chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION (STUFFY NOSE/CONGESTION); This spontaneous report received from a consumer concerned a 61-year-old male of unspecified ethnicity and race. The patient's height and weight were not reported. The patient's concurrent conditions included Chronic obstructive pulmonary disease (COPD) and High blood pressure (HBP). Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: unknown) 1 total, dose was not reported, administered on 06-MAR-2021 at left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 23-JUN-2021, the patient experienced stuffy nose. On 26-JUN-2021, the patient tested positive for covid-19 antigen test (confirmed covid-19 infection, confirmed clinical vaccination failure). Next day, on 27-JUN-2021, to verify whether the previous result was correct, patient was tested again using a PCR test kit and result was positive again. On the same day, patient received Regeneron monoclonal antibodies. On 30-JUN-2021, at the time of reporting, patient still had some congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection (stuffy nose/congestion) and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210700296-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: Headache, Hyperhidrosis, Malaise, Pain in extremity, Sleep disorder
Clinical narrative: SWEATING; VOMITING; CAN NOT SLEEP ON LEFT SIDE; DON'T FEEL GOOD RIGHT NOW; LEFT ARM PAIN; MILD HEADACHES; 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 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, treatment medications included: paracetamol. On 13-MAY-2021, the subject experienced sweating. On 13-MAY-2021, the subject experienced vomiting. On 13-MAY-2021, the subject experienced can not sleep on left side. On 13-MAY-2021, the subject experienced don't feel good right now. On 13-MAY-2021, the subject experienced left arm pain. On 13-MAY-2021, the subject experienced mild headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, vomiting, and mild headaches, had not recovered from don't feel good right now, and left arm pain, and the outcome of can not sleep on left side was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: SWEATING; VOMITING; CAN NOT SLEEP ON LEFT SIDE; DON'T FEEL GOOD RIGHT NOW; LEFT ARM PAIN; MILD HEADACHES; 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 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, treatment medications included: paracetamol. On 13-MAY-2021, the subject experienced sweating. On 13-MAY-2021, the subject experienced vomiting. On 13-MAY-2021, the subject experienced can not sleep on left side. On 13-MAY-2021, the subject experienced don't feel good right now. On 13-MAY-2021, the subject experienced left arm pain. On 13-MAY-2021, the subject experienced mild headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, vomiting, and mild headaches, had not recovered from don't feel good right now, and left arm pain, and the outcome of can not sleep on left side was not reported. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: DULL CONTINUOUS SORENESS AT THE SITE OF THE INJECTION; This spontaneous report received from a patient via a company representative concerned a 42 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: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAY-2021, the subject experienced dull continuous soreness at the site of the injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dull continuous soreness at the site of the injection. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Arthralgia
Clinical narrative: STLL FEEL LIKE; EVERY JOINT IN MY BODY HURTS; 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 not reported, batch number: Unknown) dose was not reported, administered on 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 an unspecified date, the subject experienced stll feel like, and every joint in my body hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the every joint in my body hurts and stll feel like was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SUFFERED 8 DAYS WITH REACTION / UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high risk health concerns.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 subject experienced suffered 8 days with reaction / unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suffered 8 days with reaction / unspecified adverse event. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: FEELING LIKE BODY HURT; FEVER FOR ABOUT 24 HOURS; 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 not reported, batch number: Unk) dose, start therapy date were not reported 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 an unspecified date, the subject experienced feeling like body hurt, and fever for about 24 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever for about 24 hours, and the outcome of feeling like body hurt was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Malaise, Nausea, Vomiting
Clinical narrative: NAUSEA; VOMITING; FELT SICK; FELT TIRED; LETHARGIC; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-JUN-2021, the subject experienced lethargic. On 25-JUN-2021, the subject experienced felt tired. On 26-JUN-2021, the subject experienced vomiting. On 26-JUN-2021, the subject experienced felt sick. On 29-JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt sick on 28-JUN-2021, was recovering from vomiting, had not recovered from lethargic, and felt tired, and the outcome of nausea was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION (TESTED POSITIVE FOR CORONA VIRUS BY USING COVID-19 TESTING KIT AT HOME); 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 not reported, batch number: Unk) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On JUN-2021, the subject experienced suspected covid-19 infection (tested positive for corona virus by using covid-19 testing kit at home). Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection (tested positive for corona virus by using covid-19 testing kit at home) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210666578.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: DOSE WAS GIVEN FROM PREVIOUSLY PUNCTURED VIAL STORED IN THE REFRIGERATOR FOR OVER 24 HOURS; This spontaneous report received from a pharmacist concerned multiple patients.  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: 182128B, and batch number: 182128B expiry: 06-SEP-2021) dose was not reported, administered on 29-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUN-2021, the subject experienced dose was given from previously punctured vial stored in the refrigerator for over 24 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose was given from previously punctured vial stored in the refrigerator for over 24 hours was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac infection
Clinical narrative: SERIOUS INFECTION AROUND HEART; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received Covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total was administered, 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 serious infection around heart, she was taken to the hospital. It was reported she might need an open heart surgery. The action taken with Covid-19 vaccine was not applicable. The outcome of serious infection around heart was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210700618-Covid-19 vaccine -serious infection around heart. This event(s) is considered unassessable. The event(s) has an unknown/unclear 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: Glycosylated haemoglobin decreased, Glycosylated haemoglobin increased, Pain in extremity, Therapeutic response unexpected
Clinical narrative: UNEXPECTED THERAPEUTIC BENEFIT (NO LONGER A DIABETIC); IT FELT LIKE MY ARM GOT HIT WITH A MALLET; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included diabetes, and concurrent conditions included do not exercise. The patient was previously treated with metformin for diabetes. 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 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included liraglutide for diabetes. On JUN-2021, Laboratory data included: HbA1C decreased (NR: not provided) 5.1. On an unspecified date, the subject experienced unexpected therapeutic benefit (no longer a diabetic), and it felt like my arm got hit with a mallet. Laboratory data (dates unspecified) included: HbA1C increased (NR: not provided) 7.2. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the it felt like my arm got hit with a mallet and unexpected therapeutic benefit (no longer a diabetic) was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; 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 not reported, batch number: Unknown) 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 subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Migraine, Pyrexia
Clinical narrative: MIGRAINE; CHILLS; FEVER; 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 not reported, batch number: Unknown) dose, start therapy date were not reported 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 an unspecified date, the subject experienced migraine, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and migraine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: FEVER OF 102; WIPED ME OUT; 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 not reported, batch number: Unknown) dose, start therapy date were not reported 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 an unspecified date, the subject experienced fever of 102, and wiped me out. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 102 and wiped me out was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; HIGH FEVER; 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 not reported, batch number: Unknown) dose, start therapy date were not reported 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 an unspecified date, the subject experienced body aches, chills, and high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high fever, chills, and body aches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: Blood in stools; Severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in stools) and DIARRHOEA (Severe diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (Severe diarrhea) (seriousness criterion medically significant). On 21-May-2021, the patient experienced HAEMATOCHEZIA (Blood in stools) (seriousness criterion medically significant). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. At the time of the report, HAEMATOCHEZIA (Blood in stools) and DIARRHOEA (Severe diarrhea) had not resolved.            Concomitant medications included High blood pressure medication and Cholesterol medication. Treatment medications included antibiotics along with above mentioned medications. Patient has a colonoscopy scheduled. Patient had another episode of diarrhea on 21-MAY-2021. Action taken with mRNA-1273 in response to the events was not applicable.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: Diarrhea; Blood in stools; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in stools) in an elderly 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 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 21-May-2021, the patient experienced HAEMATOCHEZIA (Blood in stools) (seriousness criterion medically significant). On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, HAEMATOCHEZIA (Blood in stools) and DIARRHOEA (Diarrhea) had not resolved.            No relevant concomitant medications were reported. Treatment of the event diarrhea included, antibiotics. After a week and a half of second dose reporter started with severe diarrhea. Diarrhea stopped and restarted on 21-May-2021, with blood in stools. Action taken with mRNA-1273 in response to the events was not applicable  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Dyspnoea, Fatigue, Feeling hot
