chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   NO concomitant drug information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment medications were provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications were reported. Reporter stated that there were no symptoms or quality issues reported.No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. No Medical History information was reported.On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications reported by reporter. No treatment medications provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Expired vaccine used; Error resulting in administration of expired Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired Vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired Vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired Vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product information was provided. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-392935 (Patient Link).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea
Clinical narrative: Extreme nausea, muscle pain and soreness, headache, extreme chills
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Dizziness, Fatigue, Influenza like illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back was wide open hurting/ bad back ache), MUSCULAR WEAKNESS (legs were weak), DIZZINESS (lightheaded that she had to hold on to the counter, oozy), INFLUENZA LIKE ILLNESS (flu-like symptoms) and FATIGUE (fatigue) in a 78-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 19-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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, the patient experienced BACK PAIN (back was wide open hurting/ bad back ache), MUSCULAR WEAKNESS (legs were weak), DIZZINESS (lightheaded that she had to hold on to the counter, oozy), INFLUENZA LIKE ILLNESS (flu-like symptoms), FATIGUE (fatigue) and CHILLS (chills). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, BACK PAIN (back was wide open hurting/ bad back ache), MUSCULAR WEAKNESS (legs were weak), DIZZINESS (lightheaded that she had to hold on to the counter, oozy), INFLUENZA LIKE ILLNESS (flu-like symptoms), FATIGUE (fatigue) and CHILLS (chills) was resolving. No concomitant medication was reported by the reporter.Patient felt better after using heating pad.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back was wide open hurting/ bad back ache), MUSCULAR WEAKNESS (legs were weak), DIZZINESS (lightheaded that she had to hold on to the counter, oozy), INFLUENZA LIKE ILLNESS (flu-like symptoms) and FATIGUE (fatigue) in a 78-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 19-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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, the patient experienced BACK PAIN (back was wide open hurting/ bad back ache), MUSCULAR WEAKNESS (legs were weak), DIZZINESS (lightheaded that she had to hold on to the counter, oozy), INFLUENZA LIKE ILLNESS (flu-like symptoms), FATIGUE (fatigue) and CHILLS (chills). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, BACK PAIN (back was wide open hurting/ bad back ache), MUSCULAR WEAKNESS (legs were weak), DIZZINESS (lightheaded that she had to hold on to the counter, oozy), INFLUENZA LIKE ILLNESS (flu-like symptoms), FATIGUE (fatigue) and CHILLS (chills) was resolving. No concomitant medication was reported by the reporter.Patient felt better after using heating pad.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discomfort, Breast pain, Chills, Dermatitis, Influenza like illness
Clinical narrative: Felt her breast is very full./The circle around is all stretched out as if full of milk./. It felt heavy; Sore breast; Big red blotch on the left breast; Glands on her left under arm is very sore; Arm very sore; Achy; Chills; Not feeling well; Eyes are watery; Flu like symptoms; Skin was inflamed; This spontaneous case was reported by a consumer and describes the occurrence of BREAST DISCOMFORT (Felt her breast is very full./The circle around is all stretched out as if full of milk./. It felt heavy), BREAST PAIN (Sore breast), RASH MACULAR (Big red blotch on the left breast), MALAISE (Not feeling well) and LACRIMATION INCREASED (Eyes are watery) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 039B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced MALAISE (Not feeling well), LACRIMATION INCREASED (Eyes are watery), INFLUENZA LIKE ILLNESS (Flu like symptoms), DERMATITIS (Skin was inflamed), VACCINATION SITE PAIN (Arm very sore), MYALGIA (Achy) and CHILLS (Chills). On 20-Nov-2021, the patient experienced BREAST DISCOMFORT (Felt her breast is very full./The circle around is all stretched out as if full of milk./. It felt heavy), BREAST PAIN (Sore breast), RASH MACULAR (Big red blotch on the left breast) and LYMPHADENOPATHY (Glands on her left under arm is very sore). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 20-Nov-2021, MALAISE (Not feeling well), LACRIMATION INCREASED (Eyes are watery), INFLUENZA LIKE ILLNESS (Flu like symptoms), DERMATITIS (Skin was inflamed), VACCINATION SITE PAIN (Arm very sore), MYALGIA (Achy) and CHILLS (Chills) had resolved. At the time of the report, BREAST DISCOMFORT (Felt her breast is very full./The circle around is all stretched out as if full of milk./. It felt heavy), BREAST PAIN (Sore breast), RASH MACULAR (Big red blotch on the left breast) and LYMPHADENOPATHY (Glands on her left under arm is very sore) outcome was unknown.  Concomitant medication information was not provided by the reporter.This case was linked to MOD-2021-395698 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Lymphadenopathy, Malaise, Myalgia, Rash macular
Clinical narrative: Felt her breast is very full./The circle around is all stretched out as if full of milk./. It felt heavy; Sore breast; Big red blotch on the left breast; Glands on her left under arm is very sore; Arm very sore; Achy; Chills; Not feeling well; Eyes are watery; Flu like symptoms; Skin was inflamed; This spontaneous case was reported by a consumer and describes the occurrence of BREAST DISCOMFORT (Felt her breast is very full./The circle around is all stretched out as if full of milk./. It felt heavy), BREAST PAIN (Sore breast), RASH MACULAR (Big red blotch on the left breast), MALAISE (Not feeling well) and LACRIMATION INCREASED (Eyes are watery) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 039B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced MALAISE (Not feeling well), LACRIMATION INCREASED (Eyes are watery), INFLUENZA LIKE ILLNESS (Flu like symptoms), DERMATITIS (Skin was inflamed), VACCINATION SITE PAIN (Arm very sore), MYALGIA (Achy) and CHILLS (Chills). On 20-Nov-2021, the patient experienced BREAST DISCOMFORT (Felt her breast is very full./The circle around is all stretched out as if full of milk./. It felt heavy), BREAST PAIN (Sore breast), RASH MACULAR (Big red blotch on the left breast) and LYMPHADENOPATHY (Glands on her left under arm is very sore). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 20-Nov-2021, MALAISE (Not feeling well), LACRIMATION INCREASED (Eyes are watery), INFLUENZA LIKE ILLNESS (Flu like symptoms), DERMATITIS (Skin was inflamed), VACCINATION SITE PAIN (Arm very sore), MYALGIA (Achy) and CHILLS (Chills) had resolved. At the time of the report, BREAST DISCOMFORT (Felt her breast is very full./The circle around is all stretched out as if full of milk./. It felt heavy), BREAST PAIN (Sore breast), RASH MACULAR (Big red blotch on the left breast) and LYMPHADENOPATHY (Glands on her left under arm is very sore) outcome was unknown.  Concomitant medication information was not provided by the reporter.This case was linked to MOD-2021-395698 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Felt her breast is very full./The circle around is all stretched out as if full of milk./. It felt heavy; Sore breast; Big red blotch on the left breast; Glands on her left under arm is very sore; Arm very sore; Achy; Chills; Not feeling well; Eyes are watery; Flu like symptoms; Skin was inflamed; This spontaneous case was reported by a consumer and describes the occurrence of BREAST DISCOMFORT (Felt her breast is very full./The circle around is all stretched out as if full of milk./. It felt heavy), BREAST PAIN (Sore breast), RASH MACULAR (Big red blotch on the left breast), MALAISE (Not feeling well) and LACRIMATION INCREASED (Eyes are watery) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 039B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced MALAISE (Not feeling well), LACRIMATION INCREASED (Eyes are watery), INFLUENZA LIKE ILLNESS (Flu like symptoms), DERMATITIS (Skin was inflamed), VACCINATION SITE PAIN (Arm very sore), MYALGIA (Achy) and CHILLS (Chills). On 20-Nov-2021, the patient experienced BREAST DISCOMFORT (Felt her breast is very full./The circle around is all stretched out as if full of milk./. It felt heavy), BREAST PAIN (Sore breast), RASH MACULAR (Big red blotch on the left breast) and LYMPHADENOPATHY (Glands on her left under arm is very sore). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 20-Nov-2021, MALAISE (Not feeling well), LACRIMATION INCREASED (Eyes are watery), INFLUENZA LIKE ILLNESS (Flu like symptoms), DERMATITIS (Skin was inflamed), VACCINATION SITE PAIN (Arm very sore), MYALGIA (Achy) and CHILLS (Chills) had resolved. At the time of the report, BREAST DISCOMFORT (Felt her breast is very full./The circle around is all stretched out as if full of milk./. It felt heavy), BREAST PAIN (Sore breast), RASH MACULAR (Big red blotch on the left breast) and LYMPHADENOPATHY (Glands on her left under arm is very sore) outcome was unknown.  Concomitant medication information was not provided by the reporter.This case was linked to MOD-2021-395698 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal, Headache, Injection site pain, Injection site pruritus
Clinical narrative: I feel like I have sinus infection kind of (booster); fuzzy headed; little bit of cough (booster); Body aches; real bad headache; arm still hurts a little bit (booster); itchy (booster); swollen a little bit at the site, when touches it hurts (booster); swollen a little bit at the site, when touches it hurts (booster); This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (I feel like I have sinus infection kind of (booster)), FEELING ABNORMAL (fuzzy headed), COUGH (little bit of cough (booster)), MYALGIA (Body aches) and HEADACHE (real bad headache) 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced SINUSITIS (I feel like I have sinus infection kind of (booster)), FEELING ABNORMAL (fuzzy headed), COUGH (little bit of cough (booster)), MYALGIA (Body aches), HEADACHE (real bad headache), INJECTION SITE PAIN (arm still hurts a little bit (booster)), INJECTION SITE PRURITUS (itchy (booster)), VACCINATION SITE PAIN (swollen a little bit at the site, when touches it hurts (booster)) and VACCINATION SITE SWELLING (swollen a little bit at the site, when touches it hurts (booster)). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 1-2 dose per day and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, SINUSITIS (I feel like I have sinus infection kind of (booster)) and VACCINATION SITE PAIN (swollen a little bit at the site, when touches it hurts (booster)) outcome was unknown, FEELING ABNORMAL (fuzzy headed), MYALGIA (Body aches), INJECTION SITE PRURITUS (itchy (booster)) and VACCINATION SITE SWELLING (swollen a little bit at the site, when touches it hurts (booster)) had resolved and COUGH (little bit of cough (booster)), HEADACHE (real bad headache) and INJECTION SITE PAIN (arm still hurts a little bit (booster)) had not resolved. No concomitant drug details were reported by the reporter.  This case was linked to MOD-2021-395755, MOD-2021-395756 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Sinusitis, Vaccination site pain, Vaccination site swelling
Clinical narrative: I feel like I have sinus infection kind of (booster); fuzzy headed; little bit of cough (booster); Body aches; real bad headache; arm still hurts a little bit (booster); itchy (booster); swollen a little bit at the site, when touches it hurts (booster); swollen a little bit at the site, when touches it hurts (booster); This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (I feel like I have sinus infection kind of (booster)), FEELING ABNORMAL (fuzzy headed), COUGH (little bit of cough (booster)), MYALGIA (Body aches) and HEADACHE (real bad headache) 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced SINUSITIS (I feel like I have sinus infection kind of (booster)), FEELING ABNORMAL (fuzzy headed), COUGH (little bit of cough (booster)), MYALGIA (Body aches), HEADACHE (real bad headache), INJECTION SITE PAIN (arm still hurts a little bit (booster)), INJECTION SITE PRURITUS (itchy (booster)), VACCINATION SITE PAIN (swollen a little bit at the site, when touches it hurts (booster)) and VACCINATION SITE SWELLING (swollen a little bit at the site, when touches it hurts (booster)). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 1-2 dose per day and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, SINUSITIS (I feel like I have sinus infection kind of (booster)) and VACCINATION SITE PAIN (swollen a little bit at the site, when touches it hurts (booster)) outcome was unknown, FEELING ABNORMAL (fuzzy headed), MYALGIA (Body aches), INJECTION SITE PRURITUS (itchy (booster)) and VACCINATION SITE SWELLING (swollen a little bit at the site, when touches it hurts (booster)) had resolved and COUGH (little bit of cough (booster)), HEADACHE (real bad headache) and INJECTION SITE PAIN (arm still hurts a little bit (booster)) had not resolved. No concomitant drug details were reported by the reporter.  This case was linked to MOD-2021-395755, MOD-2021-395756 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pruritus
