chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT FROM THIGH TO ANKLE; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex and race. 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 26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot from thigh to ankle. As per the reporter "After J&J vaccine. The patient ended up with blood clot from thigh to ankle". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot from thigh to ankle was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211244555-Covid-19 vaccine ad26.cov2.s- Blood clot from thigh to ankle. 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.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This spontaneous report received from a patient concerned a 35 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, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total administered on 05-MAY-2021 to left arm for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported. On 14-DEC-2021, the patient experienced headache with fatigue on 15-DEC-2021 and congestion on friday 17-DEC-2021 (coded under confirmed covid-19 infection). On 19-DEC-2021, the patient tested positive for Covid-19 (confirmed clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000207983.; Sender's Comments: V0: 20211244701-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
Symptoms: Body temperature, Feeling abnormal, Pyrexia
Clinical narrative: FELT LIKE RUN OVER BY A TRUCK; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: crohn's disease, and coronary artery disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced felt like run over by a truck, and low grade fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) low grade. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like run over by a truck, and low grade fever on APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: CONVULSIONS; This spontaneous report received from a parent via a company representative concerned a female of unspecified age, race and ethnicity. 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: unknown expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination (dose number in series 1). 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 convulsions. As per reporter, "My daughter went into convulsions after taking your vaccine" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of convulsions was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20211244735-Covid-19 vaccine ad26.cov2.s- Convulsions. 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
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a consumer via social media via a company representative concerned a male of unspecified age, race and ethnicity. 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, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reporter stated that, "Healthy people and #Jnjvaccineinjured#vaccineinjuredpeople. Need healthy planet. My husband paralyzed and had a stroke after your vaccine what are you doing too help us?". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211244768- stroke. 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: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient via a company representative 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, and batch number were not reported) dose was not reported, administered on 17-DEC-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 17-DEC-2021, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: IRREGULAR MENSTRUAL CYCLES AFTER ONE DOSE JANSSEN COVID-19 VACCINE; This spontaneous report received from a patient via a company representative concerned an adult female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: menstrual cycle was very predictable before receiving the vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 28-MAR-2021, the patient experienced irregular menstrual cycles after one dose janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from irregular menstrual cycles after one dose janssen covid-19 vaccine. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT; This spontaneous report received from a patient concerned a female 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. 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 adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 INFECTION; This spontaneous report received from a patient via a company representative 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, and batch number were not reported) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On NOV-2021, the patient experienced covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from covid-19 infection. This report was non-serious. This report was associated with a product quality complaint :90000207823.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SYMPTOMS DUE TO VACCINE/ UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a parent concerned a female 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. 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 symptoms due to vaccine/ unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of symptoms due to vaccine/ unspecified adverse event was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SOME MILD SYMPTOMS; This spontaneous report received from a consumer via a company representative concerned a female 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. 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 mild symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild symptoms was not reported. This report was non-serious. This case, from the same reporter is linked to 20211245092.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient via a company representative 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, and batch number were not reported) dose was not reported, administered on MAR-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 an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SEVERE REACTIONS; This spontaneous report received from a patient via a company representative concerned a female 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 was not reported, administered on MAY-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 an unspecified date, the patient experienced severe reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe reactions was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENT NOS; This spontaneous report received from a patient via a company representative 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. 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 adverse event nos. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event nos was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: General physical health deterioration
