chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients were administered vaccine that were in the refrigerator beyond 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered vaccine that were in the refrigerator beyond 30 days) 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 EXPIRED PRODUCT ADMINISTERED (Patients were administered vaccine that were in the refrigerator beyond 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered vaccine that were in the refrigerator beyond 30 days) 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 reported.  Treatment medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Initial Additional-1
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I got my first shot in march and still need second; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I got my first shot in march and still need second) 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 PRODUCT DOSE OMISSION ISSUE (I got my first shot in march and still need second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I got my first shot in march and still need second) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second COVID shot, and it's only been 14 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second COVID shot, and it's only been 14 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    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, 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 (second COVID shot, and it's only been 14 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second COVID shot, and it's only been 14 days) outcome was unknown.            Concomitant information was not reported. Treatment information was not reported. The action taken with mRNA-1273 with the event was considered as not applicable.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Erythema, Heart rate, Nervousness
Clinical narrative: shaky still; Pressure went to 176 systolic; Heart rate was 126; she turned very red; difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (she turned very red), DYSPNOEA (difficulty breathing), NERVOUSNESS (shaky still), SYSTOLIC HYPERTENSION (Pressure went to 176 systolic) and TACHYCARDIA (Heart rate was 126) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jun-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 20-Jun-2021, the patient experienced ERYTHEMA (she turned very red), DYSPNOEA (difficulty breathing), SYSTOLIC HYPERTENSION (Pressure went to 176 systolic) and TACHYCARDIA (Heart rate was 126). On an unknown date, the patient experienced NERVOUSNESS (shaky still). The patient was treated with EPINEPHRINE ongoing since an unknown date at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) ongoing since an unknown date at an unspecified dose and frequency and ALBUTEROL [SALBUTAMOL] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ERYTHEMA (she turned very red), DYSPNOEA (difficulty breathing), NERVOUSNESS (shaky still), SYSTOLIC HYPERTENSION (Pressure went to 176 systolic) and TACHYCARDIA (Heart rate was 126) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: 120 (Inconclusive) blood pressure is 120's systolic. On 20-Jun-2021, Blood pressure measurement: 176 (Inconclusive) blood pressure went to 176 systolic. On 20-Jun-2021, Heart rate: 126 (Inconclusive) heart rate was 126 ..         Concomitant product were not provided/unknown. Treatment product includes fluids were reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Systolic hypertension, Tachycardia
Clinical narrative: shaky still; Pressure went to 176 systolic; Heart rate was 126; she turned very red; difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (she turned very red), DYSPNOEA (difficulty breathing), NERVOUSNESS (shaky still), SYSTOLIC HYPERTENSION (Pressure went to 176 systolic) and TACHYCARDIA (Heart rate was 126) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jun-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 20-Jun-2021, the patient experienced ERYTHEMA (she turned very red), DYSPNOEA (difficulty breathing), SYSTOLIC HYPERTENSION (Pressure went to 176 systolic) and TACHYCARDIA (Heart rate was 126). On an unknown date, the patient experienced NERVOUSNESS (shaky still). The patient was treated with EPINEPHRINE ongoing since an unknown date at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) ongoing since an unknown date at an unspecified dose and frequency and ALBUTEROL [SALBUTAMOL] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ERYTHEMA (she turned very red), DYSPNOEA (difficulty breathing), NERVOUSNESS (shaky still), SYSTOLIC HYPERTENSION (Pressure went to 176 systolic) and TACHYCARDIA (Heart rate was 126) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: 120 (Inconclusive) blood pressure is 120's systolic. On 20-Jun-2021, Blood pressure measurement: 176 (Inconclusive) blood pressure went to 176 systolic. On 20-Jun-2021, Heart rate: 126 (Inconclusive) heart rate was 126 ..         Concomitant product were not provided/unknown. Treatment product includes fluids were reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: pain in your arm after the shot; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in your arm after the shot) 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 MYALGIA (pain in your arm after the shot). At the time of the report, MYALGIA (pain in your arm after the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chest pain, Chills, Cough
