chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pain
Clinical narrative: Whole body ached; feeling nauseated; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Whole body ached) and NAUSEA (feeling nauseated) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN (Whole body ached) and NAUSEA (feeling nauseated). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN (Whole body ached) and NAUSEA (feeling nauseated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Body temperature: 101 f High.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Palmar erythema, Pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Had heat, swelling and a little soreness at injection site), VACCINATION SITE SWELLING (Had heat, swelling and a little soreness at injection site), VACCINATION SITE PAIN (Had heat, swelling and a little soreness at injection site), VACCINATION SITE WARMTH (heat, swelling and a little soreness at injection site) and VACCINATION SITE SWELLING (heat, swelling and a little soreness at injection site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Coronary artery disease, High cholesterol (high cholesterol controlled), Blood pressure high, Prostate cancer and Lymphoma. Concurrent medical conditions included Drug allergy (sulfa drugs). On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Had heat, swelling and a little soreness at injection site), VACCINATION SITE SWELLING (Had heat, swelling and a little soreness at injection site) and VACCINATION SITE PAIN (Had heat, swelling and a little soreness at injection site). On 21-Mar-2021, the patient experienced VACCINATION SITE WARMTH (heat, swelling and a little soreness at injection site), VACCINATION SITE SWELLING (heat, swelling and a little soreness at injection site) and VACCINATION SITE PAIN (heat, swelling and a little soreness at injection site). On 30-Mar-2021, the patient experienced PALMAR ERYTHEMA (palms of hands are reddened). On an unknown date, the patient experienced PRURITUS (redness and itciness in right armpit; itching bilateral hands) and ERYTHEMA (armpit redness). At the time of the report, VACCINATION SITE WARMTH (Had heat, swelling and a little soreness at injection site), VACCINATION SITE SWELLING (Had heat, swelling and a little soreness at injection site), VACCINATION SITE PAIN (Had heat, swelling and a little soreness at injection site), VACCINATION SITE WARMTH (heat, swelling and a little soreness at injection site), VACCINATION SITE SWELLING (heat, swelling and a little soreness at injection site), VACCINATION SITE PAIN (heat, swelling and a little soreness at injection site), PALMAR ERYTHEMA (palms of hands are reddened), PRURITUS (redness and itciness in right armpit; itching bilateral hands) and ERYTHEMA (armpit redness) outcome was unknown. Not Provided. This case was linked to US-MODERNATX, INC.-MOD-2021-062719 (E2B Linked Report). This case was linked to MOD-2021-062719, MOD-2021-062719 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062719:
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Had heat, swelling and a little soreness at injection site), VACCINATION SITE SWELLING (Had heat, swelling and a little soreness at injection site), VACCINATION SITE PAIN (Had heat, swelling and a little soreness at injection site), VACCINATION SITE WARMTH (heat, swelling and a little soreness at injection site) and VACCINATION SITE SWELLING (heat, swelling and a little soreness at injection site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Coronary artery disease, High cholesterol (high cholesterol controlled), Blood pressure high, Prostate cancer and Lymphoma. Concurrent medical conditions included Drug allergy (sulfa drugs). On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Had heat, swelling and a little soreness at injection site), VACCINATION SITE SWELLING (Had heat, swelling and a little soreness at injection site) and VACCINATION SITE PAIN (Had heat, swelling and a little soreness at injection site). On 21-Mar-2021, the patient experienced VACCINATION SITE WARMTH (heat, swelling and a little soreness at injection site), VACCINATION SITE SWELLING (heat, swelling and a little soreness at injection site) and VACCINATION SITE PAIN (heat, swelling and a little soreness at injection site). On 30-Mar-2021, the patient experienced PALMAR ERYTHEMA (palms of hands are reddened). On an unknown date, the patient experienced PRURITUS (redness and itciness in right armpit; itching bilateral hands) and ERYTHEMA (armpit redness). At the time of the report, VACCINATION SITE WARMTH (Had heat, swelling and a little soreness at injection site), VACCINATION SITE SWELLING (Had heat, swelling and a little soreness at injection site), VACCINATION SITE PAIN (Had heat, swelling and a little soreness at injection site), VACCINATION SITE WARMTH (heat, swelling and a little soreness at injection site), VACCINATION SITE SWELLING (heat, swelling and a little soreness at injection site), VACCINATION SITE PAIN (heat, swelling and a little soreness at injection site), PALMAR ERYTHEMA (palms of hands are reddened), PRURITUS (redness and itciness in right armpit; itching bilateral hands) and ERYTHEMA (armpit redness) outcome was unknown. Not Provided. This case was linked to US-MODERNATX, INC.