chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTERED VACCINE FROM A PUNCTURED VIAL LONGER THAN 6 HOURS; This spontaneous report received from a pharmacist 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-JUN-2021, the subject experienced administered vaccine from a punctured vial longer than 6 hours. The action taken with covid-19 vaccine was not applicable. The outcome of administered vaccine from a punctured vial longer than 6 hours was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Off label use, Product storage error
Clinical narrative: POTENTIAL ADMINISTRATION ERROR (ADMINISTRATION OF AN EXPIRED VACCINE); OFF LABEL USE; TEMPERATURE EXCURSION; This spontaneous report received from a physician 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 (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 23-JUN-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced potential administration error (administration of an expired vaccine). On 07-JUN-2021, the subject experienced off label use. On 07-JUN-2021, the subject experienced temperature excursion. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from potential administration error (administration of an expired vaccine), and the outcome of off label use and temperature excursion was not reported. This report was non-serious. This case, from the same reporter is linked to 20210616952 and 20210617020.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Muscle spasms, Muscle tightness
Clinical narrative: MUSCLE TENSION; MUSCLE CRAMPS IN THE LEGS, ARMS AND KNEES; TIGHTENING OF THE NECK; I DON'T HAVE ENERGY AT ALL; 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 was not reported, administered on 02-APR-2021 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 muscle tension, muscle cramps in the legs, arms and knees, tightening of the neck, and i don't have energy at all. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the i don't have energy at all, muscle tension, muscle cramps in the legs, arms and knees and tightening of the neck was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Haematochezia, Pollakiuria
Clinical narrative: BLOOD IN STOOL; FREQUENT URINATION; PAIN IN STOMACH; This spontaneous report received from a consumer concerned a male patient of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient had no existing medical conditions and the patient was not taking any medications at the time of vaccination or at report time. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAY-2021, the patient started experiencing adverse symptoms of frequent urination, blood in stool, and pain in stomach. He reached out to medical staff to run further testing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the frequent urination, blood in stool and pain in stomach was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210616825-COVID-19 VACCINE AD26.COV2.S- Blood in stool. 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: Arthralgia, Decreased appetite, Fatigue, Gait disturbance, Insomnia
Clinical narrative: WALKING DIFFICULTY/COULD BARELY WALK 2 STEPS FROM ONE ROOM TO ANOTHER; TIRED; JOINT PAIN IN ELBOWS AND KNEES; PROBLEM SLEEPING; NOT MUCH APPETITE/COULD NOT EAT ANYMORE; 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: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the subject experienced problem sleeping. On 02-APR-2021, the subject experienced not much appetite/could not eat anymore. On 02-APR-2021, the subject experienced joint pain in elbows and knees. On an unspecified date, the subject experienced walking difficulty/could barely walk 2 steps from one room to another, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, and the outcome of joint pain in elbows and knees, problem sleeping, not much appetite/could not eat anymore and walking difficulty/could barely walk 2 steps from one room to another was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU-LIKE SYMPTOMS; 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, expiry: unknown) dose was not reported, start therapy date were 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 subject experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu-like symptoms was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: SORE THROAT; FEVER; MUSCLES ACHES; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non smoker, and other pre-existing medical conditions included patient have no known allergies, no drug abuse or illicit drug usage, no medical history, no etoh.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 642A2119 expiry: UNKNOWN) dose was not reported, administered on 08-JUN-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 08-JUN-2021, the subject experienced sore throat. On 08-JUN-2021, the subject experienced fever. On 08-JUN-2021, the subject experienced muscles aches. Laboratory data included: Body temperature (NR: not provided) 100.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, sore throat, and muscles aches. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: TIREDNESS; SMALL LOW GRADE FEVER; 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 (suspension for injection, route of admin 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 MAY-2021, the subject experienced tiredness. On MAY-2021, the subject experienced small low grade fever. The action taken with covid-19 vaccine  was not applicable. The patient recovered from tiredness, and small low grade fever on MAY-2021. This report was non-serious.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Headache, Nausea