Clinical narrative: back pain; chest pain; sweating bricks; extremely weak; sore arm that I cannot move; feel the heat in my throat; slight coughing; hurts when someone touches me anywhere on my body/sore arm that I cannot move; bad headache; chills all over; tired; nauseous so I have not eaten; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), CHEST PAIN (chest pain), HYPERHIDROSIS (sweating bricks), ASTHENIA (extremely weak) and VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (sore arm that I cannot move) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-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 BACK PAIN (back pain), CHEST PAIN (chest pain), HYPERHIDROSIS (sweating bricks), ASTHENIA (extremely weak), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (sore arm that I cannot move), OROPHARYNGEAL DISCOMFORT (feel the heat in my throat), COUGH (slight coughing), MYALGIA (hurts when someone touches me anywhere on my body/sore arm that I cannot move), HEADACHE (bad headache), CHILLS (chills all over), FATIGUE (tired) and NAUSEA (nauseous so I have not eaten). At the time of the report, BACK PAIN (back pain), CHEST PAIN (chest pain), HYPERHIDROSIS (sweating bricks), ASTHENIA (extremely weak), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (sore arm that I cannot move), OROPHARYNGEAL DISCOMFORT (feel the heat in my throat), COUGH (slight coughing), MYALGIA (hurts when someone touches me anywhere on my body/sore arm that I cannot move), HEADACHE (bad headache), CHILLS (chills all over), FATIGUE (tired) and NAUSEA (nauseous so I have not eaten) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not given.  No concomitant medications was reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Myalgia, Nausea
Clinical narrative: back pain; chest pain; sweating bricks; extremely weak; sore arm that I cannot move; feel the heat in my throat; slight coughing; hurts when someone touches me anywhere on my body/sore arm that I cannot move; bad headache; chills all over; tired; nauseous so I have not eaten; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), CHEST PAIN (chest pain), HYPERHIDROSIS (sweating bricks), ASTHENIA (extremely weak) and VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (sore arm that I cannot move) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-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 BACK PAIN (back pain), CHEST PAIN (chest pain), HYPERHIDROSIS (sweating bricks), ASTHENIA (extremely weak), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (sore arm that I cannot move), OROPHARYNGEAL DISCOMFORT (feel the heat in my throat), COUGH (slight coughing), MYALGIA (hurts when someone touches me anywhere on my body/sore arm that I cannot move), HEADACHE (bad headache), CHILLS (chills all over), FATIGUE (tired) and NAUSEA (nauseous so I have not eaten). At the time of the report, BACK PAIN (back pain), CHEST PAIN (chest pain), HYPERHIDROSIS (sweating bricks), ASTHENIA (extremely weak), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (sore arm that I cannot move), OROPHARYNGEAL DISCOMFORT (feel the heat in my throat), COUGH (slight coughing), MYALGIA (hurts when someone touches me anywhere on my body/sore arm that I cannot move), HEADACHE (bad headache), CHILLS (chills all over), FATIGUE (tired) and NAUSEA (nauseous so I have not eaten) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not given.  No concomitant medications was reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Vaccination site joint movement impairment
Clinical narrative: back pain; chest pain; sweating bricks; extremely weak; sore arm that I cannot move; feel the heat in my throat; slight coughing; hurts when someone touches me anywhere on my body/sore arm that I cannot move; bad headache; chills all over; tired; nauseous so I have not eaten; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), CHEST PAIN (chest pain), HYPERHIDROSIS (sweating bricks), ASTHENIA (extremely weak) and VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (sore arm that I cannot move) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-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 BACK PAIN (back pain), CHEST PAIN (chest pain), HYPERHIDROSIS (sweating bricks), ASTHENIA (extremely weak), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (sore arm that I cannot move), OROPHARYNGEAL DISCOMFORT (feel the heat in my throat), COUGH (slight coughing), MYALGIA (hurts when someone touches me anywhere on my body/sore arm that I cannot move), HEADACHE (bad headache), CHILLS (chills all over), FATIGUE (tired) and NAUSEA (nauseous so I have not eaten). At the time of the report, BACK PAIN (back pain), CHEST PAIN (chest pain), HYPERHIDROSIS (sweating bricks), ASTHENIA (extremely weak), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (sore arm that I cannot move), OROPHARYNGEAL DISCOMFORT (feel the heat in my throat), COUGH (slight coughing), MYALGIA (hurts when someone touches me anywhere on my body/sore arm that I cannot move), HEADACHE (bad headache), CHILLS (chills all over), FATIGUE (tired) and NAUSEA (nauseous so I have not eaten) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not given.  No concomitant medications was reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, SARS-CoV-2 test, Vaccination site erythema, Vaccination site induration
Clinical narrative: hard at the injection site; body aches; exhaustion; sore at the injection site; red at the injection site/injection site was red; swollen at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hard at the injection site), MYALGIA (body aches), FATIGUE (exhaustion), VACCINATION SITE PAIN (sore at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site/injection site was red) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced VACCINATION SITE INDURATION (hard at the injection site), MYALGIA (body aches), FATIGUE (exhaustion), VACCINATION SITE PAIN (sore at the injection site), VACCINATION SITE ERYTHEMA (red at the injection site/injection site was red) and VACCINATION SITE SWELLING (swollen at the injection site). On 14-May-2021, MYALGIA (body aches) had resolved. On 16-May-2021, VACCINATION SITE INDURATION (hard at the injection site), VACCINATION SITE PAIN (sore at the injection site) and VACCINATION SITE SWELLING (swollen at the injection site) had resolved. On 18-Jun-2021, FATIGUE (exhaustion) and VACCINATION SITE ERYTHEMA (red at the injection site/injection site was red) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information were reported by the reporter.  