chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Intestinal obstruction
Clinical narrative: bowels have been acting differently and  are off.; some stomach irregularities/his bowels have been acting differently; This spontaneous case was reported by a consumer and describes the occurrence of INTESTINAL OBSTRUCTION (bowels have been acting differently and  are off.) in a male patient of an unknown age 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 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 INTESTINAL OBSTRUCTION (bowels have been acting differently and  are off.) (seriousness criterion medically significant) and ABDOMINAL DISCOMFORT (some stomach irregularities/his bowels have been acting differently). At the time of the report, INTESTINAL OBSTRUCTION (bowels have been acting differently and  are off.) and ABDOMINAL DISCOMFORT (some stomach irregularities/his bowels have been acting differently) outcome was unknown.            No concomitant medication was mentioned.  Reporter stated that patient received the 3rd full Moderna covid-19 dose three weeks ago and since receiving the injection her husband has been experiencing some stomach irregularities and stated his bowels have been acting differently and were off.  No treatment medication was mentioned.  Company comment- This case concerns a unknown age male patient with no medical history provided, who experienced the unexpected  serious adverse event of Intestinal obstruction (seriousness criterion medically significant) and the non serious event of Abdominal discomfort. The patient received the third dose of mRNA-1273 (Moderna COVID-19 Vaccine) on an uknown date. According to her husband, three weeks later he started to experienced Intestinal obstruction and Abdominal discomfort.The rechallenge was unknown as there's no information available about the first or second dose. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a unknown age male patient with no medical history provided, who experienced the unexpected  serious adverse event of Intestinal obstruction (seriousness criterion medically significant) and the non serious event of Abdominal discomfort. The patient received the third dose of mRNA-1273 (Moderna COVID-19 Vaccine) on an uknown date. According to her husband, three weeks later he started to experienced Intestinal obstruction and Abdominal discomfort.The rechallenge was unknown as there's no information available about the first or second dose. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Diarrhoea, Flatulence, Vaccination site pain
Clinical narrative: stomach irregularity and stated her bowels are now acting differently; has been "gassier"; started out with diarrhea; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of BOWEL MOVEMENT IRREGULARITY (stomach irregularity and stated her bowels are now acting differently), FLATULENCE (has been "gassier"), DIARRHOEA (started out with diarrhea) and VACCINATION SITE PAIN (arm pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BOWEL MOVEMENT IRREGULARITY (stomach irregularity and stated her bowels are now acting differently), FLATULENCE (has been "gassier"), DIARRHOEA (started out with diarrhea) and VACCINATION SITE PAIN (arm pain). At the time of the report, BOWEL MOVEMENT IRREGULARITY (stomach irregularity and stated her bowels are now acting differently) was resolving and FLATULENCE (has been "gassier"), DIARRHOEA (started out with diarrhea) and VACCINATION SITE PAIN (arm pain) outcome was unknown.            No concomitant medication details was reported.  Patient had the 3rd full dose three weeks ago. She reported experiencing arm pain that lasted two days after the injection. The caller also stated that she had stomach irregularity and stated her bowels were now acting differently and she had been "gassier" since received the 3rd dose.  She stated that initially the stomach irregularity started out with diarrhea but progressed into stomach irregularity. The caller stated that the stomach irregularity had gotten a little better now but was still ongoing.   No treatment medication details was reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after 30 days of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30 days of expiry) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     no medical history was reported.  Concomitant products included ETHINYLESTRADIOL for an unknown indication.    On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30 days of expiry). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after 30 days of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Others concomitant medications included Multivitamin  No treatment medication was reported
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: had joint pain everywhere for a day; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (had joint pain everywhere for a day) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced ARTHRALGIA (had joint pain everywhere for a day). In April 2021, ARTHRALGIA (had joint pain everywhere for a day) had resolved.            No concomitant medications was provided by the reporter No treatment medications was provided by the reporter   This case was linked to MOD-2021-362108 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Pain in extremity, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Sore arm; More tired; Left arm was swollen from the injections site; Left arm was red from the injections site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (More tired), VACCINATION SITE SWELLING (Left arm was swollen from the injections site) and VACCINATION SITE ERYTHEMA (Left arm was red from the injections site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Take medication twice a day). 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 16-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 PAIN IN EXTREMITY (Sore arm), FATIGUE (More tired), VACCINATION SITE SWELLING (Left arm was swollen from the injections site) and VACCINATION SITE ERYTHEMA (Left arm was red from the injections site). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (More tired) outcome was unknown and VACCINATION SITE SWELLING (Left arm was swollen from the injections site) and VACCINATION SITE ERYTHEMA (Left arm was red from the injections site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 120/70 (normal) Blood pressure was typically less120/70..         No treatment medication was provided.   This case was linked to MOD-2021-361891, MOD-2021-361984 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: hit them like a ton of bricks/ maybe it is because they got like 3 shots; 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 VACCINATION SITE PAIN (hit them like a ton of bricks/ maybe it is because they got like 3 shots) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (hit them like a ton of bricks/ maybe it is because they got like 3 shots). At the time of the report, VACCINATION SITE PAIN (hit them like a ton of bricks/ maybe it is because they got like 3 shots) outcome was unknown.            Reporter stated that the doctor had COVID-19 and then 2 shots.  No relevant concomitant medications were reported. No treatment information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose received 16 days after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received 16 days after the 1st dose) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-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) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received 16 days after the 1st dose). On 12-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received 16 days after the 1st dose) had resolved.            Concomitant product use was not provided by the reporter.  No treatment information was provided. Patient wanted to know where she can get the booster vaccine.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) 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 (Expired vaccine used). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The vaccine expiry date was on 15-Oct-2021. No adverse effects was experienced by the patient. The Moderna vial was removed from the freezer to the refrigerator on 11-Oct-2021 without any temperature variations in the transfer from the freezer. The solution was off white in color.  No variation in color from all the other previously used vials.   This case was linked to MOD-2021-355973 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (bad reaction). At the time of the report, VACCINATION COMPLICATION (bad reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration
Clinical narrative: red hard raised spot about 5 inches in diameter; red hard raised spot about 5 inches in diameter; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (red hard raised spot about 5 inches in diameter) and VACCINATION SITE INDURATION (red hard raised spot about 5 inches in diameter) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concomitant products included THIAMAZOLE (METHIMAZOLE) and PROPRANOLOL for an unknown indication.    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red hard raised spot about 5 inches in diameter) and VACCINATION SITE INDURATION (red hard raised spot about 5 inches in diameter). On 19-Mar-2021, VACCINATION SITE ERYTHEMA (red hard raised spot about 5 inches in diameter) and VACCINATION SITE INDURATION (red hard raised spot about 5 inches in diameter) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter.   This case was linked to MOD-2021-361946 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: Patient reports feeling flushed; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Patient reports feeling flushed) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced FLUSHING (Patient reports feeling flushed). At the time of the report, FLUSHING (Patient reports feeling flushed) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-362026 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Vertigo
Clinical narrative: Was dizzy again this morning/Dizziness was strange/Had to hold on the way back from the car to her apartment due to the dizziness; Weakness in the legs like one gets when they are scared to death/Weakness feels like she is going to collapse and stated that it is strange feeling/Legs are weak; Almost like a vertigo where the head is spinning; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Was dizzy again this morning/Dizziness was strange/Had to hold on the way back from the car to her apartment due to the dizziness), ASTHENIA (Weakness in the legs like one gets when they are scared to death/Weakness feels like she is going to collapse and stated that it is strange feeling/Legs are weak) and VERTIGO (Almost like a vertigo where the head is spinning) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 016C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Cholesterol high. Concomitant products included SIMVASTATIN for Cholesterol high, APIXABAN (ELIQUIS) for an unknown indication.   On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Oct-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 DIZZINESS (Was dizzy again this morning/Dizziness was strange/Had to hold on the way back from the car to her apartment due to the dizziness), ASTHENIA (Weakness in the legs like one gets when they are scared to death/Weakness feels like she is going to collapse and stated that it is strange feeling/Legs are weak) and VERTIGO (Almost like a vertigo where the head is spinning). At the time of the report, DIZZINESS (Was dizzy again this morning/Dizziness was strange/Had to hold on the way back from the car to her apartment due to the dizziness), ASTHENIA (Weakness in the legs like one gets when they are scared to death/Weakness feels like she is going to collapse and stated that it is strange feeling/Legs are weak) and VERTIGO (Almost like a vertigo where the head is spinning) had not resolved.            Concomitant drugs included blood pressure medications.  It was reported that patient was asked by doctor to stop taking Eliquis and other medications and asked to drink water. It was reported that patient felt like about to collapse and crash any moment on the cement. She felt the dizziness was strange and had to hold on the way back from the car to her apartment. She also stated that the first dose was a breeze but for the second dose, the vaccinator went too high to the bone, to the top of the shoulder and was very hurtful.  Treatment medications were not provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Expired product administered, Feeling abnormal, Hot flush
