chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patients were inadvertently administered a dose from a vial that was punctured and left at room temperature for 5 days; A vial  was punctured and left at room temperature for 5 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were inadvertently administered a dose from a vial that was punctured and left at room temperature for 5 days) and PRODUCT STORAGE ERROR (A vial  was punctured and left at room temperature for 5 days) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 031L20A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022 at 5:15 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 27-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (A vial  was punctured and left at room temperature for 5 days). On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were inadvertently administered a dose from a vial that was punctured and left at room temperature for 5 days). On 01-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Patients were inadvertently administered a dose from a vial that was punctured and left at room temperature for 5 days) had resolved. At the time of the report, PRODUCT STORAGE ERROR (A vial  was punctured and left at room temperature for 5 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  The patient received vaccine in the deltoid region.The vial was initially stored in the refrigerator on 27 Jan 2022. The vial was punctured on 27 Jan 2022 at 8:30am.The vial was stored at room temperature post puncture. The vial did not undergo any temperature excursions.  No adverse event occurred.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2022: Updated patient demographics, suspect details (dose time) and narrative.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm with my first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm with my first dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, 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 (sore arm with my first dose). At the time of the report, PAIN IN EXTREMITY (sore arm with my first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported. No concomitant medication was reported.   This case was linked to MOD-2022-473668 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hair colour changes, Hair growth abnormal, Inappropriate schedule of product administration, Therapeutic response unexpected
Clinical narrative: thinks the vaccine has been her "fountain of youth."; month after second dose, hair is 3 feet long; month after second dose, hair is black; Moderna covid-19 vaccine the first in JUN/2021 and the second in DEC/2021; This spontaneous case was reported by a consumer and describes the occurrence of HAIR GROWTH ABNORMAL (month after second dose, hair is 3 feet long), HAIR COLOUR CHANGES (month after second dose, hair is black), THERAPEUTIC RESPONSE UNEXPECTED (thinks the vaccine has been her "fountain of youth.") and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna covid-19 vaccine the first in JUN/2021 and the second in DEC/2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna covid-19 vaccine the first in JUN/2021 and the second in DEC/2021). In January 2022, the patient experienced HAIR GROWTH ABNORMAL (month after second dose, hair is 3 feet long) and HAIR COLOUR CHANGES (month after second dose, hair is black). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (thinks the vaccine has been her "fountain of youth."). In December 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna covid-19 vaccine the first in JUN/2021 and the second in DEC/2021) had resolved. At the time of the report, HAIR GROWTH ABNORMAL (month after second dose, hair is 3 feet long), HAIR COLOUR CHANGES (month after second dose, hair is black) and THERAPEUTIC RESPONSE UNEXPECTED (thinks the vaccine has been her "fountain of youth.") outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-473560 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Mobility decreased, Myocardial infarction, Product dose omission issue
Clinical narrative: Patient is immunocompromised and did not receive his third full dose; Heart attack; Legs went out from under him could not get out of bed; Soreness in left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 021M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised and Fibromyalgia (Chronic fatigue syndrome with fibromyalgia).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced MOBILITY DECREASED (Legs went out from under him could not get out of bed) and INJECTION SITE PAIN (Soreness in left arm injection site). On 07-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient is immunocompromised and did not receive his third full dose). At the time of the report, MYOCARDIAL INFARCTION (Heart attack), MOBILITY DECREASED (Legs went out from under him could not get out of bed) and INJECTION SITE PAIN (Soreness in left arm injection site) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient is immunocompromised and did not receive his third full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Treatment information was not provided.  Patient was not hospitalized. Patient was not diagnosed with myocarditis or pericarditis. Patient did not have a history of a COVID-19 infection.  Patient was immunocompromised and did not receive third full dose of the Moderna COVID-19 vaccine as third dose in primary Moderna COVID-19 series.  