Clinical narrative: RUINED HEALTH; 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, and batch number were not reported) dose, start therapy date were not reported 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 ruined health. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of ruined health was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza, Nasopharyngitis
Clinical narrative: She has the flu. She got the flu a week ago after getting her first dose of the vaccine/her flu is very bad; Cold; Strong headaches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (She has the flu. She got the flu a week ago after getting her first dose of the vaccine/her flu is very bad), NASOPHARYNGITIS (Cold) and HEADACHE (Strong headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (She has the flu. She got the flu a week ago after getting her first dose of the vaccine/her flu is very bad), NASOPHARYNGITIS (Cold) and HEADACHE (Strong headaches). At the time of the report, INFLUENZA (She has the flu. She got the flu a week ago after getting her first dose of the vaccine/her flu is very bad) and HEADACHE (Strong headaches) had not resolved and NASOPHARYNGITIS (Cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported.  The patient received the first dose of the Moderna COVID-19 vaccine and had an appointment to get their second dose on 16-Dec-2021 but not sure of the date and the patient did not go because it was very cold, and the patient had the flu. The patient got the flu a week ago after getting their first dose of the vaccine. Reportedly, the patient had flu which was very bad and had strong headaches.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: vaccinated person got coronavirus; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (vaccinated person got coronavirus) 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 COVID-19 (vaccinated person got coronavirus). At the time of the report, COVID-19 (vaccinated person got coronavirus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication reported.  Consumer calling asking about the new variant, the Omicron variant, and how someone, who was double vaccinated and received the booster dose, got the omicron variant of the coronavirus.  Company comment: This is a spontaneous  case concerning a  male patient of an unknown age with no medical history reported, who experienced unexpected event of COVID 19 (AESI). The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous  case concerning a  male patient of an unknown age with no medical history reported, who experienced unexpected event of COVID 19 (AESI). The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye irritation, Fatigue, Feeling of body temperature change, Influenza like illness
Clinical narrative: a sore right arm; nose running; eyes are burning; itchy; it almost feels like you have the flu; she  feels hot, then 30 minutes later will feels cold; overall tiredness; Chills; After the booster dose she was tired that night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a sore right arm), RHINORRHOEA (nose running), EYE IRRITATION (eyes are burning), PRURITUS (itchy) and INFLUENZA LIKE ILLNESS (it almost feels like you have the flu) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 012M20A and 011L22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received twenty-first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (After the booster dose she was tired that night). On an unknown date, the patient experienced PAIN IN EXTREMITY (a sore right arm), RHINORRHOEA (nose running), EYE IRRITATION (eyes are burning), PRURITUS (itchy), INFLUENZA LIKE ILLNESS (it almost feels like you have the flu), FEELING OF BODY TEMPERATURE CHANGE (she will feel hot, then 30 minutes later will feel cold), FATIGUE (overall tiredness) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (a sore right arm), RHINORRHOEA (nose running), EYE IRRITATION (eyes are burning), PRURITUS (itchy), INFLUENZA LIKE ILLNESS (it almost feels like you have the flu), FEELING OF BODY TEMPERATURE CHANGE (she will feel hot, then 30 minutes later will feel cold), FATIGUE (After the booster dose she was tired that night), FATIGUE (overall tiredness) and CHILLS (Chills) outcome was unknown.            No concomitant medication and treatment information was reported.   This case was linked to MOD-2021-403979 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rhinorrhoea
Clinical narrative: a sore right arm; nose running; eyes are burning; itchy; it almost feels like you have the flu; she  feels hot, then 30 minutes later will feels cold; overall tiredness; Chills; After the booster dose she was tired that night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a sore right arm), RHINORRHOEA (nose running), EYE IRRITATION (eyes are burning), PRURITUS (itchy) and INFLUENZA LIKE ILLNESS (it almost feels like you have the flu) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 012M20A and 011L22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received twenty-first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (After the booster dose she was tired that night). On an unknown date, the patient experienced PAIN IN EXTREMITY (a sore right arm), RHINORRHOEA (nose running), EYE IRRITATION (eyes are burning), PRURITUS (itchy), INFLUENZA LIKE ILLNESS (it almost feels like you have the flu), FEELING OF BODY TEMPERATURE CHANGE (she will feel hot, then 30 minutes later will feel cold), FATIGUE (overall tiredness) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (a sore right arm), RHINORRHOEA (nose running), EYE IRRITATION (eyes are burning), PRURITUS (itchy), INFLUENZA LIKE ILLNESS (it almost feels like you have the flu), FEELING OF BODY TEMPERATURE CHANGE (she will feel hot, then 30 minutes later will feel cold), FATIGUE (After the booster dose she was tired that night), FATIGUE (overall tiredness) and CHILLS (Chills) outcome was unknown.            No concomitant medication and treatment information was reported.   This case was linked to MOD-2021-403979 (Patient Link).
