chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, SARS-CoV-2 test, Taste disorder, Weight decreased
Clinical narrative: Does not like the taste of food after 2nd shot; Does not have desire to eat after 2nd shot, does not have any Appetite after 2nd shot; Loosing weight (-59lbs) after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Does not like the taste of food after 2nd shot), DECREASED APPETITE (Does not have desire to eat after 2nd shot, does not have any Appetite after 2nd shot) and WEIGHT DECREASED (Loosing weight (-59lbs) after 2nd dose) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 006C21A) for COVID-19 vaccination.     The patient's past medical history included Hypoxia, Fibromyalgia, Arthritis, Lumbar pain, Back pain, Scoliosis and Carpal tunnel syndrome. Concurrent medical conditions included Acute respiratory failure, Aortic aneurysm, Spinal stenosis, Barrett's oesophagus, BPH, Cardiomyopathy, COPD, Coronary artery disease, Coronary atherosclerosis, Epilepsy, GERD, Hyperlipidemia, Hypertension, Obesity, Myocardial infarction, Migraine, Neuropathy NOS, Restless leg syndrome, Neurofibromatosis and Sleep apnea. Concomitant products included LEVETIRACETAM, POTASSIUM CHLORIDE, GABAPENTIN, FUROSEMIDE, VALPROATE SEMISODIUM (DIVALPROEX), CARVEDILOL, TAMSULOSIN, PANTOPRAZOLE, BACLOFEN, AMITRIPTYLINE, CLOPIDOGREL, CITALOPRAM, ATORVASTATIN, AMLODIPINE, DICLOFENAC and PRAMIPEXOLE for an unknown indication.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced TASTE DISORDER (Does not like the taste of food after 2nd shot), DECREASED APPETITE (Does not have desire to eat after 2nd shot, does not have any Appetite after 2nd shot) and WEIGHT DECREASED (Loosing weight (-59lbs) after 2nd dose). On 17-Oct-2021, WEIGHT DECREASED (Loosing weight (-59lbs) after 2nd dose) had resolved. At the time of the report, TASTE DISORDER (Does not like the taste of food after 2nd shot) and DECREASED APPETITE (Does not have desire to eat after 2nd shot, does not have any Appetite after 2nd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test.         No Treatment Information were provided by the reporter  Reporter stated that after the second shot, patient does not have any Appetite, patient is loosing weight (He is 5'7" and was 316lbs prior to Vaccination). patient  weighs 257 Lbs. now 17OCT2021.patient  states that he can taste the food, but  does not like the taste any more and has no desire to eat  and he is late for the church and can not hang on too long.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Arm was sore,Body Aches; Arm was sore,Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm was sore,Body Aches) and VACCINATION SITE PAIN (Arm was sore,Body Aches) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02FB21A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced MYALGIA (Arm was sore,Body Aches) and VACCINATION SITE PAIN (Arm was sore,Body Aches). On 10-Apr-2021, MYALGIA (Arm was sore,Body Aches) and VACCINATION SITE PAIN (Arm was sore,Body Aches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication listed.   No treatment information provided.   This case was linked to MOD-2021-355605 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient got a dose from and expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got a dose from and expired vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got a dose from and expired vial). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient got a dose from and expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Groin pain, Hypokinesia, Inappropriate schedule of product administration, Neck pain
Clinical narrative: Cannot lift her arms above her shoulders/can't do anything; Pain in her neck; Pain in her groin; Can't walk because the pain in her legs is horrible/pain went down to the right calf/pain went to the hip/pain in arms; Excruciating pain; Pain in shoulders; >35 days of vaccine admistration 1st dose 02-Mar-2021,2nd dose 14-May-2021; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Cannot lift her arms above her shoulders/can't do anything), NECK PAIN (Pain in her neck), GROIN PAIN (Pain in her groin), PAIN IN EXTREMITY (Can't walk because the pain in her legs is horrible/pain went down to the right calf/pain went to the hip/pain in arms) and PAIN (Excruciating pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days of vaccine admistration 1st dose 02-Mar-2021,2nd dose 14-May-2021). In July 2021, the patient experienced HYPOKINESIA (Cannot lift her arms above her shoulders/can't do anything), NECK PAIN (Pain in her neck), GROIN PAIN (Pain in her groin), PAIN IN EXTREMITY (Can't walk because the pain in her legs is horrible/pain went down to the right calf/pain went to the hip/pain in arms), PAIN (Excruciating pain) and ARTHRALGIA (Pain in shoulders). The patient was treated with OXYCODONE for Pain, at an unspecified dose and frequency and CANNABIDIOL (CBD OIL) for Pain, at an unspecified dose and frequency. On 14-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days of vaccine admistration 1st dose 02-Mar-2021,2nd dose 14-May-2021) had resolved. At the time of the report, HYPOKINESIA (Cannot lift her arms above her shoulders/can't do anything), NECK PAIN (Pain in her neck), GROIN PAIN (Pain in her groin), PAIN (Excruciating pain) and ARTHRALGIA (Pain in shoulders) had not resolved and PAIN IN EXTREMITY (Can't walk because the pain in her legs is horrible/pain went down to the right calf/pain went to the hip/pain in arms) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. It was reported that patient went to a cardiovascular doctor and had 3 MRIs done and they had not found anything. CBD oil does not help the pain,the only time it gets better is at 5 pm and if she keeps walking, and that only helps her legs.