chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Doses administered after 30-day use by date; Doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) and PRODUCT STORAGE ERROR (Doses administered after 30-day use by date) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) and PRODUCT STORAGE ERROR (Doses administered after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  Date the vial was initially stored in the refrigerator 17-Dec-2021. Beyond use date was on 16-Jan-2022.  The vial did not undergo any temperature excursions.  No treatment information was reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   BUD 1/16/2022 The vial does not go any temperature excursions Date the vial was initially stored in the refrigerator 17Dec2021.  No concomitant medication was reported. No treatment medication was reported.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.  vial didn't undergo any temperature excursions.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) 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.   No treatment information was reported by the reporter. No concomitants medicines were reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pyrexia
Clinical narrative: Standard reaction like a flu; A little fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Standard reaction like a flu), PYREXIA (A little fever) and HEADACHE (Headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     The patient's past medical history included Cancer from 2016 to 2017. Concurrent medical conditions included Allergy to antibiotic (sulfites), Allergy to antibiotic (Trimethoprim), Allergy to antibiotic (Ceftriaxone), Neck pain (neck issues, start date: 25 years ago), Arthritis (Start Date: 15 years ago) and Scoliosis (Start Date: since she was born). Concomitant products included IBUPROFEN for Neck pain, ACYCLOVIR [ACICLOVIR] and VITAMINS NOS for an unknown indication.    On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Standard reaction like a flu), PYREXIA (A little fever) and HEADACHE (Headache). On 21-May-2021, INFLUENZA LIKE ILLNESS (Standard reaction like a flu), PYREXIA (A little fever) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included ibuprofen for headache after 2nd dose.  Patient height was 5'8.  After second shot she got sick, she thought her immune system was wakened, and received antibiotics, then doctors told her she developed an allergic reaction to sulfites, Trimethoprim and Ceftriaxone.   This case was linked to MOD-2022-495173, MOD-2022-495241 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Head titubation, Lymphadenopathy
Clinical narrative: tremor started on her head, with no motion from left to right; she felt cranky; extreme swelling of the lymph nodes on her right arm and armpit after the injection; This spontaneous case was reported by a consumer and describes the occurrence of HEAD TITUBATION (tremor started on her head, with no motion from left to right), FEELING ABNORMAL (she felt cranky) and LYMPHADENOPATHY (extreme swelling of the lymph nodes on her right arm and armpit after the injection) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.  The patient's past medical history included Cancer (There was no recent change in status (such as improvement or worsening)) from 2016 to 2017. Previously administered products included for Drug use for unknown indication: chicken pox vaccine (The patient received chicken pox vaccine around both first 2 doses of COVID-19 vaccine). Past adverse reactions to the above products included No adverse event with chicken pox vaccine. Concurrent medical conditions included Neck discomfort (Start date: 25 years ago and there was no recent change in status (such as improvement or worsening)), Arthritis (Start date: 15 years ago and there was no recent change in status (such as improvement or worsening)) and Scoliosis (Start date: since the patient was born and there was no recent change in status (such as improvement or worsening)). Concomitant products included IBUPROFEN for Neck discomfort, ACYCLOVIR [ACICLOVIR] and VITAMINS NOS for an unknown indication.   On 31-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2022, the patient experienced FEELING ABNORMAL (she felt cranky) and LYMPHADENOPATHY (extreme swelling of the lymph nodes on her right arm and armpit after the injection). On 01-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEAD TITUBATION (tremor started on her head, with no motion from left to right). On 03-Feb-2022, FEELING ABNORMAL (she felt cranky) and LYMPHADENOPATHY (extreme swelling of the lymph nodes on her right arm and armpit after the injection) had resolved. At the time of the report, HEAD TITUBATION (tremor started on her head, with no motion from left to right) had not resolved.   The extreme swelling of the lymph nodes was lasted for 2 to 3 days. The patient thought that the tremor might be related to previous neck issues. The patient visited to her doctor because of tremor and no treatment was given, but doctor told her that they would watch the symptom for a while. The tremor was still ongoing and worsened as well.  Treatment information for the events feeling abnormal and swollen lymph nodes were not reported by the reporter.   This case was linked to MOD-2022-495240, MOD-2022-495173 (Patient Link).