-MOD-2021-062719 (E2B Linked Report). This case was linked to MOD-2021-062719, MOD-2021-062719 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062719:
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Turned red and still swollen; Fever in arm / Hot to touch / uncomfortable; Swelling; uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Turned red and still swollen), VACCINATION SITE WARMTH (Fever in arm / Hot to touch / uncomfortable), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (uncomfortable) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037k20a and 032L20a) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-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 PERIPHERAL SWELLING (Turned red and still swollen), VACCINATION SITE WARMTH (Fever in arm / Hot to touch / uncomfortable), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (uncomfortable). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Turned red and still swollen), VACCINATION SITE WARMTH (Fever in arm / Hot to touch / uncomfortable), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (uncomfortable) outcome was unknown.            Concomitant medications include cholesterol meds, blood pressure meds, kidney meds and glaucoma eye drops.   This case was linked to MOD-2021-031107 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Oropharyngeal pain, Thirst
Clinical narrative: "frog in her throat"/sore throat; left ear became "really hot", and her neck felt warm; being very thirsty; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT, THIRST, and OROPHARYNGEAL PAIN in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included Anxiety and Depression. Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL, HCTZ, and SERTRALINE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced FEELING HOT, and THIRST. On 29-Mar-2021, the patient experienced OROPHARYNGEAL PAIN. The patient was treated with TYLENOL at an unspecified dose and frequency. At the time of the report, FEELING HOT, THIRST, and OROPHARYNGEAL PAIN outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment medications to the events includes drinking fluids. The consumer stated that the second dose in the series from Moderna's vaccine is scheduled for today (30Mar2021).
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Burning sensation, Myalgia
Clinical narrative: Stomach going crazy; burning feeling; Bloating feeling; Typical sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach going crazy), BURNING SENSATION (burning feeling), ABDOMINAL DISTENSION (Bloating feeling) and MYALGIA (Typical sore arm) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Anxiety and GERD.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach going crazy), BURNING SENSATION (burning feeling), ABDOMINAL DISTENSION (Bloating feeling) and MYALGIA (Typical sore arm). At the time of the report, ABDOMINAL DISCOMFORT (Stomach going crazy), BURNING SENSATION (burning feeling), ABDOMINAL DISTENSION (Bloating feeling) and MYALGIA (Typical sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment information were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness postural
Clinical narrative: feels dizzy,; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS POSTURAL feels dizzy,) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 immunisation.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS POSTURAL feels dizzy,). At the time of the report, DIZZINESS POSTURAL (feels dizzy,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient takes medication for pre-diabetes.   This case was linked to MOD21-065775 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: ADR Form received on 17-MAY-2021 Contains No new information; Sender's Comments:  MOD21-065775:1st patient