Clinical narrative: Itchy lump at the vaccination site; Itchy lump at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Itchy lump at the vaccination site) and VACCINATION SITE PRURITUS (Itchy lump at the vaccination site) 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 VACCINATION SITE MASS (Itchy lump at the vaccination site) and VACCINATION SITE PRURITUS (Itchy lump at the vaccination site). At the time of the report, VACCINATION SITE MASS (Itchy lump at the vaccination site) and VACCINATION SITE PRURITUS (Itchy lump at the vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (administration of 3rd dose instead of booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination. No Medical History information was reported.On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (administration of 3rd dose instead of booster). On 19-Nov-2021, PRODUCT ADMINISTRATION ERROR (administration of 3rd dose instead of booster) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported.Treatment medication was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness Of Breath (SOB) after booster) and FATIGUE (Tired after booster) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 014M20A and 012M20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high (Blood Pressure is under control by taking Medication).Concomitant products included OMEPRAZOLE (AZORAN [OMEPRAZOLE]) for an unknown indication.On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced DYSPNOEA (Shortness Of Breath (SOB) after booster) and FATIGUE (Tired after booster). At the time of the report, DYSPNOEA (Shortness Of Breath (SOB) after booster) and FATIGUE (Tired after booster) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. Lab test included Cardiac Lab values ECG, cardiac test, cardiac enzymes. No treatment information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, Oral herpes, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (cold sore) and FUNGAL INFECTION (yeast infection) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 29L20A) for COVID-19 vaccination. No Medical History information was reported.On 12-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, the patient experienced ORAL HERPES (cold sore). On 18-Nov-2021, the patient experienced FUNGAL INFECTION (yeast infection). The patient was treated with LYSINE for Cold sores, at an unspecified dose and frequency. On 13-Nov-2021, ORAL HERPES (cold sore) had resolved. On 18-Nov-2021, FUNGAL INFECTION (yeast infection) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):In October 2021, SARS-CoV-2 test: positive (Positive) Positive. Patient is not sexually active and has no allergies or maintenance medications No relevant concomitant medications were reported.Treatment medications include Monostat for Yeast infection. This case was linked to MOD-2021-395722, MOD-2021-395729 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm on the site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. No Medical History information was reported.On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm on the site). At the time of the report, VACCINATION SITE PAIN (sore arm on the site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2021-395711, MOD-2021-395729 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Skin discolouration
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Fingertips are turning blue) and PAIN IN EXTREMITY (It hurts really bad) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (Fingertips are turning blue) and PAIN IN EXTREMITY (It hurts really bad). At the time of the report, SKIN DISCOLOURATION (Fingertips are turning blue) and PAIN IN EXTREMITY (It hurts really bad) outcome was unknown. No Concomitant medications were reported. No treatment details were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (painful injection site after the first vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.  