chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Pyrexia
Clinical narrative: BOWEL SOUNDS EVEN WHEN SHE IS NOT HUNGRY; COULD NOT SLEEP; INTENSIVE STOMACH PAIN ON THE RIGHT, LEFT SIDE AND IN THE MIDDLE; DID NOT HAVE BOWEL MOVEMENT; COULD NOT GET OUT OF BED; HEADACHE; LOW-GRADE FEVER; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included: did colonoscopy and broke into rash (less rash), and concurrent conditions included: non alcoholic, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient experienced hives and rash severe all over her body and red and inflamed when treated with sulfamethoxazole/trimethoprim for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A expiry: 21-DEC-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-SEP-2021, the patient experienced could not get out of bed. On 24-SEP-2021, the patient experienced headache. On 24-SEP-2021, the patient experienced low-grade fever. On 27-SEP-2021, the patient experienced intensive stomach pain on the right, left side and in the middle. On 27-SEP-2021, the patient experienced did not have bowel movement. On 27-OCT-2021, the patient experienced could not sleep. On an unspecified date, the patient experienced bowel sounds even when she is not hungry. Laboratory data (dates unspecified) included: Colonoscopy (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not get out of bed, headache, and low-grade fever on 26-SEP-2021, was recovering from intensive stomach pain on the right, left side and in the middle, and did not have bowel movement, and the outcome of bowel sounds even when she is not hungry and could not sleep was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: OVERALL SORENESS; ARM WAS A KILLER; HEADACHE; BIT TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On OCT-2021, the patient experienced overall soreness. On OCT-2021, the patient experienced arm was a killer. On OCT-2021, the patient experienced headache. On OCT-2021, the patient experienced bit tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bit tired, headache, overall soreness and arm was a killer was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis
Clinical narrative: ONLY SWEATS; CHILLS; This spontaneous report received from a consumer concerned an 83 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: immune issue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced only sweats, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the only sweats and chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: SICK FROM THE J AND J BUT ONLY FOR 20 HOURS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On MAR-2021, the patient experienced sick from the j and j but only for 20 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick from the j and j but only for 20 hours on MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20211055134 and 20211055777.
Sex: F
Vaccine: COVID19
Symptoms: Blood disorder, Body temperature, Breast pain, Burning sensation, Chills
Clinical narrative: MUSCLE ACHES; FATIGUE; SLIGHT FEVER OF 99; HEADACHE; CHILLS; ARM PAIN; HEART RATE WENT UP TO 96-100 BPM/ELEVATED RESTING HEART RATE; BLOOD THICKER THAN NORMAL; SWOLLEN ARM; BURNING SENSATION ON LEFT SHOULDER, GOING UP INTO ARM AND UP THE NECK, AND INTO THE JAW; BURNING SENSATION TO THE SIDE OF BREAST; PAIN; This spontaneous report received from a consumer concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: heart murmur. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On OCT-2021, the patient experienced heart rate went up to 96-100 bpm/elevated resting heart rate. On OCT-2021, the patient experienced blood thicker than normal. On OCT-2021, the patient experienced swollen arm. On OCT-2021, the patient experienced burning sensation on left shoulder, going up into arm and up the neck, and into the jaw. On OCT-2021, the patient experienced burning sensation to the side of breast. On OCT-2021, the patient experienced arm pain. On OCT-2021, the patient experienced pain. Laboratory data included: Diagnostic procedure NOS (NR: not provided) Blood little thicker than normal, Electrocardiogram (NR: not provided) Blood little thicker than normal, and Heart rate (NR: not provided) 96-100 bpm. On 21-OCT-2021, the patient experienced chills. On 21-OCT-2021, the patient experienced muscle aches. On 21-OCT-2021, the patient experienced fatigue. On 21-OCT-2021, the patient experienced slight fever of 99. On 21-OCT-2021, the patient experienced headache. Laboratory data included: Body temperature (NR: not provided) Fever of 99. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain, had not recovered from heart rate went up to 96-100 bpm/elevated resting heart rate, arm pain, and swollen arm, and the outcome of slight fever of 99, chills, headache, fatigue, muscle aches, burning sensation on left shoulder, going up into arm and up the neck, and into the jaw, blood thicker than normal and burning sensation to the side of breast was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diagnostic procedure, Electrocardiogram, Fatigue, Headache, Heart rate