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Allergic to Booster shot; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic to Booster shot) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    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 ALLERGY TO VACCINE (Allergic to Booster shot). At the time of the report, ALLERGY TO VACCINE (Allergic to Booster shot) outcome was unknown. Not Provided          No Concomitant medications were reported. No Treatment details were reported. It was reported that patient required Medical attention.  Company comment: This is a spontaneous case concerning a 76-year-old patient of an unknown gender with no relevant medical history, who experienced event of allergy to vaccine. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. It was reported that patient required medical attention but clinical course and treatment details were not provided. Further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 76-year-old patient of an unknown gender with no relevant medical history, who experienced event of allergy to vaccine. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. It was reported that patient required medical attention but clinical course and treatment details were not provided. Further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: lack of drug effect; tested positive for Covid in November of 2021; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (lack of drug effect) and COVID-19 (tested positive for Covid in November of 2021) 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced DRUG INEFFECTIVE (lack of drug effect) and COVID-19 (tested positive for Covid in November of 2021). At the time of the report, DRUG INEFFECTIVE (lack of drug effect) and COVID-19 (tested positive for Covid in November of 2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID on November 2021.         Concomitant medication was not reported. Treatment information was not reported.  Company comment: This spontaneous case concerns a male patient, with no medical history reported in this case, who experienced the non-serious AESI of COVID-19. Additionally, Drug ineffective was also reported.  The events were reported to occur approximately 8 months after the administration of a proper schedule of vaccination with the mRNA-1273 vaccine (28 days between doses) and, at the time of the report, the outcome is unknown.  The causality is not applicable as per the nature of the event.  No further information on clinical course, diagnosis or treatment was provided.  The rechallenge is not applicable as the events occurred after the administration of the second dose of the mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient, with no medical history reported in this case, who experienced the non-serious AESI of COVID-19. Additionally, Drug ineffective was also reported.  The events were reported to occur approximately 8 months after the administration of a proper schedule of vaccination with the mRNA-1273 vaccine (28 days between doses) and, at the time of the report, the outcome is unknown.  The causality is not applicable as per the nature of the event.  No further information on clinical course, diagnosis or treatment was provided.  The rechallenge is not applicable as the events occurred after the administration of the second dose of the mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt fatigued after her second dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt fatigued after her second dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (felt fatigued after her second dose). At the time of the report, FATIGUE (felt fatigued after her second dose) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   The patient received the vaccine in her right arm shoulder deltoid muscle.   This case was linked to MOD-2021-409608 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Paralysis, Urinary incontinence
Clinical narrative: Recently paralyzed for a few days; Dripping urine from penis, had no control of urine; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Recently paralyzed for a few days) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 PARALYSIS (Recently paralyzed for a few days) (seriousness criterion medically significant) and URINARY INCONTINENCE (Dripping urine from penis, had no control of urine). At the time of the report, PARALYSIS (Recently paralyzed for a few days) and URINARY INCONTINENCE (Dripping urine from penis, had no control of urine) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.  COMPANY COMMENT: This is a regulatory case concerning a 74-year-old male patient with no clinical history who experienced the unexpected events of PARALYSIS and URINARY INCONTINENCE The events occurred unknown days after third dose of mRNA-1273. The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is a regulatory case concerning a 74-year-old male patient with no clinical history who experienced the unexpected events of PARALYSIS and URINARY INCONTINENCE The events occurred unknown days after third dose of mRNA-1273. The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Rash
