chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No Treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications details were provided. No Treatment Medications details were provided.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired Vaccine used; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) and PRODUCT STORAGE ERROR (Product storage error) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 10:15 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Product storage error). On 19-Nov-2021 at 10:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 19-Nov-2021, PRODUCT STORAGE ERROR (Product storage error) had resolved. On 19-Nov-2021 at 10:15 AM, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-392935 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-392935 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment details were reported.   This case was linked to MOD-2021-392458 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-392935 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment drugs were reported   This case was linked to MOD-2021-392935 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medicines were reported. It was reported that if the patient should get the booster again or any testing done.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Expired vaccine used; error resulting in administration of expired vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Administered with expired COVID vaccine; Error resulting in administration of expired COVID vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired COVID vaccine) and PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired COVID vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired COVID vaccine) and PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired COVID vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered with expired COVID vaccine) and PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired COVID vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  As per the reporter, there were no symptoms or quality issue to report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Expired vaccine used; Drug administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Drug administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Drug administration error). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Drug administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported No Treatment medications reported
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Fatigue, Pyrexia
Clinical narrative: Diarrhea; Fatigue/still on-going symptoms of fatigue; Fever; chills; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (Diarrhea), FATIGUE (Fatigue/still on-going symptoms of fatigue), CHILLS (chills) and PYREXIA (Fever) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, ACETYLSALICYLIC ACID (BABY ASPIRIN), PRENATAL VITAMINS [ASCORBIC ACID; BETACAROTENE; CALCIUM SULFATE; COLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE; RETINOL ACETATE; RIBOFLAVIN; THIAMINE MONONITRATE; TOCOPHERYL ACETATE; ZINC OXIDE] and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced CHILLS (chills). On 21-Nov-2021, the patient experienced PYREXIA (Fever). On 22-Nov-2021, the patient experienced DIARRHOEA (Diarrhea) and FATIGUE (Fatigue/still on-going symptoms of fatigue). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of 500 mg. At the time of the report, DIARRHOEA (Diarrhea) and CHILLS (chills) outcome was unknown, FATIGUE (Fatigue/still on-going symptoms of fatigue) had not resolved and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Nov-2021, Body temperature: 104 (High) 104 °F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  It was reported that patient took 1 tablet Tylenol 500 mg Extra Strength on 20-Nov-2021, maybe 3-4 tablets and Tylenol 500 mg Extra Strength on 21-Nov-2021.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis
Clinical narrative: Diverticulitis; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Diverticulitis) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Diverticulitis (15-20 years ago. It was silent for about 20 years).   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, the patient experienced DIVERTICULITIS (Diverticulitis) (seriousness criterion medically significant). At the time of the report, DIVERTICULITIS (Diverticulitis) outcome was unknown.            No concomitant medication was reported.  It was reported that she was diagnosed with Diverticulitis and started antibiotics. She stated that she has a medical history of Diverticulitis 15-20 years ago. It was silent for about 20 years. She did not think it was related to the vaccine.  This case concerns a  84-year-old, female patient with relevant medical history of diverticulitis,  who experienced the unexpected event of Diverticulitis. The event occurred approximately 9 months after the second dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as event occurred after second dose. The patient's past medical history remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a  84-year-old, female patient with relevant medical history of diverticulitis,  who experienced the unexpected event of Diverticulitis. The event occurred approximately 9 months after the second dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as event occurred after second dose. The patient's past medical history remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site inflammation, Vaccination site warmth
Clinical narrative: Arm injection site feels warm to touch; Arm injection site feels inflamed; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE WARMTH (Arm injection site feels warm to touch) and VACCINATION SITE INFLAMMATION (Arm injection site feels inflamed) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced VACCINATION SITE WARMTH (Arm injection site feels warm to touch) and VACCINATION SITE INFLAMMATION (Arm injection site feels inflamed). At the time of the report, VACCINATION SITE WARMTH (Arm injection site feels warm to touch) and VACCINATION SITE INFLAMMATION (Arm injection site feels inflamed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details not provided.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Did not feel good all day/ felt like staying in bed; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Did not feel good all day/ felt like staying in bed) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PREDNISOLONE, TIMOLOL, ASPIRIN [ACETYLSALICYLIC ACID], BILBERRY [VACCINIUM MYRTILLUS], DILTIAZEM, GINKGO BILOBA (GINGKO BILOBA), GLUCOSAMINE, HYDRALAZINE, LOSARTAN, METOPROLOL, MULTIVITAMIN [VITAMINS NOS], FISH OIL (OMEGA 3 [FISH OIL]) and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, the patient experienced VACCINATION COMPLICATION (Did not feel good all day/ felt like staying in bed). At the time of the report, VACCINATION COMPLICATION (Did not feel good all day/ felt like staying in bed) outcome was unknown.            