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: she had fever 100.7; she had headache and fever 100.7; she had chills; her arm was hurting; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (her arm was hurting), PYREXIA (she had fever 100.7), HEADACHE (she had headache and fever 100.7) and CHILLS (she had chills) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A (Unsure)) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (her arm was hurting). On 30-Mar-2021, the patient experienced PYREXIA (she had fever 100.7), HEADACHE (she had headache and fever 100.7) and CHILLS (she had chills). At the time of the report, PAIN IN EXTREMITY (her arm was hurting), PYREXIA (she had fever 100.7), HEADACHE (she had headache and fever 100.7) and CHILLS (she had chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information were reported.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site irritation, Vaccination site pruritus, Vaccination site rash
Clinical narrative: clothing rubbing on her arm bothered it; rash; itchy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE IRRITATION (clothing rubbing on her arm bothered it), VACCINATION SITE RASH (rash) and VACCINATION SITE PRURITUS (itchy) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced INJECTION SITE IRRITATION (clothing rubbing on her arm bothered it), VACCINATION SITE RASH (rash) and VACCINATION SITE PRURITUS (itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 27-Feb-2021, INJECTION SITE IRRITATION (clothing rubbing on her arm bothered it), VACCINATION SITE RASH (rash) and VACCINATION SITE PRURITUS (itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PYREXIA (fever) and HEADACHE (headache). At the time of the report, PYREXIA (fever) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Ultrasound abdomen
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 04-Oct-2020 and the estimated date of delivery was 09-Jul-2021. On 27-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy.  On 27-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound abdomen: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient has an established prenatal care. The estimated date of conception was 17-Oct-2020. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Internal review on 28-Jul-2021 resulted in updates to the pregnancy information.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Receiving SECOND Shot 73 days after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receiving SECOND Shot 73 days after the first shot) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-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 30-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receiving SECOND Shot 73 days after the first shot). On 30-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receiving SECOND Shot 73 days after the first shot) had resolved. Not Provided          No concomitant medications were reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Palmar erythema, Pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: itch in both hands/ itchiness in right armpit; Palms of hands are reddened; redness in right armpit; Had heat, swelling and a little soreness at injection site; Had heat, swelling and a little soreness at injection site; Had heat, swelling and a little soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Had heat, swelling and a little soreness at injection site), PRURITUS (itch in both hands/ itchiness in right armpit), PALMAR ERYTHEMA (Palms of hands are reddened), ERYTHEMA (redness in right armpit) and VACCINATION SITE PAIN (Had heat, swelling and a little soreness at injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Prostate cancer (prostate CA) and Lymphoma. Concurrent medical conditions included Sulfonamide allergy (sulfa drugs), Coronary artery disease, Hypercholesterolaemia (High cholesterol controlled) and Hypertension (High blood pressure).   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Had heat, swelling and a little soreness at injection site), VACCINATION SITE PAIN (Had heat, swelling and a little soreness at injection site) and VACCINATION SITE SWELLING (Had heat, swelling and a little soreness at injection site). On 30-Mar-2021, the patient experienced PRURITUS (itch in both hands/ itchiness in right armpit), PALMAR ERYTHEMA (Palms of hands are reddened) and ERYTHEMA (redness in right armpit). At the time of the report, VACCINATION SITE WARMTH (Had heat, swelling and a little soreness at injection site), PRURITUS (itch in both hands/ itchiness in right armpit), PALMAR ERYTHEMA (Palms of hands are reddened), ERYTHEMA (redness in right armpit), VACCINATION SITE PAIN (Had heat, swelling and a little soreness at injection site) and VACCINATION SITE SWELLING (Had heat, swelling and a little soreness at injection site) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No  concomitant medications were reported.   