COMPANY COMMENT ; This spontaneous case concerns a 68-year-old male patient with no medical history reported, who experienced the serious unexpected AESI event of myocardial infraction which occurred 3 days after second dose of mRNA-1273.At the time of report event outcome unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-473727 (Patient Link).; Sender's Comments: This spontaneous case concerns a 68-year-old male patient with no medical history reported, who experienced the serious unexpected AESI event of myocardial infraction which occurred 3 days after second dose of mRNA-1273.At the time of report event outcome unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in left arm injection site) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021M20A) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia. Concurrent medical conditions included Immunocompromised and Chronic fatigue syndrome.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness in left arm injection site). At the time of the report, VACCINATION SITE PAIN (Soreness in left arm injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. No concomitant medication was reported.   This case was linked to MOD-2022-473707 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pulmonary embolism, Thrombosis
Clinical narrative: Unprovoked blood clot; PE went to his lung; suffering pains for a week prior; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Unprovoked blood clot), PULMONARY EMBOLISM (PE went to his lung) and PAIN (suffering pains for a week prior) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced THROMBOSIS (Unprovoked blood clot) (seriousness criteria hospitalization and medically significant), PULMONARY EMBOLISM (PE went to his lung) (seriousness criteria hospitalization and medically significant) and PAIN (suffering pains for a week prior) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 27-Nov-2021 due to PAIN, PULMONARY EMBOLISM and THROMBOSIS. At the time of the report, THROMBOSIS (Unprovoked blood clot), PULMONARY EMBOLISM (PE went to his lung) and PAIN (suffering pains for a week prior) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided. No concomitant medication information was provided.  COMPANY COMMENT ; This spontaneous case concerns  unknown age of male patient with no medical history reported, who experienced the serious unexpected AESI event of thrombosis, pulmonary embolism and unexpected serious event of pain which occurred on unknown day and dose of mRNA-1273. The patient was hospitalized due to PAIN, PULMONARY EMBOLISM and THROMBOSIS. At the time of report outcome of event is unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns  unknown age of male patient with no medical history reported, who experienced the serious unexpected AESI event of thrombosis, pulmonary embolism and unexpected serious event of pain which occurred on unknown day and dose of mRNA-1273. The patient was hospitalized due to PAIN, PULMONARY EMBOLISM and THROMBOSIS. At the time of report outcome of event is unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Vaccination site pain
Clinical narrative: Minor soreness for a short while at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Minor soreness for a short while at the injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Blood pressure high (Have high blood pressure, but well controlled).    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Minor soreness for a short while at the injection site). At the time of the report, VACCINATION SITE PAIN (Minor soreness for a short while at the injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 121/72 Blood pressure is good, 121/72.         No concomitant medication information provided.  Patient had unspecified test which all case back negative.   Patient had two regular Moderna shots. Patient's doctor said patient was probably immunocompromised.   No treatment information provided.   This case was linked to MOD-2022-472171, MOD-2022-472076 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Feb-2022: Follow up received included event.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Confusional state, Decreased interest, Dehydration, Depressed mood
Clinical narrative: Confusion/has confusion; he has GI issues; now he has swelling of the hands; he stay sleepy and tired; we both are losing weight; he gets dehydrated also; he has lost interest in things as well they; they were both doing very well and very happy and laughing until we took the booster shot; he stay sleepy and tired; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion/has confusion), ABDOMINAL DISCOMFORT (he has GI issues), PERIPHERAL SWELLING (now he has swelling of the hands), SOMNOLENCE (he stay sleepy and tired) and WEIGHT DECREASED (we both are losing weight) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced CONFUSIONAL STATE (Confusion/has confusion), ABDOMINAL DISCOMFORT (he has GI issues), PERIPHERAL SWELLING (now he has swelling of the hands), SOMNOLENCE (he stay sleepy and tired), WEIGHT DECREASED (we both are losing weight), DEHYDRATION (he gets dehydrated also), DECREASED INTEREST (he has lost interest in things as well they), DEPRESSED MOOD (they were both doing very well and very happy and laughing until we took the booster shot) and FATIGUE (he stay sleepy and tired). At the time of the report, CONFUSIONAL STATE (Confusion/has confusion), ABDOMINAL DISCOMFORT (he has GI issues), PERIPHERAL SWELLING (now he has swelling of the hands), SOMNOLENCE (he stay sleepy and tired), WEIGHT DECREASED (we both are losing weight), DEHYDRATION (he gets dehydrated also), DECREASED INTEREST (he has lost interest in things as well they), DEPRESSED MOOD (they were both doing very well and very happy and laughing until we took the booster shot) and FATIGUE (he stay sleepy and tired) outcome was unknown.            Concomitant products were not provided. Treatment medication were not reported.   This case was linked to MOD-2022-452014 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Peripheral swelling, Somnolence, Weight decreased
