chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Blood pressure measurement, Dizziness, Loss of consciousness, Memory impairment
Clinical narrative: passed out; little bit of memory loss; had to stop and think/, it is not like the brain would provide the information like it would normally do.; light-headed; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out), AMNESIA (little bit of memory loss), MEMORY IMPAIRMENT (had to stop and think/, it is not like the brain would provide the information like it would normally do.) and DIZZINESS (light-headed) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS. Concomitant products included MONTELUKAST, HYDROXYZINE HYDROCHLORIDE, DEXLANSOPRAZOLE (DEXILANT) and ATORVASTATIN for an unknown indication.    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 LOSS OF CONSCIOUSNESS (passed out), AMNESIA (little bit of memory loss), MEMORY IMPAIRMENT (had to stop and think/, it is not like the brain would provide the information like it would normally do.) and DIZZINESS (light-headed). At the time of the report, LOSS OF CONSCIOUSNESS (passed out) and DIZZINESS (light-headed) had resolved and AMNESIA (little bit of memory loss) and MEMORY IMPAIRMENT (had to stop and think/, it is not like the brain would provide the information like it would normally do.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) blood pressure dropped.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included drank Gatorade. Patient didn't blacked out, and that eventually patient started to feel better.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Flatulence, Headache, Nausea, Pain
Clinical narrative: Blood clot; Pain all over; could not eat anything; She felt like she had a gas; Nauseous; headache; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant), PAIN (Pain all over), FEEDING DISORDER (could not eat anything), FLATULENCE (She felt like she had a gas), NAUSEA (Nauseous) and HEADACHE (headache). At the time of the report, THROMBOSIS (Blood clot), PAIN (Pain all over), FEEDING DISORDER (could not eat anything), FLATULENCE (She felt like she had a gas), NAUSEA (Nauseous) and HEADACHE (headache) outcome was unknown.            No concomitant medication reported. No treatment information was provided.  The expiration dates for suspect drug were not provided. Patient was taking other medication. HCP was not aware of the side effects.  Company comment: This spontaneous case concerns a 83 year old female with no medical history reported. who experienced Serious  , AESI , unexpected event of thrombosis which occurred on an unknown date after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine). Other non-serious , unexpected events of pain , feeding disorder, flatulence , nausea and expected event of headache also occurred on an unknown date after vaccination with the 3rd dose of the vaccine. The re-challenge was positive for events headache , pain since patient reported events to have recurred from the 3 doses. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-404957, MOD-2021-404948 (Patient Link).; Sender's Comments: This spontaneous case concerns a 83 year old female with no medical history reported. who experienced Serious  , AESI , unexpected event of thrombosis which occurred on an unknown date after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine). Other non-serious , unexpected events of pain , feeding disorder, flatulence , nausea and expected event of headache also occurred on an unknown date after vaccination with the 3rd dose of the vaccine. The re-challenge was positive for events headache , pain since patient reported events to have recurred from the 3 doses. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot; Pain all over; could not eat anything; She felt like she had a gas; Nauseous; headache; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant), PAIN (Pain all over), FEEDING DISORDER (could not eat anything), FLATULENCE (She felt like she had a gas), NAUSEA (Nauseous) and HEADACHE (headache). At the time of the report, THROMBOSIS (Blood clot), PAIN (Pain all over), FEEDING DISORDER (could not eat anything), FLATULENCE (She felt like she had a gas), NAUSEA (Nauseous) and HEADACHE (headache) outcome was unknown.            No concomitant medication reported. No treatment information was provided.  The expiration dates for suspect drug were not provided. Patient was taking other medication. HCP was not aware of the side effects.  Company comment: This spontaneous case concerns a 83 year old female with no medical history reported. who experienced Serious  , AESI , unexpected event of thrombosis which occurred on an unknown date after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine). Other non-serious , unexpected events of pain , feeding disorder, flatulence , nausea and expected event of headache also occurred on an unknown date after vaccination with the 3rd dose of the vaccine. The re-challenge was positive for events headache , pain since patient reported events to have recurred from the 3 doses. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-404957, MOD-2021-404948 (Patient Link).; Sender's Comments: This spontaneous case concerns a 83 year old female with no medical history reported. who experienced Serious  , AESI , unexpected event of thrombosis which occurred on an unknown date after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine). Other non-serious , unexpected events of pain , feeding disorder, flatulence , nausea and expected event of headache also occurred on an unknown date after vaccination with the 3rd dose of the vaccine. The re-challenge was positive for events headache , pain since patient reported events to have recurred from the 3 doses. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia
Clinical narrative: anemic; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (anemic) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced ANAEMIA (anemic) (seriousness criterion hospitalization). The patient was hospitalized on 05-Nov-2021 due to ANAEMIA. At the time of the report, ANAEMIA (anemic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine) (unknown route), the reporter did not provide any causality assessments.  Concomitant medication was not provided.  The patient had 2 pints of blood, all kinds of blood, blood cells, as reported. The patient was wondering if she can get the booster because patient was in the hospital.  Company comment:  This case concerns a 57-year-old female patient with no medical history provided, who experienced serious unexpected event of Anaemia which required hospitalization. The event occurred approximately 9 months after the patient had received the second dose and nearly 10 months after the first dose of the mRNA-1273 vaccine. It was stated that the patient was in hospital and had two pints of blood (all kinds of blood, blood cells, as reported). The outcome of the event was unknown at the time of the report. The re-challenge is not applicable having in mind that the outcome of the event remained unknown and it also remained unknown whether the patient will receive the third (booster) dose or not. Very limited information regarding the event was provided at this point. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 57-year-old female patient with no medical history provided, who experienced serious unexpected event of Anaemia which required hospitalization. The event occurred approximately 9 months after the patient had received the second dose and nearly 10 months after the first dose of the mRNA-1273 vaccine. It was stated that the patient was in hospital and had two pints of blood (all kinds of blood, blood cells, as reported). The outcome of the event was unknown at the time of the report. The re-challenge is not applicable having in mind that the outcome of the event remained unknown and it also remained unknown whether the patient will receive the third (booster) dose or not. Very limited information regarding the event was provided at this point. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: Transverse myelitis; This spontaneous case was reported by a consumer and describes the occurrence of MYELITIS TRANSVERSE (Transverse myelitis) 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 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced MYELITIS TRANSVERSE (Transverse myelitis) (seriousness criterion medically significant). At the time of the report, MYELITIS TRANSVERSE (Transverse myelitis) outcome was unknown.            It was reported that some test results for a chronic autoimmune disease are still being awaited but this was some kind of transverse myelitis and an autoimmune reaction as id'd by oligoclonal antibodies.  Concomitant product use was not provided by reporter. Treatment information was not provided.  Company comment: This case concerns a patient of an unknown age and gender with no medical history provided who experienced serious unexpected event of special interest Myelitis transverse. The event occurred seven days after the third dose of mRNA-1273. The rechallenge was not applicable as the event occurred following the third dose of the vaccine. Very limited information regarding clinical course of the event has been provided at this time. It was reported that unspecified test results for chronic autoimmune disease were still being awaited. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-408561 (Patient Link).; Sender's Comments: This case concerns a patient of an unknown age and gender with no medical history provided who experienced serious unexpected event of special interest Myelitis transverse. The event occurred seven days after the third dose of mRNA-1273. The rechallenge was not applicable as the event occurred following the third dose of the vaccine. Very limited information regarding clinical course of the event has been provided at this time. It was reported that unspecified test results for chronic autoimmune disease were still being awaited. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Prostate cancer metastatic
Clinical narrative: metastatic prostate cancer; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Dec-2021 and was forwarded to Moderna on 07-Dec-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PROSTATE CANCER METASTATIC (metastatic prostate cancer) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced PROSTATE CANCER METASTATIC (metastatic prostate cancer) (seriousness criterion medically significant). At the time of the report, PROSTATE CANCER METASTATIC (metastatic prostate cancer) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) Negative.         