Treatment information was not provided.   This case was linked to MOD-2021-062685 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: itch in both hands/ itchiness in right armpit; Palms of hands are reddened; redness in right armpit; Had heat, swelling and a little soreness at injection site; Had heat, swelling and a little soreness at injection site; Had heat, swelling and a little soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Had heat, swelling and a little soreness at injection site), PRURITUS (itch in both hands/ itchiness in right armpit), PALMAR ERYTHEMA (Palms of hands are reddened), ERYTHEMA (redness in right armpit) and VACCINATION SITE PAIN (Had heat, swelling and a little soreness at injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Prostate cancer (prostate CA) and Lymphoma. Concurrent medical conditions included Sulfonamide allergy (sulfa drugs), Coronary artery disease, Hypercholesterolaemia (High cholesterol controlled) and Hypertension (High blood pressure).   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Had heat, swelling and a little soreness at injection site), VACCINATION SITE PAIN (Had heat, swelling and a little soreness at injection site) and VACCINATION SITE SWELLING (Had heat, swelling and a little soreness at injection site). On 30-Mar-2021, the patient experienced PRURITUS (itch in both hands/ itchiness in right armpit), PALMAR ERYTHEMA (Palms of hands are reddened) and ERYTHEMA (redness in right armpit). At the time of the report, VACCINATION SITE WARMTH (Had heat, swelling and a little soreness at injection site), PRURITUS (itch in both hands/ itchiness in right armpit), PALMAR ERYTHEMA (Palms of hands are reddened), ERYTHEMA (redness in right armpit), VACCINATION SITE PAIN (Had heat, swelling and a little soreness at injection site) and VACCINATION SITE SWELLING (Had heat, swelling and a little soreness at injection site) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No  concomitant medications were reported.   Treatment information was not provided.   This case was linked to MOD-2021-062685 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: itchiness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness) and PYREXIA (Fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040a21a and 011m20a) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PRURITUS (itchiness) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PRURITUS (itchiness) and PYREXIA (Fever) outcome was unknown. Not Provided          Patient reported that she is on lot of medications.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in his ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in his ears) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (ringing in his ears). At the time of the report, TINNITUS (ringing in his ears) had not resolved. Unknown          No concomitant medications were reported. No treatment information was provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia, Sensation of foreign body
Clinical narrative: Pain all over the body after Second Shot; Tired after Second Shot; Fever after Second Shot; Felt like a truck ran them over after Second Shot; Headache after Second Shot; This spontaneous case was reported by a consumer and describes the occurrence of SENSATION OF FOREIGN BODY (Felt like a truck ran them over after Second Shot), HEADACHE (Headache after Second Shot), MYALGIA (Pain all over the body after Second Shot), FATIGUE (Tired after Second Shot) and PYREXIA (Fever after Second Shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced SENSATION OF FOREIGN BODY (Felt like a truck ran them over after Second Shot) and HEADACHE (Headache after Second Shot). On an unknown date, the patient experienced MYALGIA (Pain all over the body after Second Shot), FATIGUE (Tired after Second Shot) and PYREXIA (Fever after Second Shot). In February 2021, SENSATION OF FOREIGN BODY (Felt like a truck ran them over after Second Shot) had resolved. In March 2021, HEADACHE (Headache after Second Shot) had resolved. At the time of the report, MYALGIA (Pain all over the body after Second Shot), FATIGUE (Tired after Second Shot) and PYREXIA (Fever after Second Shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Product reported by the reported  No treatment reported by the reporter   This case was linked to MOD21-065752, MOD21-065780 (E2B Linked Report).; Sender's Comments:  MOD21-065752:Case for husband (Patient) MOD21-065780:case for wife