Clinical narrative: MUSCLE ACHES; FATIGUE; SLIGHT FEVER OF 99; HEADACHE; CHILLS; ARM PAIN; HEART RATE WENT UP TO 96-100 BPM/ELEVATED RESTING HEART RATE; BLOOD THICKER THAN NORMAL; SWOLLEN ARM; BURNING SENSATION ON LEFT SHOULDER, GOING UP INTO ARM AND UP THE NECK, AND INTO THE JAW; BURNING SENSATION TO THE SIDE OF BREAST; PAIN; This spontaneous report received from a consumer concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: heart murmur. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On OCT-2021, the patient experienced heart rate went up to 96-100 bpm/elevated resting heart rate. On OCT-2021, the patient experienced blood thicker than normal. On OCT-2021, the patient experienced swollen arm. On OCT-2021, the patient experienced burning sensation on left shoulder, going up into arm and up the neck, and into the jaw. On OCT-2021, the patient experienced burning sensation to the side of breast. On OCT-2021, the patient experienced arm pain. On OCT-2021, the patient experienced pain. Laboratory data included: Diagnostic procedure NOS (NR: not provided) Blood little thicker than normal, Electrocardiogram (NR: not provided) Blood little thicker than normal, and Heart rate (NR: not provided) 96-100 bpm. On 21-OCT-2021, the patient experienced chills. On 21-OCT-2021, the patient experienced muscle aches. On 21-OCT-2021, the patient experienced fatigue. On 21-OCT-2021, the patient experienced slight fever of 99. On 21-OCT-2021, the patient experienced headache. Laboratory data included: Body temperature (NR: not provided) Fever of 99. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain, had not recovered from heart rate went up to 96-100 bpm/elevated resting heart rate, arm pain, and swollen arm, and the outcome of slight fever of 99, chills, headache, fatigue, muscle aches, burning sensation on left shoulder, going up into arm and up the neck, and into the jaw, blood thicker than normal and burning sensation to the side of breast was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Myalgia, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: MUSCLE ACHES; FATIGUE; SLIGHT FEVER OF 99; HEADACHE; CHILLS; ARM PAIN; HEART RATE WENT UP TO 96-100 BPM/ELEVATED RESTING HEART RATE; BLOOD THICKER THAN NORMAL; SWOLLEN ARM; BURNING SENSATION ON LEFT SHOULDER, GOING UP INTO ARM AND UP THE NECK, AND INTO THE JAW; BURNING SENSATION TO THE SIDE OF BREAST; PAIN; This spontaneous report received from a consumer concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: heart murmur. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On OCT-2021, the patient experienced heart rate went up to 96-100 bpm/elevated resting heart rate. On OCT-2021, the patient experienced blood thicker than normal. On OCT-2021, the patient experienced swollen arm. On OCT-2021, the patient experienced burning sensation on left shoulder, going up into arm and up the neck, and into the jaw. On OCT-2021, the patient experienced burning sensation to the side of breast. On OCT-2021, the patient experienced arm pain. On OCT-2021, the patient experienced pain. Laboratory data included: Diagnostic procedure NOS (NR: not provided) Blood little thicker than normal, Electrocardiogram (NR: not provided) Blood little thicker than normal, and Heart rate (NR: not provided) 96-100 bpm. On 21-OCT-2021, the patient experienced chills. On 21-OCT-2021, the patient experienced muscle aches. On 21-OCT-2021, the patient experienced fatigue. On 21-OCT-2021, the patient experienced slight fever of 99. On 21-OCT-2021, the patient experienced headache. Laboratory data included: Body temperature (NR: not provided) Fever of 99. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain, had not recovered from heart rate went up to 96-100 bpm/elevated resting heart rate, arm pain, and swollen arm, and the outcome of slight fever of 99, chills, headache, fatigue, muscle aches, burning sensation on left shoulder, going up into arm and up the neck, and into the jaw, blood thicker than normal and burning sensation to the side of breast was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: MUSCLE ACHES; FATIGUE; SLIGHT FEVER OF 99; HEADACHE; CHILLS; ARM PAIN; HEART RATE WENT UP TO 96-100 BPM/ELEVATED RESTING HEART RATE; BLOOD THICKER THAN NORMAL; SWOLLEN ARM; BURNING SENSATION ON LEFT SHOULDER, GOING UP INTO ARM AND UP THE NECK, AND INTO THE JAW; BURNING SENSATION TO THE SIDE OF BREAST; PAIN; This spontaneous report received from a consumer concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: heart murmur. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On OCT-2021, the patient experienced heart rate went up to 96-100 bpm/elevated resting heart rate. On OCT-2021, the patient experienced blood thicker than normal. On OCT-2021, the patient experienced swollen arm. On OCT-2021, the patient experienced burning sensation on left shoulder, going up into arm and up the neck, and into the jaw. On OCT-2021, the patient experienced burning sensation to the side of breast. On OCT-2021, the patient experienced arm pain. On OCT-2021, the patient experienced pain. Laboratory data included: Diagnostic procedure NOS (NR: not provided) Blood little thicker than normal, Electrocardiogram (NR: not provided) Blood little thicker than normal, and Heart rate (NR: not provided) 96-100 bpm. On 21-OCT-2021, the patient experienced chills. On 21-OCT-2021, the patient experienced muscle aches. On 21-OCT-2021, the patient experienced fatigue. On 21-OCT-2021, the patient experienced slight fever of 99. On 21-OCT-2021, the patient experienced headache. Laboratory data included: Body temperature (NR: not provided) Fever of 99. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain, had not recovered from heart rate went up to 96-100 bpm/elevated resting heart rate, arm pain, and swollen arm, and the outcome of slight fever of 99, chills, headache, fatigue, muscle aches, burning sensation on left shoulder, going up into arm and up the neck, and into the jaw, blood thicker than normal and burning sensation to the side of breast was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain, Pyrexia, Somnolence
