chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discomfort, Breast pain, Lymphadenopathy, Mammogram, Pain in extremity
Clinical narrative: pain under the left arm; swelling under the left arm; pain on their left breast; a knot around the injection site; abnormalities on their left breast; lymph nodes under their left arm were swollen; Patient did not get the second dose still; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain under the left arm), PERIPHERAL SWELLING (swelling under the left arm), BREAST PAIN (pain on their left breast), VACCINATION SITE MASS (a knot around the injection site) and BREAST DISCOMFORT (abnormalities on their left breast) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Aug-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 PAIN IN EXTREMITY (pain under the left arm), PERIPHERAL SWELLING (swelling under the left arm), BREAST PAIN (pain on their left breast), VACCINATION SITE MASS (a knot around the injection site), BREAST DISCOMFORT (abnormalities on their left breast), LYMPHADENOPATHY (lymph nodes under their left arm were swollen) and PRODUCT DOSE OMISSION ISSUE (Patient did not get the second dose still). The patient was treated with ACETAMINOPHEN for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain under the left arm), PERIPHERAL SWELLING (swelling under the left arm), BREAST PAIN (pain on their left breast), VACCINATION SITE MASS (a knot around the injection site), BREAST DISCOMFORT (abnormalities on their left breast) and LYMPHADENOPATHY (lymph nodes under their left arm were swollen) had not resolved and PRODUCT DOSE OMISSION ISSUE (Patient did not get the second dose still) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Oct-2021, Mammogram: abnormal (abnormal) some abnormalities on their left breast. On 04-Oct-2021, Ultrasound scan: abnormal (abnormal) some abnormalities on their left breast.     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 medication reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Product dose omission issue, Ultrasound scan, Vaccination site mass
Clinical narrative: pain under the left arm; swelling under the left arm; pain on their left breast; a knot around the injection site; abnormalities on their left breast; lymph nodes under their left arm were swollen; Patient did not get the second dose still; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain under the left arm), PERIPHERAL SWELLING (swelling under the left arm), BREAST PAIN (pain on their left breast), VACCINATION SITE MASS (a knot around the injection site) and BREAST DISCOMFORT (abnormalities on their left breast) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Aug-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 PAIN IN EXTREMITY (pain under the left arm), PERIPHERAL SWELLING (swelling under the left arm), BREAST PAIN (pain on their left breast), VACCINATION SITE MASS (a knot around the injection site), BREAST DISCOMFORT (abnormalities on their left breast), LYMPHADENOPATHY (lymph nodes under their left arm were swollen) and PRODUCT DOSE OMISSION ISSUE (Patient did not get the second dose still). The patient was treated with ACETAMINOPHEN for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain under the left arm), PERIPHERAL SWELLING (swelling under the left arm), BREAST PAIN (pain on their left breast), VACCINATION SITE MASS (a knot around the injection site), BREAST DISCOMFORT (abnormalities on their left breast) and LYMPHADENOPATHY (lymph nodes under their left arm were swollen) had not resolved and PRODUCT DOSE OMISSION ISSUE (Patient did not get the second dose still) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Oct-2021, Mammogram: abnormal (abnormal) some abnormalities on their left breast. On 04-Oct-2021, Ultrasound scan: abnormal (abnormal) some abnormalities on their left breast.     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 medication reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Pain in extremity, Palpitations
Clinical narrative: Can not calm down; Can not Lift the left Arm; Heart racing this morning but it is better now; Chills; Fever 100.0 F; Sore Left Arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Can not calm down), VACCINATION SITE MOVEMENT IMPAIRMENT (Can not Lift the left Arm), PAIN IN EXTREMITY (Sore Left Arm), PALPITATIONS (Heart racing this morning but it is better now) and CHILLS (Chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced PAIN IN EXTREMITY (Sore Left Arm). On 19-Oct-2021, the patient experienced FEELING ABNORMAL (Can not calm down), VACCINATION SITE MOVEMENT IMPAIRMENT (Can not Lift the left Arm), PALPITATIONS (Heart racing this morning but it is better now), CHILLS (Chills) and PYREXIA (Fever 100.0 F). The patient was treated with IBUPROFEN on 19-Oct-2021 for Fever, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (Can not calm down), VACCINATION SITE MOVEMENT IMPAIRMENT (Can not Lift the left Arm), PAIN IN EXTREMITY (Sore Left Arm), CHILLS (Chills) and PYREXIA (Fever 100.0 F) outcome was unknown and PALPITATIONS (Heart racing this morning but it is better now) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Oct-2021, Body temperature: 100 (High) Fever 100.0 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site movement impairment