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Cannot lift her arms above her shoulders/can't do anything; Pain in her neck; Pain in her groin; Can't walk because the pain in her legs is horrible/pain went down to the right calf/pain went to the hip/pain in arms; Excruciating pain; Pain in shoulders; >35 days of vaccine admistration 1st dose 02-Mar-2021,2nd dose 14-May-2021; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Cannot lift her arms above her shoulders/can't do anything), NECK PAIN (Pain in her neck), GROIN PAIN (Pain in her groin), PAIN IN EXTREMITY (Can't walk because the pain in her legs is horrible/pain went down to the right calf/pain went to the hip/pain in arms) and PAIN (Excruciating pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days of vaccine admistration 1st dose 02-Mar-2021,2nd dose 14-May-2021). In July 2021, the patient experienced HYPOKINESIA (Cannot lift her arms above her shoulders/can't do anything), NECK PAIN (Pain in her neck), GROIN PAIN (Pain in her groin), PAIN IN EXTREMITY (Can't walk because the pain in her legs is horrible/pain went down to the right calf/pain went to the hip/pain in arms), PAIN (Excruciating pain) and ARTHRALGIA (Pain in shoulders). The patient was treated with OXYCODONE for Pain, at an unspecified dose and frequency and CANNABIDIOL (CBD OIL) for Pain, at an unspecified dose and frequency. On 14-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days of vaccine admistration 1st dose 02-Mar-2021,2nd dose 14-May-2021) had resolved. At the time of the report, HYPOKINESIA (Cannot lift her arms above her shoulders/can't do anything), NECK PAIN (Pain in her neck), GROIN PAIN (Pain in her groin), PAIN (Excruciating pain) and ARTHRALGIA (Pain in shoulders) had not resolved and PAIN IN EXTREMITY (Can't walk because the pain in her legs is horrible/pain went down to the right calf/pain went to the hip/pain in arms) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. It was reported that patient went to a cardiovascular doctor and had 3 MRIs done and they had not found anything. CBD oil does not help the pain,the only time it gets better is at 5 pm and if she keeps walking, and that only helps her legs.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site pain
Clinical narrative: not pain but,felt different; the right arm was sore/still sore after 4 month/right arm still hurts/still sore; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not pain but,felt different) and VACCINATION SITE PAIN (the right arm was sore/still sore after 4 month/right arm still hurts/still sore) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 035C21A) for COVID-19 vaccination.      Medical history was not provided.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-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 FEELING ABNORMAL (not pain but,felt different) and VACCINATION SITE PAIN (the right arm was sore/still sore after 4 month/right arm still hurts/still sore). At the time of the report, FEELING ABNORMAL (not pain but,felt different) outcome was unknown and VACCINATION SITE PAIN (the right arm was sore/still sore after 4 month/right arm still hurts/still sore) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.   This case was linked to MOD-2021-355773 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Vaccine leaked out while being administered; Vaccine leaked out while being administered (the needle must not have been screwed tightly to the syringe); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Vaccine leaked out while being administered) and DEVICE CONNECTION ISSUE (Vaccine leaked out while being administered (the needle must not have been screwed tightly to the syringe)) 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 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced UNDERDOSE (Vaccine leaked out while being administered) and DEVICE CONNECTION ISSUE (Vaccine leaked out while being administered (the needle must not have been screwed tightly to the syringe)). On 18-Oct-2021, UNDERDOSE (Vaccine leaked out while being administered) and DEVICE CONNECTION ISSUE (Vaccine leaked out while being administered (the needle must not have been screwed tightly to the syringe)) 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.  No treatment information was provided by the reporter.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Accidentally gave a 0.5ml booster shot to NON-immunocompromised patient; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Accidentally gave a 0.5ml booster shot to NON-immunocompromised patient) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076c21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GLIPIZIDE for an unknown indication.    On 15-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 15-Oct-2021, the patient experienced EXTRA DOSE ADMINISTERED (Accidentally gave a 0.5ml booster shot to NON-immunocompromised patient). On 15-Oct-2021, EXTRA DOSE ADMINISTERED (Accidentally gave a 0.5ml booster shot to NON-immunocompromised patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Added Patient initials, Age, gender ,Suspect product details, Concomitant Glipizide.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chills, Fatigue, Myalgia