Clinical narrative: Pneumonia; Blood clot in his lungs; Lack of appetite; Diarrhea; Headache; High Fever; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) and PULMONARY THROMBOSIS (Blood clot in his lungs) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L201) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant), PULMONARY THROMBOSIS (Blood clot in his lungs) (seriousness criteria hospitalization and medically significant), DECREASED APPETITE (Lack of appetite), DIARRHOEA (Diarrhea), HEADACHE (Headache), PYREXIA (High Fever), CHILLS (Chills) and NAUSEA (Nausea). The patient was hospitalized from 22-Jan-2021 to 30-Jan-2021 due to PNEUMONIA and PULMONARY THROMBOSIS. At the time of the report, PNEUMONIA (Pneumonia), PULMONARY THROMBOSIS (Blood clot in his lungs), DECREASED APPETITE (Lack of appetite), DIARRHOEA (Diarrhea), HEADACHE (Headache), PYREXIA (High Fever), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood thinners, antibiotic and probiotics.  No treatment information was provided.  Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the events of fever, chills, headache, and nausea.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: New events and seriousness of hospitalization were added.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the events of fever, chills, headache, and nausea.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Pulmonary thrombosis, Pyrexia
Clinical narrative: Pneumonia; Blood clot in his lungs; Lack of appetite; Diarrhea; Headache; High Fever; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) and PULMONARY THROMBOSIS (Blood clot in his lungs) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L201) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant), PULMONARY THROMBOSIS (Blood clot in his lungs) (seriousness criteria hospitalization and medically significant), DECREASED APPETITE (Lack of appetite), DIARRHOEA (Diarrhea), HEADACHE (Headache), PYREXIA (High Fever), CHILLS (Chills) and NAUSEA (Nausea). The patient was hospitalized from 22-Jan-2021 to 30-Jan-2021 due to PNEUMONIA and PULMONARY THROMBOSIS. At the time of the report, PNEUMONIA (Pneumonia), PULMONARY THROMBOSIS (Blood clot in his lungs), DECREASED APPETITE (Lack of appetite), DIARRHOEA (Diarrhea), HEADACHE (Headache), PYREXIA (High Fever), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood thinners, antibiotic and probiotics.  No treatment information was provided.  Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the events of fever, chills, headache, and nausea.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: New events and seriousness of hospitalization were added.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the events of fever, chills, headache, and nausea.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Amnesia, Decreased appetite, Dizziness, Insomnia
Clinical narrative: Dizziness; Lupus syndrome; Lose of taste; Lose of memory; Lose of appetite; Not sleeping well; This spontaneous case was reported by a patient and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus syndrome) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus syndrome) (seriousness criterion medically significant), AGEUSIA (Lose of taste), AMNESIA (Lose of memory), DECREASED APPETITE (Lose of appetite), INSOMNIA (Not sleeping well) and DIZZINESS (Dizziness). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus syndrome), AGEUSIA (Lose of taste), AMNESIA (Lose of memory), DECREASED APPETITE (Lose of appetite), INSOMNIA (Not sleeping well) and DIZZINESS (Dizziness) outcome was unknown.            The concomitant medication were not provided. The treatment 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. However, based on the pathophysiology of systemic lupus erythematous, it is assessed as unlikely related to mRNA-1273.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow up received on 02 Jun 2021 included non significant follow up information.; 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.However, based on the pathophysiology of systemic lupus erythematous, it is assessed as unlikely related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: Dizziness; Lupus syndrome; Lose of taste; Lose of memory; Lose of appetite; Not sleeping well; This spontaneous case was reported by a patient and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus syndrome) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus syndrome) (seriousness criterion medically significant), AGEUSIA (Lose of taste), AMNESIA (Lose of memory), DECREASED APPETITE (Lose of appetite), INSOMNIA (Not sleeping well) and DIZZINESS (Dizziness). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus syndrome), AGEUSIA (Lose of taste), AMNESIA (Lose of memory), DECREASED APPETITE (Lose of appetite), INSOMNIA (Not sleeping well) and DIZZINESS (Dizziness) outcome was unknown.            The concomitant medication were not provided. The treatment 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. However, based on the pathophysiology of systemic lupus erythematous, it is assessed as unlikely related to mRNA-1273.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow up received on 02 Jun 2021 included non significant follow up information.; 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.However, based on the pathophysiology of systemic lupus erythematous, it is assessed as unlikely related to mRNA-1273.