Clinical narrative: Confusion/has confusion; he has GI issues; now he has swelling of the hands; he stay sleepy and tired; we both are losing weight; he gets dehydrated also; he has lost interest in things as well they; they were both doing very well and very happy and laughing until we took the booster shot; he stay sleepy and tired; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion/has confusion), ABDOMINAL DISCOMFORT (he has GI issues), PERIPHERAL SWELLING (now he has swelling of the hands), SOMNOLENCE (he stay sleepy and tired) and WEIGHT DECREASED (we both are losing weight) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced CONFUSIONAL STATE (Confusion/has confusion), ABDOMINAL DISCOMFORT (he has GI issues), PERIPHERAL SWELLING (now he has swelling of the hands), SOMNOLENCE (he stay sleepy and tired), WEIGHT DECREASED (we both are losing weight), DEHYDRATION (he gets dehydrated also), DECREASED INTEREST (he has lost interest in things as well they), DEPRESSED MOOD (they were both doing very well and very happy and laughing until we took the booster shot) and FATIGUE (he stay sleepy and tired). At the time of the report, CONFUSIONAL STATE (Confusion/has confusion), ABDOMINAL DISCOMFORT (he has GI issues), PERIPHERAL SWELLING (now he has swelling of the hands), SOMNOLENCE (he stay sleepy and tired), WEIGHT DECREASED (we both are losing weight), DEHYDRATION (he gets dehydrated also), DECREASED INTEREST (he has lost interest in things as well they), DEPRESSED MOOD (they were both doing very well and very happy and laughing until we took the booster shot) and FATIGUE (he stay sleepy and tired) outcome was unknown.            Concomitant products were not provided. Treatment medication were not reported.   This case was linked to MOD-2022-452014 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bell's palsy, Illness, Pain, Vaccination site injury
Clinical narrative: Bell's palsy; Pain/ Painful; Vaccine injured; Sick; Lack of energy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's palsy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant), PAIN (Pain/ Painful), VACCINATION SITE INJURY (Vaccine injured), ILLNESS (Sick) and ASTHENIA (Lack of energy). At the time of the report, BELL'S PALSY (Bell's palsy), VACCINATION SITE INJURY (Vaccine injured), ILLNESS (Sick) and ASTHENIA (Lack of energy) outcome was unknown and PAIN (Pain/ Painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that what vaccine did to her was painful, it had been 7 months and events are not recovered. Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2022: Patient gender and new serious event bell palsy was added. On 05-Feb-2022: Outcome updated for pain. On 05-Feb-2022: No new information added. On 05-Feb-2022: Vaccination site injury added as an event. On 05-Feb-2022: No new information added. On 05-Feb-2022: No new information added. On 05-Feb-2022: No new information added. On 05-Feb-2022: No new information added. On 05-Feb-2022: No new information added. On 05-Feb-2022: No new information added. On 05-Feb-2022: No new information added. On 05-Feb-2022: No new information added. On 05-Feb-2022: No new information added. On 05-Feb-2022: Sick added as an event.
Sex: U
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: Axilla is still swelling for a long time; This spontaneous case was reported by an other health care professional and describes the occurrence of AXILLARY MASS (Axilla is still swelling for a long time) 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 AXILLARY MASS (Axilla is still swelling for a long time). At the time of the report, AXILLARY MASS (Axilla is still swelling for a long time) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm still hurts deep down in the muscle where I got both of those shots; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (arm still hurts deep down in the muscle where I got both of those shots) 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.   In December 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm still hurts deep down in the muscle where I got both of those shots). At the time of the report, VACCINATION SITE PAIN (arm still hurts deep down in the muscle where I got both of those shots) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Movement disorder
