chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swelling of arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of arm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Myasthenia gravis. Concurrent medical conditions included Immunocompromised (immunocompromised with myasthenia gravis).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling of arm). At the time of the report, PERIPHERAL SWELLING (Swelling of arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that after receiving first dose of vaccine, patient developed swelling of arm for about a week and a half. Patient did not experience any adverse reaction after third dose of vaccine.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-361834 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed dose) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). On 23-Oct-2021, PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported. The reporter was going  for booster dose but because of cold she was unable to go.   Reporter did not allow further contact
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Seizure
Clinical narrative: Seizures; She can't work.; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizures) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Seizures) (seriousness criterion medically significant) and IMPAIRED WORK ABILITY (She can't work.). At the time of the report, SEIZURE (Seizures) and IMPAIRED WORK ABILITY (She can't work.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Concomitant medications were not provided. They put her in 3 different medicines and they don't work, they're at a dead end. She can't work.  Company Comment: This case concerns a 41-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of seizure. The events occurred 14 days (two weeks) after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of the doses was disclosed. The benefit-risk relationship of mRNA-1273 in not affected by this report. Further information was requested.; Sender's Comments: This case concerns a 41-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of seizure. The events occurred 14 days (two weeks) after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of the doses was disclosed. The benefit-risk relationship of mRNA-1273 in not affected by this report. Further information was requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash erythematous
Clinical narrative: She experienced high blood sugar up to 300-400 which is far above her normal level of 180; She also had a sore arm which hurt, was red, swollen; Couldn't sleep at night; She also had a sore arm which hurt, was red/ looked red for over a week; Had a big red rash; She also had a sore arm which hurt/ arm hurt for 3 days; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Oct-2021 and was forwarded to Moderna on 22-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (She experienced high blood sugar up to 300-400 which is far above her normal level of 180), PERIPHERAL SWELLING (She also had a sore arm which hurt, was red, swollen), INSOMNIA (Couldn't sleep at night), PAIN IN EXTREMITY (She also had a sore arm which hurt/ arm hurt for 3 days) and ERYTHEMA (She also had a sore arm which hurt, was red/ looked red for over a week) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088B, 001A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Wagner's disease (.). Concomitant products included PREDNISONE for Wagner's disease.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-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 BLOOD GLUCOSE INCREASED (She experienced high blood sugar up to 300-400 which is far above her normal level of 180), PERIPHERAL SWELLING (She also had a sore arm which hurt, was red, swollen), INSOMNIA (Couldn't sleep at night), PAIN IN EXTREMITY (She also had a sore arm which hurt/ arm hurt for 3 days), ERYTHEMA (She also had a sore arm which hurt, was red/ looked red for over a week) and RASH ERYTHEMATOUS (Had a big red rash). The patient was treated with GLIPIZIDE ongoing since an unknown date for Blood glucose, at a dose of 20 mg; TRAZODONE for Sleeplessness, at a dose of 1 dosage form and INSULIN for Blood sugar increased, at a dose of 1 dosage form. At the time of the report, BLOOD GLUCOSE INCREASED (She experienced high blood sugar up to 300-400 which is far above her normal level of 180), PERIPHERAL SWELLING (She also had a sore arm which hurt, was red, swollen), INSOMNIA (Couldn't sleep at night) and RASH ERYTHEMATOUS (Had a big red rash) outcome was unknown and PAIN IN EXTREMITY (She also had a sore arm which hurt/ arm hurt for 3 days) and ERYTHEMA (She also had a sore arm which hurt, was red/ looked red for over a week) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 300-400 (High) High blood sugar up to 300-400.