Patient stated that he did not have any other symptoms aside from that.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: Experiencing body aches; Severe tiredness; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Experiencing body aches), FATIGUE (Severe tiredness) and CHILLS (Chills) 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 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MYALGIA (Experiencing body aches), FATIGUE (Severe tiredness) and CHILLS (Chills). At the time of the report, MYALGIA (Experiencing body aches), FATIGUE (Severe tiredness) and CHILLS (Chills) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was provided by the reporter.  No treatment information was provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Somnolence
Clinical narrative: flu-like symptoms; very drowsy; chills; very tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), SOMNOLENCE (very drowsy), CHILLS (chills) and FATIGUE (very tired) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 013M20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021 at 9:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), SOMNOLENCE (very drowsy), CHILLS (chills) and FATIGUE (very tired). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), SOMNOLENCE (very drowsy), CHILLS (chills) and FATIGUE (very tired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported.   Patients symptoms started 12 hours after the booster dose administration and stated his symptoms are cleared up at the time of this report.  No treatment drug details was reported.   This case was linked to MOD-2021-395665, MOD-2021-395666 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: [after first two doses] sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA ([after first two doses] sore arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A, 014F21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA ([after first two doses] sore arm). At the time of the report, MYALGIA ([after first two doses] sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.    This case was linked to MOD-2021-395665, MOD-2021-395653 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Musculoskeletal stiffness, Myalgia
Clinical narrative: really bad; couldn't raise head up for like 2 days; achiness; tiredness; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (really bad), MUSCULOSKELETAL STIFFNESS (couldn't raise head up for like 2 days), MYALGIA (achiness) and FATIGUE (tiredness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027K20A) for COVID-19 vaccination.     The medical history was not provided by the reporter.     On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced FEELING ABNORMAL (really bad), MUSCULOSKELETAL STIFFNESS (couldn't raise head up for like 2 days), MYALGIA (achiness) and FATIGUE (tiredness). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 22-Jan-2021, FEELING ABNORMAL (really bad), MUSCULOSKELETAL STIFFNESS (couldn't raise head up for like 2 days), MYALGIA (achiness) and FATIGUE (tiredness) had resolved.        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 medications were reported.   This case was linked to MOD-2021-395732, MOD-2021-395733 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-396216, MOD-2021-396194 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: One of them sleeps all day; Extreme fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (One of them sleeps all day) and FATIGUE (Extreme fatigue) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (One of them sleeps all day) and FATIGUE (Extreme fatigue). At the time of the report, SOMNOLENCE (One of them sleeps all day) and FATIGUE (Extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Potentially got their doses from vials punctured longer than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Potentially got the dose from a vial punctured longer than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got the dose from a vial punctured longer than 12 hours ago) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got the dose from a vial punctured longer than 12 hours ago). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got the dose from a vial punctured longer than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: My unvaccinated family members are sick with covid. Im having symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of SUSPECTED COVID-19 (My unvaccinated family members are sick with covid. Im having symptoms) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 SUSPECTED COVID-19 (My unvaccinated family members are sick with covid. Im having symptoms). At the time of the report, SUSPECTED COVID-19 (My unvaccinated family members are sick with covid. Im having symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had 2 doses of Moderna and had a booster. No concomitant medication were provided. No treatment information were given.  This case concerns a patient of unknown gender and age with no relevant medical history, who experienced the non-serious adverse event of special interest of suspected COVID-19. The event occurred on an unknown date after the third dose of mRNA-1273. The rechallenge was assessed as not applicable since the AE occurred after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. The information regarding the vaccination dates is incomplete so lack of efficacy situation cannot be properly assessed.; Sender's Comments: This case concerns a patient of unknown gender and age with no relevant medical history, who experienced the non-serious adverse event of special interest of suspected COVID-19. The event occurred on an unknown date after the third dose of mRNA-1273. The rechallenge was assessed as not applicable since the AE occurred after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. The information regarding the vaccination dates is incomplete so lack of efficacy situation cannot be properly assessed.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: leg pain after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg pain after receiving 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (leg pain after receiving the vaccine). At the time of the report, PAIN IN EXTREMITY (leg pain after receiving the vaccine) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator: It was defrosted in room temperature 27OCT2021.  No concomitant medications were reported.  No treatment information was provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vaccination site warmth