Clinical narrative: Left arm not able to move a lot; This spontaneous case was reported by an other health care professional and describes the occurrence of MOVEMENT DISORDER (Left arm not able to move a lot) 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.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOVEMENT DISORDER (Left arm not able to move a lot). At the time of the report, MOVEMENT DISORDER (Left arm not able to move a lot) 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 medications were provided.  No treatment medications were reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Menstrual disorder, Vaccination site bruising, Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: patient had a second cycle of her menstrual period; Very swelling lymph nodes on her armpit; Patient had her menstrual period, since she entered menopause 7 months ago; Injection site still hurts; Bleeding on the injection site; Very large bruise on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bleeding on the injection site), VACCINATION SITE BRUISING (Very large bruise on the injection site), MENSTRUAL DISORDER (Patient had her menstrual period, since she entered menopause 7 months ago), MENSTRUAL DISORDER (patient had a second cycle of her menstrual period) and LYMPHADENOPATHY (Very swelling lymph nodes on her armpit) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F4A, 022C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient allergy to medications, food and other products.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding on the injection site), VACCINATION SITE BRUISING (Very large bruise on the injection site) and VACCINATION SITE PAIN (Injection site still hurts). On 12-Dec-2021, the patient experienced MENSTRUAL DISORDER (Patient had her menstrual period, since she entered menopause 7 months ago) and LYMPHADENOPATHY (Very swelling lymph nodes on her armpit). On 14-Jan-2022, the patient experienced MENSTRUAL DISORDER (patient had a second cycle of her menstrual period). On 08-Dec-2021, VACCINATION SITE HAEMORRHAGE (Bleeding on the injection site) had resolved. On 18-Dec-2021, MENSTRUAL DISORDER (Patient had her menstrual period, since she entered menopause 7 months ago) had resolved. On 22-Dec-2021, VACCINATION SITE BRUISING (Very large bruise on the injection site) had resolved. On 20-Jan-2022, MENSTRUAL DISORDER (patient had a second cycle of her menstrual period) had resolved. At the time of the report, LYMPHADENOPATHY (Very swelling lymph nodes on her armpit) outcome was unknown and VACCINATION SITE PAIN (Injection site still hurts) had not resolved.            No Concomitant No Treatment medications were reported.   This case was linked to MOD-2022-473944, MOD-2022-473947 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: really sick with it; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick with it) in a male 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (really sick with it). At the time of the report, ILLNESS (really sick with it) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided. Patient got booster shot on a Saturday and he was really sick after that.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue after 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue after 1st shot) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced FATIGUE (Fatigue after 1st shot). On 23-Apr-2021, FATIGUE (Fatigue after 1st shot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant and treatment medication was reported.   This case was linked to MOD-2022-473936, MOD-2022-473944 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low grade fever after booster shot; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Low grade fever after booster shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Low grade fever after booster shot). At the time of the report, PYREXIA (Low grade fever after booster shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Dizziness, Pain in extremity, Splenitis
Clinical narrative: pain in his stomach; he threw up food; very dizzy; abdominal started to hurt very badly right side; spleen was inflammed; arm hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurting), ABDOMINAL PAIN (abdominal started to hurt very badly right side), SPLENITIS (spleen was inflammed), ABDOMINAL PAIN UPPER (pain in his stomach) and DIZZINESS (very dizzy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Feb-2022 at 5:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm hurting). On 03-Feb-2022, the patient experienced ABDOMINAL PAIN (abdominal started to hurt very badly right side), SPLENITIS (spleen was inflammed) and DIZZINESS (very dizzy). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (pain in his stomach) and VOMITING (he threw up food). At the time of the report, PAIN IN EXTREMITY (arm hurting), ABDOMINAL PAIN (abdominal started to hurt very badly right side), SPLENITIS (spleen was inflammed), ABDOMINAL PAIN UPPER (pain in his stomach), DIZZINESS (very dizzy) and VOMITING (he threw up food) outcome was unknown.     No concomitant medications were provided by the reporter. On 3-Feb-2022, patient went to work and was very dizzy, so he came home and then his abdominal started to hurt very badly on his right side he ended up having to go to the hospital and the doctor said his spleen was inflamed and just sent him home to rest. Patient just find this to be all apart because of this vaccine. No treatment medications were provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: pain in his stomach; he threw up food; very dizzy; abdominal started to hurt very badly right side; spleen was inflammed; arm hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurting), ABDOMINAL PAIN (abdominal started to hurt very badly right side), SPLENITIS (spleen was inflammed), ABDOMINAL PAIN UPPER (pain in his stomach) and DIZZINESS (very dizzy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Feb-2022 at 5:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm hurting). On 03-Feb-2022, the patient experienced ABDOMINAL PAIN (abdominal started to hurt very badly right side), SPLENITIS (spleen was inflammed) and DIZZINESS (very dizzy). