chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Brain neoplasm
Clinical narrative: BRAIN TUMOR; This spontaneous report received from a company representative via social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration was not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 1 total 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, patient had a brain tumor since got shot.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from brain tumor. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211220778-Covid-19 vaccine ad26.cov2.s-Brain tumor. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: STILL LOSE BREATH MORE EASILY 3 MONTHS LATER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced still lose breath more easily 3 months later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of still lose my breath more easily 3 months later was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Feeling abnormal
Clinical narrative: DOWN FOR NEARLY 3 DAYS IN BED; MISERABLE TIME AFTER FIRST DOSE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced down for nearly 3 days in bed, and miserable time after first dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from down for nearly 3 days in bed, and the outcome of miserable time after first dose was not reported. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: RECEIVED ONLY 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 25 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: 1822809, and expiry: 07-MAR-2022) dose was not reported, administered on 21-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-NOV-2021, the patient experienced received only 2.5ml of the janssen covid-19 vaccine. On 21-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received only 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219681, 20211219686, 20211219701, 20211219714, 20211219731, 20211219807, 20211219871, 20211219926, 20211219953, 20211220129, 20211220145, 20211220146, 20211220152, 20211220155, 20211220177, 20211220178, 20211220206, 20211220216 and 20211220527.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 58 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: 1822809, and expiry: 07-MAR-2022) 2.5 ml, administered on 21-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-NOV-2021, the patient experienced received 2.5ml of the janssen covid-19 vaccine. On 21-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219731, 20211219686, 20211220537, 20211220233, 20211219807, 20211219953 and 20211221158.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose
Clinical narrative: RECEIVED ONLY 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 52 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: 211A21A, and expiry: 14-DEC-2021) 2.5 ml, administered on 13-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-NOV-2021, the patient experienced received only 2.5ml of the janssen covid-19 vaccine. On 13-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received only 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTERED VACCINE APPROXIMATELY 6 HOURS PAST THE EXPIRATION TIME; VACCINE STORED 6 HOURS PAST EXPIRATION TIME; 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 ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 08-DEC-2021, the patient experienced administered vaccine approximately 6 hours past the expiration time. On 08-DEC-2021, the patient experienced vaccine stored 6 hours past expiration time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered vaccine approximately 6 hours past the expiration time and vaccine stored 6 hours past expiration time was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Felt like they had slight fatigue; A low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt like they had slight fatigue) and PYREXIA (A low grade fever) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Felt like they had slight fatigue) and PYREXIA (A low grade fever). At the time of the report, FATIGUE (Felt like they had slight fatigue) and PYREXIA (A low grade fever) outcome was unknown.            No concomitant medications were provided by reporter.  No treatment medications were reported.  Patient did not experience events after second dose.   This case was linked to MOD-2021-406549 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; A little bit of tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (A little bit of tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immune system disorder NOS (Immune system issues).    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 PAIN IN EXTREMITY (Sore arm) and FATIGUE (A little bit of tiredness). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (A little bit of tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications reported.   This case was linked to MOD-2021-406184, MOD-2021-406185 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Hypoaesthesia, Magnetic resonance imaging, Vaccination complication
Clinical narrative: severe adverse reactions/only conclusion is it is a side effect of the vaccine.; When she stands up she gets very dizzy; has numbness on the side of body from the fingers, hands, and to the feet; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (severe adverse reactions/only conclusion is it is a side effect of the vaccine.), DIZZINESS (When she stands up she gets very dizzy) and HYPOAESTHESIA (has numbness on the side of body from the fingers, hands, and to the feet) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 429L21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included ROSUVASTATIN, DULOXETINE HYDROCHLORIDE (CYMBALTA), LOSARTAN, METOPROLOL, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE SODIUM (SYNTHROID), BUPROPION HYDROCHLORIDE (WELLBUTRIN), PRAMIPEXOLE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced VACCINATION COMPLICATION (severe adverse reactions/only conclusion is it is a side effect of the vaccine.), DIZZINESS (When she stands up she gets very dizzy) and HYPOAESTHESIA (has numbness on the side of body from the fingers, hands, and to the feet). At the time of the report, VACCINATION COMPLICATION (severe adverse reactions/only conclusion is it is a side effect of the vaccine.), DIZZINESS (When she stands up she gets very dizzy) and HYPOAESTHESIA (has numbness on the side of body from the fingers, hands, and to the feet) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) side effect of the vaccine.. On an unknown date, Magnetic resonance imaging: abnormal (abnormal) side effect of the vaccine..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were reported. Patient got the first shot on 28Jan2021 and second shot on 25Feb2021 (lot: 011A21A).