Clinical narrative: Sore arm; Arm was warm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Arm was warm) and FATIGUE (Fatigue) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included RIVAROXABAN (XARELTO) for Anticoagulant therapy.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE WARMTH (Arm was warm). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event NOS, at an unspecified dose and frequency and CORTISONE (topical) for Adverse event NOS, at a dose of topical cream. At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Arm was warm) and FATIGUE (Fatigue) outcome was unknown.            Treatment drugs also includes antihistamine allergy pill and arnica gel.   This case was linked to MOD-2021-395748, MOD-2021-395768 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site inflammation, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: localized inflammation and swelling at the injection site; localized inflammation and swelling at the injection site; the injection site is very painful; injection site is red; the injection site is itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (localized inflammation and swelling at the injection site), VACCINATION SITE SWELLING (localized inflammation and swelling at the injection site), VACCINATION SITE PAIN (the injection site is very painful), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE PRURITUS (the injection site is itchy) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 016M20A and 032M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu shot. Past adverse reactions to the above products included No adverse event with flu shot. Concurrent medical conditions included Arthritis and Sensitive skin. Concomitant products included RIVAROXABAN (XARELTO) for Clot blood.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (localized inflammation and swelling at the injection site), VACCINATION SITE SWELLING (localized inflammation and swelling at the injection site), VACCINATION SITE PAIN (the injection site is very painful), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE PRURITUS (the injection site is itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency; CORTISONE (topical) for Adverse event, at an unspecified dose and frequency and ARNICA [ARNICA MONTANA] for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INFLAMMATION (localized inflammation and swelling at the injection site), VACCINATION SITE SWELLING (localized inflammation and swelling at the injection site), VACCINATION SITE PAIN (the injection site is very painful), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE PRURITUS (the injection site is itchy) was resolving.            Concomitant medication included Xarelto, 10 mg every day for the last 6 years as blood thinner.   This case was linked to MOD-2021-395766, MOD-2021-395748 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Headache; Little fatigue; Not as much body ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Little fatigue) and MYALGIA (Not as much body ache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery (She was a survivor of three open heart surgeries and has artificial heart valve). Concomitant products included FLUDROCORTISONE, VITAMIN D [VITAMIN D NOS], WARFARIN SODIUM (JANTOVEN) and LIOTHYRONINE for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), FATIGUE (Little fatigue) and MYALGIA (Not as much body ache). At the time of the report, HEADACHE (Headache), FATIGUE (Little fatigue) and MYALGIA (Not as much body ache) 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 Treatment informations were reported.   This case was linked to MOD-2021-395918, MOD-2021-395919 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Fatigue, Pain in extremity
Clinical narrative: "her arm hurt"; "may had felt a little tired"; Dose administered after expiration date; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY ("her arm hurt"), EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) and FATIGUE ("may had felt a little tired") in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 031B21A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PAIN IN EXTREMITY ("her arm hurt") and FATIGUE ("may had felt a little tired"). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) had resolved. At the time of the report, PAIN IN EXTREMITY ("her arm hurt") and FATIGUE ("may had felt a little tired") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Muscular weakness, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Fingers are numb/left arm is numb/left arm will feel numb/feels like she needs to pop it; Left side of the neck is stiff; Left  arm is sore weak  and heavy; Her left arm is heavy; Sore arm/left arm is sore/sore arm is consistent/left arm will feel numb and is painful; ongoing left arm injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Fingers are numb/left arm is numb/left arm will feel numb/feels like she needs to pop it), MUSCULOSKELETAL STIFFNESS (Left side of the neck is stiff), MUSCULAR WEAKNESS (Left  arm is sore weak  and heavy), LIMB DISCOMFORT (Her left arm is heavy) and PAIN IN EXTREMITY (Sore arm/left arm is sore/sore arm is consistent/left arm will feel numb and is painful) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu vaccination (has received the flu shot in left arm). Past adverse reactions to the above products included No adverse event with Flu vaccination.   On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Fingers are numb/left arm is numb/left arm will feel numb/feels like she needs to pop it), MUSCULOSKELETAL STIFFNESS (Left side of the neck is stiff), MUSCULAR WEAKNESS (Left  arm is sore weak  and heavy), LIMB DISCOMFORT (Her left arm is heavy), PAIN IN EXTREMITY (Sore arm/left arm is sore/sore arm is consistent/left arm will feel numb and is painful) and VACCINATION SITE PAIN (ongoing left arm injection site pain). At the time of the report, HYPOAESTHESIA (Fingers are numb/left arm is numb/left arm will feel numb/feels like she needs to pop it), MUSCULOSKELETAL STIFFNESS (Left side of the neck is stiff), MUSCULAR WEAKNESS (Left  arm is sore weak  and heavy), LIMB DISCOMFORT (Her left arm is heavy), PAIN IN EXTREMITY (Sore arm/left arm is sore/sore arm is consistent/left arm will feel numb and is painful) and VACCINATION SITE PAIN (ongoing left arm injection site pain) outcome was unknown.            Patient has received both doses of the Moderna COVID-19 vaccine and states that she had a booster appointment but has not gone due to fear of becoming paralyzed in arm.   No concomitant medication reported.  No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Significant Follow-up Appended events added