chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous report received from a pharmacist concerned a 6 decade old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835 expiry: 27-APR-2022) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 03-DEC-2021, the patient experienced received a Janssen Covid-19 vaccine that the temperature of the fridge had gone up to 46.9 F for 17 minutes, and out of specification product use. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received a Janssen Covid-19 vaccine that the temperature of the fridge had gone up to 46.9 F for 17 minutes and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20220121692.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: 21-OCT-2021) dose was not reported, administered on 11-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 11-JAN-2022, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220121658.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Poor quality product administered, Product storage error
Clinical narrative: ADMINISTRATION OF VACCINE STORED OUTSIDE OF RECOMMENDED CONDITIONS; VACCINE AFTER BEING DRAWN INTO A SYRINGE 12 HOURS PRIOR; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 11-JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-JAN-2022, the patient experienced administration of vaccine stored outside of recommended conditions. On 11-JAN-2022, the patient experienced vaccine after being drawn into a syringe 12 hours prior. On 11-JAN-2022, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine stored outside of recommended conditions, vaccine after being drawn into a syringe 12 hours prior and off label use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 21-OCT-2021) dose was not reported, administered on 11-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 11-JAN-2022, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220121562.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: RECEIVED A JANSSEN COVID-19 VACCINE THAT THE TEMPERATURE OF THE FRIDGE HAD GONE UP TO 46.9 F FOR 17 MINUTES; INCORRECTLY STORED VACCINE ADMINISTERED; VACCINE STORED OUTSIDE OF THE ACCEPTABLE LIMITS; This spontaneous report received from a health care professional concerned a 19 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835, and expiry: 27-APR-2022) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On 03-DEC-2021, the patient experienced received a janssen covid-19 vaccine that the temperature of the fridge had gone up to 46.9 f for 17 minutes, incorrectly stored vaccine administered, and vaccine stored outside of the acceptable limits. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received a janssen covid-19 vaccine that the temperature of the fridge had gone up to 46.9 f for 17 minutes, incorrectly stored vaccine administered and vaccine stored outside of the acceptable limits was not reported. This report was non-serious. This case, from the same reporter is linked to 20220121547.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced adverse reactions. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reactions was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID AFTER RECEIVING THE JANSSEN COVID-19 VACCINE; This spontaneous report received from a consumer concerned a 38 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 14-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JAN-2022, Laboratory data included: COVID-19 virus test (not provided) Positive. On an unspecified date, the patient experienced covid after receiving the janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid after receiving the janssen covid-19 vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Patient tested positive for the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient tested positive for the Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Patient tested positive for the Moderna vaccine). On 07-Jan-2022, SARS-COV-2 TEST POSITIVE (Patient tested positive for the Moderna vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2022, SARS-CoV-2 test: negative negative. On an unknown date, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported. It was reported that the patient tested positive for the Moderna vaccine on the 27th (unspecified) and had been tested negative today (07-Jan-2022).  Company comment:  This case concerns a male patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19,that occurred after the dose of the mRNA-1273 . The exact time to onset and doses administered was not provided. The rechallenge was not applicable due to nature of the event, as well as unspecified number of doses administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a male patient with no reported medical history who experienced non-serious unexpected AESI of SARS-CoV-2 test positive,that occurred after the 2nd dose of the mRNA-1273 . The exact time to onset was not known. The rechallenge was not applicable due to nature of the event, as well as occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Maternal exposure during pregnancy