Clinical narrative: Can not calm down; Can not Lift the left Arm; Heart racing this morning but it is better now; Chills; Fever 100.0 F; Sore Left Arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Can not calm down), VACCINATION SITE MOVEMENT IMPAIRMENT (Can not Lift the left Arm), PAIN IN EXTREMITY (Sore Left Arm), PALPITATIONS (Heart racing this morning but it is better now) and CHILLS (Chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced PAIN IN EXTREMITY (Sore Left Arm). On 19-Oct-2021, the patient experienced FEELING ABNORMAL (Can not calm down), VACCINATION SITE MOVEMENT IMPAIRMENT (Can not Lift the left Arm), PALPITATIONS (Heart racing this morning but it is better now), CHILLS (Chills) and PYREXIA (Fever 100.0 F). The patient was treated with IBUPROFEN on 19-Oct-2021 for Fever, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (Can not calm down), VACCINATION SITE MOVEMENT IMPAIRMENT (Can not Lift the left Arm), PAIN IN EXTREMITY (Sore Left Arm), CHILLS (Chills) and PYREXIA (Fever 100.0 F) outcome was unknown and PALPITATIONS (Heart racing this morning but it is better now) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Oct-2021, Body temperature: 100 (High) Fever 100.0 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A patient received an expired 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient received an expired 1st dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient received an expired 1st dose). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (A patient received an expired 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was also reported that the vial did not undergo any temperature excursions  Concomitant medication information was not reported  Treatment information was not reported
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Frequent bowel movements, Injection site hypoaesthesia, Injection site paraesthesia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Extra Bowel Movement then before; Swelling only present during the 15 minutes after vaccination.; Tenderness only present during the 15 minutes after vaccination.; I experienced tingling in my arm during that 15 minutes; But my arm,where I was injected, I was feeling it and it is feeling a little numb; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PARAESTHESIA (I experienced tingling in my arm during that 15 minutes), INJECTION SITE HYPOAESTHESIA (But my arm,where I was injected, I was feeling it and it is feeling a little numb), FREQUENT BOWEL MOVEMENTS (Extra Bowel Movement then before), VACCINATION SITE SWELLING (Swelling only present during the 15 minutes after vaccination.) and VACCINATION SITE PAIN (Tenderness only present during the 15 minutes after vaccination.) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026021A) for COVID-19 vaccination.     Concurrent medical conditions included Immune system disorder (NOS) (Overactive immune system) and Headache.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced INJECTION SITE PARAESTHESIA (I experienced tingling in my arm during that 15 minutes), INJECTION SITE HYPOAESTHESIA (But my arm,where I was injected, I was feeling it and it is feeling a little numb), VACCINATION SITE SWELLING (Swelling only present during the 15 minutes after vaccination.) and VACCINATION SITE PAIN (Tenderness only present during the 15 minutes after vaccination.). On an unknown date, the patient experienced FREQUENT BOWEL MOVEMENTS (Extra Bowel Movement then before). On 18-Oct-2021, INJECTION SITE PARAESTHESIA (I experienced tingling in my arm during that 15 minutes), INJECTION SITE HYPOAESTHESIA (But my arm,where I was injected, I was feeling it and it is feeling a little numb), VACCINATION SITE SWELLING (Swelling only present during the 15 minutes after vaccination.) and VACCINATION SITE PAIN (Tenderness only present during the 15 minutes after vaccination.) had resolved. At the time of the report, FREQUENT BOWEL MOVEMENTS (Extra Bowel Movement then before) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow up added contact information and new event.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired first dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first dose.) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first dose.). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired first dose.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  No Treatment information was reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose given to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose given to patients) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose given to patients). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose given to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.  Date moved to refrigeration on 13-Oct-2021 and Use by date on 13-Oct-2021.   This case was linked to MOD-2021-357519 (Patient Link).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Heavy menstrual bleeding, Lip swelling, Myalgia
Clinical narrative: vaginal bleeding which was light but now it is heavy  The patient stated that she did have her period 2 weeks ago; vaginal bleeding which was light but now it is heavy. The patient stated that she did have her period 2 weeks ago; shivering; fever of 100°F; arm hurting; tingling of her lips; swelling of her lips; rash with light pink with dots on her chest; redness on both her cheeks.; She had a sore arm.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurting), PARAESTHESIA ORAL (tingling of her lips), LIP SWELLING (swelling of her lips), RASH ERYTHEMATOUS (rash with light pink with dots on her chest) and ERYTHEMA (redness on both her cheeks.) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ETHINYLESTRADIOL, NORGESTREL (CRYSELLE) for Birth control.