Clinical narrative: Felt like she was gong to to pass out; Dizziness; Felt somewhat confused; Felt hot; Felt it was hard to breathe; Heart was racing; Fatigue; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Felt like she was gong to to pass out) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D22B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included VALPROATE SEMISODIUM (DIVALPROEX) for an unknown indication.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Felt like she was gong to to pass out) (seriousness criterion medically significant), DIZZINESS (Dizziness), CONFUSIONAL STATE (Felt somewhat confused), FEELING HOT (Felt hot), DYSPNOEA (Felt it was hard to breathe), PALPITATIONS (Heart was racing), FATIGUE (Fatigue) and NAUSEA (Nauseous). At the time of the report, LOSS OF CONSCIOUSNESS (Felt like she was gong to to pass out), DIZZINESS (Dizziness), CONFUSIONAL STATE (Felt somewhat confused), DYSPNOEA (Felt it was hard to breathe) and PALPITATIONS (Heart was racing) outcome was unknown and FEELING HOT (Felt hot), FATIGUE (Fatigue) and NAUSEA (Nauseous) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication were not reported.  Patient experienced dizziness and felt somewhat confused. She also felt like it was hard to breathe, and she was going to pass out. Her heart was also racing. At the time of reporting patient further stated that she experienced fatigue, and she felt nauseous and hot but she was feeling better now.  Company comment: This case concerns a 29-year-old female with a serious unexpected event of loss of consciousness, and nonserious dizziness, confusional state, dyspnea, palpitations, feeling hot, fatigue, and nausea. Event onset 3 days after first dose mRNA-1273. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 29-year-old female with a serious unexpected event of loss of consciousness, and nonserious dizziness, confusional state, dyspnea, palpitations, feeling hot, fatigue, and nausea. Event onset 3 days after first dose mRNA-1273. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea, Palpitations
Clinical narrative: Felt like she was gong to to pass out; Dizziness; Felt somewhat confused; Felt hot; Felt it was hard to breathe; Heart was racing; Fatigue; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Felt like she was gong to to pass out) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D22B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included VALPROATE SEMISODIUM (DIVALPROEX) for an unknown indication.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Felt like she was gong to to pass out) (seriousness criterion medically significant), DIZZINESS (Dizziness), CONFUSIONAL STATE (Felt somewhat confused), FEELING HOT (Felt hot), DYSPNOEA (Felt it was hard to breathe), PALPITATIONS (Heart was racing), FATIGUE (Fatigue) and NAUSEA (Nauseous). At the time of the report, LOSS OF CONSCIOUSNESS (Felt like she was gong to to pass out), DIZZINESS (Dizziness), CONFUSIONAL STATE (Felt somewhat confused), DYSPNOEA (Felt it was hard to breathe) and PALPITATIONS (Heart was racing) outcome was unknown and FEELING HOT (Felt hot), FATIGUE (Fatigue) and NAUSEA (Nauseous) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication were not reported.  Patient experienced dizziness and felt somewhat confused. She also felt like it was hard to breathe, and she was going to pass out. Her heart was also racing. At the time of reporting patient further stated that she experienced fatigue, and she felt nauseous and hot but she was feeling better now.  Company comment: This case concerns a 29-year-old female with a serious unexpected event of loss of consciousness, and nonserious dizziness, confusional state, dyspnea, palpitations, feeling hot, fatigue, and nausea. Event onset 3 days after first dose mRNA-1273. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 29-year-old female with a serious unexpected event of loss of consciousness, and nonserious dizziness, confusional state, dyspnea, palpitations, feeling hot, fatigue, and nausea. Event onset 3 days after first dose mRNA-1273. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Confusional state, Disorientation, Dizziness, Fatigue
Clinical narrative: Memory problems; Dizziness; Little confusion; Disorientation; Don't feel safe driving/ can't drive; Joint pain; Fatigue; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Memory problems), DIZZINESS (Dizziness), CONFUSIONAL STATE (Little confusion), DISORIENTATION (Disorientation), FEELING ABNORMAL (Don't feel safe driving/ can't drive), ARTHRALGIA (Joint pain), FATIGUE (Fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     Concomitant products included BUSPIRONE, CLONAZEPAM, PAROXETINE and DONEPEZIL for an unknown indication.   On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) (seriousness criterion disability). On an unknown date, the patient experienced MEMORY IMPAIRMENT (Memory problems) (seriousness criterion disability), DIZZINESS (Dizziness) (seriousness criterion disability), CONFUSIONAL STATE (Little confusion) (seriousness criterion disability), DISORIENTATION (Disorientation) (seriousness criterion disability), FEELING ABNORMAL (Don't feel safe driving/ can't drive) (seriousness criterion disability), ARTHRALGIA (Joint pain) (seriousness criterion disability) and FATIGUE (Fatigue) (seriousness criterion disability). The patient was treated with IBUPROFEN for Joint pain, at an unspecified dose and frequency. On 21-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, MEMORY IMPAIRMENT (Memory problems), DIZZINESS (Dizziness), CONFUSIONAL STATE (Little confusion), DISORIENTATION (Disorientation), FEELING ABNORMAL (Don't feel safe driving/ can't drive), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-231068 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Inappropriate schedule of product administration, Memory impairment