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (pain in his stomach) and VOMITING (he threw up food). At the time of the report, PAIN IN EXTREMITY (arm hurting), ABDOMINAL PAIN (abdominal started to hurt very badly right side), SPLENITIS (spleen was inflammed), ABDOMINAL PAIN UPPER (pain in his stomach), DIZZINESS (very dizzy) and VOMITING (he threw up food) outcome was unknown.     No concomitant medications were provided by the reporter. On 3-Feb-2022, patient went to work and was very dizzy, so he came home and then his abdominal started to hurt very badly on his right side he ended up having to go to the hospital and the doctor said his spleen was inflamed and just sent him home to rest. Patient just find this to be all apart because of this vaccine. No treatment medications were provided by the reporter.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: HCP doesn´t remember if the patient received 0,5ML or 0,25ML as a first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (HCP doesn´t remember if the patient received 0,5ML or 0,25ML as a first dose) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (HCP doesn´t remember if the patient received 0,5ML or 0,25ML as a first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (HCP doesn´t remember if the patient received 0,5ML or 0,25ML as a first dose) 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.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Tachycardia
Clinical narrative: Why did my resting heart rate go up to 146 BPM after your vaccine. I now have to take medication to help lower it; This spontaneous case was reported by an other health care professional and describes the occurrence of TACHYCARDIA (Why did my resting heart rate go up to 146 BPM after your vaccine. I now have to take medication to help lower it) 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 TACHYCARDIA (Why did my resting heart rate go up to 146 BPM after your vaccine. I now have to take medication to help lower it). At the time of the report, TACHYCARDIA (Why did my resting heart rate go up to 146 BPM after your vaccine. I now have to take medication to help lower it) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 146 (High) Heart rate go up to 146 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient stated that they had to take medication (Unknown) to lower the heart rate.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Pruritus, Rash, Urticaria
Clinical narrative: reaction  pretty bad after a week o so/allergies all over the body; itching and redness; rush al over the body/pretty bad on her face,; hives/breaking up into hives,; itching badly/itching all the time/itching badly it been 10 days  and it si not going away/continuously itching all over  her body sometimes goes away and then comes back; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching badly/itching all the time/itching badly it been 10 days  and it si not going away/continuously itching all over  her body sometimes goes away and then comes back), HYPERSENSITIVITY (reaction  pretty bad after a week o so/allergies all over the body), URTICARIA (hives/breaking up into hives,), ERYTHEMA (itching and redness) and RASH (rush al over the body/pretty bad on her face,) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058h21a, 026b21a and 008c21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Fully recovered from COVID) on 12-Dec-2021.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2022, the patient experienced PRURITUS (itching badly/itching all the time/itching badly it been 10 days  and it si not going away/continuously itching all over  her body sometimes goes away and then comes back), URTICARIA (hives/breaking up into hives,) and RASH (rush al over the body/pretty bad on her face,). On an unknown date, the patient experienced HYPERSENSITIVITY (reaction  pretty bad after a week o so/allergies all over the body) and ERYTHEMA (itching and redness). At the time of the report, PRURITUS (itching badly/itching all the time/itching badly it been 10 days  and it si not going away/continuously itching all over  her body sometimes goes away and then comes back) and HYPERSENSITIVITY (reaction  pretty bad after a week o so/allergies all over the body) had not resolved and URTICARIA (hives/breaking up into hives,), ERYTHEMA (itching and redness) and RASH (rush al over the body/pretty bad on her face,) outcome was unknown.            Concomitant medications were not reported. Patient had no allergies of food, medicine, and other products. Recent change in status worsening, continuously itching all over the body, sometimes goes away and then come back. Patient was prescribed with allergy medicine, and steroid medicine by local doctor.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: swollen part around armpit after the booster vaccine; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (swollen part around armpit after the booster vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (swollen part around armpit after the booster vaccine). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (swollen part around armpit after the booster vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications was reported.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site irritation, Vaccination site mass, Vaccination site swelling, Vaccination site warmth
