chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Gastric disorder, Unevaluable event, Vaccination complication
Clinical narrative: Unevaluable event; Gastric disorder; Vaccination adverse reaction; This spontaneous report received from a patient via a company representative concerned an adult female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry was not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult Crohn's disease. No concomitant medications were reported. On an unspecified date, the patient experienced unevaluable event, gastric disorder, and vaccination adverse reaction.  On 09-NOV-2021, the patient was hospitalized for lot of complications (unevaluable event) and as per the patients physician that was not related to Crohn's.  On 14-NOV-2021, the patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s, and adalimumab was not applicable. The patient was recovering from unevaluable event, and the outcome of gastric disorder and vaccination adverse reaction was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20220124979-Covid-19 vaccine ad26.cov2.s-Unevaluable event.This event(s) is considered unassessable. The event(s) has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous report received from a health care professional (patient) concerned a 72 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total, administered on left arm on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, about 10 day after vaccination the patient had covid-19, patient did not have an exact date. Patient had a test done at a site that went up her nostril, and got a positive result 2-3 days later. Patient said just standard test, but did not remember what kind. Patient had a monoclonal infusion towards end of the month of April-2021, the next week after she got the positive covid result, but had no exact date. She went to the hospital and got the infusion there. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000211941.; Sender's Comments: V0: 20220126052-COVID-19 VACCINE AD26.COV2.S- Covid-19. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 56 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821287, expiry: 30-OCT-2021) dose was not reported, dose number in series was 1, 1 total, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  It was reported that the patient had covid after receiving the JnJ/Janssen Covid 19 vaccine. On 13-JAN-2022 (a day before this report), the patient was sent home from work after testing positive (confirmed clinical vaccination failure and confirmed covid-19 infection). The type of test used is unknown (dose number in series was 1).  Laboratory data included: COVID-19 virus test positive (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000211931.; Sender's Comments: V0: 20220126351-Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Thrombosis
Clinical narrative: BLOOD CLOTS; SORE THROAT; This spontaneous report received from a parent concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: unknown expiry: unknown) dose, start therapy date were not reported, dose number in series was 1, 01 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had a sore throat and blood clots after receiving the Janssen coronavirus disease-19 (COVID-19) vaccine (dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots and sore throat was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220126392-COVID-19 VACCINE AD26.COV2.S-Blood clots. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate irregular, Laboratory test, Nervous system disorder, Rash
Clinical narrative: BLOOD CLOTS; SORE THROAT; This spontaneous report received from a parent concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: unknown expiry: unknown) dose, start therapy date were not reported, dose number in series was 1, 01 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had a sore throat and blood clots after receiving the Janssen coronavirus disease-19 (COVID-19) vaccine (dose number in series was 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots and sore throat was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220126392-COVID-19 VACCINE AD26.COV2.S-Blood clots. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative concerned a 55 year old female of unspecified race and ethnicity. Initial information was processed along with the additional information received on 14-JAN-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose number in series was 1, 1 total, dose and start therapy date were not reported administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced death (dose number in series was 1). The cause of death was not reported. It was unspecified whether an autopsy was performed. The consumer reported as "My 55 year old friend took the vaccine, died within 2 weeks. It is listed as her cause of death on death certificate". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220126211, 20220126582, 20220126614, 20220126701, 20220126708, 20220126177 and 20220126174.; Sender's Comments: V0: 20220126450-Covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. No relevant medical history reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 21-APR-2021 for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 24-DEC-2021, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from covid-19. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac discomfort, Cardiac disorder, Chest pain, Dyspnoea, Feeling of body temperature change