Clinical narrative: Memory problems; Dizziness; Little confusion; Disorientation; Don't feel safe driving/ can't drive; Joint pain; Fatigue; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Memory problems), DIZZINESS (Dizziness), CONFUSIONAL STATE (Little confusion), DISORIENTATION (Disorientation), FEELING ABNORMAL (Don't feel safe driving/ can't drive), ARTHRALGIA (Joint pain), FATIGUE (Fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     Concomitant products included BUSPIRONE, CLONAZEPAM, PAROXETINE and DONEPEZIL for an unknown indication.   On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) (seriousness criterion disability). On an unknown date, the patient experienced MEMORY IMPAIRMENT (Memory problems) (seriousness criterion disability), DIZZINESS (Dizziness) (seriousness criterion disability), CONFUSIONAL STATE (Little confusion) (seriousness criterion disability), DISORIENTATION (Disorientation) (seriousness criterion disability), FEELING ABNORMAL (Don't feel safe driving/ can't drive) (seriousness criterion disability), ARTHRALGIA (Joint pain) (seriousness criterion disability) and FATIGUE (Fatigue) (seriousness criterion disability). The patient was treated with IBUPROFEN for Joint pain, at an unspecified dose and frequency. On 21-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, MEMORY IMPAIRMENT (Memory problems), DIZZINESS (Dizziness), CONFUSIONAL STATE (Little confusion), DISORIENTATION (Disorientation), FEELING ABNORMAL (Don't feel safe driving/ can't drive), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-231068 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chest discomfort, Dyspnoea, Dysstasia
Clinical narrative: Epileptic volts; Weakness; Numbness; Unable to stand; shortness of breath /severe shortness of breath/; felt as if someone was sitting on her chest; High fever; Alot of neurologic symptoms; This spontaneous case was reported by a consumer and describes the occurrence of EPILEPSY (Epileptic volts) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030C20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced EPILEPSY (Epileptic volts) (seriousness criterion medically significant), ASTHENIA (Weakness), HYPOAESTHESIA (Numbness), DYSSTASIA (Unable to stand), DYSPNOEA (shortness of breath /severe shortness of breath/), CHEST DISCOMFORT (felt as if someone was sitting on her chest), PYREXIA (High fever ) and NEUROLOGICAL SYMPTOM (Alot of neurologic symptoms). On 03-Feb-2021, EPILEPSY (Epileptic volts), ASTHENIA (Weakness), HYPOAESTHESIA (Numbness), DYSSTASIA (Unable to stand), DYSPNOEA (shortness of breath /severe shortness of breath/), CHEST DISCOMFORT (felt as if someone was sitting on her chest), PYREXIA (High fever ) and NEUROLOGICAL SYMPTOM (Alot of neurologic symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 103.7f (High) increased  For the first 13 days Patient had a high fever that went up to 103.7F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter.Treatment information was not provided  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   This case was linked to MOD-2021-231098 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Epilepsy, Hypoaesthesia, Neurological symptom, Pyrexia
Clinical narrative: Epileptic volts; Weakness; Numbness; Unable to stand; shortness of breath /severe shortness of breath/; felt as if someone was sitting on her chest; High fever; Alot of neurologic symptoms; This spontaneous case was reported by a consumer and describes the occurrence of EPILEPSY (Epileptic volts) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030C20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced EPILEPSY (Epileptic volts) (seriousness criterion medically significant), ASTHENIA (Weakness), HYPOAESTHESIA (Numbness), DYSSTASIA (Unable to stand), DYSPNOEA (shortness of breath /severe shortness of breath/), CHEST DISCOMFORT (felt as if someone was sitting on her chest), PYREXIA (High fever ) and NEUROLOGICAL SYMPTOM (Alot of neurologic symptoms). On 03-Feb-2021, EPILEPSY (Epileptic volts), ASTHENIA (Weakness), HYPOAESTHESIA (Numbness), DYSSTASIA (Unable to stand), DYSPNOEA (shortness of breath /severe shortness of breath/), CHEST DISCOMFORT (felt as if someone was sitting on her chest), PYREXIA (High fever ) and NEUROLOGICAL SYMPTOM (Alot of neurologic symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature: 103.7f (High) increased  For the first 13 days Patient had a high fever that went up to 103.7F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter.Treatment information was not provided  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   This case was linked to MOD-2021-231098 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Impaired driving ability
Clinical narrative: Extreme fatigue after first dose; Can't drive; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Extreme fatigue after first dose) and IMPAIRED DRIVING ABILITY (Can't drive) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     Concomitant products included BUSPIRONE, CLONAZEPAM, PAROXETINE and DONEPEZIL for an unknown indication.    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Extreme fatigue after first dose) (seriousness criterion disability) and IMPAIRED DRIVING ABILITY (Can't drive) (seriousness criterion disability). At the time of the report, FATIGUE (Extreme fatigue after first dose) had resolved and IMPAIRED DRIVING ABILITY (Can't drive) 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.   Treatment information was not provided.  Additional information was mentioned patient had a First shot done in left arm and second shot done in the right arm., patient don't feel safe for driving also mentioned.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events were classified as serious by regulatory authority (seriousness criteria: disability). However, as per medical criteria none of the events was serious (not IME listed and resolved).   This case was linked to MOD-2021-231034 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events were classified as serious by regulatory authority (seriousness criteria: disability). However, as per medical criteria none of the events was serious (not listed and resolved).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Gait disturbance, Insomnia, Loss of personal independence in daily activities