Sex: F
Vaccine: COVID19
Symptoms: Hirsutism
Clinical narrative: Hair growth on her upper lip/"a full mustache"; This spontaneous case was reported by a consumer and describes the occurrence of HIRSUTISM (Hair growth on her upper lip/"a full mustache") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HIRSUTISM (Hair growth on her upper lip/"a full mustache"). At the time of the report, HIRSUTISM (Hair growth on her upper lip/"a full mustache") outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Reporter stated that patient experienced adverse event after completing Moderna vaccine series.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm hurt slightly after receiving the second dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt slightly after receiving the second dose of the vaccine) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-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 PAIN IN EXTREMITY (Arm hurt slightly after receiving the second dose of the vaccine). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Arm hurt slightly after receiving the second dose of the vaccine) outcome was unknown.            No concomitant medication details was reported.   This case was linked to MOD-2021-361743 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Dizziness, Face injury, Syncope
Clinical narrative: Hurt her face as it hit the floor; Became bruised; Fainted about 6 times in different episodes/had to get a pacemaker; Began experiencing symptoms of fainting/ does get a fainting feeling about once a week; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted about 6 times in different episodes/had to get a pacemaker) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced SYNCOPE (Fainted about 6 times in different episodes/had to get a pacemaker) (seriousness criterion medically significant) and DIZZINESS (Began experiencing symptoms of fainting/ does get a fainting feeling about once a week). On an unknown date, the patient experienced FACE INJURY (Hurt her face as it hit the floor) and CONTUSION (Became bruised). At the time of the report, SYNCOPE (Fainted about 6 times in different episodes/had to get a pacemaker) had resolved, DIZZINESS (Began experiencing symptoms of fainting/ does get a fainting feeling about once a week) had not resolved and FACE INJURY (Hurt her face as it hit the floor) and CONTUSION (Became bruised) outcome was unknown.            Concomitant medication was not provided. Patient had to get a pacemaker since she had multiple episodes of fainting. Treatment information was not provided.  Company comment: This case concerns a 67 year-old, female subject with no medical history reported, who experienced the unexpected events of syncope, dizziness, face injury and contusion. The events syncope and dizziness occurred 12 days after the second dose of Moderna Covid-19 vaccine. The rechallenge is not applicable in this case as no information about the first dose was provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This case concerns a 67 year-old, female subject with no medical history reported, who experienced the unexpected events of syncope, dizziness, face injury and contusion. The events syncope and dizziness occurred 12 days after the second dose of Moderna Covid-19 vaccine. The rechallenge is not applicable in this case as no information about the first dose was provided. The benefit-risk relationship of the vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient who had been administered the Moderna covid-19 vaccine today who afterwards looked up the expiration date using the online tool showing an expiration date of 11OCT2021; 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 EXPIRED PRODUCT ADMINISTERED (patient who had been administered the Moderna covid-19 vaccine today who afterwards looked up the expiration date using the online tool showing an expiration date of 11OCT2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient who had been administered the Moderna covid-19 vaccine today who afterwards looked up the expiration date using the online tool showing an expiration date of 11OCT2021). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient who had been administered the Moderna covid-19 vaccine today who afterwards looked up the expiration date using the online tool showing an expiration date of 11OCT2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were provided No  Concomitant medications were provided
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered more than12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than12 hours post puncture) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025D21A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included METOPROLOL for an unknown indication.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than12 hours post puncture). On 23-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered more than12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   the patient had taken booster dose(12 hours post punctured) and the information related to the first vaccine is unknown  No Treatment medication was  provided by the reporter.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Rash, Urticaria, Vaccination site erythema