Clinical narrative: feeling flushed; feeling uplifted; face was red; Expired vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (feeling flushed), FEELING ABNORMAL (feeling uplifted), ERYTHEMA (face was red) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-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 HOT FLUSH (feeling flushed), FEELING ABNORMAL (feeling uplifted), ERYTHEMA (face was red) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) had resolved. At the time of the report, HOT FLUSH (feeling flushed), FEELING ABNORMAL (feeling uplifted) and ERYTHEMA (face was red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-362005 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Myalgia
Clinical narrative: A little under the weather; A little funny; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (A little under the weather), FEELING ABNORMAL (A little funny) and MYALGIA (Sore arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A, 026A21A and 011P21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced MALAISE (A little under the weather), FEELING ABNORMAL (A little funny) and MYALGIA (Sore arm). On 10-Feb-2021, MALAISE (A little under the weather) and FEELING ABNORMAL (A little funny) had resolved. On 13-Feb-2021, MYALGIA (Sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitants and Treatment medication were reported. This case concerns a 69-year-old, male patient with no previous medical history, who experienced the expected non-serious adverse event of Myalgia and unexpected non-serious adverse events of Malaise and Feeling abnormal. The events occurred on the same day after the first dose of mRNA-1273 (COVID-19 Vaccine Moderna). The rechallenge was not applicable. Dose 2 and dose 3 related events were provided in the same source. Patient Link for dose 2 and dose 3 has been created. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report.   This case was linked to MOD-2021-362098, MOD-2021-362099 (Patient Link).; Sender's Comments: This case concerns a 69-year-old, male patient with no previous medical history, who experienced the expected non-serious adverse event of Myalgia and unexpected non-serious adverse events of Malaise and Feeling abnormal. The events occurred on the same day after the first dose of mRNA-1273 (COVID-19 Vaccine Moderna). The rechallenge was not applicable. Dose 2 and dose 3 related events were provided in the same source. Patient Link for dose 2 and dose 3 has been created. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    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 (Expired vaccine used). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The vaccine expiry date was on 15-Oct-2021. No adverse effects was experienced by the patient. The Moderna vial was removed from the freezer to the refrigerator on 11-Oct-2021 without any temperature variations in the transfer from the freezer. The solution was off white in color.  No variation in color from all the other previously used vials.   This case was linked to MOD-2021-355973 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: 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 (Dose administered after a temperature excursion) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A, 031A21A and 044B21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after a temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Had temperature excursion of about 20 doses of moderna,it got down to 32 degree Fahrenheit and went unto 34degree Fahrenheit and then to 37 degree Fahrenheit over the course of an hour.The doses were put in a portable transport unit and left at 32°F, the transport unit was not prepared for enough time to maintain the temperature. No concomitant medication  were reported. No Treatment information was provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Fatigue, Hyperhidrosis, Vaccination complication
Clinical narrative: Feeling of anxiety (like tachycardia); Doesn't feel well; Patient feel sweaty; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Feeling of anxiety (like tachycardia)), VACCINATION COMPLICATION (Doesn't feel well), HYPERHIDROSIS (Patient feel sweaty), FATIGUE (Fatigue) and CHILLS (Chills) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced ANXIETY (Feeling of anxiety (like tachycardia)), VACCINATION COMPLICATION (Doesn't feel well), HYPERHIDROSIS (Patient feel sweaty), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, ANXIETY (Feeling of anxiety (like tachycardia)), VACCINATION COMPLICATION (Doesn't feel well), HYPERHIDROSIS (Patient feel sweaty), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.            Patient stated that she was immunocompromised.  Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 3 patients received a booster dose after the vial was already punctured 20 times; 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 PRODUCT ADMINISTRATION ERROR (3 patients received a booster dose after the vial was already punctured 20 times) 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 PRODUCT ADMINISTRATION ERROR (3 patients received a booster dose after the vial was already punctured 20 times). At the time of the report, PRODUCT ADMINISTRATION ERROR (3 patients received a booster dose after the vial was already punctured 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) 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 (Expired vaccine used). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. No Concomitant medication was reported. No lab data was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: concerns about some effects that I believe it is having on me; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (concerns about some effects that I believe it is having on me) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (concerns about some effects that I believe it is having on me). At the time of the report, VACCINATION COMPLICATION (concerns about some effects that I believe it is having on me) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: Sore arm; Felt under the weather; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and MALAISE (Felt under the weather) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011P21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 14-Oct-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) (seriousness criterion medically significant) and MALAISE (Felt under the weather) (seriousness criterion medically significant). On 15-Oct-2021, MALAISE (Felt under the weather) had resolved. On 17-Oct-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication details were provided.  No Treatment medication details were provided.  Company comment: This case concerns a 70 year-old male patient with no medical history provided, who experienced the unexpected events of Pain in extremity and Malaise(seriousness criterion medically significant). Both events occurred on the same day the patient received the third dose of  mRNA-1273 (Moderna COVID-19 Vaccine). The following day, Malaise had resolved, with Pain in extremity resolving 2 days after. The reporter did not provide any causality assessments. The rechallenge was unknown as there's no information available about the first or second dose. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine)  is not affected by this report.   This case was linked to MOD-2021-362098, MOD-2021-362028 (Patient Link).; Sender's Comments: This case concerns a 70 year-old male patient with no medical history provided, who experienced the unexpected events of Pain in extremity and Malaise(seriousness criterion medically significant). Both events occurred on the same day the patient received the third dose of  mRNA-1273 (Moderna COVID-19 Vaccine). The following day, Malaise had resolved, with Pain in extremity resolving 2 days after. The reporter did not provide any causality assessments. The rechallenge was unknown as there's no information available about the first or second dose. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine)  is not affected by this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Chills, Pain, Vaccination complication, Vomiting
Clinical narrative: A lot more side effects than after second dose/Side effects are lasting longer than after the second dose; Aches; I think I need to go vomit; Chills; Received 0.5mL instead of 0.25mL dose for a booster/Given a full dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (A lot more side effects than after second dose/Side effects are lasting longer than after the second dose), PAIN (Aches), VOMITING (I think I need to go vomit), CHILLS (Chills) and ACCIDENTAL OVERDOSE (Received 0.5mL instead of 0.25mL dose for a booster/Given a full dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. 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 23-Oct-2021, the patient experienced VACCINATION COMPLICATION (A lot more side effects than after second dose/Side effects are lasting longer than after the second dose), PAIN (Aches), VOMITING (I think I need to go vomit), CHILLS (Chills) and ACCIDENTAL OVERDOSE (Received 0.5mL instead of 0.25mL dose for a booster/Given a full dose). On 23-Oct-2021, ACCIDENTAL OVERDOSE (Received 0.5mL instead of 0.25mL dose for a booster/Given a full dose) had resolved. At the time of the report, VACCINATION COMPLICATION (A lot more side effects than after second dose/Side effects are lasting longer than after the second dose), PAIN (Aches) and CHILLS (Chills) outcome was unknown and VOMITING (I think I need to go vomit) had not resolved.            No concomitant medication details was provided. No treatment medication details was provided.   This case was linked to MOD-2021-363088, MOD-2021-363309 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Reporter details updated, Patient demographic updated, patient route of administration updated and Event updated.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: Long-term dizziness; Long-term imbalance; 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 DIZZINESS (Long-term dizziness) and BALANCE DISORDER (Long-term imbalance) 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.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-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 DIZZINESS (Long-term dizziness) and BALANCE DISORDER (Long-term imbalance). At the time of the report, DIZZINESS (Long-term dizziness) and BALANCE DISORDER (Long-term imbalance) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was reported.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: They gave me 0.5mL of the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (They gave me 0.5mL of the vaccine.) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A, 026B21A and 026D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-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 ACCIDENTAL OVERDOSE (They gave me 0.5mL of the vaccine.). On 22-Oct-2021, ACCIDENTAL OVERDOSE (They gave me 0.5mL of the vaccine.) had resolved.            No concomitant medication provided.  No treatment information provided.   This case was linked to MOD-2021-361945 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Experiencing side effects after booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experiencing side effects after 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Experiencing side effects after booster). At the time of the report, VACCINATION COMPLICATION (Experiencing side effects after booster) outcome was unknown.            No concomitant medications reported. No treatment information was provided.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Extra dose administered
