chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SUSPECTED  CLINICAL VACCINE  FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age of unknown race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: 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 patient tested positive for suspected covid-19 infection after getting vaccinated (suspected clinical vaccine failure). Laboratory data (dates unspecified) 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 the suspected covid-19 infection and suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210703022.; Sender's Comments: V0: 20210703179 -Covid-19 vaccine ad26.cov2.-Suspected Clinical Vaccine 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: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE GIVEN FROM VIAL THAT WAS GIVEN 20 HOURS AFTER INITIAL PUNCTURE; VIAL WAS USED AFTER THE RECOMMENDED STORAGE TIME/ IMPROPER ADMINISTRATION; This spontaneous report received from a health care professional 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine given froml that was given 20 hours after initial puncture, and vial was used after the recommended storage time/ improper administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given froml that was given 20 hours after initial puncture and vial was used after the recommended storage time/ improper administration was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site bruising
Clinical narrative: BRUISE AT THE INJECTION SITE; 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 was not reported, administered on MAY-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 MAY-2021, the subject experienced bruise at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruise at the injection site. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Headache, Ventricular extrasystoles
Clinical narrative: MILD ATRIAL FIBRILLATION; NUMEROUS PREMATURE VENTRICULAR CONTRACTIONS (PVCS); MILD HEADACHE; This spontaneous report received from a patient concerned a 57 year old white and not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa allergy, and dried onions allergy. The patient experienced drug allergy when treated with ibuprofen.  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, 1 total administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Next day after getting vaccination (on 07-MAR-2021), the patient got a mild headache. On the same day around 10:30 pm, while sitting in a reclined position, he experienced palpitations in the neck. He put on his wife watch and it showed atrial fibrillation. Upon arriving to Emergency room (ER), he had mild atrial fibrillation and numerous premature ventricular contractions (PVCs). He was hospitalized for a few days. Various testing indicated no problems and was all fine. He was on 30 day monitor by his cardiologist. During that time, he continued to have premature ventricular contractions (PVCs) and 1 episode of atrial fibrillation. As of now (at the time of this report) he felt okay. Patient was waiting for insurance to cover testing inflammation of the heart. Last time he felt anything out of rhythm was 03-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild atrial fibrillation, numerous premature ventricular contractions (pvcs), and mild headache. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210703427-covid-19 vaccine ad26.cov2.s-mild atrial fibrillation, numerous premature ventricular contractions (PVCs). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: TREMOR IN BOTH LEGS FOR THE PAST HALF AN HOUR; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 05-AUG-2021) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced tremor in both legs for the past half an hour. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tremor in both legs for the past half an hour. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: SORE ARM; LITTLE FEVER; 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 not reported, batch number: UNKNOWN) dose was not reported, administered on 30-JUN-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 01-JUL-2021, the subject experienced sore arm. On 01-JUL-2021, the subject experienced little fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and little fever was not reported. This report was non-serious.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Headache, Heart rate
Clinical narrative: LOSS OF WORK; FAST HEART RATE; DIZZINESS; LOSS OF APPETITE; WEAKNESS; BAD HEADACHE; This spontaneous report received from a patient concerned a 59 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 05-AUG-2021) dose was not reported, administered on 28-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-JUN-2021, the subject experienced fast heart rate. On 29-JUN-2021, the subject experienced dizziness. On 29-JUN-2021, the subject experienced loss of appetite. On 29-JUN-2021, the subject experienced weakness. On 29-JUN-2021, the subject experienced bad headache. On an unspecified date, the subject experienced loss of work. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) fast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fast heart rate, dizziness, weakness, bad headache, and loss of appetite, and the outcome of loss of work was not reported. This report was non-serious.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased, Impaired work ability
Clinical narrative: LOSS OF WORK; FAST HEART RATE; DIZZINESS; LOSS OF APPETITE; WEAKNESS; BAD HEADACHE; This spontaneous report received from a patient concerned a 59 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 05-AUG-2021) dose was not reported, administered on 28-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-JUN-2021, the subject experienced fast heart rate. On 29-JUN-2021, the subject experienced dizziness. On 29-JUN-2021, the subject experienced loss of appetite. On 29-JUN-2021, the subject experienced weakness. On 29-JUN-2021, the subject experienced bad headache. On an unspecified date, the subject experienced loss of work. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) fast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fast heart rate, dizziness, weakness, bad headache, and loss of appetite, and the outcome of loss of work was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Malaise, Panic attack
Clinical narrative: PANIC ATTACK; SWEATING; DID NOT LOOK SO GOOD; This spontaneous report received from a pharmacist 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 panic attack, sweating, and did not look so good. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from panic attack, sweating, and did not look so good. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Dyspnoea, Eye swelling