Clinical narrative: 69 expired doses administered; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 10-Jan-2022, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that there were a total of 69 administered doses between  January 6, 2022 and January 11, 2022. It was reported that Of these, 68 doses were boosters and 1 dose was a first dose. No concomitant medication information was provided. No treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Symptoms following booser vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Symptoms following booser vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Symptoms following booser vaccine). At the time of the report, VACCINATION COMPLICATION (Symptoms following booser vaccine) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Was sick with my 2 vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (Was sick with my 2 vaccines) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Was sick with my 2 vaccines). At the time of the report, ILLNESS (Was sick with my 2 vaccines) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-448499 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: had a horrible reaction was blacking out, He was passed out for 45 minute; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (had a horrible reaction was blacking out, He was passed out for 45 minute) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Prior to getting vaccine.).    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, the patient experienced LOSS OF CONSCIOUSNESS (had a horrible reaction was blacking out, He was passed out for 45 minute) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (had a horrible reaction was blacking out, He was passed out for 45 minute) had resolved.            Concomitant medications were not provided. Patient got the second dose and had a horrible reaction to the second dose. After receiving vaccine for 12 or13 mins patient went blacking out. Patient doesn't remember doing but woke up by the toilet hunched over. Patient was passed out for 45 mins. Patient would be released from prison on 07 Feb 2022 and was also scared to get the booster. Patient had COVID prior to getting the vaccine. Reporter was not sure of the date of second dose.   Treatment medication was not provided.  Company comment: This case concerns a 45-year-old male patient, with no relevant medical history, who experienced the serious, unexpected event of loss of consciousness. The event occurred on unknown date after second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient passed out for 45 minutes. At the time of report, loss of consciousness had resolved. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2022-439943 (Patient Link).; Sender's Comments: This case concerns a 45-year-old male patient, with no relevant medical history, who experienced the serious, unexpected event of loss of consciousness. The event occurred on unknown date after second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient passed out for 45 minutes. At the time of report, loss of consciousness had resolved. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 11 Doses administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (11 Doses administered after 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the Moderna vaccine put out of the freezer on 01-Dec-2021 and placed in the refrigerator , so it was not supposed to be used beyond 31-Dec-2021 but 11 doses were administered on 5-Jan-2022. And also stated that the vial did not undergo any temperature excursions.  No concomitant product use was provided. No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: rash/hives after taking Moderna booster.; Rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (rash/hives after taking Moderna booster.) and RASH (Rash) 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 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 URTICARIA (rash/hives after taking Moderna booster.) and RASH (Rash). At the time of the report, URTICARIA (rash/hives after taking Moderna booster.) and RASH (Rash) outcome was unknown. Not Provided          No Concomitant medication information was reported. No Treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: patients received vaccine after temperature excursions; product storage error; Expired product administered/vaccine was given from a punctured vial of moderna past 30 day BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients received vaccine after temperature excursions), PRODUCT STORAGE ERROR (product storage error) and EXPIRED PRODUCT ADMINISTERED (Expired product administered/vaccine was given from a punctured vial of moderna past 30 day BUD) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired product administered/vaccine was given from a punctured vial of moderna past 30 day BUD). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients received vaccine after temperature excursions) and PRODUCT STORAGE ERROR (product storage error). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired product administered/vaccine was given from a punctured vial of moderna past 30 day BUD) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients received vaccine after temperature excursions) and PRODUCT STORAGE ERROR (product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 02 Nov 2021, the vial was initially stored in the refrigerator and was first punctured. The Vial was stored in refrigerator post puncture.  No concomitant medication was provided.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Dec-2021: Follow up received and included Non Significant information. On 10-Jan-2022: Follow up received included vaccine information, event start date and stop date was updated.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Discomfort, Fatigue, Malaise, Myalgia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (they have been having joint and muscle aches that have continued still specially affecting their knees and legs), DISCOMFORT (they experienced discomfort), MALAISE (not feeling well), ARTHRALGIA (have been having joint and muscle aches that have continued still, specially affecting their knees) and MYALGIA (they have been having joint and muscle aches that have continued still) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension, Celiac disease (autoimmune disease), Hashimoto's disease (autoimmune disease), Connective tissue disorder (autoimmune disease) and Osteoarthritis (autoimmune disease). Concomitant products included AMLODIPINE for Blood pressure management, LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (they have been having joint and muscle aches that have continued still