Clinical narrative: SLEEPY; SUPER AWFUL; BODY ACHES; BAD FEVER; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sleepy, super awful, body aches, bad fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sleepy, super awful, body aches, bad fever and fatigue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER FOR ABOUT 3 HOURS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced chills, and fever for about 3 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever for about 3 hours. This report was non-serious. This case, from the same reporter is linked to 20211055553 and 20211055134.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Pain in extremity
Clinical narrative: SORE ARM; TWITCHING OF ARM/MINOR TWITCHING ALL OVER THE BODY(FEET, LEGS, BACK); This spontaneous report received from a patient concerned a 41 year old female. The patient's weight was 112 pounds, and height was 60.5 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-SEP-2021, the patient experienced twitching of arm/minor twitching all over the body (feet, legs, back). On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and had not recovered from twitching of arm/minor twitching all over the body(feet, legs, back). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Depressed mood, Headache
Clinical narrative: FELT A BIT DOWN FOR ABOUT 12 HOURS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced headache, and felt a bit down for about 12 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and felt a bit down for about 12 hours. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding, Rash erythematous
Clinical narrative: Like a third degree sunburn; Maternal exposure during breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Like a third degree sunburn) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Sep-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On 04-Oct-2021, the patient experienced RASH ERYTHEMATOUS (Like a third degree sunburn). On 26-Sep-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. At the time of the report, RASH ERYTHEMATOUS (Like a third degree sunburn) was resolving.        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.   No concomitant medication provided by reporter. No treatment medication provided by reporter.  Patient delivered a baby on 19-Sep-2021.Other than delivering a baby and having the shot nothing else was new. The rash was on her chest, stomach, arms and face.  She stated it was not on her legs, butt or back. Her obstetrician told her the rash could have been as a result of the mixture of the epidural, hormones and vaccine. She states she was still in the process of healing as she was regenerating new skin. The rash was similar to a third degree sunburn. The caller received the injection into the muscle of her right, upper arm at the facility.  Company Comment: This case concerns a 25 year old breastfeeding female with no other reported history who experienced the non-serious, unlisted AESI of Maternal exposure during breastfeeding the day of dose 1 of mRNA-1273. Re-challenge is unknown as no information on dose 2 is reported. Benefit-risk relationship of mRNA-1237 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Follow up received on 18-Oct-2021 and updated Reporter's Detail, Patient initial , Patient DOB, gender, New event and Dosage detail  were updated.; Sender's Comments: This case concerns a 25 year old breastfeeding female with no other reported history who experienced the non-serious, unlisted AESI of Maternal exposure during breastfeeding the day of dose 1 of mRNA-1273. Re-challenge is unknown as no information on dose 2 is reported. Benefit-risk relationship of mRNA-1237 is not affected by this report.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during breast feeding, Pain in extremity
Clinical narrative: Maternal exposure during breast feeding; had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (had a sore arm) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced PAIN IN EXTREMITY (had a sore arm). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). At the time of the report, PAIN IN EXTREMITY (had a sore arm) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter.  Treatment information was not provided by reporter.  Patient's weight was 200 COMPANY COMMENT: This case concerns a 25 year old breastfeeding female with no reported history who experienced the non-serious, unlisted AESI of Maternal exposure during breastfeeding and the event Pain in extremity the day of dose 1 of mRNA-1273. Re-challenge is positive for pain in extremity as it recurred with dose 2. Benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-355915 (Parent-Child Link). This case was linked to MOD-2021-356130 (Patient Link).   See case MOD-2021-355915 for details regarding the child case.; Sender's Comments: This case concerns a 25 year old breastfeeding female with no reported history who experienced the non-serious, unlisted AESI of Maternal exposure during breastfeeding and the event Pain in extremity the day of dose 1 of mRNA-1273. Re-challenge is positive for pain in extremity as it recurred with dose 2. Benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Eye infection