Clinical narrative: Got every bit of flu symptoms; Had 99 something fever; Had headache; Started feeling dizzy / had about 10 episodes of dizzy spells; Had chills / chills were really bad; Throat closed; Difficult breathing; The eye swollen up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Difficult breathing) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (The patient had COVID around 20 Mar 2020.) on 20-Mar-2020.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced DYSPNOEA (Difficult breathing) (seriousness criterion medically significant), EYE SWELLING (The eye swollen up), THROAT TIGHTNESS (Throat closed) and CHILLS (Had chills / chills were really bad). On 23-Feb-2021, the patient experienced DIZZINESS (Started feeling dizzy / had about 10 episodes of dizzy spells) and HEADACHE (Had headache). On 24-Feb-2021, the patient experienced INFLUENZA (Got every bit of flu symptoms). 24-Feb-2021, the patient experienced PYREXIA (Had 99 something fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Throat tightness, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Difficult breathing), EYE SWELLING (The eye swollen up), INFLUENZA (Got every bit of flu symptoms), THROAT TIGHTNESS (Throat closed), DIZZINESS (Started feeling dizzy / had about 10 episodes of dizzy spells), CHILLS (Had chills / chills were really bad), HEADACHE (Had headache) and PYREXIA (Had 99 something fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Body temperature: 99 (Inconclusive) 99. something Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided..  Treatment medications included a breathing treatment at the emergency room.  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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza, Pyrexia, Throat tightness
Clinical narrative: Got every bit of flu symptoms; Had 99 something fever; Had headache; Started feeling dizzy / had about 10 episodes of dizzy spells; Had chills / chills were really bad; Throat closed; Difficult breathing; The eye swollen up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Difficult breathing) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (The patient had COVID around 20 Mar 2020.) on 20-Mar-2020.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced DYSPNOEA (Difficult breathing) (seriousness criterion medically significant), EYE SWELLING (The eye swollen up), THROAT TIGHTNESS (Throat closed) and CHILLS (Had chills / chills were really bad). On 23-Feb-2021, the patient experienced DIZZINESS (Started feeling dizzy / had about 10 episodes of dizzy spells) and HEADACHE (Had headache). On 24-Feb-2021, the patient experienced INFLUENZA (Got every bit of flu symptoms). 24-Feb-2021, the patient experienced PYREXIA (Had 99 something fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Throat tightness, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Difficult breathing), EYE SWELLING (The eye swollen up), INFLUENZA (Got every bit of flu symptoms), THROAT TIGHTNESS (Throat closed), DIZZINESS (Started feeling dizzy / had about 10 episodes of dizzy spells), CHILLS (Had chills / chills were really bad), HEADACHE (Had headache) and PYREXIA (Had 99 something fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Body temperature: 99 (Inconclusive) 99. something Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided..  Treatment medications included a breathing treatment at the emergency room.  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: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune hepatitis, Fatigue, Pain, SARS-CoV-2 antibody test, Somnolence
Clinical narrative: autoimmune hepatitis; Pain in various parts of the body; Slept for 15 hrs a day; Constant ring in the ears; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE HEPATITIS (autoimmune hepatitis) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), CICLOSPORIN (RESTASIS), QUETIAPINE FUMARATE (SEROQUEL) and AZATHIOPRINE for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN (Pain in various parts of the body), SOMNOLENCE (Slept for 15 hrs a day), TINNITUS (Constant ring in the ears) and FATIGUE (Extreme fatigue). On an unknown date, the patient experienced AUTOIMMUNE HEPATITIS (autoimmune hepatitis) (seriousness criterion medically significant). On 15-Mar-2021, PAIN (Pain in various parts of the body), SOMNOLENCE (Slept for 15 hrs a day), TINNITUS (Constant ring in the ears) and FATIGUE (Extreme fatigue) had resolved. At the time of the report, AUTOIMMUNE HEPATITIS (autoimmune hepatitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 antibody test: negative (Negative) Negative.     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.   Patient 's Concomitant medications reported were PII(36):AaS6l0Skg/HfTSAD212iZdgVLaJ0VFhupdqo 10mg daily  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.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received on 25-jun-2021; 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: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: autoimmune hepatitis; Pain in various parts of the body; Slept for 15 hrs a day; Constant ring in the ears; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE HEPATITIS (autoimmune hepatitis) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), CICLOSPORIN (RESTASIS), QUETIAPINE FUMARATE (SEROQUEL) and AZATHIOPRINE for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN (Pain in various parts of the body), SOMNOLENCE (Slept for 15 hrs a day), TINNITUS (Constant ring in the ears) and FATIGUE (Extreme fatigue). On an unknown date, the patient experienced AUTOIMMUNE HEPATITIS (autoimmune hepatitis) (seriousness criterion medically significant). On 15-Mar-2021, PAIN (Pain in various parts of the body), SOMNOLENCE (Slept for 15 hrs a day), TINNITUS (Constant ring in the ears) and FATIGUE (Extreme fatigue) had resolved. At the time of the report, AUTOIMMUNE HEPATITIS (autoimmune hepatitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 antibody test: negative (Negative) Negative.     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.   Patient 's Concomitant medications reported were PII(36):AaS6l0Skg/HfTSAD212iZdgVLaJ0VFhupdqo 10mg daily  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.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received on 25-jun-2021; 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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypertension, Vaccination complication