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Coma, Hypokinesia, Lethargy, Unresponsive to stimuli
Clinical narrative: went into coma; cannot use his arms and legs; patient was lethargic; cannot speak; unresponsive; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COMA (went into coma) and UNRESPONSIVE TO STIMULI (unresponsive) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced COMA (went into coma) (seriousness criteria hospitalization and medically significant) and UNRESPONSIVE TO STIMULI (unresponsive) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPOKINESIA (cannot use his arms and legs), LETHARGY (patient was lethargic) and APHASIA (cannot speak). On 18-May-2021, COMA (went into coma) had resolved. At the time of the report, UNRESPONSIVE TO STIMULI (unresponsive), HYPOKINESIA (cannot use his arms and legs), LETHARGY (patient was lethargic) and APHASIA (cannot speak) outcome was unknown.            No relevant concomitant medication provided. No treatment information provided.  Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 02-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (Blood clot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not  provided. Concomitant product use was not provided by the reporter.  Company comment Very limited information has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information has been provided at this time. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: accute hearing loss; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 02-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (accute hearing loss) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (accute hearing loss) (seriousness criterion medically significant). At the time of the report, DEAFNESS (accute hearing loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.  Company comments: Very limited information regarding this event has been provided at this time.  Further information can't be requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information can't be requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Red rash all over face, head, ears, neck; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of RASH ERYTHEMATOUS (Red rash all over face, head, ears, neck) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 048B21A) for COVID-19 vaccination.     The patient's past medical history included Autoimmune arthritis.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash all over face, head, ears, neck) (seriousness criteria disability and medically significant). The patient was treated with TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE [TRIAMCINOLONE ACETONIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Red rash all over face, head, ears, neck) had not resolved.            Concomitant products were not provided/unknown.  Based on the 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.   This case was linked to MOD-2021-194729 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow-up received on 02-Jun-2021 contains non-significant information: E-mail id added; Sender's Comments: Based on the 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: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood test, Chest X-ray, Electrocardiogram, Loss of consciousness
Clinical narrative: Atrial fibrillation; Blacked out; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Blacked out) and ATRIAL FIBRILLATION (Atrial fibrillation) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included DVT. Concurrent medical conditions included Chronic pain and Spinal stenosis lumbar.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (Blacked out) (seriousness criterion medically significant). On 12-Feb-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Blacked out) and ATRIAL FIBRILLATION (Atrial fibrillation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Blood test: inconclusive (Inconclusive) Inconclusive. On 12-Feb-2021, Chest X-ray: abnormal (abnormal) Abnormal. On 12-Feb-2021, Electrocardiogram: abnormal (abnormal) Abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication used was not provided. No Treatment information was 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-2021-194935 (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: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Feeling abnormal, Gallbladder disorder, Pyrexia
Clinical narrative: issues with my gall bladder; I felt a lot of pain in my back/ radiating throughout the lower back; reflux; fever; chills; I felt the usual rough day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GALLBLADDER DISORDER (issues with my gall bladder) in a 39-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 was provided by the reporter.  Concomitant products included ESOMEPRAZOLE, LOSARTAN, HYDROXYZINE and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced FEELING ABNORMAL (I felt the usual rough day), PYREXIA (fever) and CHILLS (chills). On 27-Apr-2021, the patient experienced BACK PAIN (I felt a lot of pain in my back/ radiating throughout the lower back) and REFLUX GASTRITIS (reflux). On 30-May-2021, the patient experienced GALLBLADDER DISORDER (issues with my gall bladder) (seriousness criterion hospitalization). The patient was hospitalized on 30-May-2021 due to GALLBLADDER DISORDER. The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL 8 HOUR) at an unspecified dose and frequency. At the time of the report, GALLBLADDER DISORDER (issues with my gall bladder), BACK PAIN (I felt a lot of pain in my back/ radiating throughout the lower back), FEELING ABNORMAL (I felt the usual rough day), REFLUX GASTRITIS (reflux), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            Treatment medications included Muscle Relaxer. Action taken with mRNA-1273 in response to the drug 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.; 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: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Reflux gastritis