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. On 17-Dec-2021, the vial was initially stored in the refrigerator. Vial didn't underwent temperature excursions. BUD (beyond use date) was on 16-Jan-2022. No treatment information were given.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (administered after 30-day use-by-date) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 027H21B) for COVID-19 immunization. No medical history reported. On Feb 21, 2022, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 21, 2022, patient administered expired product (administered after 30-day use-by-date). At the time of the report, administered expired product (administered after 30-day use-by-date) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Beyond-use-date of the vaccine was Jan 16, 2022. The vial (initially stored in the refrigerator on Dec 17, 2021) did not undergo any temperature excursion.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) 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. No treatment medications were reported.  Date the vial was initially stored in the refrigerator was 17Dec2021.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of allergy to vaccine (allergic reaction due to the Moderna vaccine) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19  immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced allergy to vaccine (allergic reaction due to the Moderna vaccine). At the time of the report, allergy to vaccine (allergic reaction due to the Moderna vaccine) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose had been given to the patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose had been given to the patient) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022 at 8:31 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Jan-2022 at 8:31 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose had been given to the patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose had been given to the patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. No treatment information was provided.  The Moderna vaccine was pulled from freezer on 16-Dec-2021 and the beyond use date of the vaccine of 15-Jan-2022 was printed in red and taped to the top of the boxes of vials.  On 26-Jan-2022, the staff brought it to the reporter's attention that it was still in the fridge and had expired.  On 31-Jan-2022, the reporter was informed that revaccination was not required for the patient. The patient was notified that revaccination was not required and the patient denied having any adverse effects.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow-up received included non significant information.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose had been given to the patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose had been given to the patient) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022 at 7:40 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 21-Jan-2022 at 7:40 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose had been given to the patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose had been given to the patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. No treatment information was provided.  The Moderna vaccine was pulled from freezer on 16-Dec-2021 and the beyond use date of the vaccine of 15-Jan-2022 was printed in red and taped to the top of the boxes of vials.  On 26-Jan-2022, the staff brought it to the reporter's attention that it was still in the fridge and had expired.  On 31-Jan-2022, the reporter was informed that revaccination was not required for the patient. The patient was notified that revaccination was not required and the patient denied having any adverse effects.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: follow up document contains no new information
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired - 5 doses had been given at that point; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired - 5 doses had been given at that point) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022 at 2:20 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Jan-2022 at 2:20 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired - 5 doses had been given at that point). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired - 5 doses had been given at that point) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication information was provided.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 14 year old received the 1st dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 14 year old received the 1st dose of the Moderna COVID-19 vaccine) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 14 year old received the 1st dose of the Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 14 year old received the 1st dose of the Moderna COVID-19 vaccine) 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.   Height of patient was  5 Ft 10 No concomitant medication were provided. No treatment information were given.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Somnolence
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of malaise (didn't feel well at all) and somnolence (wanted to go to bed and sleep) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. February 2022, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. February 2022, patient experienced malaise (didn't feel well at all) and somnolence (wanted to go to bed and sleep). At the time of the report, malaise (didn't feel well at all) and somnolence (wanted to go to bed and sleep) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Patient wanted to know why the dosage for the booster is 5 times of the primary series. She wanted to know if there is any information available about that. She also wanted  to know if she may have the same side effects when she goes for her 2nd dose after 3 weeks. Patient did not elaborate on her adverse reactions. No concomitant medication or treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a dose (patient's booster dose) from a vial that had been punctured for more than 12 hours.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose (patient's booster dose) from a vial that had been punctured for more than 12 hours.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose (patient's booster dose) from a vial that had been punctured for more than 12 hours.