Patient was taking lot of medications (names not mentioned) including chemotherapy. It was reported that antibody test showed they were almost no existent and HCP assumed it was because of the chemotherapy. No treatment medication was provided COMPANY COMMENT: This is a regulatory case concerning a 80-year-old patient with no clinical history who experienced the unexpected event of  PROSTATE CANCER METASTATIC  The event occurred unknown days after the first dose of mRNA-1273. The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2021: Non Significant follow-up appended; Sender's Comments: COMPANY COMMENT: This is a regulatory case concerning a 80-year-old patient with no clinical history who experienced the unexpected event of PROSTATE CANCER METASTATIC  The event occurred unknown days after the first dose of mRNA-1273. The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: contracted COVID/had a head cold with a runny nose and tiredness; Lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted COVID/had a head cold with a runny nose and tiredness) and DRUG INEFFECTIVE (Lack of efficacy) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol. Concomitant products included FLECAINIDE, APIXABAN (ELIQUIS), ATENOLOL and LISINOPRIL for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced COVID-19 (contracted COVID/had a head cold with a runny nose and tiredness) and DRUG INEFFECTIVE (Lack of efficacy). The patient was treated with VITAMIN D [VITAMIN D NOS] for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (contracted COVID/had a head cold with a runny nose and tiredness) had resolved and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.            The patient contracted COVID-19 disease through the patient's grandson who contracted it in school. Patient did not experience any fever. The symptoms lasted for a week. Concomitant medication included cholesterol medication.  This spontaneous case concerns an 80-year-old female patient with no relevant medical history, who experienced non-serious unexpected event of special interest (AESI) of COVID-19. The event occurred more than four months after the second dose of properly scheduled second dose of mRNA-1723 vaccine. Symptoms of reported event included head cold with a runny nose and tiredness, which lasted for one week. The rechallenge is not applicable, as the event happened only after the second dose. The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This spontaneous case concerns an 80-year-old female patient with no relevant medical history, who experienced non-serious unexpected event of special interest (AESI) of COVID-19. The event occurred more than four months after the second dose of properly scheduled second dose of mRNA-1723 vaccine. Symptoms of reported event included head cold with a runny nose and tiredness, which lasted for one week. The rechallenge is not applicable, as the event happened only after the second dose. The benefit-risk relationship of drug is not affected by this report.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inappropriate schedule of vaccine administered, first dose administered on 17feb2021 and second dose taken on 07mar2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered, first dose administered on 17feb2021 and second dose taken on 07mar2021) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included Clot blood and Leg operation. Concurrent medical conditions included Sensitive skin, COPD, Grass allergy, and Pollen allergy.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered, first dose administered on 17feb2021 and second dose taken on 07mar2021). The patient was treated with TYLENOL at an unspecified dose and frequency. On 07-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered, first dose administered on 17feb2021 and second dose taken on 07mar2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by the reporter.   This case was linked to MOD-2021-409850 (Patient Link).   Most recent FOLLOW-UP information incorporated above included on 13-Dec-2021 the Follow-up document contains no new information.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore arm / Just being sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm / Just being sore) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Concomitant products included HYDROCORTISONE for Fibromyalgia.    On 10-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced MYALGIA (sore arm / Just being sore). At the time of the report, MYALGIA (sore arm / Just being sore) had not resolved.        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 treatment information was provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Could not lift my left arm over my head.; sore left arm./Arm pain from booster dose was far worse than pain from flu and pneumonia vaccines; felt wiped out after her booster dose./went home to go to bed.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift my left arm over my head.), VACCINATION SITE PAIN (sore left arm./Arm pain from booster dose was far worse than pain from flu and pneumonia vaccines) and FATIGUE (felt wiped out after her booster dose./went home to go to bed.) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 017B21A and 037B21A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM EXTRA STRENGTH) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift my left arm over my head.), VACCINATION SITE PAIN (sore left arm./Arm pain from booster dose was far worse than pain from flu and pneumonia vaccines) and FATIGUE (felt wiped out after her booster dose./went home to go to bed.). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift my left arm over my head.), VACCINATION SITE PAIN (sore left arm./Arm pain from booster dose was far worse than pain from flu and pneumonia vaccines) and FATIGUE (felt wiped out after her booster dose./went home to go to bed.) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. It was reported that arm pain from booster dose was far worse than pain from flu and pneumonia vaccines.   This case was linked to MOD-2021-409876, MOD-2021-409868 (Patient Link).