specially affecting their knees and legs), DISCOMFORT (they experienced discomfort), MALAISE (not feeling well), ARTHRALGIA (have been having joint and muscle aches that have continued still, specially affecting their knees), MYALGIA (they have been having joint and muscle aches that have continued still) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (they have been having joint and muscle aches that have continued still specially affecting their knees and legs), ARTHRALGIA (have been having joint and muscle aches that have continued still, specially affecting their knees) and MYALGIA (they have been having joint and muscle aches that have continued still) had not resolved and DISCOMFORT (they experienced discomfort), MALAISE (not feeling well) and FATIGUE (fatigue) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications also included vitamins. No treatment details were reported. This case was linked to MOD-2022-449279, MOD-2022-449286, MOD-2022-449374 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (they have been having joint and muscle aches that have continued still specially affecting their knees and legs), DISCOMFORT (they experienced discomfort), MALAISE (not feeling well), ARTHRALGIA (have been having joint and muscle aches that have continued still, specially affecting their knees) and MYALGIA (they have been having joint and muscle aches that have continued still) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension, Celiac disease (autoimmune disease), Hashimoto's disease (autoimmune disease), Connective tissue disorder (autoimmune disease) and Osteoarthritis (autoimmune disease). Concomitant products included AMLODIPINE for Blood pressure management, LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (they have been having joint and muscle aches that have continued still specially affecting their knees and legs), DISCOMFORT (they experienced discomfort), MALAISE (not feeling well), ARTHRALGIA (have been having joint and muscle aches that have continued still, specially affecting their knees), MYALGIA (they have been having joint and muscle aches that have continued still) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (they have been having joint and muscle aches that have continued still specially affecting their knees and legs), ARTHRALGIA (have been having joint and muscle aches that have continued still, specially affecting their knees) and MYALGIA (they have been having joint and muscle aches that have continued still) had not resolved and DISCOMFORT (they experienced discomfort), MALAISE (not feeling well) and FATIGUE (fatigue) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications also included vitamins. No treatment details were reported. This case was linked to MOD-2022-449279, MOD-2022-449286, MOD-2022-449374 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (they have been having joint and muscle aches that have continued still specially affecting their knees and legs), DISCOMFORT (they experienced discomfort), MALAISE (not feeling well), ARTHRALGIA (have been having joint and muscle aches that have continued still, specially affecting their knees) and MYALGIA (they have been having joint and muscle aches that have continued still) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension, Celiac disease (autoimmune disease), Hashimoto's disease (autoimmune disease), Connective tissue disorder (autoimmune disease) and Osteoarthritis (autoimmune disease). Concomitant products included AMLODIPINE for Blood pressure management, LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (they have been having joint and muscle aches that have continued still specially affecting their knees and legs), DISCOMFORT (they experienced discomfort), MALAISE (not feeling well), ARTHRALGIA (have been having joint and muscle aches that have continued still, specially affecting their knees), MYALGIA (they have been having joint and muscle aches that have continued still) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (they have been having joint and muscle aches that have continued still specially affecting their knees and legs), ARTHRALGIA (have been having joint and muscle aches that have continued still, specially affecting their knees) and MYALGIA (they have been having joint and muscle aches that have continued still) had not resolved and DISCOMFORT (they experienced discomfort), MALAISE (not feeling well) and FATIGUE (fatigue) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications also included vitamins. No treatment details were reported. This case was linked to MOD-2022-449279, MOD-2022-449286, MOD-2022-449374 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Discomfort, Fatigue, Malaise, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), DISCOMFORT (They feel really uncomfortable), MALAISE (not feeling well), RASH (Rashes) and ARTHRALGIA (have been having joint and muscle ache specially affecting their knees and legs.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Celiac disease (Autoimmune disease), Hashimoto's disease (Autoimmune disease), Connective tissue disorder (Autoimmune disease), Osteoarthritis (Autoimmune disease) and Blood pressure high. Concomitant products included AMLODIPINE for Blood pressure high, LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives), DISCOMFORT (They feel really uncomfortable), MALAISE (not feeling well), RASH (Rashes), ARTHRALGIA (have been having joint and muscle ache specially affecting their knees and legs.), MYALGIA (have been having joint and muscle ache specially affecting their knees and legs.) and FATIGUE (fatigue). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency; CIMETIDINE for Adverse event, at a dose of 300 mg four times per day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK, qhs. At the time of the report, URTICARIA (Hives), RASH (Rashes), ARTHRALGIA (have been having joint and muscle ache specially affecting their knees and legs.) and MYALGIA (have been having joint and muscle ache specially affecting their knees and legs.) had not resolved and DISCOMFORT (They feel really uncomfortable), MALAISE (not feeling well) and FATIGUE (fatigue) outcome was unknown. Reporter stated that she have consulted four different doctors and they prescribed them different medications for the hives. After the second dose of the Moderna vaccine they have been experiencing hives and rashes for the past seven months and they have become allergic to all the products they were using on their skin. The onset was about a month after the second dose and they are still breaking out in hives.  This case was linked to MOD-2022-449262, MOD-2022-449374 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), DISCOMFORT (They feel really uncomfortable), MALAISE (not feeling well), RASH (Rashes) and ARTHRALGIA (have been having joint and muscle ache specially affecting their knees and legs.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Celiac disease (Autoimmune disease), Hashimoto's disease (Autoimmune disease), Connective tissue disorder (Autoimmune disease), Osteoarthritis (Autoimmune disease) and Blood pressure high. Concomitant products included AMLODIPINE for Blood pressure high, LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives), DISCOMFORT (They feel really uncomfortable), MALAISE (not feeling well), RASH (Rashes), ARTHRALGIA (have been having joint and muscle ache specially affecting their knees and legs.), MYALGIA (have been having joint and muscle ache specially affecting their knees and legs.) and FATIGUE (fatigue). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency; CIMETIDINE for Adverse event, at a dose of 300 mg four times per day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK, qhs. At the time of the report, URTICARIA (Hives), RASH (Rashes), ARTHRALGIA (have been having joint and muscle ache specially affecting their knees and legs.) and MYALGIA (have been having joint and muscle ache specially affecting their knees and legs.) had not resolved and DISCOMFORT (They feel really uncomfortable), MALAISE (not feeling well) and FATIGUE (fatigue) outcome was unknown. Reporter stated that she have consulted four different doctors and they prescribed them different medications for the hives. After the second dose of the Moderna vaccine they have been experiencing hives and rashes for the past seven months and they have become allergic to all the products they were using on their skin. The onset was about a month after the second dose and they are still breaking out in hives.  This case was linked to MOD-2022-449262, MOD-2022-449374 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), DISCOMFORT (They feel really uncomfortable), MALAISE (not feeling well), RASH (Rashes) and ARTHRALGIA (have been having joint and muscle ache specially affecting their knees and legs.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Celiac disease (Autoimmune disease), Hashimoto's disease (Autoimmune disease), Connective tissue disorder (Autoimmune disease), Osteoarthritis (Autoimmune disease) and Blood pressure high. Concomitant products included AMLODIPINE for Blood pressure high, LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives), DISCOMFORT (They feel really uncomfortable), MALAISE (not feeling well), RASH (Rashes), ARTHRALGIA (have been having joint and muscle ache specially affecting their knees and legs.), MYALGIA (have been having joint and muscle ache specially affecting their knees and legs.) and FATIGUE (fatigue). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency; CIMETIDINE for Adverse event, at a dose of 300 mg four times per day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK, qhs. At the time of the report, URTICARIA (Hives), RASH (Rashes), ARTHRALGIA (have been having joint and muscle ache specially affecting their knees and legs.) and MYALGIA (have been having joint and muscle ache specially affecting their knees and legs.) had not resolved and DISCOMFORT (They feel really uncomfortable), MALAISE (not feeling well) and FATIGUE (fatigue) outcome was unknown. Reporter stated that she have consulted four different doctors and they prescribed them different medications for the hives. After the second dose of the Moderna vaccine they have been experiencing hives and rashes for the past seven months and they have become allergic to all the products they were using on their skin. The onset was about a month after the second dose and they are still breaking out in hives.  This case was linked to MOD-2022-449262, MOD-2022-449374 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) 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 provided.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 23-year-old male patient 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, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be related.    Concomitant and treatment medication was not reported.  It was reported that the authors presented a patient who is typical of a patient presenting with myocarditis post-COVID-19 mRNA- 1273 Moderna vaccination (young males, onset several days after second dose of the mRNA vaccine, and excellent short term complete recovery). Follow-up at 128 days revealed no residual sequelae in the patient.  