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Eye pain, Fatigue, Limb discomfort, Musculoskeletal discomfort
Clinical narrative: Ectremely anxious; rubber band sensation extended to neck; rubber band sensation extended to throat.; exhausted; pain behind the eyes, like there were pins and needles; rubber bands tightly bound on her toes.rubber band sensation extended to her; pain in the throat, described as constricting and odd; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (pain in the throat, described as constricting and odd), ANXIETY (Ectremely anxious), EYE PAIN (pain behind the eyes, like there were pins and needles), LIMB DISCOMFORT (rubber bands tightly bound on her toes.rubber band sensation extended to her) and MUSCULOSKELETAL DISCOMFORT (rubber band sensation extended to neck) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (pain in the throat, described as constricting and odd), EYE PAIN (pain behind the eyes, like there were pins and needles), LIMB DISCOMFORT (rubber bands tightly bound on her toes.rubber band sensation extended to her) and FATIGUE (exhausted). On 16-Nov-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (rubber band sensation extended to neck) and OROPHARYNGEAL DISCOMFORT (rubber band sensation extended to throat.). On an unknown date, the patient experienced ANXIETY (Ectremely anxious). On 13-Nov-2021, OROPHARYNGEAL PAIN (pain in the throat, described as constricting and odd) and EYE PAIN (pain behind the eyes, like there were pins and needles) had resolved. At the time of the report, ANXIETY (Ectremely anxious), LIMB DISCOMFORT (rubber bands tightly bound on her toes.rubber band sensation extended to her), MUSCULOSKELETAL DISCOMFORT (rubber band sensation extended to neck), OROPHARYNGEAL DISCOMFORT (rubber band sensation extended to throat.) and FATIGUE (exhausted) outcome was unknown.            No concomitant medication was provided by reporter. No treatment information was provided by reporter. The patient almost 4 weeks post booster and still have daily neuropathy. The patient had seen GP and had an appointment with a neurologist. That was concerning.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Non Significant Follow Up Appended; Reporters E-mail Address obtained. On 08-Dec-2021: Follow-up received on 08-Dec-2021: Narrative updated.; Sender's Comments: The only reported events in this case are non-serious, hence no CC is required.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Oropharyngeal pain
Clinical narrative: Ectremely anxious; rubber band sensation extended to neck; rubber band sensation extended to throat.; exhausted; pain behind the eyes, like there were pins and needles; rubber bands tightly bound on her toes.rubber band sensation extended to her; pain in the throat, described as constricting and odd; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (pain in the throat, described as constricting and odd), ANXIETY (Ectremely anxious), EYE PAIN (pain behind the eyes, like there were pins and needles), LIMB DISCOMFORT (rubber bands tightly bound on her toes.rubber band sensation extended to her) and MUSCULOSKELETAL DISCOMFORT (rubber band sensation extended to neck) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (pain in the throat, described as constricting and odd), EYE PAIN (pain behind the eyes, like there were pins and needles), LIMB DISCOMFORT (rubber bands tightly bound on her toes.rubber band sensation extended to her) and FATIGUE (exhausted). On 16-Nov-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (rubber band sensation extended to neck) and OROPHARYNGEAL DISCOMFORT (rubber band sensation extended to throat.). On an unknown date, the patient experienced ANXIETY (Ectremely anxious). On 13-Nov-2021, OROPHARYNGEAL PAIN (pain in the throat, described as constricting and odd) and EYE PAIN (pain behind the eyes, like there were pins and needles) had resolved. At the time of the report, ANXIETY (Ectremely anxious), LIMB DISCOMFORT (rubber bands tightly bound on her toes.rubber band sensation extended to her), MUSCULOSKELETAL DISCOMFORT (rubber band sensation extended to neck), OROPHARYNGEAL DISCOMFORT (rubber band sensation extended to throat.) and FATIGUE (exhausted) outcome was unknown.            No concomitant medication was provided by reporter. No treatment information was provided by reporter. The patient almost 4 weeks post booster and still have daily neuropathy. The patient had seen GP and had an appointment with a neurologist. That was concerning.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Non Significant Follow Up Appended; Reporters E-mail Address obtained. On 08-Dec-2021: Follow-up received on 08-Dec-2021: Narrative updated.; Sender's Comments: The only reported events in this case are non-serious, hence no CC is required.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Passed away) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Death occurred on September 2021 The patient died in September 2021. The cause of death was not reported. It is unknown if an autopsy was performed.            No relevant concomitant medications were reported. No treatment information was provided.  