Clinical narrative: Skin to break out; My arm was red; vaccination site eryhema; Arm was red" and in a couple of days later "sore"; It break out in hives in different parts of the body,the hives was inside; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (My arm was red), VACCINATION SITE ERYTHEMA (vaccination site eryhema), PAIN IN EXTREMITY (Arm was red" and in a couple of days later "sore"), URTICARIA (It break out in hives in different parts of the body,the hives was inside) and RASH (Skin to break out) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 12A21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   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 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ERYTHEMA (My arm was red). In March 2021, the patient experienced VACCINATION SITE ERYTHEMA (vaccination site eryhema), PAIN IN EXTREMITY (Arm was red" and in a couple of days later "sore") and URTICARIA (It break out in hives in different parts of the body,the hives was inside). On an unknown date, the patient experienced RASH (Skin to break out). The patient was treated with CORTISONE (topical) for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (My arm was red), VACCINATION SITE ERYTHEMA (vaccination site eryhema), PAIN IN EXTREMITY (Arm was red" and in a couple of days later "sore"), URTICARIA (It break out in hives in different parts of the body,the hives was inside) and RASH (Skin to break out) outcome was unknown.            Concomitant medications reported included blood pressure meds.  The patient reported that post their 2nd dose of the Moderna COVID-19 vaccine, on the same day the patient noticed their arm was red and in a couple of days later it was sore and then it broke out in hives in different parts of the body. The patient went to the doctor 2 or 3 times and, they told that the hives was inside the patient's body and caused the skin to break out. It was also reported that the patient was taking blood pressure meds as regular medication and for the treatment a cortisone cream. The patient also informed other regular med and, other cream the patient was taking but was not clear.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: A cancer patient received 0.25 mL of Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (A cancer patient received 0.25 mL of Moderna) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (A cancer patient received 0.25 mL of Moderna). On 22-Oct-2021, ACCIDENTAL UNDERDOSE (A cancer patient received 0.25 mL of Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The reporter stated that a patient came in requesting a booster dose of the Moderna COVID-19 vaccine and was given 0.25 mL of the same on 22-Oct-2021. The reporter later found out that the patient had a history of cancer and the reporter was unsure whether the patient was receiving active treatment for cancer at this time. The patient had not reported any adverse reactions to the booster dose so far.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Feeling abnormal, Pain in extremity
Clinical narrative: arm hurt slightly; worse after the 3rd dose; it was like someone hit him in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt slightly), CONDITION AGGRAVATED (worse after the 3rd dose) and FEELING ABNORMAL (it was like someone hit him in the arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088B, 001A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-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 PAIN IN EXTREMITY (arm hurt slightly). an unknown date, the patient experienced CONDITION AGGRAVATED (worse after the 3rd dose) and FEELING ABNORMAL (it was like someone hit him in the arm). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm hurt slightly) had resolved and CONDITION AGGRAVATED (worse after the 3rd dose) and FEELING ABNORMAL (it was like someone hit him in the arm) outcome was unknown.            Concomitant product use was not provided by the reporter.    This case was linked to MOD-2021-361686 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: temperature excursion; Dose administered after a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Dose administered after a temperature excursion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Dose administered after a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) outcome was unknown and EXPIRED PRODUCT ADMINISTERED (Dose administered after a temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated that they had a temperature excursion of about 20 doses of Moderna, it got down to 32 degree F, went up to 34 degree F, then up to 36 degree F, then up to 37 degree F over the course of an hour. The doses were put in a portable transport unit and left at 32-degree F, the transport unit was not prepared for enough time to maintain the temperature.  Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: right dominant arm got sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (right dominant arm got sore) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043a21am and 005c21a) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, CURCUMA LONGA (CURCUMA), MAGNESIUM, METOPROLOL, METFORMIN, LISINOPRIL, ALLOPURINOL, SITAGLIPTIN PHOSPHATE (JANUVIA), VITAMIN D3 and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jun-2021, the patient experienced VACCINATION SITE PAIN (right dominant arm got sore). At the time of the report, VACCINATION SITE PAIN (right dominant arm got sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included as Diabetes medication and Vitamin 12.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling tired after second Moderna Covid-19 vaccination; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (feeling tired after second Moderna Covid-19 vaccination) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (feeling tired after second Moderna Covid-19 vaccination). At the time of the report, FATIGUE (feeling tired after second Moderna Covid-19 vaccination) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter No treatment medications were provided by the reporter.   This case was linked to MOD-2021-361761 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Movement disorder, Myalgia, Pain
