after booster dose)chills; (after booster dose)headache; (after booster dose)fever; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE ((after booster dose)loss of appetite), ASTHENIA ((after booster dose)she felt very weak.), FATIGUE ((after booster dose)mostly fatigue), CHILLS ((after booster dose)chills) and HEADACHE ((after booster dose)headache) in a 70-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.     No Medical History information was reported.   On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE ((after booster dose)loss of appetite), ASTHENIA ((after booster dose)she felt very weak.), FATIGUE ((after booster dose)mostly fatigue), CHILLS ((after booster dose)chills), HEADACHE ((after booster dose)headache) and PYREXIA ((after booster dose)fever). At the time of the report, DECREASED APPETITE ((after booster dose)loss of appetite), ASTHENIA ((after booster dose)she felt very weak.), FATIGUE ((after booster dose)mostly fatigue), CHILLS ((after booster dose)chills), HEADACHE ((after booster dose)headache) and PYREXIA ((after booster dose)fever) outcome was unknown.            Patient was born in 1951.  Concomitant medication was not reported.   Symptoms started on ??-NOV-2021.   Treatment medication information was not provided.   This case was linked to MOD-2021-378184 (Patient Link).