Company Comment: This case concerns an 88-year-old, female patient with unknown medical history, who experienced the unexpected event of Death. The event occurred unknown number of days after the two doses of mRNA-1273 vaccine which were administered a month apart. Cause of death has been reported as unknown, and, it's also unknown if an autopsy was performed. At the time of the report, very limited information has been provided about the patient and about the event leading to the fatal outcome. The patient's elderly age remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns an 88-year-old, female patient with unknown medical history, who experienced the unexpected event of Death. The event occurred unknown number of days after the two doses of mRNA-1273 vaccine which were administered a month apart. Cause of death has been reported as unknown, and, it's also unknown if an autopsy was performed. At the time of the report, very limited information has been provided about the patient and about the event leading to the fatal outcome. The patient's elderly age remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Developed PII(28): palsy; This spontaneous case was reported by an other health care professional and describes the occurrence of BELL'S PALSY (Developed PII(28): palsy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Developed PII(28): palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Developed PII(28): palsy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided No treatment medication information provided  patient developed PII(28): palsy a month after my booster shot is there any known side effect like that  Company comment: This spontaneous case concerns a patient with no relevant medical history reported who experienced serious expected event of Bell's palsy. The event occurred approximately a month after the booster dose of the mRNA-1273 .Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient with no relevant medical history reported who experienced serious expected event of Bell's palsy. The event occurred approximately a month after the booster dose of the mRNA-1273 .Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms for two days/which she also had with her second dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms for two days/which she also had with her second dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 029L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms for two days/which she also had with her second dose). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms for two days/which she also had with her second dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   This case was linked to MOD-2021-398629 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: Was shaky; Didn't feel good overall; Fever; Chills; Very tired; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of TREMOR (Was shaky), MALAISE (Didn't feel good overall), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Very tired) and HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Seasonal allergy, OMEPRAZOLE for an unknown indication.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced TREMOR (Was shaky) (seriousness criterion medically significant), MALAISE (Didn't feel good overall) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), FATIGUE (Very tired) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, TREMOR (Was shaky), MALAISE (Didn't feel good overall), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Very tired) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Company comment: This case concerns a 50-year-old female patient with no relevant medical history reported, who experienced the serious unexpected events of tremor, malaise, pyrexia, chills, fatigue, headache. The events occurred on the same day after the second dose of mRNA-1273. The rechallenge is not applicable since the AEs occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-403240, MOD-2021-403241 (Patient Link).; Sender's Comments: This case concerns a 50-year-old female patient with no relevant medical history reported, who experienced the serious unexpected events of tremor, malaise, pyrexia, chills, fatigue, headache. The events occurred on the same day after the second dose of mRNA-1273. The rechallenge is not applicable since the AEs occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Was shaky; Didn't feel good overall; Fever; Chills; Very tired; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of TREMOR (Was shaky), MALAISE (Didn't feel good overall), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Very tired) and HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Seasonal allergy, OMEPRAZOLE for an unknown indication.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced TREMOR (Was shaky) (seriousness criterion medically significant), MALAISE (Didn't feel good overall) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), FATIGUE (Very tired) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, TREMOR (Was shaky), MALAISE (Didn't feel good overall), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Very tired) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Company comment: This case concerns a 50-year-old female patient with no relevant medical history reported, who experienced the serious unexpected events of tremor, malaise, pyrexia, chills, fatigue, headache. The events occurred on the same day after the second dose of mRNA-1273. The rechallenge is not applicable since the AEs occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-403240, MOD-2021-403241 (Patient Link).; Sender's Comments: This case concerns a 50-year-old female patient with no relevant medical history reported, who experienced the serious unexpected events of tremor, malaise, pyrexia, chills, fatigue, headache. The events occurred on the same day after the second dose of mRNA-1273. The rechallenge is not applicable since the AEs occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Facial paralysis
Clinical narrative: went to the doctor and said he has bell's palsy; started experiencing paralysis on the right side of his face; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Dec-2021 and was forwarded to Moderna on 01-Dec-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (started experiencing paralysis on the right side of his face) and BELL'S PALSY (went to the doctor and said he has bell's palsy) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Nov-2021, the patient experienced FACIAL PARALYSIS (started experiencing paralysis on the right side of his face) (seriousness criterion medically significant). On an unknown date, the patient experienced BELL'S PALSY (went to the doctor and said he has bell's palsy) (seriousness criterion medically significant). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and VALACICLOVIR for Adverse event, at an unspecified dose and frequency. At the time of the report, FACIAL PARALYSIS (started experiencing paralysis on the right side of his face) and BELL'S PALSY (went to the doctor and said he has bell's palsy) outcome was unknown.            No concomitant medications reported.  It was reported that patient started experiencing paralysis on the right side of his face, he went to the doctor and said he has bell's palsy. The doctor didn't say if it was related or not to the vaccine.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  COMPANY COMMENT: This is a spontaneous case concerning a 30-year-old male patient with no significant clinical history who experienced the expected events of FACIAL PARALYSIS and BELL'S PALSY  The events occurred 31days after second dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about second dose was disclosed  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is a spontaneous case concerning a 30-year-old male patient with no significant clinical history who experienced the expected events of FACIAL PARALYSIS and BELL'S PALSY  The events occurred 31days after second dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about second dose was disclosed  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Plasma cell myeloma
Clinical narrative: Multiple myeloma; This spontaneous case was reported by a consumer and describes the occurrence of PLASMA CELL MYELOMA (Multiple myeloma) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN and GLIMEPIRIDE for Diabetes.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced PLASMA CELL MYELOMA (Multiple myeloma) (seriousness criterion medically significant). At the time of the report, PLASMA CELL MYELOMA (Multiple myeloma) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.  Prior to vaccine shots, patient was an active surfer and diver. In Sep-2021, there was some problem in his lower back, and the doctor diagnosed him with multiple myeloma. He mentioned he would be going for radiation treatment and chemotherapy in Dec-2021. Prior to those shots, he had no problem and after the shots, his whole life changed with the diagnosis of cancer. He thought the shot affected him with cancer. He mentioned he had no family history of such cancer. He had 4 siblings -  two sisters and two brothers, all alive. His parents passed away, but they never had this in his family. He wanted to sue this (Escalation to Legal). He mentioned that someone must be responsible for the vaccine, he did not think he could sue the federal government, but someone must be responsible. He mentioned he did not want to get vaccinated initially, he got it because his wife got Moderna, but from a different place.  COMPANY COMMENT: This is a spontaneous case concerning a 70-year-old male patient with no significant clinical history who experienced the unexpected event of PLASMA CELL MYELOMA The event occurred unknown unknown after second dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about second dose was disclosed  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is a spontaneous case concerning a 70-year-old male patient with no significant clinical history who experienced the unexpected event of PLASMA CELL MYELOMA The event occurred unknown unknown after second dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about second dose was disclosed  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Decreased activity, Illness, Mobility decreased
Clinical narrative: feels sick to her stomach/pretty sick; arm pain, can't even touch it; upset stomach; arm  is very sore; chills; it wasn't a good reaction; was in bed all day and the next day; could not function; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feels sick to her stomach/pretty sick), PAIN IN EXTREMITY (arm pain, can't even touch it), VACCINATION COMPLICATION (it wasn't a good reaction), MOBILITY DECREASED (was in bed all day and the next day) and DECREASED ACTIVITY (could not function) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 015M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (it wasn't a good reaction), MOBILITY DECREASED (was in bed all day and the next day) and DECREASED ACTIVITY (could not function). On 02-Dec-2021, the patient experienced ILLNESS (feels sick to her stomach/pretty sick), PAIN IN EXTREMITY (arm pain, can't even touch it), ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (arm  is very sore) and CHILLS (chills). At the time of the report, ILLNESS (feels sick to her stomach/pretty sick), PAIN IN EXTREMITY (arm pain, can't even touch it), VACCINATION COMPLICATION (it wasn't a good reaction), MOBILITY DECREASED (was in bed all day and the next day), DECREASED ACTIVITY (could not function), ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (arm  is very sore) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported No treatment medications were reported It was reported that patient had a little bit of problem before with Moderna about a year ago.   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Non significant follow up received, contains No new information On 08-Dec-2021: Followup information received  Added new events pretty sick, it was not a good reaction, was in bed all day and the next day could not function.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Vaccination complication