Clinical narrative: entire body ached; Difficulty to move because everything is sore; Discomfort; muscles in the body are in continuous ache, sore and tender; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (entire body ached), MOVEMENT DISORDER (Difficulty to move because everything is sore), DISCOMFORT (Discomfort) and MYALGIA (muscles in the body are in continuous ache, sore and tender) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A29A and 006B21A) for COVID-19 vaccination.     The patient's past medical history included Blood cholesterol abnormal. Concurrent medical conditions included Asthma and AFib. Concomitant products included SIMVASTATIN for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced PAIN (entire body ached), MOVEMENT DISORDER (Difficulty to move because everything is sore), DISCOMFORT (Discomfort) and MYALGIA (muscles in the body are in continuous ache, sore and tender). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (entire body ached), MOVEMENT DISORDER (Difficulty to move because everything is sore), DISCOMFORT (Discomfort) and MYALGIA (muscles in the body are in continuous ache, sore and tender) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included steroids. The patient takes steroids for asthma condition. The patient's muscles in the left arm were still very sore and tender. The patient is very active and does yoga and stretching.   This case was linked to MOD-2021-362546, MOD-2021-362552 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Device connection issue
Clinical narrative: A syringe leaked while being used to give a dose of the Moderna COVID-19 vaccine; patient received approximately half to little more than half of the 0.5mL dose; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (A syringe leaked while being used to give a dose of the Moderna COVID-19 vaccine) and ACCIDENTAL OVERDOSE (patient received approximately half to little more than half of the 0.5mL dose) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included NAFTIFINE HYDROCHLORIDE (NAFTIN) and AZATHIOPRINE (AZATHIOPRIN) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced DEVICE CONNECTION ISSUE (A syringe leaked while being used to give a dose of the Moderna COVID-19 vaccine) and ACCIDENTAL OVERDOSE (patient received approximately half to little more than half of the 0.5mL dose). On 22-Oct-2021, DEVICE CONNECTION ISSUE (A syringe leaked while being used to give a dose of the Moderna COVID-19 vaccine) and ACCIDENTAL OVERDOSE (patient received approximately half to little more than half of the 0.5mL dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided. It was reported that patient was administered approximately half to little more than half of the 0.5mL dose. The patient is not experiencing any side effects or symptoms.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Interchange of vaccine products
Clinical narrative: administered 0.5 mL of the Moderna COVID-19 Vaccine for booster dose; This patient had the Jensen and ended up giving the 0.5ml of Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (administered 0.5 mL of the Moderna COVID-19 Vaccine for booster dose) and INTERCHANGE OF VACCINE PRODUCTS (This patient had the Jensen and ended up giving the 0.5ml of Moderna) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 for COVID-19 vaccination.    No Medical History information was reported.   On 17-Mar-2021, the patient received dose of COVID-19 VACCINE NRVV AD26 (unknown route) 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (administered 0.5 mL of the Moderna COVID-19 Vaccine for booster dose) and INTERCHANGE OF VACCINE PRODUCTS (This patient had the Jensen and ended up giving the 0.5ml of Moderna). At the time of the report, INCORRECT DOSE ADMINISTERED (administered 0.5 mL of the Moderna COVID-19 Vaccine for booster dose) and INTERCHANGE OF VACCINE PRODUCTS (This patient had the Jensen and ended up giving the 0.5ml of Moderna) 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 patient had the Jensen vaccine and it was more than 2 months. An unknown dose was received on 17-Mar-2021.  No treatment information was provided by the reporter.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pulmonary embolism, Thrombosis
Clinical narrative: pulmonary embolism; She had huge blood clots in both lungs; She had shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (pulmonary embolism) and THROMBOSIS (She had huge blood clots in both lungs) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Polycythemia vera. Concomitant products included RUXOLITINIB PHOSPHATE (JAKAFI) for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced DYSPNOEA (She had shortness of breath). On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PULMONARY EMBOLISM (pulmonary embolism) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced THROMBOSIS (She had huge blood clots in both lungs) (seriousness criterion medically significant). The patient was hospitalized on 27-Aug-2021 due to PULMONARY EMBOLISM. The patient was treated with APIXABAN (ELIQUIS) for Adverse reaction, at an unspecified dose and frequency and Surgery (Surgically removed) for Pulmonary embolism. At the time of the report, PULMONARY EMBOLISM (pulmonary embolism) had resolved and THROMBOSIS (She had huge blood clots in both lungs) and DYSPNOEA (She had shortness of breath) outcome was unknown.            On 27Aug2021 the patient was taken to the hospital where she was diagnosed with pulmonary embolism which had to be treated with surgery. After discharge and treatment, future follow ups did not reveal the presence of other embolisms. Currently there are no side effects or symptoms ongoing.  Company comment: This case concerns a 93 year-old, female subject with a history of polycythemia vera, who experienced the unexpected events of pulmonary embolism, thrombosis and dyspnoea. The event occurred approximately 200 days after the second dose of Moderna Covid-19 vaccine. The rechallenge is not applicable since no data of the first dose was given. The benefit-risk relationship of the vaccine is not affected by this report; Sender's Comments: This case concerns a 93 year-old, female subject with a history of polycythemia vera, who experienced the unexpected events of pulmonary embolism, thrombosis and dyspnoea. The event occurred approximately 200 days after the second dose of Moderna Covid-19 vaccine. The rechallenge is not applicable since no data of the first dose was given. The benefit-risk relationship of the vaccine is not affected by this report
Age: 68.0
Sex: M