Clinical narrative: Rash was big/ It started small and gradually became bigger/she noticed a lump or a red rash next to the site of injection; Lump or red rash next to the site of injection/the rash was big/rash still there; Redness at the injection site/ It started small and gradually became bigger/growing anymore and getting better; Weakness; Back pain; Chills; Fatigue; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), BACK PAIN (Back pain), VACCINATION SITE MASS (Rash was big/ It started small and gradually became bigger/she noticed a lump or a red rash next to the site of injection), CHILLS (Chills) and FATIGUE (Fatigue) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced ASTHENIA (Weakness), BACK PAIN (Back pain), FATIGUE (Fatigue) and MYALGIA (Body aches). 15-Oct-2021, the patient experienced CHILLS (Chills). On 16-Oct-2021, the patient experienced VACCINATION SITE MASS (Rash was big/ It started small and gradually became bigger/she noticed a lump or a red rash next to the site of injection). 16-Oct-2021, the patient experienced VACCINATION SITE RASH (Lump or red rash next to the site of injection/the rash was big/rash still there) and VACCINATION SITE ERYTHEMA (Redness at the injection site/ It started small and gradually became bigger/growing anymore and getting better). On 15-Oct-2021, ASTHENIA (Weakness), BACK PAIN (Back pain), CHILLS (Chills), FATIGUE (Fatigue) and MYALGIA (Body aches) had resolved. At the time of the report, VACCINATION SITE MASS (Rash was big/ It started small and gradually became bigger/she noticed a lump or a red rash next to the site of injection), VACCINATION SITE RASH (Lump or red rash next to the site of injection/the rash was big/rash still there) and VACCINATION SITE ERYTHEMA (Redness at the injection site/ It started small and gradually became bigger/growing anymore and getting better) was resolving.            No concomitant and treatment information provided.   This case was linked to MOD-2021-355758.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site rash
Clinical narrative: Rash was big/ It started small and gradually became bigger/she noticed a lump or a red rash next to the site of injection; Lump or red rash next to the site of injection/the rash was big/rash still there; Redness at the injection site/ It started small and gradually became bigger/growing anymore and getting better; Weakness; Back pain; Chills; Fatigue; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), BACK PAIN (Back pain), VACCINATION SITE MASS (Rash was big/ It started small and gradually became bigger/she noticed a lump or a red rash next to the site of injection), CHILLS (Chills) and FATIGUE (Fatigue) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced ASTHENIA (Weakness), BACK PAIN (Back pain), FATIGUE (Fatigue) and MYALGIA (Body aches). 15-Oct-2021, the patient experienced CHILLS (Chills). On 16-Oct-2021, the patient experienced VACCINATION SITE MASS (Rash was big/ It started small and gradually became bigger/she noticed a lump or a red rash next to the site of injection). 16-Oct-2021, the patient experienced VACCINATION SITE RASH (Lump or red rash next to the site of injection/the rash was big/rash still there) and VACCINATION SITE ERYTHEMA (Redness at the injection site/ It started small and gradually became bigger/growing anymore and getting better). On 15-Oct-2021, ASTHENIA (Weakness), BACK PAIN (Back pain), CHILLS (Chills), FATIGUE (Fatigue) and MYALGIA (Body aches) had resolved. At the time of the report, VACCINATION SITE MASS (Rash was big/ It started small and gradually became bigger/she noticed a lump or a red rash next to the site of injection), VACCINATION SITE RASH (Lump or red rash next to the site of injection/the rash was big/rash still there) and VACCINATION SITE ERYTHEMA (Redness at the injection site/ It started small and gradually became bigger/growing anymore and getting better) was resolving.            No concomitant and treatment information provided.   This case was linked to MOD-2021-355758.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Sep-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 16-Sep-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported by reporter No treatment medications provided by the reporter  Patient stated that sore arm lasted little over a day   This case was linked to MOD-2021-355719 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose left out at room temperature for more than 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Dose left out at room temperature for more than 24 hours) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Dose left out at room temperature for more than 24 hours). On 18-Oct-2021, PRODUCT STORAGE ERROR (Dose left out at room temperature for more than 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The pharmacist had a vial of Moderna COVID19 Vaccine that was open on 17-Oct-2021 around noon.They administered 2 doses of that vial on 18-Oct-2021 around 11:30 EST. No concomitant medications were reported. No treatment medications were reported.  .