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: one of the patients who received the booster shot was under the age of 18 years; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (one of the patients who received the booster shot was under the age of 18 years) in a 16-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.  Previously administered products included for COVID-19 vaccination: Pfizer vaccine (First and second dose). Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On 12-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (one of the patients who received the booster shot was under the age of 18 years). On 12-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (one of the patients who received the booster shot was under the age of 18 years) had 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 reporter was unable to provide the dates for first 2 doses.  The patient did not receive any corrective treatment.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore left arm). At the time of the report, PAIN IN EXTREMITY (sore left arm) outcome was unknown.            Patient is immunocompromised with no  known drug or food allergies.  No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2021-409869 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Mobility decreased
Clinical narrative: unable to move; extreme fatigue; body feels heavy; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (unable to move), FATIGUE (extreme fatigue) and DISCOMFORT (body feels heavy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced MOBILITY DECREASED (unable to move), FATIGUE (extreme fatigue) and DISCOMFORT (body feels heavy). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (unable to move), FATIGUE (extreme fatigue) and DISCOMFORT (body feels heavy) outcome was unknown.            Concomitant medications include Memory pill
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination complication, Vaccination site pain
Clinical narrative: She had a severe reaction; all her joints are aching like a bad case of arthritis; Her arm where the shot was given is so very sore and achy. It is more than just a typical ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She had a severe reaction), ARTHRALGIA (all her joints are aching like a bad case of arthritis) and VACCINATION SITE PAIN (Her arm where the shot was given is so very sore and achy. It is more than just a typical ache) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A and 065E21A (026A21A)) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (She had a severe reaction), ARTHRALGIA (all her joints are aching like a bad case of arthritis) and VACCINATION SITE PAIN (Her arm where the shot was given is so very sore and achy. It is more than just a typical ache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (She had a severe reaction), ARTHRALGIA (all her joints are aching like a bad case of arthritis) and VACCINATION SITE PAIN (Her arm where the shot was given is so very sore and achy. It is more than just a typical ache) outcome was unknown.            Patient was concerned because by now she shouldn't be feeling anything.  Reporter stated that patient has concomitant medications, but her daughter (primary reporter) did not have the list.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Headache, Myalgia, Pyrexia
Clinical narrative: it says it expired October 13,2021. But we administered it without knowing to our patients; fever; body aches; headaches; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (it says it expired October 13,2021. But we administered it without knowing to our patients), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headaches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (it says it expired October 13,2021. But we administered it without knowing to our patients), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headaches). At the time of the report, EXPIRED PRODUCT ADMINISTERED (it says it expired October 13,2021. But we administered it without knowing to our patients) had resolved and PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications details were reported.  The health care professional reported that, they had a stock of lot number and when they checked it was expired. The vials were Manufacturer on 23-Jun-2021 and expired on 13-Oct-2021 and they were still continuing to use those vials.   The number of doses per vials were 200-250 patients per doses. The vials stayed in the freezer since they were received on 08-Sep-2021 and they take the vials out of the freezer and move them to the fridge each day of administration. These vaccines were administered between 14-Oct-2021 to 08-Dec-2021 and they did not undergo the temperature excursion. Further health care profession reports, the patient had called in with fever, body aches, headaches and normal side effects.   Most recent FOLLOW-UP information incorporated above includes: On 13-Dec-2021: Follow-up information received includes new events added, reporter details and vaccine details were updated. On 13-Dec-2021: Follow-up information includes no new information.