Clinical narrative: HEART HURT/STABBING PAIN AND TIGHTNESS IN HEART; QUIVERING IN HEART; VISION BECAME BLURRY; SHORT OF BREATH; MUSCLES STARTED TO SPASM; BECOME HOT AND COLD; HEART PRESSURE; PSYCHOLOGICALLY STRESSED; SKIN TURN RED AND BECOME ITCHY ALL OVER; SCREAMING TINNITUS IN EARS; TINGLING IN MY ARM, LEG, AND FACE/TINGLING SPREAD THROUGHOUT BODY; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On SEP-2021, the patient experienced tingling in my arm, leg, and face/tingling spread throughout body. On an unspecified date, the patient experienced heart hurt/stabbing pain and tightness in heart, quivering in heart, vision became blurry, short of breath, muscles started to spasm, become hot and cold, heart pressure, psychologically stressed, skin turn red and become itchy all over, and screaming tinnitus in ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vision became blurry, short of breath, tingling in my arm, leg, and face/tingling spread throughout body, muscles started to spasm, become hot and cold, skin turn red and become itchy all over, screaming tinnitus in ears, heart hurt/stabbing pain and tightness in heart, quivering in heart, and heart pressure, and the outcome of psychologically stressed was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Paraesthesia, Rash pruritic, Stress, Tinnitus
Clinical narrative: HEART HURT/STABBING PAIN AND TIGHTNESS IN HEART; QUIVERING IN HEART; VISION BECAME BLURRY; SHORT OF BREATH; MUSCLES STARTED TO SPASM; BECOME HOT AND COLD; HEART PRESSURE; PSYCHOLOGICALLY STRESSED; SKIN TURN RED AND BECOME ITCHY ALL OVER; SCREAMING TINNITUS IN EARS; TINGLING IN MY ARM, LEG, AND FACE/TINGLING SPREAD THROUGHOUT BODY; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On SEP-2021, the patient experienced tingling in my arm, leg, and face/tingling spread throughout body. On an unspecified date, the patient experienced heart hurt/stabbing pain and tightness in heart, quivering in heart, vision became blurry, short of breath, muscles started to spasm, become hot and cold, heart pressure, psychologically stressed, skin turn red and become itchy all over, and screaming tinnitus in ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vision became blurry, short of breath, tingling in my arm, leg, and face/tingling spread throughout body, muscles started to spasm, become hot and cold, skin turn red and become itchy all over, screaming tinnitus in ears, heart hurt/stabbing pain and tightness in heart, quivering in heart, and heart pressure, and the outcome of psychologically stressed was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: HEART HURT/STABBING PAIN AND TIGHTNESS IN HEART; QUIVERING IN HEART; VISION BECAME BLURRY; SHORT OF BREATH; MUSCLES STARTED TO SPASM; BECOME HOT AND COLD; HEART PRESSURE; PSYCHOLOGICALLY STRESSED; SKIN TURN RED AND BECOME ITCHY ALL OVER; SCREAMING TINNITUS IN EARS; TINGLING IN MY ARM, LEG, AND FACE/TINGLING SPREAD THROUGHOUT BODY; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On SEP-2021, the patient experienced tingling in my arm, leg, and face/tingling spread throughout body. On an unspecified date, the patient experienced heart hurt/stabbing pain and tightness in heart, quivering in heart, vision became blurry, short of breath, muscles started to spasm, become hot and cold, heart pressure, psychologically stressed, skin turn red and become itchy all over, and screaming tinnitus in ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vision became blurry, short of breath, tingling in my arm, leg, and face/tingling spread throughout body, muscles started to spasm, become hot and cold, skin turn red and become itchy all over, screaming tinnitus in ears, heart hurt/stabbing pain and tightness in heart, quivering in heart, and heart pressure, and the outcome of psychologically stressed was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious
Sex: U
Vaccine: COVID19
Symptoms: Muscle atrophy, Pain in extremity, Sensory loss, Vaccination site pain
Clinical narrative: MUSCLE  LOSS; LOSS OF SENSATION ON THE SIDE; IT HURTS TO TRY TO MAKE THE ARM MOVE; VACCINATION SITE PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: UNKNOWN) dose was not reported, administered on 31-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On JAN-2022, the patient experienced muscle loss. On JAN-2022, the patient experienced loss of sensation on the side. On JAN-2022, the patient experienced it hurts to try to make the arm move. On JAN-2022, the patient experienced vaccination site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle loss, loss of sensation on the side, it hurts to try to make the arm move, and vaccination site pain. This report was non-serious. This report was associated with product quality complaint:90000212229
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia
Clinical narrative: DIZZINESS; UNUSUAL TASTE IN MOUTH; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced dizziness, and unusual taste in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness, and unusual taste in mouth. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: It was punctured on 13Jan2022 at 12:15 pm. They gave 2 doses from this vial this morning; First dose received on 06Dec2021 and second dose on 14Jan2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (It was punctured on 13Jan2022 at 12:15 pm. They gave 2 doses from this vial this morning) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 06Dec2021 and second dose on 14Jan2022) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A and 939909) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2022 at 1:04 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (It was punctured on 13Jan2022 at 12:15 pm. They gave 2 doses from this vial this morning) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 06Dec2021 and second dose on 14Jan2022). On 14-Jan-2022, EXPIRED PRODUCT ADMINISTERED (It was punctured on 13Jan2022 at 12:15 pm. They gave 2 doses from this vial this morning) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 06Dec2021 and second dose on 14Jan2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reported  No treatment medication was provided by the reporter.  