No Medical History information was reported.On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE PAIN (painful injection site after the first vaccine). At the time of the report, VACCINATION SITE PAIN (painful injection site after the first vaccine) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.No concomitant medication was reported by the reporter.No treatment was reported by the reporter.This case was linked to MOD-2021-395870, MOD-2021-395871 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: sore arms on the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arms on the site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 29L20A and 025J20A) for COVID-19 vaccination. No Medical History information was reported. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arms on the site). At the time of the report, VACCINATION SITE PAIN (sore arms on the site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive in October. No concomitant medication details was provided.No treatment medication details was provided. This case was linked to MOD-2021-395722, MOD-2021-395711 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Hypersensitivity, Nausea, Pain
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of HYPERSENSITIVITY (looked like an allergic reaction), NAUSEA (nausea), VACCINATION SITE WARMTH (hot), VACCINATION SITE SWELLING (swollen/ It goes to her elbow on the anterior part of her arm) and VACCINATION SITE ERYTHEMA (red/ It goes to her elbow on the anterior part of her arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced HYPERSENSITIVITY (looked like an allergic reaction), NAUSEA (nausea), VACCINATION SITE WARMTH (hot), VACCINATION SITE SWELLING (swollen/ It goes to her elbow on the anterior part of her arm), VACCINATION SITE ERYTHEMA (red/ It goes to her elbow on the anterior part of her arm), VACCINATION SITE PAIN (tender/ It goes to her elbow on the anterior part of her arm), PAIN (achy) and PYREXIA (fever of 99.2°F). 19-Nov-2021, the patient experienced FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form; ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at a dose of 1 dosage form; CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for Adverse event, at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. On 21-Nov-2021, PYREXIA (fever of 99.2°F) had resolved. At the time of the report, HYPERSENSITIVITY (looked like an allergic reaction), NAUSEA (nausea), VACCINATION SITE WARMTH (hot), VACCINATION SITE SWELLING (swollen/ It goes to her elbow on the anterior part of her arm), VACCINATION SITE ERYTHEMA (red/ It goes to her elbow on the anterior part of her arm), VACCINATION SITE PAIN (tender/ It goes to her elbow on the anterior part of her arm), PAIN (achy) and FATIGUE (tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Nov-2021, Body temperature: 99.2 (High) 99.2°F.For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Treatment: Ice on the injection site.No concomitant information were reported by the reporter. This case was linked to MOD-2021-395732, MOD-2021-395697 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of HYPERSENSITIVITY (looked like an allergic reaction), NAUSEA (nausea), VACCINATION SITE WARMTH (hot), VACCINATION SITE SWELLING (swollen/ It goes to her elbow on the anterior part of her arm) and VACCINATION SITE ERYTHEMA (red/ It goes to her elbow on the anterior part of her arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced HYPERSENSITIVITY (looked like an allergic reaction), NAUSEA (nausea), VACCINATION SITE WARMTH (hot), VACCINATION SITE SWELLING (swollen/ It goes to her elbow on the anterior part of her arm), VACCINATION SITE ERYTHEMA (red/ It goes to her elbow on the anterior part of her arm), VACCINATION SITE PAIN (tender/ It goes to her elbow on the anterior part of her arm), PAIN (achy) and PYREXIA (fever of 99.2°F). 19-Nov-2021, the patient experienced FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form; ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at a dose of 1 dosage form; CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for Adverse event, at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. On 21-Nov-2021, PYREXIA (fever of 99.2°F) had resolved. At the time of the report, HYPERSENSITIVITY (looked like an allergic reaction), NAUSEA (nausea), VACCINATION SITE WARMTH (hot), VACCINATION SITE SWELLING (swollen/ It goes to her elbow on the anterior part of her arm), VACCINATION SITE ERYTHEMA (red/ It goes to her elbow on the anterior part of her arm), VACCINATION SITE PAIN (tender/ It goes to her elbow on the anterior part of her arm), PAIN (achy) and FATIGUE (tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Nov-2021, Body temperature: 99.2 (High) 99.2°F.For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Treatment: Ice on the injection site.No concomitant information were reported by the reporter. This case was linked to MOD-2021-395732, MOD-2021-395697 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, SARS-CoV-2 test, Tachycardia