Clinical narrative: issues with my gall bladder; I felt a lot of pain in my back/ radiating throughout the lower back; reflux; fever; chills; I felt the usual rough day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GALLBLADDER DISORDER (issues with my gall bladder) in a 39-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 was provided by the reporter.  Concomitant products included ESOMEPRAZOLE, LOSARTAN, HYDROXYZINE and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced FEELING ABNORMAL (I felt the usual rough day), PYREXIA (fever) and CHILLS (chills). On 27-Apr-2021, the patient experienced BACK PAIN (I felt a lot of pain in my back/ radiating throughout the lower back) and REFLUX GASTRITIS (reflux). On 30-May-2021, the patient experienced GALLBLADDER DISORDER (issues with my gall bladder) (seriousness criterion hospitalization). The patient was hospitalized on 30-May-2021 due to GALLBLADDER DISORDER. The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL 8 HOUR) at an unspecified dose and frequency. At the time of the report, GALLBLADDER DISORDER (issues with my gall bladder), BACK PAIN (I felt a lot of pain in my back/ radiating throughout the lower back), FEELING ABNORMAL (I felt the usual rough day), REFLUX GASTRITIS (reflux), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            Treatment medications included Muscle Relaxer. Action taken with mRNA-1273 in response to the drug 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.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided.  No relevant concomitant medication provided.  Company comment:Based on the 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: Based on the 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Dyspnoea, Pharyngeal swelling, Product dose omission issue
Clinical narrative: Product dose omission; Difficulty breathing; Loss of voice; Swelling of throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Difficulty breathing) in a 66-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.     No Medical History information reported.     On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DYSPNOEA (Difficulty breathing) (seriousness criterion medically significant), APHONIA (Loss of voice) and PHARYNGEAL SWELLING (Swelling of throat). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Product dose omission). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and EPINEPHRINE (EPIPEN) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Difficulty breathing), APHONIA (Loss of voice) and PHARYNGEAL SWELLING (Swelling of throat) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Product dose omission) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  This is a report of a 66-years female, whose medical history and medications were not provided; who presented an immediate reaction after receiving the first dose of the product.  As per medical judgment are not considered life-threatening; thus, as this is a SPONTANEOUS REPORT, seriousness has manually been overridden.  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. However, for the event Product dose omission issue of mRNA-1273, causality is not applicable.; 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. However, for the event Product dose omission issue of mRNA-1273, causality is not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Spontaneous miscarriage; Spontaneous miscarriage; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Spontaneous miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (Spontaneous miscarriage) (seriousness criterion medically significant) and EXPOSURE DURING PREGNANCY (Spontaneous miscarriage). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. Spontaneous miscarriage. Gestation period not reported. At the time of the report, ABORTION SPONTANEOUS (Spontaneous miscarriage) and EXPOSURE DURING PREGNANCY (Spontaneous miscarriage) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not provided.  Company Comment: This case concerns a female patient, unknown age, who experienced an event of drug exposure during pregnancy and also experienced an event of spontaneous abortion. Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender's Comments: This case concerns a female patient, unknown age, who experienced an event of drug exposure during pregnancy and also experienced an event of spontaneous abortion. Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Pulmonary embolism, Vaccination site pain
Clinical narrative: Blood clots, one on the lung; Gonna pass out; Extremely dizzy; Lightheaded; Little bit of soreness after injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Blood clots, one on the lung) and LOSS OF CONSCIOUSNESS (Gonna pass out) in a 42-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.     Concurrent medical conditions included COPD and Diabetes. Concomitant products included INSULIN and OMEPRAZOLE for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PAIN (Little bit of soreness after injection). On 04-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Gonna pass out) (seriousness criterion medically significant), DIZZINESS (Extremely dizzy) and DIZZINESS (Lightheaded). On 06-Apr-2021, the patient experienced PULMONARY EMBOLISM (Blood clots, one on the lung) (seriousness criteria hospitalization and medically significant). On 03-Apr-2021, VACCINATION SITE PAIN (Little bit of soreness after injection) had resolved. On 04-Apr-2021, LOSS OF CONSCIOUSNESS (Gonna pass out) and DIZZINESS (Extremely dizzy) had resolved. At the time of the report, PULMONARY EMBOLISM (Blood clots, one on the lung) outcome was unknown and DIZZINESS (Lightheaded) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included medications for (diabetic) nerve pain and inhalers used for chronic obstructive pulmonary disease.  