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Little welts on the body/They are on the back of the leg, are all on the back/There are 10 welts on the back, 8 on one leg, 3 on the ankles, they are multiplying; itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Little welts on the body/They are on the back of the leg, are all on the back/There are 10 welts on the back, 8 on one leg, 3 on the ankles, they are multiplying) and PRURITUS (itchy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03142A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included VITAMIN D [VITAMIN D NOS], VITAMIN B12 [VITAMIN B12 NOS], MACROGOL 3350 (MIRALAX) and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Little welts on the body/They are on the back of the leg, are all on the back/There are 10 welts on the back, 8 on one leg, 3 on the ankles, they are multiplying) and PRURITUS (itchy). At the time of the report, URTICARIA (Little welts on the body/They are on the back of the leg, are all on the back/There are 10 welts on the back, 8 on one leg, 3 on the ankles, they are multiplying) had not resolved and PRURITUS (itchy) outcome was unknown.            No treatment information was provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: achy; sweaty; tired; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), HYPERHIDROSIS (sweaty), FATIGUE (tired), PYREXIA (fever) and HEADACHE (headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     The patient's past medical history included Pertussis in 2007 and Pertussis (bronchioles was effected) in 2012. Previously administered products included for Product used for unknown indication: Pfizer on 01-Mar-2021 and Pfizer on 21-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Cough.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (achy), HYPERHIDROSIS (sweaty), FATIGUE (tired), PYREXIA (fever) and HEADACHE (headache). At the time of the report, PAIN (achy), HYPERHIDROSIS (sweaty), FATIGUE (tired), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.            No concomitant medications provided. No treatment medications provided.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Vaccination complication
Clinical narrative: Unsure if she got the full dose or half dose/Unsure if she got 3rd dose or booster dose; Reaction/Severe reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION and INCORRECT DOSE ADMINISTERED (Unsure if she got the full dose or half dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 006B21A, and 008B21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT DOSE ADMINISTERED (Unsure if she got the full dose or half dose). In December 2021, the patient experienced VACCINATION COMPLICATION. On 10-Dec-2021, INCORRECT DOSE ADMINISTERED (Unsure if she got the full dose or half dose) had resolved. At the time of the report, VACCINATION COMPLICATION outcome was unknown.            Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site pain
Clinical narrative: 24 hours later the patient felt "yucky"; Sore left arm for 3 days after the first Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (24 hours later the patient felt "yucky") and VACCINATION SITE PAIN (Sore left arm for 3 days after the first Moderna Covid-19 vaccine) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Bronchitis. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]), FINASTERIDE, ROSUVASTATIN CALCIUM (CRESTOR), NIFEDIPINE, RABEPRAZOLE SODIUM (ACIPHEX), HYOSCYAMINE SULFATE (LEVSINEX) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore left arm for 3 days after the first Moderna Covid-19 vaccine). On 12-Jan-2021, the patient experienced FEELING ABNORMAL (24 hours later the patient felt "yucky"). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 13-Jan-2021, VACCINATION SITE PAIN (Sore left arm for 3 days after the first Moderna Covid-19 vaccine) had resolved. At the time of the report, FEELING ABNORMAL (24 hours later the patient felt "yucky") outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient received the second dose on 08-Feb-2021 and third full dose on 13-Oct-2021.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Diarrhoea, Fatigue, Headache, Limb discomfort
Clinical narrative: continued to get worse; her arm was very heavy; pinpoint pain traveling down her elbow and around down to her middle finger; throbbing, continued to get worse; diarrhea; raised a bit, red, and started itching; raised, spreading where injection site was,bigger than size of a baseball,raised a bit; raised a bit, red, and started itching; body aches; fatigue, tired, just wants to sleep; headache; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (continued to get worse), LIMB DISCOMFORT (her arm was very heavy), PAIN IN EXTREMITY (pinpoint pain traveling down her elbow and around down to her middle finger), PAIN (throbbing, continued to get worse) and DIARRHOEA (diarrhea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 003A21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol and Insomnia. Concomitant products included SIMVASTATIN for Cholesterol, ALPRAZOLAM and TRAZODONE for Insomnia, NORTRIPTYLINE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, the patient experienced CONDITION AGGRAVATED (continued to get worse), LIMB DISCOMFORT (her arm was very heavy), PAIN IN EXTREMITY (pinpoint pain traveling down her elbow and around down to her middle finger), PAIN (throbbing, continued to get worse), DIARRHOEA (diarrhea), VACCINATION SITE PRURITUS (raised a bit, red, and started itching), VACCINATION SITE SWELLING (raised, spreading where injection site was,bigger than size of a baseball,raised a bit), VACCINATION SITE ERYTHEMA (raised a bit, red, and started itching), MYALGIA (body aches), FATIGUE (fatigue, tired, just wants to sleep) and HEADACHE (headache). The patient was treated with BETAMETHASONE for Adverse event, at a dose of topical cream 0.1%. At the time of the report, CONDITION AGGRAVATED (continued to get worse), LIMB DISCOMFORT (her arm was very heavy), PAIN IN EXTREMITY (pinpoint pain traveling down her elbow and around down to her middle finger), PAIN (throbbing, continued to get worse), DIARRHOEA (diarrhea), VACCINATION SITE PRURITUS (raised a bit, red, and started itching), VACCINATION SITE SWELLING (raised, spreading where injection site was,bigger than size of a baseball,raised a bit), VACCINATION SITE ERYTHEMA (raised a bit, red, and started itching), MYALGIA (body aches), FATIGUE (fatigue, tired, just wants to sleep) and HEADACHE (headache) outcome was unknown.            