Treatment information included massage.   This case was linked to MOD-2021-231152 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: hard at the injection site; body aches; exhaustion; sore at the injection site; red at the injection site/injection site was red; swollen at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hard at the injection site), MYALGIA (body aches), FATIGUE (exhaustion), VACCINATION SITE PAIN (sore at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site/injection site was red) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced VACCINATION SITE INDURATION (hard at the injection site), MYALGIA (body aches), FATIGUE (exhaustion), VACCINATION SITE PAIN (sore at the injection site), VACCINATION SITE ERYTHEMA (red at the injection site/injection site was red) and VACCINATION SITE SWELLING (swollen at the injection site). On 14-May-2021, MYALGIA (body aches) had resolved. On 16-May-2021, VACCINATION SITE INDURATION (hard at the injection site), VACCINATION SITE PAIN (sore at the injection site) and VACCINATION SITE SWELLING (swollen at the injection site) had resolved. On 18-Jun-2021, FATIGUE (exhaustion) and VACCINATION SITE ERYTHEMA (red at the injection site/injection site was red) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information were reported by the reporter.  Treatment information included massage.   This case was linked to MOD-2021-231152 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Herpes zoster, Hypersensitivity, Illness, Pain
Clinical narrative: Very painful; shingles; very ill; Rash appeared at the injection site; Hypersensitivity reaction; itching; redness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), PAIN (Very painful), HERPES ZOSTER (shingles), PRURITUS (itching) and ERYTHEMA (redness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Wasp sting (sting 15 times, whole body rash, itching lasted forever a week) in 2019, Asthma, Hay fever, Urticaria and Hives.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction), PRURITUS (itching), ERYTHEMA (redness) and INJECTION SITE RASH (Rash appeared at the injection site). On an unknown date, the patient experienced PAIN (Very painful), HERPES ZOSTER (shingles) and ILLNESS (very ill). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 06-Mar-2021 to 20-Mar-2021 at an unspecified dose and frequency. On 21-Mar-2021, HYPERSENSITIVITY (Hypersensitivity reaction), PRURITUS (itching), ERYTHEMA (redness) and INJECTION SITE RASH (Rash appeared at the injection site) had resolved. At the time of the report, PAIN (Very painful) outcome was unknown and HERPES ZOSTER (shingles) and ILLNESS (very ill) had resolved.            Treatment information was not provided. Concomitant product use was not provided.   This case was linked to MOD-2021-042758, MOD-2021-042758 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up report received on 29-Jul-2021 and added new event information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site rash
Clinical narrative: Very painful; shingles; very ill; Rash appeared at the injection site; Hypersensitivity reaction; itching; redness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), PAIN (Very painful), HERPES ZOSTER (shingles), PRURITUS (itching) and ERYTHEMA (redness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Wasp sting (sting 15 times, whole body rash, itching lasted forever a week) in 2019, Asthma, Hay fever, Urticaria and Hives.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction), PRURITUS (itching), ERYTHEMA (redness) and INJECTION SITE RASH (Rash appeared at the injection site). On an unknown date, the patient experienced PAIN (Very painful), HERPES ZOSTER (shingles) and ILLNESS (very ill). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 06-Mar-2021 to 20-Mar-2021 at an unspecified dose and frequency. On 21-Mar-2021, HYPERSENSITIVITY (Hypersensitivity reaction), PRURITUS (itching), ERYTHEMA (redness) and INJECTION SITE RASH (Rash appeared at the injection site) had resolved. At the time of the report, PAIN (Very painful) outcome was unknown and HERPES ZOSTER (shingles) and ILLNESS (very ill) had resolved.            Treatment information was not provided. Concomitant product use was not provided.   This case was linked to MOD-2021-042758, MOD-2021-042758 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up report received on 29-Jul-2021 and added new event information.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test, Vaccination site erythema
Clinical narrative: exhaustion; red at the injection site/injection site was red; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (exhaustion) and VACCINATION SITE ERYTHEMA (red at the injection site/injection site was red) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in February 2021.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced FATIGUE (exhaustion) and VACCINATION SITE ERYTHEMA (red at the injection site/injection site was red). The patient was treated with Physical therapy for Vaccination site erythema. On 18-Jun-2021, VACCINATION SITE ERYTHEMA (red at the injection site/injection site was red) had resolved. At the time of the report, FATIGUE (exhaustion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2021, SARS-CoV-2 test: positive (Positive) positive.         It was reported that her gynecologist scheduled her for exploratory surgery to check for possible cancer. No concomitant medications were reported. Treatment included taking a massage.  Body temperature was taken on an unknown date and the results were 97.6 degrees F   This case was linked to MOD-2021-231139 (Patient Link).