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced MYALGIA (She had a sore arm.). On 19-Oct-2021, the patient experienced PAIN IN EXTREMITY (arm hurting), PARAESTHESIA ORAL (tingling of her lips), LIP SWELLING (swelling of her lips), RASH ERYTHEMATOUS (rash with light pink with dots on her chest), ERYTHEMA (redness on both her cheeks.), CHILLS (shivering) and PYREXIA (fever of 100°F). On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (vaginal bleeding which was light but now it is heavy  The patient stated that she did have her period 2 weeks ago) and POLYMENORRHOEA (vaginal bleeding which was light but now it is heavy. The patient stated that she did have her period 2 weeks ago). At the time of the report, PAIN IN EXTREMITY (arm hurting), PARAESTHESIA ORAL (tingling of her lips), LIP SWELLING (swelling of her lips), RASH ERYTHEMATOUS (rash with light pink with dots on her chest), ERYTHEMA (redness on both her cheeks.), POLYMENORRHOEA (vaginal bleeding which was light but now it is heavy. The patient stated that she did have her period 2 weeks ago), CHILLS (shivering), PYREXIA (fever of 100°F) and MYALGIA (She had a sore arm.) outcome was unknown and HEAVY MENSTRUAL BLEEDING (vaginal bleeding which was light but now it is heavy  The patient stated that she did have her period 2 weeks ago) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: significant follow up appended : Event Updated , Patient details updated
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia oral, Polymenorrhoea, Pyrexia, Rash erythematous
Clinical narrative: vaginal bleeding which was light but now it is heavy  The patient stated that she did have her period 2 weeks ago; vaginal bleeding which was light but now it is heavy. The patient stated that she did have her period 2 weeks ago; shivering; fever of 100°F; arm hurting; tingling of her lips; swelling of her lips; rash with light pink with dots on her chest; redness on both her cheeks.; She had a sore arm.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurting), PARAESTHESIA ORAL (tingling of her lips), LIP SWELLING (swelling of her lips), RASH ERYTHEMATOUS (rash with light pink with dots on her chest) and ERYTHEMA (redness on both her cheeks.) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ETHINYLESTRADIOL, NORGESTREL (CRYSELLE) for Birth control.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced MYALGIA (She had a sore arm.). On 19-Oct-2021, the patient experienced PAIN IN EXTREMITY (arm hurting), PARAESTHESIA ORAL (tingling of her lips), LIP SWELLING (swelling of her lips), RASH ERYTHEMATOUS (rash with light pink with dots on her chest), ERYTHEMA (redness on both her cheeks.), CHILLS (shivering) and PYREXIA (fever of 100°F). On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (vaginal bleeding which was light but now it is heavy  The patient stated that she did have her period 2 weeks ago) and POLYMENORRHOEA (vaginal bleeding which was light but now it is heavy. The patient stated that she did have her period 2 weeks ago). At the time of the report, PAIN IN EXTREMITY (arm hurting), PARAESTHESIA ORAL (tingling of her lips), LIP SWELLING (swelling of her lips), RASH ERYTHEMATOUS (rash with light pink with dots on her chest), ERYTHEMA (redness on both her cheeks.), POLYMENORRHOEA (vaginal bleeding which was light but now it is heavy. The patient stated that she did have her period 2 weeks ago), CHILLS (shivering), PYREXIA (fever of 100°F) and MYALGIA (She had a sore arm.) outcome was unknown and HEAVY MENSTRUAL BLEEDING (vaginal bleeding which was light but now it is heavy  The patient stated that she did have her period 2 weeks ago) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: significant follow up appended : Event Updated , Patient details updated
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got first dose on 30Dec2020 and another "first" dose on 24Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got first dose on 30Dec2020 and another "first" dose on 24Apr2021) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got first dose on 30Dec2020 and another "first" dose on 24Apr2021). On 24-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got first dose on 30Dec2020 and another "first" dose on 24Apr2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient got another "first" dose of the Moderna vaccine (at second dose provider contact) on 24Apr2021, also on the left arm. No concomitant medication was reported.  No treatment medication use was reported.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information were provided.  Patient had not reported any events.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Headache, Inappropriate schedule of product administration, Nausea, Vertigo
Clinical narrative: completely weak,; everything started to spin; vomiting; headache; nausea; third dose was administered on 17Oct2021; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (completely weak,), VERTIGO (everything started to spin), VOMITING (vomiting), HEADACHE (headache) and NAUSEA (nausea) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025021A, 030A21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (Patient did not had chemotherapy). Concurrent medical conditions included Arthritis and Vasculitis.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Oct-2021, the patient experienced ASTHENIA (completely weak,), VERTIGO (everything started to spin), VOMITING (vomiting), HEADACHE (headache), NAUSEA (nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third dose was administered on 17Oct2021). On 17-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third dose was administered on 17Oct2021) had resolved. At the time of the report, ASTHENIA (completely weak,), VERTIGO (everything started to spin), VOMITING (vomiting), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.  Patient had no effects after first and second dose.