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Non-injected arm developed itchiness; Non-injected arm developed welts; Rash on foot; Elbow of injected arm developed a rash; Injected arm developed sweatiness; Diarrhea; Both hands became numb; Both hands felt dead; Headache; Chills; Nausea; Fatigue; injected arm felt tingly; injected arm felt cold; Injected arm felt itchy; Stomach became itchy; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (injected arm felt tingly), INJECTION SITE COLDNESS (injected arm felt cold), PRURITUS (Injected arm felt itchy), ABDOMINAL DISCOMFORT (Stomach became itchy) and DIARRHOEA (Diarrhea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune disorder. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PARAESTHESIA (injected arm felt tingly), INJECTION SITE COLDNESS (injected arm felt cold), PRURITUS (Injected arm felt itchy) and ABDOMINAL DISCOMFORT (Stomach became itchy). On 13-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), HYPOAESTHESIA (Both hands became numb), HYPOAESTHESIA (Both hands felt dead), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue). On 19-Mar-2021, the patient experienced HYPERHIDROSIS (Injected arm developed sweatiness) and RASH (Elbow of injected arm developed a rash). On 24-Mar-2021, the patient experienced RASH (Rash on foot). On 28-Mar-2021, the patient experienced PRURITUS (Non-injected arm developed itchiness) and URTICARIA (Non-injected arm developed welts). At the time of the report, PARAESTHESIA (injected arm felt tingly), INJECTION SITE COLDNESS (injected arm felt cold), PRURITUS (Injected arm felt itchy), ABDOMINAL DISCOMFORT (Stomach became itchy), DIARRHOEA (Diarrhea), HYPOAESTHESIA (Both hands became numb), HYPOAESTHESIA (Both hands felt dead), HYPERHIDROSIS (Injected arm developed sweatiness), PRURITUS (Non-injected arm developed itchiness), URTICARIA (Non-injected arm developed welts), RASH (Rash on foot), RASH (Elbow of injected arm developed a rash), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: Patient has used cold cream and Calmoseptine ointment.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Injection site coldness, Nausea, Paraesthesia
Clinical narrative: Non-injected arm developed itchiness; Non-injected arm developed welts; Rash on foot; Elbow of injected arm developed a rash; Injected arm developed sweatiness; Diarrhea; Both hands became numb; Both hands felt dead; Headache; Chills; Nausea; Fatigue; injected arm felt tingly; injected arm felt cold; Injected arm felt itchy; Stomach became itchy; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (injected arm felt tingly), INJECTION SITE COLDNESS (injected arm felt cold), PRURITUS (Injected arm felt itchy), ABDOMINAL DISCOMFORT (Stomach became itchy) and DIARRHOEA (Diarrhea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune disorder. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PARAESTHESIA (injected arm felt tingly), INJECTION SITE COLDNESS (injected arm felt cold), PRURITUS (Injected arm felt itchy) and ABDOMINAL DISCOMFORT (Stomach became itchy). On 13-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), HYPOAESTHESIA (Both hands became numb), HYPOAESTHESIA (Both hands felt dead), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue). On 19-Mar-2021, the patient experienced HYPERHIDROSIS (Injected arm developed sweatiness) and RASH (Elbow of injected arm developed a rash). On 24-Mar-2021, the patient experienced RASH (Rash on foot). On 28-Mar-2021, the patient experienced PRURITUS (Non-injected arm developed itchiness) and URTICARIA (Non-injected arm developed welts). At the time of the report, PARAESTHESIA (injected arm felt tingly), INJECTION SITE COLDNESS (injected arm felt cold), PRURITUS (Injected arm felt itchy), ABDOMINAL DISCOMFORT (Stomach became itchy), DIARRHOEA (Diarrhea), HYPOAESTHESIA (Both hands became numb), HYPOAESTHESIA (Both hands felt dead), HYPERHIDROSIS (Injected arm developed sweatiness), PRURITUS (Non-injected arm developed itchiness), URTICARIA (Non-injected arm developed welts), RASH (Rash on foot), RASH (Elbow of injected arm developed a rash), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: Patient has used cold cream and Calmoseptine ointment.