Clinical narrative: Blood Pressure over 200/My blood pressure was over 200; I became light headed; I had a reaction to my second shot of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood Pressure over 200/My blood pressure was over 200), DIZZINESS (I became light headed) and VACCINATION COMPLICATION (I had a reaction to my second shot of Moderna) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (Blood Pressure over 200/My blood pressure was over 200) (seriousness criteria hospitalization prolonged and life threatening), DIZZINESS (I became light headed) (seriousness criterion hospitalization prolonged) and VACCINATION COMPLICATION (I had a reaction to my second shot of Moderna) (seriousness criterion hospitalization prolonged). At the time of the report, HYPERTENSION (Blood Pressure over 200/My blood pressure was over 200), DIZZINESS (I became light headed) and VACCINATION COMPLICATION (I had a reaction to my second shot of Moderna) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood pressure measurement: increased (High) Blood pressure was over 200.         No concomitant product information was provided.  No treatment information was provided.  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.  Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Live follow up received contains new events light headed and vaccination complication.; Sender's Comments: Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Diagnosed with a blot clot in the left leg lower below knee.; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Diagnosed with a blot clot in the left leg lower below knee.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008c21a) for COVID-19 vaccination.     Concomitant products included HYDROCODONE for an unknown indication.   On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 13-May-2021, the patient experienced THROMBOSIS (Diagnosed with a blot clot in the left leg lower below knee.) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Diagnosed with a blot clot in the left leg lower below knee.) outcome was unknown.            No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable.  Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Hospitalisation, Inappropriate schedule of product administration
Clinical narrative: Hospitalization; it has been more than 90 days; This spontaneous case was reported by a pharmacist and describes the occurrence of HOSPITALISATION (Hospitalization) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPITALISATION (Hospitalization) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it has been more than 90 days). At the time of the report, HOSPITALISATION (Hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (it has been more than 90 days) outcome was unknown.        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.   No concomitant medication was reported.  No treatment information was 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.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cataract, Hair colour changes, Premature ageing, Skin wrinkling
Clinical narrative: Cataract; appeared to have aged significantly with; Appeared to have aged significantly overnight with more gray hair; More lines on face / More lines on lips; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (Cataract) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cataract.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced HAIR COLOUR CHANGES (Appeared to have aged significantly overnight with more gray hair) and SKIN WRINKLING (More lines on face / More lines on lips). On an unknown date, the patient experienced CATARACT (Cataract) (seriousness criterion medically significant) and PREMATURE AGEING (appeared to have aged significantly with). The patient was treated with Surgery for Cataract. At the time of the report, CATARACT (Cataract), HAIR COLOUR CHANGES (Appeared to have aged significantly overnight with more gray hair), SKIN WRINKLING (More lines on face / More lines on lips) and PREMATURE AGEING (appeared to have aged significantly with) outcome was unknown. Not Provided          No concomitant medication was provided.  No treatment medication was provided.  The action taken for m-RNA-1273 Covid-19 Moderna Vaccine was not applicable.  On 19-MAY-2021 (reported as 19-MAY), the patient had her first cataract surgery. The following day, she was shocked when she looked at the mirror as she appeared to have aged significantly overnight. The patient stated that she could only think of the vaccine she had and the anesthesia from the cataract surgery. It was unknown if the patient was treated for the events more gray hair and more lines on her face and lips.  Very limited information regarding this event has been provided at this time; Sender's Comments: Very limited information regarding this event has been provided at this time
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clots after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots after the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots after the vaccine) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter. Treatment information was not provided.  Very limited information regarding this event has been provided at this time and a causal relationship cannot be excluded.   This case was linked to MOD-2021-233535 (Patient Link).; Sender's Comments: Very limited information regarding this event has been provided at this time and a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: developed DVT with PE; developed DVT with PE; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (developed DVT with PE) and PULMONARY EMBOLISM (developed DVT with PE) 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 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. In June 2021, the patient experienced DEEP VEIN THROMBOSIS (developed DVT with PE) (seriousness criterion medically significant) and PULMONARY EMBOLISM (developed DVT with PE) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (developed DVT with PE) and PULMONARY EMBOLISM (developed DVT with PE) outcome was unknown.            The patient had no history of DVT or clotting issues. No concomitants medicines were reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter
Clinical narrative: Heart flutter; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Heart flutter) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced CARDIAC FLUTTER (Heart flutter) (seriousness criterion medically significant). At the time of the report, CARDIAC FLUTTER (Heart flutter) outcome was unknown.            No concomitant medication information was provided by the reporter.  The patient received treatment from a cardiologist, who gave her a beta blocker.  Action taken with mRNA-1273 in response to the events was not Applicable.  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.