Company comment: This case concerns a 23-year-old male patient with no medical history provided who experienced serious expected event of special interest Myocarditis. As per RA, the event occurred several days after the second dose of mRNA-1273. At the time of the report, the event resolved. It was reported that follow-up at 128 days revealed no residual sequelae. No further information was provided. No information regarding laboratory nor diagnostic tests was provided. The Reporter assessed the event as related to the suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 23-year-old male patient with no medical history provided who experienced serious expected event of special interest Myocarditis. As per RA, the event occurred several days after the second dose of mRNA-1273. At the time of the report, the event resolved. It was reported that follow-up at 128 days revealed no residual sequelae. No further information was provided. No information regarding laboratory nor diagnostic tests was provided. The Reporter assessed the event as related to the suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the second dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the second dose) 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 medications were reported.Company comment: This spontaneous case concerns a patient of unknown age and gender who reported a Product dose omission issue. Patient reported that the second dose of vaccination was missed and wants to know if vaccination schedule needs to be started all over. No further relevant information was provided; however, since the patient mentions some doubts regarding COVID-19 infection, a query has been raised to confirm if the patient had COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a patient of unknown age and gender who reported a Product dose omission issue. Patient reported that the second dose of vaccination was missed and wants to know if vaccination schedule needs to be started all over. No further relevant information was provided; however, since the patient mentions some doubts regarding COVID-19 infection, a query has been raised to confirm if the patient had COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (has Covid) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Overweight. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (has Covid). At the time of the report, COVID-19 (has Covid) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101°f (High) 101°F. It was reported that patient was offered monoclonal infusion because of his age. No concomitant medications were reported. It was reported that patient had very mild symptoms: 101°F temperature, sniffles, barely coughing. Company comment: This spontaneous case concerns a 78-year-old XX patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19. Onset date of the event and vaccination dates were not reported; however, the narrative states that patient had received the second dose of mRNA-1273 more than 6 months prior to the event. Monoclonal infusion therapy was offered; however, it is it not clear if patient received it. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2022-438394 (Patient Link). Sender's Comments: This spontaneous case concerns a 78-year-old XX patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19. Onset date of the event and vaccination dates were not reported; however, the narrative states that patient had received the second dose of mRNA-1273 more than 6 months prior to the event. Monoclonal infusion therapy was offered; however, it is it not clear if patient received it. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (tested positive for COVID-19) 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 COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.  Company comment: This spontaneous case concerns a patient of unknown age and gender, with no reports on medical history, who experienced the non-serious unexpected AESI of COVID-19. The event occurred on an unknown date after receiving a third dose of mRNA-1273. Vaccination dates were not provided; hence schedule cannot be assessed. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.    Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with no reports on medical history, who experienced the non-serious unexpected AESI of COVID-19. The event occurred on an unknown date after receiving a third dose of mRNA-1273. Vaccination dates were not provided; hence schedule cannot be assessed. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Staphylococcal infection
Clinical narrative: Had a bad MRSA infection; This spontaneous case was reported by a consumer and describes the occurrence of STAPHYLOCOCCAL INFECTION (Had a bad MRSA infection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced STAPHYLOCOCCAL INFECTION (Had a bad MRSA infection) (seriousness criterion hospitalization). At the time of the report, STAPHYLOCOCCAL INFECTION (Had a bad MRSA infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  Company comment: This is a spontaneous case concerning a male patient of an unknown age with no medical history reported, who experienced unexpected event of staphylococcal infection (seriousness criterion hospitalization). The event occurred on an unknown date after the administration of mRNA-1273 vaccine. The reporter mentioned that her son had a bad MRSA infection right before Christmas of 2021 and was hospitalized for a week after having the Moderna Covid-19 Vaccine primary series in early 2021. Very limited information regarding this event has been provided at this time.  Further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-439087.; Sender's Comments: This is a spontaneous case concerning a male patient of an unknown age with no medical history reported, who experienced unexpected event of staphylococcal infection (seriousness criterion hospitalization). The event occurred on an unknown date after the administration of mRNA-1273 vaccine. The reporter mentioned that her son had a bad MRSA infection right before Holidays of 2021 and was hospitalized for a week after having the Moderna Covid-19 Vaccine primary series in early 2021. Very limited information regarding this event has been provided at this time.  Further information has been requested. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.