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Non-injected arm developed itchiness; Non-injected arm developed welts; Rash on foot; Elbow of injected arm developed a rash; Injected arm developed sweatiness; Diarrhea; Both hands became numb; Both hands felt dead; Headache; Chills; Nausea; Fatigue; injected arm felt tingly; injected arm felt cold; Injected arm felt itchy; Stomach became itchy; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (injected arm felt tingly), INJECTION SITE COLDNESS (injected arm felt cold), PRURITUS (Injected arm felt itchy), ABDOMINAL DISCOMFORT (Stomach became itchy) and DIARRHOEA (Diarrhea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune disorder. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PARAESTHESIA (injected arm felt tingly), INJECTION SITE COLDNESS (injected arm felt cold), PRURITUS (Injected arm felt itchy) and ABDOMINAL DISCOMFORT (Stomach became itchy). On 13-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), HYPOAESTHESIA (Both hands became numb), HYPOAESTHESIA (Both hands felt dead), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue). On 19-Mar-2021, the patient experienced HYPERHIDROSIS (Injected arm developed sweatiness) and RASH (Elbow of injected arm developed a rash). On 24-Mar-2021, the patient experienced RASH (Rash on foot). On 28-Mar-2021, the patient experienced PRURITUS (Non-injected arm developed itchiness) and URTICARIA (Non-injected arm developed welts). At the time of the report, PARAESTHESIA (injected arm felt tingly), INJECTION SITE COLDNESS (injected arm felt cold), PRURITUS (Injected arm felt itchy), ABDOMINAL DISCOMFORT (Stomach became itchy), DIARRHOEA (Diarrhea), HYPOAESTHESIA (Both hands became numb), HYPOAESTHESIA (Both hands felt dead), HYPERHIDROSIS (Injected arm developed sweatiness), PRURITUS (Non-injected arm developed itchiness), URTICARIA (Non-injected arm developed welts), RASH (Rash on foot), RASH (Elbow of injected arm developed a rash), HEADACHE (Headache), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: Patient has used cold cream and Calmoseptine ointment.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Anxiety, Aphasia, Confusional state, Feeling abnormal
Clinical narrative: memory loss; "fuzzy brain"; "brain fog"; "having difficulty remembering names"; "brain is racing at night"; having trouble sleeping; anxiety; headache; soreness in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the left arm), HEADACHE (headache), AMNESIA (memory loss), CONFUSIONAL STATE ("fuzzy brain") and FEELING ABNORMAL ("brain fog") in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included PRAVASTATIN and MULTIVITAMINS & MINERALS PLUS LUTEIN for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in the left arm). On 26-Feb-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced AMNESIA (memory loss), CONFUSIONAL STATE ("fuzzy brain"), FEELING ABNORMAL ("brain fog"), APHASIA ("having difficulty remembering names"), ANXIETY ("brain is racing at night"), INSOMNIA (having trouble sleeping) and ANXIETY (anxiety). On 27-Feb-2021, PAIN IN EXTREMITY (soreness in the left arm) had resolved. At the time of the report, HEADACHE (headache), AMNESIA (memory loss), CONFUSIONAL STATE ("fuzzy brain"), FEELING ABNORMAL ("brain fog"), APHASIA ("having difficulty remembering names") and ANXIETY ("brain is racing at night") had resolved and INSOMNIA (having trouble sleeping) and ANXIETY (anxiety) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Pain in extremity
Clinical narrative: memory loss; "fuzzy brain"; "brain fog"; "having difficulty remembering names"; "brain is racing at night"; having trouble sleeping; anxiety; headache; soreness in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the left arm), HEADACHE (headache), AMNESIA (memory loss), CONFUSIONAL STATE ("fuzzy brain") and FEELING ABNORMAL ("brain fog") in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included PRAVASTATIN and MULTIVITAMINS & MINERALS PLUS LUTEIN for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in the left arm). On 26-Feb-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced AMNESIA (memory loss), CONFUSIONAL STATE ("fuzzy brain"), FEELING ABNORMAL ("brain fog"), APHASIA ("having difficulty remembering names"), ANXIETY ("brain is racing at night"), INSOMNIA (having trouble sleeping) and ANXIETY (anxiety). On 27-Feb-2021, PAIN IN EXTREMITY (soreness in the left arm) had resolved. At the time of the report, HEADACHE (headache), AMNESIA (memory loss), CONFUSIONAL STATE ("fuzzy brain"), FEELING ABNORMAL ("brain fog"), APHASIA ("having difficulty remembering names") and ANXIETY ("brain is racing at night") had resolved and INSOMNIA (having trouble sleeping) and ANXIETY (anxiety) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Heart rate, Malaise, Oxygen saturation