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a dose (patient's booster dose) from a vial that had been punctured for more than 12 hours.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information were provided. The Vial was first punctured at 4:55pm Wednesday 23Feb2022 (two doses were withdrawn). The vaccine was returned to fridge. At 5:15pm (23Feb2022) vial was placed back into the refrigerator. Then transported (in refrigerated state from 6:50pm - 7:01pm) back to the main facility then placed back to the refrigerator at 7:01pm (at 5.38C). Thursday 24Feb2022 vial was removed at 9:32am (at 5.48C). Transported to another facility (arrived at 10:05 am with a temp of 5.27 C). At 5:00pm a dose from vial was administered. The vial undergo any temperature excursions.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: immunocompromised patient received booster dose instead of full 3rd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient received booster dose instead of full 3rd dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2201200-16) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (was on immunosuppressive medication).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 20-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 20-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient received booster dose instead of full 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised patient received booster dose instead of full 3rd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.  The reporter had a question for the patient who had history of an immunocompromised condition and was on immunosuppressive medication, which would have made her eligible to receive a full 3rd dose. Patient did not experience any side effects after receiving the booster dose.   This case was linked to MOD-2022-495993 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: It was reported that the patient got the COVID shot several months back and it affected another syndrome which she was having and; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (It was reported that the patient got the COVID shot several months back and it affected another syndrome which she was having and) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL DIOLAMIN (ORENITRAM) for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension since 24-Oct-2019. Concomitant products included RIOCIGUAT (ADEMPAS) and DILTIAZEM HYDROCHLORIDE for Pulmonary arterial hypertension.   On 24-Oct-2019, the patient TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 5 milligram. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) 1 milligram. On an unknown date, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 17 milligram every eight hours. On an unknown date, the patient experienced VACCINATION COMPLICATION (It was reported that the patient got the COVID shot several months back and it affected another syndrome which she was having and). At the time of the report, VACCINATION COMPLICATION (It was reported that the patient got the COVID shot several months back and it affected another syndrome which she was having and) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient got the COVID shot several months back and it affected another syndrome which she was having and it had been a little harder to get back to baseline.  No treatment drugs were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose of the Moderna COVID-19 vaccine on 12-Feb-2021 and the 2nd dose on 22-Mar-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the Moderna COVID-19 vaccine on 12-Feb-2021 and the 2nd dose on 22-Mar-2021) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Concurrent medical conditions included Immunocompromised.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 22-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the Moderna COVID-19 vaccine on 12-Feb-2021 and the 2nd dose on 22-Mar-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of the Moderna COVID-19 vaccine on 12-Feb-2021 and the 2nd dose on 22-Mar-2021) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitantly the patient was on immunosuppressive medication.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-495908 (Patient Link).
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: injection site arm was sore for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site arm was sore for 3 days) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced INJECTION SITE PAIN (injection site arm was sore for 3 days). On 18-Mar-2021, INJECTION SITE PAIN (injection site arm was sore for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-496059 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2022: Live Follow-up received contains no new information.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired- 5 doses had been given at that point; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired- 5 doses had been given at that point) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022 at 9:57 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired- 5 doses had been given at that point). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired- 5 doses had been given at that point) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), 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.  Moderna vaccine pulled from freezer on 16 Dec 2021. BUD of 15 Jan 2022 printed in red and taped to the top of boxes. On 26 Jan 2022, staff brought it to the attention that it was still in the fridge and expired. On 31 Jan 2022, Moderna responded that re-vaccination not required.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: IRD updated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Diarrhoea, Extra dose administered, Headache, Hot flush