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Bursitis, Dizziness, Fall
Clinical narrative: begun to feel dizzy and very light-headed/Dizziness; weak; had been falling a lot as well; Loss of balance; Can Barely Walk/Can't get around because it hurts so bad; Extreme Muscle Weakness; "Out of Sorts"; Delayed receiving second dose because he "bumped his elbow"; bursitis; bumped his elbow; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIZZINESS (begun to feel dizzy and very light-headed/Dizziness), ASTHENIA (weak), FALL (had been falling a lot as well), BALANCE DISORDER (Loss of balance) and GAIT DISTURBANCE (Can Barely Walk/Can't get around because it hurts so bad) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (begun to feel dizzy and very light-headed/Dizziness), ASTHENIA (weak), FALL (had been falling a lot as well), BALANCE DISORDER (Loss of balance), GAIT DISTURBANCE (Can Barely Walk/Can't get around because it hurts so bad), MUSCULAR WEAKNESS (Extreme Muscle Weakness), FEELING ABNORMAL ("Out of Sorts"), INTENTIONAL PRODUCT USE ISSUE (Delayed receiving second dose because he "bumped his elbow"), BURSITIS (bursitis) and JOINT INJURY (bumped his elbow). The patient was treated with PREDNISOLONE for Bursitis, at an unspecified dose and frequency. At the time of the report, DIZZINESS (begun to feel dizzy and very light-headed/Dizziness), ASTHENIA (weak), FALL (had been falling a lot as well), BALANCE DISORDER (Loss of balance), GAIT DISTURBANCE (Can Barely Walk/Can't get around because it hurts so bad), MUSCULAR WEAKNESS (Extreme Muscle Weakness), FEELING ABNORMAL ("Out of Sorts"), INTENTIONAL PRODUCT USE ISSUE (Delayed receiving second dose because he "bumped his elbow"), BURSITIS (bursitis) and JOINT INJURY (bumped his elbow) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  It was reported that caller is returning call from safety to provide email address.    This case was linked to MOD-2021-231221 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Treatment medication are added and New events are added. On 16-Jul-2021: Follow up document received contains No significant information (NNI).