Clinical narrative: angioedema; nonurticarial rash; This literature-study case was reported in a literature article and describes the occurrence of ANGIOEDEMA (angioedema) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE: Graded administration of second dose of Moderna and Pfizer-BioNTech COVID-19 mRNAvaccines in patients with hypersensitivity to first dose. Open Forum Infect Dis. 2021;8(12)     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 ANGIOEDEMA (angioedema) (seriousness criterion medically significant) and RASH (nonurticarial rash). At the time of the report, ANGIOEDEMA (angioedema) and RASH (nonurticarial rash) 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 considered ANGIOEDEMA (angioedema) and RASH (nonurticarial rash) to be related.    Patient experienced hypersensitivity reactions to the first dose Company Comment This case concerns a 28-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of angioedema. The event occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was unknown since no information regarding the second dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-409757, MOD-2021-409798, MOD-2021-409799, MOD-2021-409803, MOD-2021-409801, MOD-2021-409802, MOD-2021-409800, MOD-2021-411105, MOD-2021-411106, MOD-2021-411107 (Patient Link).; Sender's Comments: This case concerns a 28-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of angioedema. The event occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was unknown since no information regarding the second dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test, Chest pain, Dyspnoea, Electrocardiogram, Hypersensitivity
Clinical narrative: A week after the first dose or second dose, patient reports of some chest pains; Had a little bit of trouble breathing; After the first dose, had a slight allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (A week after the first dose or second dose, patient reports of some chest pains) and DYSPNOEA (Had a little bit of trouble breathing) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included TERAZOSIN HYDROCHLORIDE (TERAZIN) for Thyroid disorder NOS.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced DYSPNOEA (Had a little bit of trouble breathing) (seriousness criterion medically significant) and HYPERSENSITIVITY (After the first dose, had a slight allergic reaction). In 2021, the patient experienced CHEST PAIN (A week after the first dose or second dose, patient reports of some chest pains) (seriousness criterion hospitalization). The patient was hospitalized for 1 day due to CHEST PAIN. At the time of the report, CHEST PAIN (A week after the first dose or second dose, patient reports of some chest pains), DYSPNOEA (Had a little bit of trouble breathing) and HYPERSENSITIVITY (After the first dose, had a slight allergic reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: negative (Negative) Negative. On an unknown date, Electrocardiogram: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment medications were not provided. Patient experienced slight allergic reaction post first vaccination with Moderna but was not sure whether it was anxiety.  Patient never had allergies to a vaccine before. Patient was admitted overnight in the hospital.   This case was linked to MOD-2021-409940 (Patient Link).; Sender's Comments: This case concerns a 52-year-old, female patient with relevant medical history, thyroid disorder who experienced the unexpected events of Allergic reaction, Dyspnea, and Chest pain. The events of allergic reaction and dyspnea occurred approximately 1 day after the first dose of mRNA-1273 (Moderna covid-19 vaccine); patient was admitted into the hospital approximately a week after the first dose for chest pain. EKG and stress test were done, which were both negative. The rechallenge was not applicable, as the event happened after the first dose. This patient's underlying medical condition remains a contributory factor. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal operation, Vaccination site pain
Clinical narrative: Cervical spine area surgery; sore left arm for 24 hours after the first Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL OPERATION (Cervical spine area surgery) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (The patient had been in the hospital for cervical spine area surgery 2 weeks before second dose.).    On 30-Mar-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore left arm for 24 hours after the first Covid-19 vaccine). In April 2021, the patient experienced SPINAL OPERATION (Cervical spine area surgery) (seriousness criterion hospitalization). The patient was hospitalized on sometime in April 2021 due to SPINAL OPERATION. The patient was treated with DIPHENHYDRAMINE, PARACETAMOL (EXTRA STRENGTH TYLENOL PM) in April 2021 for Adverse event, at a dose of 2 tablets. At the time of the report, SPINAL OPERATION (Cervical spine area surgery) and VACCINATION SITE PAIN (sore left arm for 24 hours after the first Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. COMPANY COMMENT: This is an spontaneous case concerning an 39-year-old female patient with no clinical history who experienced the unexpected event of SPINAL OPERATION and a non-serious event The events occurred unknown days after first dose of mRNA-1273. The rechallenge was not applicable since only information about first dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-409876, MOD-2021-409877 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Dec-2021: Follow-up information included no new information.