Clinical narrative: Extra dose administered; Chills; Joint pain; Tightness in the chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightness in the chest), EXTRA DOSE ADMINISTERED (Extra dose administered), CHILLS (Chills) and ARTHRALGIA (Joint pain) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, 028A21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced CHEST DISCOMFORT (Tightness in the chest), CHILLS (Chills) and ARTHRALGIA (Joint pain). On 23-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 23-Oct-2021, EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved. At the time of the report, CHEST DISCOMFORT (Tightness in the chest) and CHILLS (Chills) was resolving and ARTHRALGIA (Joint pain) had not resolved.            No Concomitant medication was reported.   This case was linked to MOD-2021-362076 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Lip swelling, Product dose omission issue, Swelling face
Clinical narrative: I had an allergic reaction to it; He went to get the second shot the pharmacist on call told him not to receive the second shot and he has not.; Face also started swelling; Lower lip was swollen unbelievably, He states if he had gone out in the rain, he would have drowned. It was so swollen.; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Lower lip was swollen unbelievably, He states if he had gone out in the rain, he would have drowned. It was so swollen.), SWELLING FACE (Face also started swelling), HYPERSENSITIVITY (I had an allergic reaction to it) and PRODUCT DOSE OMISSION ISSUE (He went to get the second shot the pharmacist on call told him not to receive the second shot and he has not.) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced LIP SWELLING (Lower lip was swollen unbelievably, He states if he had gone out in the rain, he would have drowned. It was so swollen.). In April 2021, the patient experienced SWELLING FACE (Face also started swelling). On an unknown date, the patient experienced HYPERSENSITIVITY (I had an allergic reaction to it) and PRODUCT DOSE OMISSION ISSUE (He went to get the second shot the pharmacist on call told him not to receive the second shot and he has not.). At the time of the report, LIP SWELLING (Lower lip was swollen unbelievably, He states if he had gone out in the rain, he would have drowned. It was so swollen.), SWELLING FACE (Face also started swelling) and HYPERSENSITIVITY (I had an allergic reaction to it) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (He went to get the second shot the pharmacist on call told him not to receive the second shot and he has not.) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were provided.  No treatment medications were reported.     Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow-up document received include reporter and patient details, suspect drug details additional events.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache that is bothering her/ a middle headache on the day of the vaccination but it went away; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache that is bothering her/ a middle headache on the day of the vaccination but it went away) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091d21a) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Oct-2021, the patient experienced HEADACHE (headache that is bothering her/ a middle headache on the day of the vaccination but it went away). On 21-Oct-2021, HEADACHE (headache that is bothering her/ a middle headache on the day of the vaccination but it went away) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  Treatment medication information was not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Joint swelling, Lymphadenopathy, Pain
Clinical narrative: She also had aches and pains; Hands were swollen; Knees were swollen/knee replacements were so swelled up that she couldn't bend them; Lymph nodes were swollen; Fever that went up to 104° F and it went down to 101° F.; knee replacements hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (She also had aches and pains), PERIPHERAL SWELLING (Hands were swollen), JOINT SWELLING (Knees were swollen/knee replacements were so swelled up that she couldn't bend them), LYMPHADENOPATHY (Lymph nodes were swollen) and PYREXIA (Fever that went up to 104° F and it went down to 101° F.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement (Had two knee replacement.). Concomitant products included METFORMIN, ATORVASTATIN CALCIUM (LIPITOR), CARVEDILOL and CANDESARTAN for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PAIN (She also had aches and pains), PERIPHERAL SWELLING (Hands were swollen), JOINT SWELLING (Knees were swollen/knee replacements were so swelled up that she couldn't bend them), LYMPHADENOPATHY (Lymph nodes were swollen), PYREXIA (Fever that went up to 104° F and it went down to 101° F.) and ARTHRALGIA (knee replacements hurt). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (She also had aches and pains), PERIPHERAL SWELLING (Hands were swollen), LYMPHADENOPATHY (Lymph nodes were swollen) and PYREXIA (Fever that went up to 104° F and it went down to 101° F.) outcome was unknown and JOINT SWELLING (Knees were swollen/knee replacements were so swelled up that she couldn't bend them) and ARTHRALGIA (knee replacements hurt) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104° F and 101 (High) 101° F.         Treatment provided also included cold shower.  Patient reported that she had a pretty violent reaction on  12-Feb-2021,after receiving the vaccine. Patient also reported that it took a couple of days to loosen up the knees.   This case was linked to MOD-2021-362373 (Patient Link).