Clinical narrative: a swollen, lump and hot to touch irritation on the injection site; a swollen, lump and hot to touch irritation on the injection site; a swollen, lump and hot to touch irritation on the injection site; a swollen, lump and hot to touch irritation on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (a swollen, lump and hot to touch irritation on the injection site), VACCINATION SITE IRRITATION (a swollen, lump and hot to touch irritation on the injection site), VACCINATION SITE MASS (a swollen, lump and hot to touch irritation on the injection site) and VACCINATION SITE SWELLING (a swollen, lump and hot to touch irritation on the injection site) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to nuts.    On 05-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (a swollen, lump and hot to touch irritation on the injection site), VACCINATION SITE IRRITATION (a swollen, lump and hot to touch irritation on the injection site), VACCINATION SITE MASS (a swollen, lump and hot to touch irritation on the injection site) and VACCINATION SITE SWELLING (a swollen, lump and hot to touch irritation on the injection site). At the time of the report, VACCINATION SITE WARMTH (a swollen, lump and hot to touch irritation on the injection site), VACCINATION SITE IRRITATION (a swollen, lump and hot to touch irritation on the injection site), VACCINATION SITE MASS (a swollen, lump and hot to touch irritation on the injection site) and VACCINATION SITE SWELLING (a swollen, lump and hot to touch irritation on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and treatment information were not provided by reporter.  The patient was in an urgent care.  The patient had no known allergy with medications.  The patient had no known medical history.  Lot number and expiration date couldn't provide by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dyspnoea, Feeling abnormal, Hypertension, Pain in extremity
Clinical narrative: blood pressure was very high; difficult breathing; still really bad at night; a rash/ a lot of rash had  expread really fast all over her body; fever really bad; got pain in the arm and swollen; got pain in the arm and swollen; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure was very high), DYSPNOEA (difficult breathing), FEELING ABNORMAL (still really bad at night), PAIN IN EXTREMITY (got pain in the arm and swollen) and PERIPHERAL SWELLING (got pain in the arm and swollen) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042521a, 032m20a and 011m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2022, the patient experienced PAIN IN EXTREMITY (got pain in the arm and swollen) and PERIPHERAL SWELLING (got pain in the arm and swollen). On 06-Feb-2022, the patient experienced DYSPNOEA (difficult breathing), FEELING ABNORMAL (still really bad at night), RASH (a rash/ a lot of rash had  expread really fast all over her body) and PYREXIA (fever really bad). On an unknown date, the patient experienced HYPERTENSION (blood pressure was very high). At the time of the report, HYPERTENSION (blood pressure was very high), DYSPNOEA (difficult breathing), FEELING ABNORMAL (still really bad at night), PAIN IN EXTREMITY (got pain in the arm and swollen), PERIPHERAL SWELLING (got pain in the arm and swollen), RASH (a rash/ a lot of rash had  expread really fast all over her body) and PYREXIA (fever really bad) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure increased: high (High) very high.         Patient height was reported as 5 Foot and 4 inches.  It was reported that patient had allergies (medications, food and other products) to a drug that was no longer in the Market.  Concomitant medications included vitamins. No treatment medications were provided.  Patient had no COVID test or diagnosis. Patient did not experienced a similar event in the past.   This case was linked to MOD-2022-474191 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Rash
Clinical narrative: blood pressure was very high; difficult breathing; still really bad at night; a rash/ a lot of rash had  expread really fast all over her body; fever really bad; got pain in the arm and swollen; got pain in the arm and swollen; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure was very high), DYSPNOEA (difficult breathing), FEELING ABNORMAL (still really bad at night), PAIN IN EXTREMITY (got pain in the arm and swollen) and PERIPHERAL SWELLING (got pain in the arm and swollen) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042521a, 032m20a and 011m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2022, the patient experienced PAIN IN EXTREMITY (got pain in the arm and swollen) and PERIPHERAL SWELLING (got pain in the arm and swollen). On 06-Feb-2022, the patient experienced DYSPNOEA (difficult breathing), FEELING ABNORMAL (still really bad at night), RASH (a rash/ a lot of rash had  expread really fast all over her body) and PYREXIA (fever really bad). On an unknown date, the patient experienced HYPERTENSION (blood pressure was very high). At the time of the report, HYPERTENSION (blood pressure was very high), DYSPNOEA (difficult breathing), FEELING ABNORMAL (still really bad at night), PAIN IN EXTREMITY (got pain in the arm and swollen), PERIPHERAL SWELLING (got pain in the arm and swollen), RASH (a rash/ a lot of rash had  expread really fast all over her body) and PYREXIA (fever really bad) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure increased: high (High) very high.         Patient height was reported as 5 Foot and 4 inches.  It was reported that patient had allergies (medications, food and other products) to a drug that was no longer in the Market.  Concomitant medications included vitamins. No treatment medications were provided.  Patient had no COVID test or diagnosis. Patient did not experienced a similar event in the past.   This case was linked to MOD-2022-474191 (Patient Link).