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: completely weak,; everything started to spin; vomiting; headache; nausea; third dose was administered on 17Oct2021; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (completely weak,), VERTIGO (everything started to spin), VOMITING (vomiting), HEADACHE (headache) and NAUSEA (nausea) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025021A, 030A21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (Patient did not had chemotherapy). Concurrent medical conditions included Arthritis and Vasculitis.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Oct-2021, the patient experienced ASTHENIA (completely weak,), VERTIGO (everything started to spin), VOMITING (vomiting), HEADACHE (headache), NAUSEA (nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third dose was administered on 17Oct2021). On 17-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third dose was administered on 17Oct2021) had resolved. At the time of the report, ASTHENIA (completely weak,), VERTIGO (everything started to spin), VOMITING (vomiting), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.  Patient had no effects after first and second dose.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Electrocardiogram, Feeling abnormal, Heart rate, Infection
Clinical narrative: Little nervous; infection from the red tide; cardiac problems/ pulse is running really low/ problem with a lower pulse/ pulse dips down to 32, 34 beats per minute/ pulse was 34; He doesn't want to go to sleep and not wake up; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (cardiac problems/ pulse is running really low/ problem with a lower pulse/ pulse dips down to 32, 34 beats per minute/ pulse was 34), NERVOUSNESS (Little nervous), FEELING ABNORMAL (He doesn't want to go to sleep and not wake up) and INFECTION (infection from the red tide) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 022B21A) for COVID-19 vaccination.     The patient's past medical history included Block heart and Stent placement.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced CARDIAC DISORDER (cardiac problems/ pulse is running really low/ problem with a lower pulse/ pulse dips down to 32, 34 beats per minute/ pulse was 34) and FEELING ABNORMAL (He doesn't want to go to sleep and not wake up). On 05-Sep-2021, the patient experienced INFECTION (infection from the red tide). On an unknown date, the patient experienced NERVOUSNESS (Little nervous). At the time of the report, CARDIAC DISORDER (cardiac problems/ pulse is running really low/ problem with a lower pulse/ pulse dips down to 32, 34 beats per minute/ pulse was 34), NERVOUSNESS (Little nervous), FEELING ABNORMAL (He doesn't want to go to sleep and not wake up) and INFECTION (infection from the red tide) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Electrocardiogram: normal (normal) normal. In June 2021, Heart rate: 32 (Low) 32 beats per minute. In September 2021, Heart rate: 34 (Low) 34 beats per minute.         Concomitant information was not provided.  The patient was treated with IV antibiotic for about 6 weeks for the infection. Patient reports no other treatment taken in addition to this.  It was reported that the patient was instructed to insert the pacemaker as a part of correction procedure and patient confirms that patient doesn't have atrial fibrillation.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Nervousness
Clinical narrative: Little nervous; infection from the red tide; cardiac problems/ pulse is running really low/ problem with a lower pulse/ pulse dips down to 32, 34 beats per minute/ pulse was 34; He doesn't want to go to sleep and not wake up; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (cardiac problems/ pulse is running really low/ problem with a lower pulse/ pulse dips down to 32, 34 beats per minute/ pulse was 34), NERVOUSNESS (Little nervous), FEELING ABNORMAL (He doesn't want to go to sleep and not wake up) and INFECTION (infection from the red tide) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 022B21A) for COVID-19 vaccination.     The patient's past medical history included Block heart and Stent placement.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced CARDIAC DISORDER (cardiac problems/ pulse is running really low/ problem with a lower pulse/ pulse dips down to 32, 34 beats per minute/ pulse was 34) and FEELING ABNORMAL (He doesn't want to go to sleep and not wake up). On 05-Sep-2021, the patient experienced INFECTION (infection from the red tide). On an unknown date, the patient experienced NERVOUSNESS (Little nervous). At the time of the report, CARDIAC DISORDER (cardiac problems/ pulse is running really low/ problem with a lower pulse/ pulse dips down to 32, 34 beats per minute/ pulse was 34), NERVOUSNESS (Little nervous), FEELING ABNORMAL (He doesn't want to go to sleep and not wake up) and INFECTION (infection from the red tide) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Electrocardiogram: normal (normal) normal. In June 2021, Heart rate: 32 (Low) 32 beats per minute. In September 2021, Heart rate: 34 (Low) 34 beats per minute.         Concomitant information was not provided.  The patient was treated with IV antibiotic for about 6 weeks for the infection. Patient reports no other treatment taken in addition to this.  It was reported that the patient was instructed to insert the pacemaker as a part of correction procedure and patient confirms that patient doesn't have atrial fibrillation.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm after both of her doses of the Moderna Covid-19 Vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm after both of her doses of the Moderna Covid-19 Vaccine.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 VACCINATION SITE PAIN (sore arm after both of her doses of the Moderna Covid-19 Vaccine.). At the time of the report, VACCINATION SITE PAIN (sore arm after both of her doses of the Moderna Covid-19 Vaccine.) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-358258, MOD-2021-358220 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, Pyrexia, SARS-CoV-2 test