Moderna vial sat out at room temperature unpunctured for greater than 12 hours and gave 2 doses from this vial on 14-JAN-2022.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: An opened vial of the Moderna Covid-19 Vaccine was left out of the refrigerator over the weekend & a dose was given to a patient today; received their first dose of from a vial that was left out at room temp for 72 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An opened vial of the Moderna Covid-19 Vaccine was left out of the refrigerator over the weekend & a dose was given to a patient today) and PRODUCT STORAGE ERROR (received their first dose of from a vial that was left out at room temp for 72 hours) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (An opened vial of the Moderna Covid-19 Vaccine was left out of the refrigerator over the weekend & a dose was given to a patient today) and PRODUCT STORAGE ERROR (received their first dose of from a vial that was left out at room temp for 72 hours). On 17-Jan-2022, EXPIRED PRODUCT ADMINISTERED (An opened vial of the Moderna Covid-19 Vaccine was left out of the refrigerator over the weekend & a dose was given to a patient today) and PRODUCT STORAGE ERROR (received their first dose of from a vial that was left out at room temp for 72 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.  Vial was initially stored in the refrigerator on 11Jan2022 and vial was first punctured on 14Jan2022 at 8:30am and  vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jan-2022: Updated dose number as one for suspect product
Sex: U
Vaccine: COVID19
Symptoms: Foetal death, Foetal vascular malperfusion
Clinical narrative: clotting at the placenta/caused the baby to not receive any blood; Baby was deceased on: 26Oct2021; This spontaneous case was reported by a consumer and describes the occurrence of FOETAL VASCULAR MALPERFUSION (clotting at the placenta/caused the baby to not receive any blood) and FOETAL DEATH (Baby was deceased on: 26Oct2021) in a foetus patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 026D21D) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Maternal exposure during pregnancy.    No Medical History information was reported.   On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) 1 dosage form. On 20-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FOETAL VASCULAR MALPERFUSION (clotting at the placenta/caused the baby to not receive any blood) (seriousness criteria death and medically significant) and FOETAL DEATH (Baby was deceased on: 26Oct2021) (seriousness criteria death and medically significant). The patient died on 26-Oct-2021. The reported cause of death was clotting at the placenta. It is unknown if an autopsy was performed.            No concomitant and treatment medication were provided Patient stated that this is my "rainbow baby" as her previous baby passed away due to doctor negligence in 2019 as she stated that it had nothing to do with health it was doctor's negligence in 2019.  Company Comment: This case refers to a foetal patient of unspecified age and gender with a medical history of mother reporting maternal exposure during pregnancy. The patient experienced the unexpected event of Foetal vascular malperfusion on an unspecified date after the second dose of mRNA-1273 vaccine but experienced the unexpected event of Foetal death approximately 6 days after receiving the second dose of the vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-440025 (Patient Link).; Sender's Comments: This case refers to a foetal patient of unspecified age and gender with a medical history of mother reporting maternal exposure during pregnancy. The patient experienced the unexpected event of Foetal vascular malperfusion on an unspecified date after the second dose of mRNA-1273 vaccine but experienced the unexpected event of Foetal death approximately 6 days after receiving the second dose of the vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Clotting at the placenta
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: she took the booster and die; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (she took the booster and die) in a 98-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant product was provided. No treatment information was provided. Patient was very healthy, days before vaccination, in TV she said she was very well.  Company Comment: This is a spontaneous case concerning a 98-year-old, female patient with no  medical history reported, who experienced the unexpected serious event of death. The event occurred at an unknown date after the booster dose of mRNA-1273 vaccine. Cause of death was not reported, it is unknown if an autopsy was performed. Patient´s age remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious due to death and important medical event.    Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a 98-year-old, female patient with no  medical history reported, who experienced the unexpected serious event of death. The event occurred at an unknown date after the booster dose of mRNA-1273 vaccine. Cause of death was not reported, it is unknown if an autopsy was performed. Patient´s age remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious due to death and important medical event.; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: SIRVA; This spontaneous case was reported by an other health care professional and describes the occurrence of SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION 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 SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION. At the time of the report, SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION 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 reported. No treatment medications were reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Idiopathic pulmonary fibrosis