Clinical narrative: feels sick to her stomach/pretty sick; arm pain, can't even touch it; upset stomach; arm  is very sore; chills; it wasn't a good reaction; was in bed all day and the next day; could not function; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feels sick to her stomach/pretty sick), PAIN IN EXTREMITY (arm pain, can't even touch it), VACCINATION COMPLICATION (it wasn't a good reaction), MOBILITY DECREASED (was in bed all day and the next day) and DECREASED ACTIVITY (could not function) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 015M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (it wasn't a good reaction), MOBILITY DECREASED (was in bed all day and the next day) and DECREASED ACTIVITY (could not function). On 02-Dec-2021, the patient experienced ILLNESS (feels sick to her stomach/pretty sick), PAIN IN EXTREMITY (arm pain, can't even touch it), ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (arm  is very sore) and CHILLS (chills). At the time of the report, ILLNESS (feels sick to her stomach/pretty sick), PAIN IN EXTREMITY (arm pain, can't even touch it), VACCINATION COMPLICATION (it wasn't a good reaction), MOBILITY DECREASED (was in bed all day and the next day), DECREASED ACTIVITY (could not function), ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (arm  is very sore) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported No treatment medications were reported It was reported that patient had a little bit of problem before with Moderna about a year ago.   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Non significant follow up received, contains No new information On 08-Dec-2021: Followup information received  Added new events pretty sick, it was not a good reaction, was in bed all day and the next day could not function.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer female
Clinical narrative: Diagnosed with Breast Cancer; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER FEMALE (Diagnosed with Breast Cancer) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 029L20A) 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 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced BREAST CANCER FEMALE (Diagnosed with Breast Cancer) (seriousness criterion medically significant). At the time of the report, BREAST CANCER FEMALE (Diagnosed with Breast Cancer) outcome was unknown.            Company comment: This is a spontaneous case concerning a 74-year-old female patient with no reported medical history, who experienced the serious (medically significant) unexpected event Breast cancer. Gynecologist found a lump in patient's breast after the 1st dose of mRNA-1273 and was diagnosed with breast cancer two weeks after the second dose. Treated with chemotherapy on her 6th infusion. The reporter assessed the event as unlikely related to the vaccine.  The benefit-risk relationship of mRNA-1273 is not affected by this report.  Concomitant product use was not provided by reporter. It was reported that patient's gynecologist found a lump in patient's breast after the 1st dose. She stated that the lump was there before she received the 2nd dose.  She was diagnosed with breast cancer two weeks after her 2nd dose in Feb 2021. Patient further conveyed that she did not thought the vaccine caused the cancer.  She had 6 infusions of chemo and her last chemotherapy was 29 Oct 2021. She was scheduled to see her doctor on 02 Dec 2021 to discuss further if she should get the booster or the third dose.   This case was linked to MOD-2021-403863 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 74-year-old female patient with no reported medical history, who experienced the serious (medically significant) unexpected event Breast cancer. Gynecologist found a lump in patient's breast after the 1st dose of mRNA-1273 and was diagnosed with breast cancer two weeks after the second dose. Treated with chemotherapy on her 6th infusion. The reporter assessed the event as unlikely related to the vaccine.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Injury, Renal failure
Clinical narrative: Had kidney failure, but he stated that the kidney failure is not related to getting the vaccine; injuries; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (Had kidney failure, but he stated that the kidney failure is not related to getting the vaccine) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RENAL FAILURE (Had kidney failure, but he stated that the kidney failure is not related to getting the vaccine) (seriousness criterion medically significant) and INJURY (injuries). At the time of the report, RENAL FAILURE (Had kidney failure, but he stated that the kidney failure is not related to getting the vaccine) outcome was unknown and INJURY (injuries) was resolving.            Concomitant product was not provided by the reporter Patient had  received 2 doses of the Moderna COVID 19 vaccine stated that patient was  in a rehab facility because patient was  recovering from injuries. Patient  was injured in an assault and  had kidney failure. Patient was  stated that the kidney failure was not related to getting the vaccine, the vaccine was good according to patient  Treatment product was not provided by the reporter  COMPANY COMMENT: This is a spontaneous case concerning an unknown-year-old male patient with no significant clinical history who experienced the expected events of INJURY and RENAL FAILURE  The events occurred unknown days after a dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about a dose was disclosed  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is a spontaneous case concerning an unknown-year-old male patient with no significant clinical history who experienced the expected events of INJURY and RENAL FAILURE  The events occurred unknown days after a dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about a dose was disclosed  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for covid-19) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         No relevant concomitant product were taken. This case concerns a 59-year-old female patient with no medical history, who experienced the unexpected event of COVID-19 virus test positive  6 months and 21 days after the second dose of mRNA-1273 Moderna COVID-19 Vaccine. No additional information is available at the time of this report.  The benefit-risk relationship of mRNA1237 in not affected by this report.; Sender's Comments: This case concerns a 59-year-o ld female patient with no medical history, who experienced the unexpected event of COVID-19 virus test positive  6 months and 21 days after the second dose of mRNA-1273 Moderna  COVID-19 Vaccine. No additional information is available at the time of this report.  The benefit-risk relationship of mRNA1237 in not affected by this report.