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an 39-year-old female patient with no clinical history who experienced the unexpected event of SPINAL OPERATION and a non-serious event The events occurred unknown days after first dose of mRNA-1273. The rechallenge was not applicable since only information about first dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Maternal exposure during pregnancy, Muscle spasms
Clinical narrative: I started having some bleeding; cramping day 2 post injection; I am 5 months pregnant and received the Moderna booster; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of HAEMORRHAGE (I started having some bleeding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 02-Dec-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (I am 5 months pregnant and received the Moderna booster). On 04-Dec-2021, the patient experienced HAEMORRHAGE (I started having some bleeding) (seriousness criterion medically significant) and MUSCLE SPASMS (cramping day 2 post injection). On 02-Dec-2021, MATERNAL EXPOSURE DURING PREGNANCY (I am 5 months pregnant and received the Moderna booster) had resolved. At the time of the report, HAEMORRHAGE (I started having some bleeding) and MUSCLE SPASMS (cramping day 2 post injection) outcome was unknown. Not Provided          No Concomitant medication were reported.  No Treatment information was reported.; Sender's Comments: This case concerns a female patient with no relevant medical history, who experienced the unexpected event of Hemorrhage. The event occurred approximately 3 days after the third dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as event occurred after third dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received third dose, unknown immunological status; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Received third dose, unknown immunological status) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced ACCIDENTAL OVERDOSE (Received third dose, unknown immunological status). In December 2021, ACCIDENTAL OVERDOSE (Received third dose, unknown immunological status) had resolved.            No concomitant medication was provided. The patient had third dose last week and it looks like it was a full 100 mcg/0.5 mL. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain in extremity, Pyrexia, Rash
Clinical narrative: a lot of swelling; not well enough; soreness/ achiness; huge rash on my arm; headaches; fever finally broke today; fever for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (a lot of swelling), MALAISE (not well enough), PAIN IN EXTREMITY (soreness/ achiness), RASH (huge rash on my arm) and HEADACHE (headaches) in a  patient of an unknown age and gender 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. In December 2021, the patient experienced PYREXIA (fever finally broke today). On an unknown date, the patient experienced SWELLING (a lot of swelling), MALAISE (not well enough), PAIN IN EXTREMITY (soreness/ achiness), RASH (huge rash on my arm), HEADACHE (headaches) and PYREXIA (fever for 3 days). At the time of the report, SWELLING (a lot of swelling), MALAISE (not well enough), PAIN IN EXTREMITY (soreness/ achiness), RASH (huge rash on my arm), HEADACHE (headaches) and PYREXIA (fever finally broke today) outcome was unknown and PYREXIA (fever for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided. No treatment medication information provided.
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: a lot of swelling; not well enough; soreness/ achiness; huge rash on my arm; headaches; fever finally broke today; fever for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (a lot of swelling), MALAISE (not well enough), PAIN IN EXTREMITY (soreness/ achiness), RASH (huge rash on my arm) and HEADACHE (headaches) in a  patient of an unknown age and gender 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. In December 2021, the patient experienced PYREXIA (fever finally broke today). On an unknown date, the patient experienced SWELLING (a lot of swelling), MALAISE (not well enough), PAIN IN EXTREMITY (soreness/ achiness), RASH (huge rash on my arm), HEADACHE (headaches) and PYREXIA (fever for 3 days). At the time of the report, SWELLING (a lot of swelling), MALAISE (not well enough), PAIN IN EXTREMITY (soreness/ achiness), RASH (huge rash on my arm), HEADACHE (headaches) and PYREXIA (fever finally broke today) outcome was unknown and PYREXIA (fever for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided. No treatment medication information provided.