Clinical narrative: unbearable pain in vertebrae down to her ankles; May kill myself due to pain; cannot sleep; pain in bones; destroyed her daily living condition; inability to walk; pain in vertebra; This spontaneous case was reported by a consumer and describes the occurrence of SUICIDAL IDEATION (May kill myself due to pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025621A and 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rheumatoid arthritis (Rheumatoid Arthritis for 45 years  Recommended: advil, tylenol, Performed epidural in spine with zero effect).   On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced INSOMNIA (cannot sleep), BONE PAIN (pain in bones), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (destroyed her daily living condition), GAIT DISTURBANCE (inability to walk) and SPINAL PAIN (pain in vertebra). On 22-Jun-2021, the patient experienced SUICIDAL IDEATION (May kill myself due to pain) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHRALGIA (unbearable pain in vertebrae down to her ankles). At the time of the report, SUICIDAL IDEATION (May kill myself due to pain), INSOMNIA (cannot sleep), BONE PAIN (pain in bones), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (destroyed her daily living condition), GAIT DISTURBANCE (inability to walk), SPINAL PAIN (pain in vertebra) and ARTHRALGIA (unbearable pain in vertebrae down to her ankles) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received the Moderna vaccine series and experienced adverse events. Symptoms included inability to walk, unbearable pain in vertebrae down to her ankles, pain in all her bones, cannot sleep and and its destroyed her daily living condition and she wants the antidote or may kill herself. Medical history includes rheumatoid Arthritis for 45 years. HCP was consulted. Second Injection: LOT #049C21A with administration date: May 31, 2021.Patient stated she does not like the Moderna vaccine.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. There is confounding by a self-reported medical history of rheumatoid arthritis.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. There is confounding by a self-reported medical history of rheumatoid arthritis.
Sex: F
Vaccine: COVID19
Symptoms: Spinal pain, Suicidal ideation
Clinical narrative: unbearable pain in vertebrae down to her ankles; May kill myself due to pain; cannot sleep; pain in bones; destroyed her daily living condition; inability to walk; pain in vertebra; This spontaneous case was reported by a consumer and describes the occurrence of SUICIDAL IDEATION (May kill myself due to pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025621A and 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rheumatoid arthritis (Rheumatoid Arthritis for 45 years  Recommended: advil, tylenol, Performed epidural in spine with zero effect).   On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced INSOMNIA (cannot sleep), BONE PAIN (pain in bones), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (destroyed her daily living condition), GAIT DISTURBANCE (inability to walk) and SPINAL PAIN (pain in vertebra). On 22-Jun-2021, the patient experienced SUICIDAL IDEATION (May kill myself due to pain) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHRALGIA (unbearable pain in vertebrae down to her ankles). At the time of the report, SUICIDAL IDEATION (May kill myself due to pain), INSOMNIA (cannot sleep), BONE PAIN (pain in bones), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (destroyed her daily living condition), GAIT DISTURBANCE (inability to walk), SPINAL PAIN (pain in vertebra) and ARTHRALGIA (unbearable pain in vertebrae down to her ankles) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received the Moderna vaccine series and experienced adverse events. Symptoms included inability to walk, unbearable pain in vertebrae down to her ankles, pain in all her bones, cannot sleep and and its destroyed her daily living condition and she wants the antidote or may kill herself. Medical history includes rheumatoid Arthritis for 45 years. HCP was consulted. Second Injection: LOT #049C21A with administration date: May 31, 2021.Patient stated she does not like the Moderna vaccine.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. There is confounding by a self-reported medical history of rheumatoid arthritis.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. There is confounding by a self-reported medical history of rheumatoid arthritis.
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Quadracel was missed when the patient was younger with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00657506) and transmitted to Sanofi on 25-Jun-2021.  This case involves a 7 years old male patient who missed a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number and expiry date were not reported) when he was young (product dose omission issue).  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   It was reported that a dose of Quadracel was missed when the patient was younger at a different clinic. Because of this, the patient is now 7 years old and behind on his Adacel dose. The Quadracel dose was never given.  It was an actual medication error case due to missed dose (latency: same day).  At the time of reporting, the patient experienced no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.