It was reported that patient was on BRAT diet.   This case was linked to MOD-2021-033090, MOD-2021-410512 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: continued to get worse; her arm was very heavy; pinpoint pain traveling down her elbow and around down to her middle finger; throbbing, continued to get worse; diarrhea; raised a bit, red, and started itching; raised, spreading where injection site was,bigger than size of a baseball,raised a bit; raised a bit, red, and started itching; body aches; fatigue, tired, just wants to sleep; headache; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (continued to get worse), LIMB DISCOMFORT (her arm was very heavy), PAIN IN EXTREMITY (pinpoint pain traveling down her elbow and around down to her middle finger), PAIN (throbbing, continued to get worse) and DIARRHOEA (diarrhea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 003A21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol and Insomnia. Concomitant products included SIMVASTATIN for Cholesterol, ALPRAZOLAM and TRAZODONE for Insomnia, NORTRIPTYLINE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, the patient experienced CONDITION AGGRAVATED (continued to get worse), LIMB DISCOMFORT (her arm was very heavy), PAIN IN EXTREMITY (pinpoint pain traveling down her elbow and around down to her middle finger), PAIN (throbbing, continued to get worse), DIARRHOEA (diarrhea), VACCINATION SITE PRURITUS (raised a bit, red, and started itching), VACCINATION SITE SWELLING (raised, spreading where injection site was,bigger than size of a baseball,raised a bit), VACCINATION SITE ERYTHEMA (raised a bit, red, and started itching), MYALGIA (body aches), FATIGUE (fatigue, tired, just wants to sleep) and HEADACHE (headache). The patient was treated with BETAMETHASONE for Adverse event, at a dose of topical cream 0.1%. At the time of the report, CONDITION AGGRAVATED (continued to get worse), LIMB DISCOMFORT (her arm was very heavy), PAIN IN EXTREMITY (pinpoint pain traveling down her elbow and around down to her middle finger), PAIN (throbbing, continued to get worse), DIARRHOEA (diarrhea), VACCINATION SITE PRURITUS (raised a bit, red, and started itching), VACCINATION SITE SWELLING (raised, spreading where injection site was,bigger than size of a baseball,raised a bit), VACCINATION SITE ERYTHEMA (raised a bit, red, and started itching), MYALGIA (body aches), FATIGUE (fatigue, tired, just wants to sleep) and HEADACHE (headache) outcome was unknown.            It was reported that patient was on BRAT diet.   This case was linked to MOD-2021-033090, MOD-2021-410512 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: continued to get worse; her arm was very heavy; pinpoint pain traveling down her elbow and around down to her middle finger; throbbing, continued to get worse; diarrhea; raised a bit, red, and started itching; raised, spreading where injection site was,bigger than size of a baseball,raised a bit; raised a bit, red, and started itching; body aches; fatigue, tired, just wants to sleep; headache; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (continued to get worse), LIMB DISCOMFORT (her arm was very heavy), PAIN IN EXTREMITY (pinpoint pain traveling down her elbow and around down to her middle finger), PAIN (throbbing, continued to get worse) and DIARRHOEA (diarrhea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 003A21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol and Insomnia. Concomitant products included SIMVASTATIN for Cholesterol, ALPRAZOLAM and TRAZODONE for Insomnia, NORTRIPTYLINE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, the patient experienced CONDITION AGGRAVATED (continued to get worse), LIMB DISCOMFORT (her arm was very heavy), PAIN IN EXTREMITY (pinpoint pain traveling down her elbow and around down to her middle finger), PAIN (throbbing, continued to get worse), DIARRHOEA (diarrhea), VACCINATION SITE PRURITUS (raised a bit, red, and started itching), VACCINATION SITE SWELLING (raised, spreading where injection site was,bigger than size of a baseball,raised a bit), VACCINATION SITE ERYTHEMA (raised a bit, red, and started itching), MYALGIA (body aches), FATIGUE (fatigue, tired, just wants to sleep) and HEADACHE (headache). The patient was treated with BETAMETHASONE for Adverse event, at a dose of topical cream 0.1%. At the time of the report, CONDITION AGGRAVATED (continued to get worse), LIMB DISCOMFORT (her arm was very heavy), PAIN IN EXTREMITY (pinpoint pain traveling down her elbow and around down to her middle finger), PAIN (throbbing, continued to get worse), DIARRHOEA (diarrhea), VACCINATION SITE PRURITUS (raised a bit, red, and started itching), VACCINATION SITE SWELLING (raised, spreading where injection site was,bigger than size of a baseball,raised a bit), VACCINATION SITE ERYTHEMA (raised a bit, red, and started itching), MYALGIA (body aches), FATIGUE (fatigue, tired, just wants to sleep) and HEADACHE (headache) outcome was unknown.            It was reported that patient was on BRAT diet.   This case was linked to MOD-2021-033090, MOD-2021-410512 (Patient Link).