Sex: U
Vaccine: COVID19
Symptoms: Presyncope, Tremor
Clinical narrative: Uncontrollable shaking; Almost passed out after second dose; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Uncontrollable shaking) and PRESYNCOPE (Almost passed out after 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Uncontrollable shaking) and PRESYNCOPE (Almost passed out after second dose). At the time of the report, TREMOR (Uncontrollable shaking) and PRESYNCOPE (Almost passed out after second dose) outcome was unknown. Not Provided          Reporter has reported that the patient almost passed out after second dose and visited E. R. in May 2021. No concomitant medication was given by reporter. No treatment medication was given by reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Bad diarrhea the day of the vaccination.; Fever of 101.2 degrees Farenheight.; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Bad diarrhea the day of the vaccination.) and PYREXIA (Fever of 101.2 degrees Farenheight.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced DIARRHOEA (Bad diarrhea the day of the vaccination.) and PYREXIA (Fever of 101.2 degrees Farenheight.). On 28-Feb-2021, DIARRHOEA (Bad diarrhea the day of the vaccination.) had resolved. At the time of the report, PYREXIA (Fever of 101.2 degrees Farenheight.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment informations were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Vaginal discharge, Vaginal haemorrhage
Clinical narrative: bleeding every day and losing a lot of blood; had some discharge/the discharge was first light and then got darker; got sick the next day; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (bleeding every day and losing a lot of blood), VAGINAL DISCHARGE (had some discharge/the discharge was first light and then got darker) and ILLNESS (got sick the next day) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Menopausal.   On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (got sick the next day). On an unknown date, the patient experienced VAGINAL HAEMORRHAGE (bleeding every day and losing a lot of blood) and VAGINAL DISCHARGE (had some discharge/the discharge was first light and then got darker). At the time of the report, VAGINAL HAEMORRHAGE (bleeding every day and losing a lot of blood) and VAGINAL DISCHARGE (had some discharge/the discharge was first light and then got darker) had not resolved and ILLNESS (got sick the next day) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported.
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Myalgia
Clinical narrative: two doses of Pfizer and the received two doses of Moderna.; body ache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache), FATIGUE (fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two doses of Pfizer and the received two doses of Moderna.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer from 24-Jan-2021 to 13-Feb-2021. Past adverse reactions to the above products included Vaccination site tenderness with Pfizer. Concurrent medical conditions included Immunosuppression NOS. Concomitant products included METFORMIN, GABAPENTIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), LISINOPRIL, TRAZODONE, ACETYLSALICYLIC ACID (BABY ASPIRIN), ESCITALOPRAM OXALATE (LEXAPRO), ATORVASTATIN and CERTOLIZUMAB PEGOL (CIMZIA) for an unknown indication.    On 13-Aug-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 MYALGIA (body ache), FATIGUE (fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two doses of Pfizer and the received two doses of Moderna.). At the time of the report, MYALGIA (body ache), FATIGUE (fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two doses of Pfizer and the received two doses of Moderna.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment was received.   This case was linked to MOD-2021-355797 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site coldness
Clinical narrative: Second vaccine felt cold when it was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE COLDNESS (Second vaccine felt cold when it was given) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Sepsis and Heart attack.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE COLDNESS (Second vaccine felt cold when it was given). On 10-Feb-2021, VACCINATION SITE COLDNESS (Second vaccine felt cold when it was given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-355785 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: vaginal bleeding; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (vaginal bleeding) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VAGINAL HAEMORRHAGE (vaginal bleeding). At the time of the report, VAGINAL HAEMORRHAGE (vaginal bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter Treatment information was not provided
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Palpitations, Visual impairment