Sex: U
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Rheumatoid arthritis
Clinical narrative: flare up of Neuropathy disease; flare up of RA and Neuropathy disease/pain in  left knee/neck pains; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (flare up of Neuropathy disease) and RHEUMATOID ARTHRITIS (flare up of RA and Neuropathy disease/pain in  left knee/neck pains) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis rheumatoid and Neuropathy (Neuropathy diisease).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (flare up of Neuropathy disease) (seriousness criterion medically significant) and RHEUMATOID ARTHRITIS (flare up of RA and Neuropathy disease/pain in  left knee/neck pains) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (flare up of Neuropathy disease) and RHEUMATOID ARTHRITIS (flare up of RA and Neuropathy disease/pain in  left knee/neck pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter. No treatment information was provided by the reporter.  Company Comment: Alternative explanation is that the serious unexpected events Rheumatoid arthritis and Peripheral neuropathy were possibly consistent with the flare up of pre-existing conditions.; Sender's Comments: Alternative explanation is that the serious unexpected events Rheumatoid arthritis and Peripheral neuropathy were possibly consistent with the flare up of pre-existing conditions.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Dyspnoea, Myalgia
Clinical narrative: sore arm; afib; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (afib) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE and BUPROPION for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced ATRIAL FIBRILLATION (afib) (seriousness criterion medically significant) and DYSPNOEA (shortness of breath). On 31-Mar-2021, the patient experienced MYALGIA (sore arm). The patient was treated with FUROSEMIDE (LASIX [FUROSEMIDE]) at a dose of 1 dosage form; AMIODARONE at a dose of 1 dosage form and APIXABAN (ELIQUIS) at a dose of 1 dosage form. At the time of the report, ATRIAL FIBRILLATION (afib), DYSPNOEA (shortness of breath) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient is wearing a life vest with a wearable defibrillator.  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.
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Visual impairment, Walking disability
Clinical narrative: Diagnosed by her neurologist as having Guillain-Barré syndrome; Can't walk; Her vision is decreasing rapidly; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Diagnosed by her neurologist as having Guillain-Barré syndrome), WALKING DISABILITY (Can't walk) and VISUAL IMPAIRMENT (Her vision is decreasing rapidly) in a female patient of an unknown age 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 GUILLAIN-BARRE SYNDROME (Diagnosed by her neurologist as having Guillain-Barré syndrome) (seriousness criteria hospitalization and medically significant), WALKING DISABILITY (Can't walk) (seriousness criterion hospitalization) and VISUAL IMPAIRMENT (Her vision is decreasing rapidly) (seriousness criterion hospitalization). At the time of the report, GUILLAIN-BARRE SYNDROME (Diagnosed by her neurologist as having Guillain-Barré syndrome), WALKING DISABILITY (Can't walk) and VISUAL IMPAIRMENT (Her vision is decreasing rapidly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  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.   Reporter did not allow further contact; 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: F
Vaccine: COVID19
Symptoms: Pancreatic carcinoma
Clinical narrative: Suddenly diagnosed with pancreatic cancer; This spontaneous case was reported by a consumer and describes the occurrence of PANCREATIC CARCINOMA (Suddenly diagnosed with pancreatic cancer) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   In March 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) (unknown route) 1 dosage form. In June 2021, the patient experienced PANCREATIC CARCINOMA (Suddenly diagnosed with pancreatic cancer) (seriousness criterion medically significant). At the time of the report, PANCREATIC CARCINOMA (Suddenly diagnosed with pancreatic cancer) outcome was unknown.            Concomitant product use was not provided by the reporter. It was reported that 2 weeks ago, she was suddenly diagnosed with pancreatic cancer. She was on hospice.Treatment information 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. Unlikely, that the event is related to the vaccine.; 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.Unlikely, that the event is related to the vaccine.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Condition aggravated, Erythema, Fatigue, Pyrexia