Clinical narrative: feeling pretty sick; Jaw pain; dripping sweat; diarrhea; hot flashes; Constipation; Headache; Nausea; got fourth Covid vaccine so thought that could have increased her symptoms.; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling pretty sick), PAIN IN JAW (Jaw pain), HYPERHIDROSIS (dripping sweat), DIARRHOEA (diarrhea) and HOT FLUSH (hot flashes) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TREPROSTINIL DIOLAMIN (ORENITRAM) for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension, Palpitations, Hypotension (blood pressure machine cannot read the blood pressure maybe because too low), Hyperhidrosis, Presyncope and Hypoaesthesia. Concomitant products included AMBRISENTAN and TADALAFIL for an unknown indication.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) 5 milligram. On an unknown date, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 10 milligram three times a day and TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to UNK, increased dose. On an unknown date, the patient experienced MALAISE (feeling pretty sick), PAIN IN JAW (Jaw pain), HYPERHIDROSIS (dripping sweat), DIARRHOEA (diarrhea), HOT FLUSH (hot flashes), CONSTIPATION (Constipation), HEADACHE (Headache), NAUSEA (Nausea) and EXTRA DOSE ADMINISTERED (got fourth Covid vaccine so thought that could have increased her symptoms.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, MALAISE (feeling pretty sick), PAIN IN JAW (Jaw pain), HYPERHIDROSIS (dripping sweat), DIARRHOEA (diarrhea) and HEADACHE (Headache) had not resolved and HOT FLUSH (hot flashes), CONSTIPATION (Constipation), NAUSEA (Nausea) and EXTRA DOSE ADMINISTERED (got fourth Covid vaccine so thought that could have increased her symptoms.) outcome was unknown.            The patient reported that she continued to have jaw pain and headaches since increased PO Orenitram to 10 mg  three times a day, and for which Tylenol did not work. The reporter's causality for the event of headache with PO Orenitram was considered to be possibly related and reporter causality was not reported  for the events of hot flush, nausea and constipation.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Malaise, Nausea, Pain in jaw
Clinical narrative: feeling pretty sick; Jaw pain; dripping sweat; diarrhea; hot flashes; Constipation; Headache; Nausea; got fourth Covid vaccine so thought that could have increased her symptoms.; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling pretty sick), PAIN IN JAW (Jaw pain), HYPERHIDROSIS (dripping sweat), DIARRHOEA (diarrhea) and HOT FLUSH (hot flashes) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TREPROSTINIL DIOLAMIN (ORENITRAM) for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension, Palpitations, Hypotension (blood pressure machine cannot read the blood pressure maybe because too low), Hyperhidrosis, Presyncope and Hypoaesthesia. Concomitant products included AMBRISENTAN and TADALAFIL for an unknown indication.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) 5 milligram. On an unknown date, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 10 milligram three times a day and TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to UNK, increased dose. On an unknown date, the patient experienced MALAISE (feeling pretty sick), PAIN IN JAW (Jaw pain), HYPERHIDROSIS (dripping sweat), DIARRHOEA (diarrhea), HOT FLUSH (hot flashes), CONSTIPATION (Constipation), HEADACHE (Headache), NAUSEA (Nausea) and EXTRA DOSE ADMINISTERED (got fourth Covid vaccine so thought that could have increased her symptoms.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, MALAISE (feeling pretty sick), PAIN IN JAW (Jaw pain), HYPERHIDROSIS (dripping sweat), DIARRHOEA (diarrhea) and HEADACHE (Headache) had not resolved and HOT FLUSH (hot flashes), CONSTIPATION (Constipation), NAUSEA (Nausea) and EXTRA DOSE ADMINISTERED (got fourth Covid vaccine so thought that could have increased her symptoms.) outcome was unknown.            The patient reported that she continued to have jaw pain and headaches since increased PO Orenitram to 10 mg  three times a day, and for which Tylenol did not work. The reporter's causality for the event of headache with PO Orenitram was considered to be possibly related and reporter causality was not reported  for the events of hot flush, nausea and constipation.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022 at 6:25 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-Jan-2022 at 6:25 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow up received: No new information.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered
Clinical narrative: Expired  5 doses had been given at that point.; Dose 0.5 ml was admistered to the patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired  5 doses had been given at that point.) and ACCIDENTAL OVERDOSE (Dose 0.5 ml was admistered to the patient) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022 at 2:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Jan-2022 at 2:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired  5 doses had been given at that point.) and ACCIDENTAL OVERDOSE (Dose 0.5 ml was admistered to the patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired  5 doses had been given at that point.) and ACCIDENTAL OVERDOSE (Dose 0.5 ml was admistered to the patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that the Moderna vaccine was pulled from freezer on 16-Dec-2021. The Beyond use date of 15-Jan-2022 was printed in red and taped to the top of the boxes.  On 26-Jan-2022, the staff brought it to attention that it was still in the fridge and expired-5 doses had been given at that point. Moderna contacted and report filed. The beyond use date added to the daily Covid usage and wastage report. On 27-Jan-2022, the reporter checked all the other agency sites. Every clinic had done the same, without noticing the beyond use date.  On 31-Jan-2022, Moderna responded- revaccination not required, but adverse event report needed to be completed.  It was also reported that the patient was notified of error and that a repeat vaccine was not required. The patient denied any adverse effects.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow up received with significant information - IRD was changed from 25-Feb-2022 to 24-Feb-2022.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired-5 doses had been given at that point; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given at that point) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022 at 3:33 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Jan-2022 at 3:33 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given at that point). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given at that point) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 16-Dec-2021 Moderna vaccine was pulled from freezer. Beyond use date (BUD) of 15-Jan-2022 was printed in red and taped to the top of the boxes. The patient was notified of the error and patient denied adverse effects.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow up received. IRD changed (25-feb-2022 to 24-Feb-2022).