Clinical narrative: Heart palpitations that varied after 2nd dose/It was every other heartbeat/Lasted for an hour; Extreme vision changes/Had a spot in the center of the vision/Continued to grow/Kept getting bigger/Circle looked like a "kaleidoscope" and was moving/Circle continued to get bigger/Went outside of her vision/Vision felt a little off after that; Developed headache; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations that varied after 2nd dose/It was every other heartbeat/Lasted for an hour), VISUAL IMPAIRMENT (Extreme vision changes/Had a spot in the center of the vision/Continued to grow/Kept getting bigger/Circle looked like a "kaleidoscope" and was moving/Circle continued to get bigger/Went outside of her vision/Vision felt a little off after that) and HEADACHE (Developed headache) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A and 026D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-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 PALPITATIONS (Heart palpitations that varied after 2nd dose/It was every other heartbeat/Lasted for an hour), VISUAL IMPAIRMENT (Extreme vision changes/Had a spot in the center of the vision/Continued to grow/Kept getting bigger/Circle looked like a "kaleidoscope" and was moving/Circle continued to get bigger/Went outside of her vision/Vision felt a little off after that) and HEADACHE (Developed headache). At the time of the report, PALPITATIONS (Heart palpitations that varied after 2nd dose/It was every other heartbeat/Lasted for an hour), VISUAL IMPAIRMENT (Extreme vision changes/Had a spot in the center of the vision/Continued to grow/Kept getting bigger/Circle looked like a "kaleidoscope" and was moving/Circle continued to get bigger/Went outside of her vision/Vision felt a little off after that) and HEADACHE (Developed headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication listed.   No treatment information provided.   This case was linked to MOD-2021-355883 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Myalgia, Palpitations, Pyrexia, Vaccination site pain
Clinical narrative: Very agitated; Body ache; Arm pain; Fever; Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), AGITATION (Very agitated), MYALGIA (Body ache), VACCINATION SITE PAIN (Arm pain) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     Concurrent medical conditions included Dizziness. Concomitant products included MECLIZINE [MECLOZINE] for Dizziness.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced PALPITATIONS (Palpitations), MYALGIA (Body ache), VACCINATION SITE PAIN (Arm pain) and PYREXIA (Fever). On an unknown date, the patient experienced AGITATION (Very agitated). On 19-Sep-2021, MYALGIA (Body ache), VACCINATION SITE PAIN (Arm pain) and PYREXIA (Fever) had resolved. At the time of the report, PALPITATIONS (Palpitations) and AGITATION (Very agitated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include Meclizine for Dizziness.   This case was linked to MOD-2021-355813 (Patient Link).
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Faeces discoloured
Clinical narrative: black stool; diarrhea that is watery and charcoal colored/diarrhea very frequent; not eating; This spontaneous case was reported by a consumer and describes the occurrence of FAECES DISCOLOURED (black stool), DIARRHOEA (diarrhea that is watery and charcoal colored/diarrhea very frequent) and DECREASED APPETITE (not eating) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A and 939902) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included HYDROCHLOROTHIAZIDE and PRAVASTATIN for an unknown indication.   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced FAECES DISCOLOURED (black stool), DIARRHOEA (diarrhea that is watery and charcoal colored/diarrhea very frequent) and DECREASED APPETITE (not eating). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FAECES DISCOLOURED (black stool), DIARRHOEA (diarrhea that is watery and charcoal colored/diarrhea very frequent) and DECREASED APPETITE (not eating) had not resolved.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Allergic respiratory symptom
Clinical narrative: Experiencing some allergies symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGIC RESPIRATORY SYMPTOM (Experiencing some allergies symptoms) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-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 ALLERGIC RESPIRATORY SYMPTOM (Experiencing some allergies symptoms). The patient was treated with FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D) at an unspecified dose and frequency. At the time of the report, ALLERGIC RESPIRATORY SYMPTOM (Experiencing some allergies symptoms) outcome was unknown.            No concomitant product use was provided by the reporter.  The patient stated that don't feel very bad, but want to know if this could be season allergies.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Palpitations, Pyrexia, Tachycardia