Clinical narrative: Fast heart rate/ the same night, her heart rate was 62 beats per minute which is faster than normal for her/ climbed up to the 70s and 80 and during the day it was mostly between 84-110 beats per minute/ heart rate peaked at 128 beats per minute; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Fast heart rate/ the same night, her heart rate was 62 beats per minute which is faster than normal for her/ climbed up to the 70s and 80 and during the day it was mostly between 84-110 beats per minute/ heart rate peaked at 128 beats per minute) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (The patient had lost her sense of taste and smell and experienced an increase in heart rate as well) on 17-Dec-2020, Heart rate increased (Heart rate in the 120s. It has happened once or twice before that as well. ) in January 2020 and Left bundle branch block (Diagnosed with approximately 10 years ago) in 2011. Concomitant products included LOSARTAN, LEVOTHYROXINE, CETIRIZINE, FAMOTIDINE, SIMVASTATIN, ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS), BIOTIN, COLECALCIFEROL (VITAMIN D3), LORAZEPAM and BEVACIZUMAB (AVASTIN [BEVACIZUMAB]) for an unknown indication.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TACHYCARDIA (Fast heart rate/ the same night, her heart rate was 62 beats per minute which is faster than normal for her/ climbed up to the 70s and 80 and during the day it was mostly between 84-110 beats per minute/ heart rate peaked at 128 beats per minute). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 08-Mar-2021, TACHYCARDIA (Fast heart rate/ the same night, her heart rate was 62 beats per minute which is faster than normal for her/ climbed up to the 70s and 80 and during the day it was mostly between 84-110 beats per minute/ heart rate peaked at 128 beats per minute) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive. On 06-Mar-2021, Heart rate: 62 (High) 62 beats per minute, climbed up to the 70s and 80. On 07-Mar-2021, Heart rate: 84-110 (High) 84-110 beats per minute and 128 (High) 128 beats per minute.         Concomitant medication also included unspecified Probiotic   This case was linked to MOD-2021-395703 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal, Headache, Myalgia, Pain in extremity
Clinical narrative: fuzzy headed; arm hurt; little bit of cough; Body ache; real bad headache; swollen at the site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (fuzzy headed), PAIN IN EXTREMITY (arm hurt), COUGH (little bit of cough), MYALGIA (Body ache) and HEADACHE (real bad headache) 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 18-Nov-2021, 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 experienced FEELING ABNORMAL (fuzzy headed), PAIN IN EXTREMITY (arm hurt), COUGH (little bit of cough), MYALGIA (Body ache), HEADACHE (real bad headache) and VACCINATION SITE SWELLING (swollen at the site). At the time of the report, FEELING ABNORMAL (fuzzy headed), PAIN IN EXTREMITY (arm hurt), COUGH (little bit of cough), MYALGIA (Body ache), HEADACHE (real bad headache) and VACCINATION SITE SWELLING (swollen at the site) had not resolved. No concomitant medications and treatment medications reported.This case was linked to MOD-2021-395585, MOD-2021-395756 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: fuzzy headed; arm hurt; little bit of cough; Body ache; real bad headache; swollen at the site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (fuzzy headed), PAIN IN EXTREMITY (arm hurt), COUGH (little bit of cough), MYALGIA (Body ache) and HEADACHE (real bad headache) 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 18-Nov-2021, 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 experienced FEELING ABNORMAL (fuzzy headed), PAIN IN EXTREMITY (arm hurt), COUGH (little bit of cough), MYALGIA (Body ache), HEADACHE (real bad headache) and VACCINATION SITE SWELLING (swollen at the site). At the time of the report, FEELING ABNORMAL (fuzzy headed), PAIN IN EXTREMITY (arm hurt), COUGH (little bit of cough), MYALGIA (Body ache), HEADACHE (real bad headache) and VACCINATION SITE SWELLING (swollen at the site) had not resolved. No concomitant medications and treatment medications reported.This case was linked to MOD-2021-395585, MOD-2021-395756 (Patient Link).