Treatment for the event included blood thinners.  Based on the current available information and temporal association between the use of the product and the start date of the event vaccination site pain, a causal relationship cannot be excluded. Very limited information regarding the events loss of consciousness, dizziness, and pulmonary embolism has been provided at this time. However, the patient's underlying medical conditions remains as confounders. Further information is not expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event vaccination site pain, a causal relationship cannot be excluded. Very limited information regarding the events loss of consciousness, dizziness, and pulmonary embolism has been provided at this time. However, the patient's underlying medical conditions remains as confounders. Further information is not expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Rectal haemorrhage
Clinical narrative: Bleeding from the rectum; Flu like symptoms; This spontaneous case was reported by a patient and describes the occurrence of RECTAL HAEMORRHAGE (Bleeding from the rectum) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 18-Apr-2021, the patient experienced RECTAL HAEMORRHAGE (Bleeding from the rectum) (seriousness criterion medically significant). At the time of the report, RECTAL HAEMORRHAGE (Bleeding from the rectum) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.            No concomitant medication reported. No treatment medication reported.  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.; 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Pain in extremity, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Arm like a cellulitis; Pain in the arm; Itchy arm; Redness; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Arm like a cellulitis) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B2) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced CELLULITIS (Arm like a cellulitis) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in the arm), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, CELLULITIS (Arm like a cellulitis), PAIN IN EXTREMITY (Pain in the arm), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.            No concomitant medications mentioned.  No treatment information included.  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.; 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: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Anxiety, Cold sweat, Hyperhidrosis, Panic attack, Poor quality sleep
Clinical narrative: had an anxiety attack/the anxiety attack was really out of the ordinary; had a horrible panic attack/having hot fiery panic attacks; bad taste in the mouth; couldn't sleep real well/she can fall asleep, but she cant stay asleep, she recalls on the first night after getting the vaccine, on 19Feb2021 she would wake up every hour; her hands are clammy, she is sweating; her hands are clammy, she is sweating; This is a spontaneous report from a contactable consumer (patient herself). A 62-year old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unspecified route of administration in the left arm on 19Feb2021 (Batch lot number EN6200) (at the age of 62-year old) at single dose for Covid-19 immunization and alprazolam (XANAX XR) orally at 2 mg in the morning at 6 AM and 1 mg at 1 PM (3 mg daily total) for anxiety. She actually had 2 separate prescriptions: one was a Xanax Extended Release 2 mg pill, and the other was a Xanax Extended Release 1mg pill. Relevant medical history included breast cancer from 2006, high blood pressure and cholesterol abnormal. Concomitant drugs included medication for high blood pressure and cholesterol medication. The patient reported that usually her anxiety was managed by medicine, however after the shot, Friday at noon, it was weird she had a horrible panic attack. She also had the panic attack Sunday, yesterday, and a little today. Her anxiety was always controlled prior to the first dose of vaccine but after the shot, it wass not, her anxiety was out of control. She noticed her anxiety incident probably Saturday morning around 6 AM. She did have complications on Friday 19Feb2021, it was a bad taste in the mouth and she couldn't sleep real well at night. She clarified that she can fall asleep, but she cant stay asleep, she recalled on the first night after getting the vaccine, on 19Feb2021 she would wake up every hour. Anxiety was not controlled: it would say being controlled by her medicine as far as intensity of the anxiety attack. On Saturday and Sunday was the biggest anxiety attack, and it was as if she was not even on the medication that's what it felt like, she was not better, the anxiety was still there. Like during the panic attack her hands were clammy, she was sweating, its an anxiety attack, it could be hormones. This was like as if she was not even taking her Xanax XR, she was having hot fiery panic attacks. She just had a physician appointment 2 weeks before the report (and before the vaccination) and everything was fine: "perfectly fine". The outcome of bad taste was recovering, the outcome of sleep unwell was not recovered while the outcome of the other events was unknown.  No follow-up attempts are possible. No further information is expected.