Clinical narrative: She continues with those palpitations; She feels like she has tachycardia; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (She continues with those palpitations), TACHYCARDIA (She feels like she has tachycardia), CHILLS (Chills) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076c21a and 053E21A) for COVID-19 vaccination.     No medical history were provided by the reporter.  Concomitant products included MECLIZINE [MECLOZINE] for Dizziness.   On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced TACHYCARDIA (She feels like she has tachycardia), CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced PALPITATIONS (She continues with those palpitations). At the time of the report, PALPITATIONS (She continues with those palpitations), TACHYCARDIA (She feels like she has tachycardia), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            This is a spontaneous case concerning a 65-year-old female patient with no relevant medical history reported, who experienced non-serious unexpected events of Palpitations, Tachycardia, Chills and Pyrexia. The events occurred on an unknown date after the second dose of mRNA-1273. The rechallenge for event Palpitations was not applicable as the outcome after dose 1 is unknown. The rechallenge for event Tachycardia and Chills was not applicable as these events occurred only after second dose and no additional dosing is expected. The rechallenge for event Pyrexia was positive as the adverse event resolved prior to second dose and reoccur. The benefit-risk relationship of mRNA-1273 is not affected by this report. No treatment medications provided. She felt like she had tachycardia.   This case was linked to MOD-2021-355796 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 65-year-old female patient with no relevant medical history reported, who experienced non-serious unexpected events of Palpitations, Tachycardia, Chills and Pyrexia. The events occurred on an unknown date after the second dose of mRNA-1273. The rechallenge for event Palpitations was not applicable as the outcome after dose 1 is unknown. The rechallenge for event Tachycardia and Chills was not applicable as these events occurred only after second dose and no additional dosing is expected. The rechallenge for event Pyrexia was positive as the adverse event resolved prior to second dose and reoccur. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Received 3rd shot instead of booster; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Received 3rd shot instead of booster) 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 OFF LABEL USE (Received 3rd shot instead of booster). At the time of the report, OFF LABEL USE (Received 3rd shot instead of booster) had resolved.            No concomitant medication were reported. No treatment information was provided by the reporter.  The patient was not immunocompromised and received third full dose.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Very positive and unusual response to the third dose of the Moderna COVID19 vaccine/Unusual excellent eye site/ Vision had significantly improved compared to previous visitations; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Very positive and unusual response to the third dose of the Moderna COVID19 vaccine/Unusual excellent eye site/ Vision had significantly improved compared to previous visitations) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 048A21A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included Wet macular degeneration. Concurrent medical conditions included Immunocompromised and Rheumatoid arthritis. Concomitant products included METHOTREXATE for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Oct-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Very positive and unusual response to the third dose of the Moderna COVID19 vaccine/Unusual excellent eye site/ Vision had significantly improved compared to previous visitations). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Very positive and unusual response to the third dose of the Moderna COVID19 vaccine/Unusual excellent eye site/ Vision had significantly improved compared to previous visitations) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Significant follow up appended: date for doses added, lot/batch no added for doses,  con med added
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: Could not move the arm for a week/Could not move the arm/Can hardly function; Joint pain in hips, knees and ankles/Hips are the worst/Pain is incredible; vaccine "killed my arm," swelled up and could not move the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (vaccine "killed my arm," swelled up and could not move the arm), MOBILITY DECREASED (Could not move the arm for a week/Could not move the arm/Can hardly function) and ARTHRALGIA (Joint pain in hips, knees and ankles/Hips are the worst/Pain is incredible) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A and 066D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (vaccine "killed my arm," swelled up and could not move the arm), MOBILITY DECREASED (Could not move the arm for a week/Could not move the arm/Can hardly function) and ARTHRALGIA (Joint pain in hips, knees and ankles/Hips are the worst/Pain is incredible). At the time of the report, PAIN IN EXTREMITY (vaccine "killed my arm," swelled up and could not move the arm), MOBILITY DECREASED (Could not move the arm for a week/Could not move the arm/Can hardly function) and ARTHRALGIA (Joint pain in hips, knees and ankles/Hips are the worst/Pain is incredible) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Had few heart palpitations after the 1st dose Sporadic; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Had few heart palpitations after the 1st dose Sporadic) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Had few heart palpitations after the 1st dose Sporadic). At the time of the report, PALPITATIONS (Had few heart palpitations after the 1st dose Sporadic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-355784 (Patient Link).