Clinical narrative: admitted to hospital with heart problems, Ventricular Contractions TWICE in one day; large red rash on right arm from elbow to top of arm; worse at night around supper time and it lasted about 4-6 hours. He mentioned it would come and go; felt fatigued; sick with 100 degrees F temperature and 99 degrees F; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (admitted to hospital with heart problems, Ventricular Contractions TWICE in one day) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Mar-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 30-Mar-2021, the patient experienced PYREXIA (sick with 100 degrees F temperature and 99 degrees F). On 01-Apr-2021, the patient experienced CONDITION AGGRAVATED (worse at night around supper time and it lasted about 4-6 hours. He mentioned it would come and go) and FATIGUE (felt fatigued). On 02-Apr-2021, the patient experienced CARDIAC DISORDER (admitted to hospital with heart problems, Ventricular Contractions TWICE in one day) (seriousness criterion hospitalization). On 03-Apr-2021, the patient experienced ERYTHEMA (large red rash on right arm from elbow to top of arm). On 31-Mar-2021, PYREXIA (sick with 100 degrees F temperature and 99 degrees F) had resolved. On 08-Apr-2021, CARDIAC DISORDER (admitted to hospital with heart problems, Ventricular Contractions TWICE in one day), CONDITION AGGRAVATED (worse at night around supper time and it lasted about 4-6 hours. He mentioned it would come and go), ERYTHEMA (large red rash on right arm from elbow to top of arm) and FATIGUE (felt fatigued) had resolved.            Concomitant product use was not provided by the reporter. 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.; 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: Myocarditis
Clinical narrative: Myocarditis; This spontaneous case was reported by a non-health professional and describes the occurrence of MYOCARDITIS (Myocarditis) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were reported. No treatment medication details was reported.  Company comment Very limited information regarding the event has been provided at this time. Further information is not expected.; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information is not expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Diplegia, Fall, Hypoglycaemia, Insulin resistance
Clinical narrative: Paralyzed legs; Broke his nose; Experiencing insulin resistance/feels like his insulin is not working; Fall; Hypoglycemic; This spontaneous case was reported by a consumer and describes the occurrence of DIPLEGIA (Paralyzed legs), NASAL INJURY (Broke his nose), INSULIN RESISTANCE (Experiencing insulin resistance/feels like his insulin is not working), FALL (Fall) and HYPOGLYCAEMIA (Hypoglycemic) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044H21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus (type 1). Concomitant products included INSULIN ASPART (NOVOLOG) for Diabetes mellitus, LISINOPRIL, GABAPENTIN, CYCLOBENZAPRINE, ATORVASTATIN, OXYCODONE, OMEPRAZOLE and GLUCAGON (BAQSIMI) for an unknown indication.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIPLEGIA (Paralyzed legs) (seriousness criteria medically significant and life threatening), NASAL INJURY (Broke his nose) (seriousness criterion life threatening), INSULIN RESISTANCE (Experiencing insulin resistance/feels like his insulin is not working) (seriousness criteria medically significant and life threatening), FALL (Fall) (seriousness criterion life threatening) and HYPOGLYCAEMIA (Hypoglycemic) (seriousness criterion life threatening). At the time of the report, DIPLEGIA (Paralyzed legs), NASAL INJURY (Broke his nose), INSULIN RESISTANCE (Experiencing insulin resistance/feels like his insulin is not working), FALL (Fall) and HYPOGLYCAEMIA (Hypoglycemic) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 500 (High) High.         The treatment information was not provided.  The action taken with mRNA 1273 with the events was considered as not applicable.  Very limited information regarding these events has been provided at this time. However, medical history of Diabetes mellitus (type 1)may remain as confounding factor.Further information is required.; Sender's Comments: Very limited information regarding these events has been provided at this time. However, medical history of Diabetes mellitus (type 1)may remain as confounding factor.Further information is required.