Clinical narrative: Pulmonary fibrosis rapidly progressed & flare up after moderna covid 19; This spontaneous case was reported by a health care professional and describes the occurrence of IDIOPATHIC PULMONARY FIBROSIS (Pulmonary fibrosis rapidly progressed & flare up after moderna covid 19) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     Concurrent medical conditions included Idiopathic pulmonary fibrosis. Concomitant products included PIRFENIDONE (ESBRIET) for an unknown indication.    On 04-Apr-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 IDIOPATHIC PULMONARY FIBROSIS (Pulmonary fibrosis rapidly progressed & flare up after moderna covid 19) (seriousness criteria hospitalization and medically significant). At the time of the report, IDIOPATHIC PULMONARY FIBROSIS (Pulmonary fibrosis rapidly progressed & flare up after moderna covid 19) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details were not provided. Patient was stabilized since first encounter on 7-Mar-2018.  Company comment: This is a spontaneous case concerning a 73-year-old male patient with concurrent condition of idiopathic pulmonary fibrosis treated with Esbriet, and no other medical history reported, who experienced the serious, unexpected, according CCDS, event of idiopathic pulmonary fibrosis. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The medical history of atrial fibrillation remains a confounder for atrial fibrillation. The concurrent condition of idiopathic pulmonary fibrosis remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 73-year-old male patient with concurrent condition of idiopathic pulmonary fibrosis treated with Esbriet, and no other medical history reported, who experienced the serious, unexpected, according CCDS, event of idiopathic pulmonary fibrosis. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The medical history of atrial fibrillation remains a confounder for atrial fibrillation. The concurrent condition of idiopathic pulmonary fibrosis remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Pain, Palpitations
Clinical narrative: Caused her pain on the left side underneath the rib/ is a dull pain that is there 24/7; EKG showed palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (EKG showed palpitations) and PAIN (Caused her pain on the left side underneath the rib/ is a dull pain that is there 24/7) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 001B21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Caused her pain on the left side underneath the rib/ is a dull pain that is there 24/7). In January 2022, the patient experienced PALPITATIONS (EKG showed palpitations). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, PALPITATIONS (EKG showed palpitations) and PAIN (Caused her pain on the left side underneath the rib/ is a dull pain that is there 24/7) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2022, Electrocardiogram: palpitations (abnormal) Showed palpitations.         Concomitant medications were not provided by the reporter.  Patient experienced a pain on the left side underneath on rib. The patient was being sent by the doctor on a referral for chest X-rays, full panel blood work including troponin levels on 17JAN 2022. The patient stated that her doctor said that the pain is not due to myocarditis and pericarditis. Doctor told that there were no antibiotics for such pain. Pain had been there for 3 weeks as of no and it was not full-on chest pain, it was a dull pain. It was reported that palpitations started a week after the pain started. Patient did not had a history of COVID-19 and Myocarditis/Pericarditis.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness/stinging at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness/stinging at the injection site) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness/stinging at the injection site). At the time of the report, VACCINATION SITE PAIN (soreness/stinging at the injection site) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No Concomitant use were reported.  No Treatment were reported.   This case was linked to MOD-2021-079424 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jan-2022: Follow up received on 06-JAN-2022: New event (suspected COVID-19) added. Corresponding fields and narrative updated accordingly.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: Had a small red circle on the arm, it swelled a little; After first shot she had a small red circle on the arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Had a small red circle on the arm, it swelled a little) and RASH (After first shot she had a small red circle on the arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PERIPHERAL SWELLING (Had a small red circle on the arm, it swelled a little). 22-Jan-2021, the patient experienced RASH (After first shot she had a small red circle on the arm). At the time of the report, PERIPHERAL SWELLING (Had a small red circle on the arm, it swelled a little) and RASH (After first shot she had a small red circle on the arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication provided. No treatment information mentioned.  Patient reported after having first dose, had a small red circle on the arm which swelled a little.   This case was linked to MOD-2022-451538 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Fatigue, Hypoaesthesia oral, Pyrexia