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Intentional product use issue, Joint injury, Muscular weakness
Clinical narrative: begun to feel dizzy and very light-headed/Dizziness; weak; had been falling a lot as well; Loss of balance; Can Barely Walk/Can't get around because it hurts so bad; Extreme Muscle Weakness; "Out of Sorts"; Delayed receiving second dose because he "bumped his elbow"; bursitis; bumped his elbow; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIZZINESS (begun to feel dizzy and very light-headed/Dizziness), ASTHENIA (weak), FALL (had been falling a lot as well), BALANCE DISORDER (Loss of balance) and GAIT DISTURBANCE (Can Barely Walk/Can't get around because it hurts so bad) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (begun to feel dizzy and very light-headed/Dizziness), ASTHENIA (weak), FALL (had been falling a lot as well), BALANCE DISORDER (Loss of balance), GAIT DISTURBANCE (Can Barely Walk/Can't get around because it hurts so bad), MUSCULAR WEAKNESS (Extreme Muscle Weakness), FEELING ABNORMAL ("Out of Sorts"), INTENTIONAL PRODUCT USE ISSUE (Delayed receiving second dose because he "bumped his elbow"), BURSITIS (bursitis) and JOINT INJURY (bumped his elbow). The patient was treated with PREDNISOLONE for Bursitis, at an unspecified dose and frequency. At the time of the report, DIZZINESS (begun to feel dizzy and very light-headed/Dizziness), ASTHENIA (weak), FALL (had been falling a lot as well), BALANCE DISORDER (Loss of balance), GAIT DISTURBANCE (Can Barely Walk/Can't get around because it hurts so bad), MUSCULAR WEAKNESS (Extreme Muscle Weakness), FEELING ABNORMAL ("Out of Sorts"), INTENTIONAL PRODUCT USE ISSUE (Delayed receiving second dose because he "bumped his elbow"), BURSITIS (bursitis) and JOINT INJURY (bumped his elbow) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  It was reported that caller is returning call from safety to provide email address.    This case was linked to MOD-2021-231221 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Treatment medication are added and New events are added. On 16-Jul-2021: Follow up document received contains No significant information (NNI).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Pain, Pyrexia
Clinical narrative: lower back pain; body aches; Lowgrade fever of around 99-100 degrees; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (lower back pain), PAIN (body aches) and PYREXIA (Lowgrade fever of around 99-100 degrees) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B212A and 040B27A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced BACK PAIN (lower back pain), PAIN (body aches) and PYREXIA (Lowgrade fever of around 99-100 degrees). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at a dose of 1 dosage form. On 16-May-2021, PAIN (body aches) and PYREXIA (Lowgrade fever of around 99-100 degrees) had resolved. At the time of the report, BACK PAIN (lower back pain) had not resolved.            Patient used arthritic cream for his back as corrective.   No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Chest pain
Clinical narrative: chest pain; Abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) and ABDOMINAL PAIN (Abdominal pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain) and ABDOMINAL PAIN (Abdominal pain). At the time of the report, CHEST PAIN (chest pain) and ABDOMINAL PAIN (Abdominal pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Dysstasia, Feeling drunk, Feeling hot
Clinical narrative: pain in the back/sore back/lower back pain; pain in the lower back, kidneys and lungs; hotness; dizziness; could not stand; Covid-19-like symptoms; drunk-likeness; nausea; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain in the back/sore back/lower back pain), PAIN (pain in the lower back, kidneys and lungs), FEELING HOT (hotness), DIZZINESS (dizziness) and DYSSTASIA (could not stand) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced BACK PAIN (pain in the back/sore back/lower back pain), PAIN (pain in the lower back, kidneys and lungs), FEELING HOT (hotness), DIZZINESS (dizziness), DYSSTASIA (could not stand), SUSPECTED COVID-19 (Covid-19-like symptoms), FEELING DRUNK (drunk-likeness) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 29-May-2021, FEELING HOT (hotness), DIZZINESS (dizziness), DYSSTASIA (could not stand), FEELING DRUNK (drunk-likeness) and NAUSEA (nausea) had resolved. On 08-Jun-2021, BACK PAIN (pain in the back/sore back/lower back pain), PAIN (pain in the lower back, kidneys and lungs) and SUSPECTED COVID-19 (Covid-19-like symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported by the reporter
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Suspected COVID-19
Clinical narrative: pain in the back/sore back/lower back pain; pain in the lower back, kidneys and lungs; hotness; dizziness; could not stand; Covid-19-like symptoms; drunk-likeness; nausea; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain in the back/sore back/lower back pain), PAIN (pain in the lower back, kidneys and lungs), FEELING HOT (hotness), DIZZINESS (dizziness) and DYSSTASIA (could not stand) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced BACK PAIN (pain in the back/sore back/lower back pain), PAIN (pain in the lower back, kidneys and lungs), FEELING HOT (hotness), DIZZINESS (dizziness), DYSSTASIA (could not stand), SUSPECTED COVID-19 (Covid-19-like symptoms), FEELING DRUNK (drunk-likeness) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 29-May-2021, FEELING HOT (hotness), DIZZINESS (dizziness), DYSSTASIA (could not stand), FEELING DRUNK (drunk-likeness) and NAUSEA (nausea) had resolved. On 08-Jun-2021, BACK PAIN (pain in the back/sore back/lower back pain), PAIN (pain in the lower back, kidneys and lungs) and SUSPECTED COVID-19 (Covid-19-like symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported by the reporter
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Urinary tract infection, Vertigo