Clinical narrative: hallucination which lasted for 2 1/2 weeks; fever; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucination which lasted for 2 1/2 weeks) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 14M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (hallucination which lasted for 2 1/2 weeks) (seriousness criterion medically significant) and PYREXIA (fever). At the time of the report, HALLUCINATION (hallucination which lasted for 2 1/2 weeks) and PYREXIA (fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant medications was not provided by the reporter Treatment information was not provided  This case concerns a  69-year-old, female patient with no relevant medical history, who experienced the unexpected event of Hallucination. The event on an unspecified date after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was as event occurred after the second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.   This case was linked to MOD-2021-358365 (Patient Link).; Sender's Comments: This case concerns a  69-year-old, female patient with no relevant medical history, who experienced the unexpected event of Hallucination. The event on an unspecified date after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was as event occurred after the second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired first dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first dose.) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first dose.). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired first dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.   This case was linked to MOD-2021-357255 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart problem after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (heart problem after the vaccine) in a 69-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (heart problem after the vaccine). At the time of the report, CARDIAC DISORDER (heart problem after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. No Treatment information was reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received a dose more than 12 hours after vial puncture.; wouldn't take it to room temperature, just take it out of the refrigerator, drag a dose, and back; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose more than 12 hours after vial puncture.) and PRODUCT STORAGE ERROR (wouldn't take it to room temperature, just take it out of the refrigerator, drag a dose, and back) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose more than 12 hours after vial puncture.) and PRODUCT STORAGE ERROR (wouldn't take it to room temperature, just take it out of the refrigerator, drag a dose, and back). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a dose more than 12 hours after vial puncture.) and PRODUCT STORAGE ERROR (wouldn't take it to room temperature, just take it out of the refrigerator, drag a dose, and back) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Had headaches after both doses of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Had headaches after both doses of the vaccine) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Had headaches after both doses of the vaccine). At the time of the report, HEADACHE (Had headaches after both doses of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment information was reported by the reporter.   This case was linked to MOD-2021-358541 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-358529 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (joint pain). At the time of the report, ARTHRALGIA (joint pain) 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.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired dose) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received dose from vial expired 5 days before; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vial expired 5 days before) 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 EXPIRED PRODUCT ADMINISTERED (received dose from vial expired 5 days before). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received dose from vial expired 5 days before) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: gout/symptoms started a week ago; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (gout/symptoms started a week ago) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D NOS for an unknown indication.   On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Oct-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 GOUT (gout/symptoms started a week ago). At the time of the report, GOUT (gout/symptoms started a week ago) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  Other Concomitant medications included blood pressure medicine, high sugar medications. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: adverse event with our temperature data logger; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (adverse event with our temperature data logger) 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 COMPLICATION (adverse event with our temperature data logger). At the time of the report, VACCINATION COMPLICATION (adverse event with our temperature data logger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter   Reporter did not allow further contact
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.            No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-359055 (Patient Link).