Clinical narrative: Had a small red circle on the arm, it swelled a little; After first shot she had a small red circle on the arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Had a small red circle on the arm, it swelled a little) and RASH (After first shot she had a small red circle on the arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PERIPHERAL SWELLING (Had a small red circle on the arm, it swelled a little). 22-Jan-2021, the patient experienced RASH (After first shot she had a small red circle on the arm). At the time of the report, PERIPHERAL SWELLING (Had a small red circle on the arm, it swelled a little) and RASH (After first shot she had a small red circle on the arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication provided. No treatment information mentioned.  Patient reported after having first dose, had a small red circle on the arm which swelled a little.   This case was linked to MOD-2022-451538 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Peripheral swelling
Clinical narrative: Had a small red circle on the arm, it swelled a little; After first shot she had a small red circle on the arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Had a small red circle on the arm, it swelled a little) and RASH (After first shot she had a small red circle on the arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PERIPHERAL SWELLING (Had a small red circle on the arm, it swelled a little). 22-Jan-2021, the patient experienced RASH (After first shot she had a small red circle on the arm). At the time of the report, PERIPHERAL SWELLING (Had a small red circle on the arm, it swelled a little) and RASH (After first shot she had a small red circle on the arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication provided. No treatment information mentioned.  Patient reported after having first dose, had a small red circle on the arm which swelled a little.   This case was linked to MOD-2022-451538 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: My booster was more like a pinch/Nit a noramal vacc/It was not a poke; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION COMPLICATION (My booster was more like a pinch/Nit a noramal vacc/It was not a poke) 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 (My booster was more like a pinch/Nit a noramal vacc/It was not a poke). At the time of the report, VACCINATION COMPLICATION (My booster was more like a pinch/Nit a noramal vacc/It was not a poke) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I have had COVID was out for 5 weeks. I also had both shots of Moderna; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (I have had COVID was out for 5 weeks. I also had both shots of Moderna) 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 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 COVID-19 (I have had COVID was out for 5 weeks. I also had both shots of Moderna). At the time of the report, COVID-19 (I have had COVID was out for 5 weeks. I also had both shots of Moderna) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided. Company comment:This is a case concerning patient of an unknown age and gender with no medical history reported, who experienced the unexpected non-serious AESI COVID-19 (with SARS-CoV-2 test positive). The event occurred on unknown date after the first dose of mRNA-1273 vaccine. Patient was reported to be fully vaccinated before the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as non-serious as per Regulatory Authority´s report.    Reporter did not allow further contact; Sender's Comments: This is a case concerning patient of an unknown age and gender with no medical history reported, who experienced the unexpected non-serious AESI COVID-19 (with SARS-CoV-2 test positive). The event occurred on unknown date after the first dose of mRNA-1273 vaccine. Patient was reported to be fully vaccinated before the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as non-serious as per Regulatory Authority´s report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I had COVID19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (I had COVID19) 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 17-Dec-2021, the patient experienced COVID-19 (I had COVID19). At the time of the report, COVID-19 (I had COVID19) 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 reported. No treatment medications were reported.  Company comment:  This spontaneous case concerns a patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19, that occurred after the dose of the mRNA-1273. The exact time to onset and number of doses administered was not provided  The rechallenge was not applicable due to unspecified number of doses and nature of the event.  Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19, that occurred after the dose of the mRNA-1273. The exact time to onset and number of doses administered was not provided  The rechallenge was not applicable due to unspecified number of doses and nature of the event.  Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Had covid after 2 Moderna shots; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Had covid after 2 Moderna 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.   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. In December 2021, the patient experienced COVID-19 (Had covid after 2 Moderna shots). At the time of the report, COVID-19 (Had covid after 2 Moderna shots) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.  Company comment:  This regulatory authority case concerns a patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19, that occurred after the 2nd dose of the mRNA-1273 . The exact time to onset was not provided. The rechallenge was not applicable due to occurrence after the 2nd dose and nature of the event. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This regulatory authority case concerns a patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19, that occurred after the 2nd dose of the mRNA-1273 . The exact time to onset was not provided. The rechallenge was not applicable due to occurrence after the 2nd dose and nature of the event. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.