Clinical narrative: urinary tract infection; experiences vertigo "usually when I get up" / vertigo while sitting and throughout day; headache the day of receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (experiences vertigo "usually when I get up" / vertigo while sitting and throughout day), URINARY TRACT INFECTION (urinary tract infection) and HEADACHE (headache the day of receiving the vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Not provided and not provided) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (headache the day of receiving the vaccine). On 13-Feb-2021, the patient experienced VERTIGO (experiences vertigo "usually when I get up" / vertigo while sitting and throughout day). On an unknown date, the patient experienced URINARY TRACT INFECTION (urinary tract infection). At the time of the report, VERTIGO (experiences vertigo "usually when I get up" / vertigo while sitting and throughout day), URINARY TRACT INFECTION (urinary tract infection) and HEADACHE (headache the day of receiving the vaccine) outcome was unknown.            No Treatment information was reported
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Muscle spasms, Muscle twitching, Vaccination site mass
Clinical narrative: muscle spasm by the injection site, it's like a twitching sensation under the muscle; Feels like she has a bug on her legs, but she doesn't; had bumps at the injection site; Twitching is all over her body; Achiness in her joints especially her wrist; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE SPASMS (muscle spasm by the injection site, it's like a twitching sensation under the muscle), FEELING ABNORMAL (Feels like she has a bug on her legs, but she doesn't), VACCINATION SITE MASS (had bumps at the injection site), MUSCLE TWITCHING (Twitching is all over her body) and ARTHRALGIA (Achiness in her joints especially her wrist) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (muscle spasm by the injection site, it's like a twitching sensation under the muscle), FEELING ABNORMAL (Feels like she has a bug on her legs, but she doesn't), VACCINATION SITE MASS (had bumps at the injection site), MUSCLE TWITCHING (Twitching is all over her body) and ARTHRALGIA (Achiness in her joints especially her wrist). At the time of the report, MUSCLE SPASMS (muscle spasm by the injection site, it's like a twitching sensation under the muscle), FEELING ABNORMAL (Feels like she has a bug on her legs, but she doesn't), VACCINATION SITE MASS (had bumps at the injection site), MUSCLE TWITCHING (Twitching is all over her body) and ARTHRALGIA (Achiness in her joints especially her wrist) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose from vial that was opened on 6/18/21 was administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose from vial that was opened on 6/18/21 was administered) in a 46-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 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose from vial that was opened on 6/18/21 was administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose from vial that was opened on 6/18/21 was administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received on 22-JUN-2021 contains patient demographics and event information.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine was expired/ expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was expired/ expired dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine was expired/ expired dose). On 22-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The vaccine was expired/ expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No concomitant medication reported by reporter. No treatment medication reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Received a new document, address of the reporter, patient initials, date of birth, the expiry date and patient route of administration of second dose was updated.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm/worse with touching it; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/worse with touching it) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B27A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm/worse with touching it) and HEADACHE (headache). On 16-Apr-2021, HEADACHE (headache) had resolved. On 20-Apr-2021, PAIN IN EXTREMITY (sore arm/worse with touching it) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  After the first dose of the vaccine, the patient experienced a headache for 2-3 hours and a sore arm for 3-4 days. The arm was worse with touching it. No treatment information was provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-231296 (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 events, a causal relationship cannot be excluded.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination complication
Clinical narrative: patient has been diagnosed with a medical problem; chills; mild fever, fever for a month after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (patient has been diagnosed with a medical problem), PYREXIA (mild fever, fever for a month after 1st dose) and CHILLS (chills) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     The patient's past medical history included Colonoscopy. Concurrent medical conditions included Blood pressure. Concomitant products included LISINOPRIL for Blood pressure, ALENDRONATE SODIUM, CALCIUM, COLECALCIFEROL (ALOXIN) for an unknown indication.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced PYREXIA (mild fever, fever for a month after 1st dose). On an unknown date, the patient experienced VACCINATION COMPLICATION (patient has been diagnosed with a medical problem) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (patient has been diagnosed with a medical problem), PYREXIA (mild fever, fever for a month after 1st dose) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had been diagnosed with a medical problem (denied sharing more information on this) that might had been causing the fever they reported before, so patient believes their reactions in not related to the vaccine and sees no point in filling the questioners, although they mention that if Safety still wants those filled, they will do it.   This case was linked to MOD-2021-253098 (Dose 2) (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Additional event