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dermatitis
Clinical narrative: inflammatory response on both cheeks; This spontaneous case was reported by a nurse and describes the occurrence of DERMATITIS (inflammatory response on both cheeks) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Co-suspect product included non-company product HYALURONIC ACID, LIDOCAINE HYDROCHLORIDE (RESTYLANE DEFYNE) injection for an unknown indication.  No Medical History information was reported.  In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-2021, the patient started HYALURONIC ACID, LIDOCAINE HYDROCHLORIDE (RESTYLANE DEFYNE) (unknown route) injected to the cheeks and chin area. On 02-Sep-2021, the patient experienced DERMATITIS (inflammatory response on both cheeks). At the time of the report, DERMATITIS (inflammatory response on both cheeks) had not resolved.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication of the patient was not reported.   The patient was injected with Restyane Defyne to the cheeks and chin area. The patient had inflammatory response on both cheeks and symptoms included cheeks would get red, hard and itchy and then resolved. Symptoms of the patient were recurring.   The patient did not receive any corrective treatment.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Myalgia, Peripheral swelling, Pyrexia
Clinical narrative: Swelling from her elbow to the injection site that is getting bigger/swollen left arm; Redness from her elbow to the injection site that is getting bigger; Excruciating body pain; Also had Chills; Also had fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (Swelling from her elbow to the injection site that is getting bigger/swollen left arm), ERYTHEMA (Redness from her elbow to the injection site that is getting bigger), MYALGIA (Excruciating body pain), CHILLS (Also had Chills) and PYREXIA (Also had fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022, the patient experienced PERIPHERAL SWELLING (Swelling from her elbow to the injection site that is getting bigger/swollen left arm), ERYTHEMA (Redness from her elbow to the injection site that is getting bigger), MYALGIA (Excruciating body pain), CHILLS (Also had Chills) and PYREXIA (Also had fever). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Fever, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swelling from her elbow to the injection site that is getting bigger/swollen left arm), ERYTHEMA (Redness from her elbow to the injection site that is getting bigger), MYALGIA (Excruciating body pain), CHILLS (Also had Chills) and PYREXIA (Also had fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised-Cancer, who received the first 2 Moderna vaccine and got a booster dose for the 3rd one/booster dose was given out of sequence; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised-Cancer, who received the first 2 Moderna vaccine and got a booster dose for the 3rd one/booster dose was given out of sequence) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Immunocompromised) and Immunocompromised.   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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 ACCIDENTAL UNDERDOSE (Immunocompromised-Cancer, who received the first 2 Moderna vaccine and got a booster dose for the 3rd one/booster dose was given out of sequence). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised-Cancer, who received the first 2 Moderna vaccine and got a booster dose for the 3rd one/booster dose was given out of sequence) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter stated that the patient was confused about what they were asking for and asked for a booster dose instead of a third dose. It was also stated that patient was asking for second booster dose. No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after BUD of 15-Jan-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after BUD of 15-Jan-2022) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2022 at 10:51 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Jan-2022 at 10:51 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after BUD of 15-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after BUD of 15-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), 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.  Reporter stated that Moderna vaccine was pulled from freezer on 16-Dec-2021 and Before use by date was 15-Jan-2022 printed in red and taped to the top of boxes. On 26-Jan-2022, staff brought it to the attention that it was still in the fridge and expired. On 27-Jan-2022 staff contacted the vaccine manufacturer and on 31-Jan-2022, the vaccine manufacturer responded that re-vaccination was not required.