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 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 029K20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Ex-smoker.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 patients received dose from expired vial; 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 EXPIRED PRODUCT ADMINISTERED (5 patients received dose from expired vial) 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 (5 patients received dose from expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 patients received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported. Date the vial was initially stored in the refrigerator: 13Sep2021 Date(s) of administration of vaccine: 14Oct2021 through the 21Oct2021 included.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 15 patients received dose from expired vial; 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 EXPIRED PRODUCT ADMINISTERED (15 patients received dose from expired vial) 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.   In October 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (15 patients received dose from expired vial). In October 2021, EXPIRED PRODUCT ADMINISTERED (15 patients received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter reported Number of doses/vials: 20 doses (15-dose vial) Date the vial was initially stored in the refrigerator: 13Sep2021 Date(s) of administration of vaccine: 14-Oct-2021 through the 21-Oct-2021 included  No relevant concomitant medications were reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received dose from a vial that had been punctured for 48 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from a vial that had been punctured for 48 hours) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from a vial that had been punctured for 48 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received dose from a vial that had been punctured for 48 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.    Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: Injection site pain for 1 to 2 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Injection site pain for 1 to 2 days) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ATORVASTATIN, PROGESTERONE, LISINOPRIL, FINASTERIDE, ESTRADIOL VALERATE, DUPILUMAB (DUPIXENT), ASPIRIN [ACETYLSALICYLIC ACID] and CANNABIS for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site pain for 1 to 2 days). At the time of the report, VACCINATION SITE PAIN (Injection site pain for 1 to 2 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 antibody test: abnormal (abnormal) No immunity to COVID-19.         Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; little bit tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (little bit tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included VALSARTAN, HYDRALAZINE, HYDROCHLOROTHIAZIDE and ATENOLOL for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (little bit tired). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (little bit tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was reported.  Patient stated that she takes unspecified medication for hypertension twice a day and also checks her blood pressure first thing in the morning and she stated that the blood pressure is typically less 120/70.   This case was linked to MOD-2021-361949, MOD-2021-361984 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia oral, Pain in extremity, Pharyngeal hypoaesthesia
Clinical narrative: Numb sensation in the left side of her tongue after three shots; Numb sensation in the throat after three shots; Sore arm; A litlle tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numb sensation in the left side of her tongue after three shots), PHARYNGEAL HYPOAESTHESIA (Numb sensation in the throat after three shots), PAIN IN EXTREMITY (Sore arm) and FATIGUE (A litlle tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Pericarditis (myo or pericarditis when she was 2 years of age), Myocarditis (when she was 2 years of age), TIA (TIA a couple of years ago) and Numbness (TIA a couple of years ago and the left side of face and arm got numb.). Concomitant products included LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (Numb sensation in the left side of her tongue after three shots) and PHARYNGEAL HYPOAESTHESIA (Numb sensation in the throat after three shots). In January 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (A litlle tired). On 07-Jan-2021, HYPOAESTHESIA ORAL (Numb sensation in the left side of her tongue after three shots) and PHARYNGEAL HYPOAESTHESIA (Numb sensation in the throat after three shots) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (A litlle tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment to the events not reported.  Patient got a numb sensation in the left side of the tongue and in the throat. It started about 25 minutes after the shot and lasts for about 1-2 hours.   This case was linked to MOD-2021-361902, MOD-2021-361778 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Pharyngeal hypoaesthesia
Clinical narrative: numb sensation in the left side of her tongue after three shots; numb sensation in the throat after three shots; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (numb sensation in the left side of her tongue after three shots) and PHARYNGEAL HYPOAESTHESIA (numb sensation in the throat after three shots) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included TIA (the left side of face and arm got numb, she does not know if this can be related). Concomitant products included LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced HYPOAESTHESIA ORAL (numb sensation in the left side of her tongue after three shots) and PHARYNGEAL HYPOAESTHESIA (numb sensation in the throat after three shots). On 22-Oct-2021, HYPOAESTHESIA ORAL (numb sensation in the left side of her tongue after three shots) and PHARYNGEAL HYPOAESTHESIA (numb sensation in the throat after three shots) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that after the first and second dose, and now after the booster, she got a numb sensation in the left side of her tongue and in her throat. It started about 25 minutes after the shot and lasted for about 1-2 hours.  Myo or pericarditis when she was 2 years of age.   This case was linked to MOD-2021-361901, MOD-2021-361778 (Patient Link).