Clinical narrative: general feeling sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (general feeling sick) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced MALAISE (general feeling sick). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, MALAISE (general feeling sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: increased (High) Increased. On 09-Mar-2021, Heart rate: increased (High) Increased. On 09-Mar-2021, Oxygen saturation: decreased (Low) decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant product was reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Body temperature, COVID-19, Fatigue, Headache
Clinical narrative: Felt like a truck ran him over; Headache; Pain all over the body; Tired; Fever 99.4 F; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Felt like a truck ran him over), HEADACHE (Headache), PAIN (Pain all over the body), FATIGUE (Tired) and PYREXIA (Fever 99.4 F) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Symptomatic COVID Disease) on 29-Dec-2020.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced ADVERSE REACTION (Felt like a truck ran him over), HEADACHE (Headache), PAIN (Pain all over the body), FATIGUE (Tired) and PYREXIA (Fever 99.4 F). At the time of the report, ADVERSE REACTION (Felt like a truck ran him over), HEADACHE (Headache), PAIN (Pain all over the body), FATIGUE (Tired) and PYREXIA (Fever 99.4 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, COVID-19: (Positive) positive. On an unknown date, Body temperature: 37.4 degree Celsius (abnormal) (99.4) Fahrenheit..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.  Treatment medication was not provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Felt like a truck ran him over; Headache; Pain all over the body; Tired; Fever 99.4 F; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Felt like a truck ran him over), HEADACHE (Headache), PAIN (Pain all over the body), FATIGUE (Tired) and PYREXIA (Fever 99.4 F) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Symptomatic COVID Disease) on 29-Dec-2020.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced ADVERSE REACTION (Felt like a truck ran him over), HEADACHE (Headache), PAIN (Pain all over the body), FATIGUE (Tired) and PYREXIA (Fever 99.4 F). At the time of the report, ADVERSE REACTION (Felt like a truck ran him over), HEADACHE (Headache), PAIN (Pain all over the body), FATIGUE (Tired) and PYREXIA (Fever 99.4 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, COVID-19: (Positive) positive. On an unknown date, Body temperature: 37.4 degree Celsius (abnormal) (99.4) Fahrenheit..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.  Treatment medication was not provided.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Mass, Rash, Rash erythematous
Clinical narrative: Lumpy area; Red rash; The area felt tight; Patchy; Rash extending from below the area where she got the shot to the back of her arm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Lumpy area), RASH ERYTHEMATOUS (Red rash), INDURATION (The area felt tight), RASH (Patchy) and RASH (Rash extending from below the area where she got the shot to the back of her arm) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced MASS (Lumpy area), RASH ERYTHEMATOUS (Red rash), INDURATION (The area felt tight), RASH (Patchy), RASH (Rash extending from below the area where she got the shot to the back of her arm) and RASH (Rash). At the time of the report, MASS (Lumpy area), RASH ERYTHEMATOUS (Red rash), INDURATION (The area felt tight), RASH (Patchy), RASH (Rash extending from below the area where she got the shot to the back of her arm) and RASH (Rash) had not resolved.            No concomitant medications were reported Treatment of the events included, diphenhydramine Action taken with mRNA-1273 in response to the events was not Applicable. Lot number - 031A21A was provided in the source but the reporter was not sure for which dose number this lot number was related.   This case was linked to MOD-2021-062705 (E2B Linked Report).; Sender's Comments:  MOD-2021-062705:First Dose
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: began to experience pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (began to experience pain) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History was reported). Concomitant products included AMITRIPTYLINE, GABAPENTIN, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and SILYBUM MARIANUM FRUIT, TAURINE (MILK THISTLE 35000 PLUS TAURINE) for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN (began to experience pain). At the time of the report, PAIN (began to experience pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.