Clinical narrative: Eye infection; This spontaneous case was reported by a consumer and describes the occurrence of EYE INFECTION (Eye infection) 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.   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 EYE INFECTION (Eye infection). The patient was treated with DEXAMETHASONE, TOBRAMYCIN (TOBRAMYCIN + DEXAMETHASONE) for Eye infection, at an unspecified dose and frequency. At the time of the report, EYE INFECTION (Eye infection) outcome was unknown. Not Provided          No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow up received included non significant information.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient received a 4 day expired vaccine.; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a 4 day expired vaccine.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a 4 day expired vaccine.). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a 4 day expired vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Problem, Large reaction; 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 COMPLICATION (Problem, Large 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 (Problem, Large reaction). At the time of the report, VACCINATION COMPLICATION (Problem, Large reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment information was not reported.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received third dose from vial refrigerated for more than 30 days; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter reported that the vaccine was defrosted in 30-Aug-2021. Date the vial was initially stored in the refrigerator was 30-Aug-2021. The reporter stated that it is unknown if patient is immunocompromised.   This case was linked to MOD-2021-358921, MOD-2021-358773 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacist called in to report patients received an expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist called in to report patients received an expired dose of the Moderna vaccine) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist called in to report patients received an expired dose of the Moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist called in to report patients received an expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2 doses that expired 13Oct2021 were administered; 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 (2 doses that expired 13Oct2021 were administered) 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 19-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 doses that expired 13Oct2021 were administered). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2 doses that expired 13Oct2021 were administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Paraesthesia, Tremor
Clinical narrative: left arm started to tingle/tingling in his lower leg and foot/ felt pins and needles; The next day, his left hand was shaking; shooting pain every time he took a step; burning sensation over part of his chest/his ribs were burning/his left leg was burning; This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA (left arm started to tingle/tingling in his lower leg and foot/ felt pins and needles), BURNING SENSATION (burning sensation over part of his chest/his ribs were burning/his left leg was burning), TREMOR (The next day, his left hand was shaking) and PAIN (shooting pain every time he took a step) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cervical disc disease.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced BURNING SENSATION (burning sensation over part of his chest/his ribs were burning/his left leg was burning). On 01-Aug-2021, the patient experienced PARAESTHESIA (left arm started to tingle/tingling in his lower leg and foot/ felt pins and needles), TREMOR (The next day, his left hand was shaking) and PAIN (shooting pain every time he took a step). At the time of the report, PARAESTHESIA (left arm started to tingle/tingling in his lower leg and foot/ felt pins and needles), BURNING SENSATION (burning sensation over part of his chest/his ribs were burning/his left leg was burning), TREMOR (The next day, his left hand was shaking) and PAIN (shooting pain every time he took a step) had not resolved.        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.   No concomitant medications were reported. No treatment medications were reported. Lab data included CT scan of the brain, ultrasound of his leg, and bloodwork  were normal.  It was reported that his complete neurological exam on 20-Oct-2021 was normal. The physician reported that the patient went to the emergency room on 02-Aug-2021 but was not hospitalized. Neurological exam was normal including light touch, pin prick, vibratory sense, simultaneous  stimulation and temperature .   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Significant follow up received contain  Patient demographic details added, Medical history added, events outcome updated, event verbatim added, lab data added.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: receiving a dose of an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving a dose of an expired vaccine) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving a dose of an expired vaccine). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (receiving a dose of an expired vaccine) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was mentioned.  No treatment medication was mentioned.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered an expired vaccine) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Oct-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. On 16-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered an expired vaccine). On 16-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient administered an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  Reporter reported that Vaccine moved to refrigeration on 15Oct2021 and Used by13Oct2021   This case was linked to MOD-2021-013872 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Follow up document included no new information.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: band-aid mark on the injection site (right arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (band-aid mark on the injection site (right arm)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-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 VACCINATION SITE REACTION (band-aid mark on the injection site (right arm)). At the time of the report, VACCINATION SITE REACTION (band-aid mark on the injection site (right arm)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.   This case was linked to MOD-2021-358960 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Heart rate, Heart rate increased, Hypertension
Clinical narrative: had some kidney stones removed; heart rate increased significantly; body pain; joint pain; sore arm; blood pressure increased significantly; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (had some kidney stones removed) in a 61-year-old male 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 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (sore arm), MYALGIA (body pain) and ARTHRALGIA (joint pain). In May 2021, the patient experienced HEART RATE INCREASED (heart rate increased significantly). In 2021, the patient experienced HYPERTENSION (blood pressure increased significantly). On an unknown date, the patient experienced NEPHROLITHIASIS (had some kidney stones removed) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and PARACETAMOL (MINAMOL) at an unspecified dose and frequency. At the time of the report, NEPHROLITHIASIS (had some kidney stones removed), HYPERTENSION (blood pressure increased significantly), PAIN IN EXTREMITY (sore arm), HEART RATE INCREASED (heart rate increased significantly), MYALGIA (body pain) and ARTHRALGIA (joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood pressure measurement: increased (High) increased. In May 2021, Heart rate: increased (High) increased. In June 2021, Blood pressure measurement: increased (High) increased. In June 2021, Heart rate: increased (High) increased.         The patient reported that, they are a high risk patient..  The Patient 1 stated that on 01Nov2021 they will be going to the hospital for a  procedure on their kidneys.  No concomitant medications were provided by the reporter.  Company Comment: This case concerns a 61-year-old, male patient with no relevant medical history, who experienced the serious unexpected event of Nephrolithiasis. The event occurred after unspecified time after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the event occurred after the second dose. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-055014 (Patient Link).; Sender's Comments: This case concerns a 61-year-old, male patient with no relevant medical history, who experienced the serious unexpected event of Nephrolithiasis. The event occurred after unspecified time after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the event occurred after the second dose. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nephrolithiasis, Pain in extremity
Clinical narrative: had some kidney stones removed; heart rate increased significantly; body pain; joint pain; sore arm; blood pressure increased significantly; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (had some kidney stones removed) in a 61-year-old male 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 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (sore arm), MYALGIA (body pain) and ARTHRALGIA (joint pain). In May 2021, the patient experienced HEART RATE INCREASED (heart rate increased significantly). In 2021, the patient experienced HYPERTENSION (blood pressure increased significantly). On an unknown date, the patient experienced NEPHROLITHIASIS (had some kidney stones removed) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and PARACETAMOL (MINAMOL) at an unspecified dose and frequency. At the time of the report, NEPHROLITHIASIS (had some kidney stones removed), HYPERTENSION (blood pressure increased significantly), PAIN IN EXTREMITY (sore arm), HEART RATE INCREASED (heart rate increased significantly), MYALGIA (body pain) and ARTHRALGIA (joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood pressure measurement: increased (High) increased. In May 2021, Heart rate: increased (High) increased. In June 2021, Blood pressure measurement: increased (High) increased. In June 2021, Heart rate: increased (High) increased.         The patient reported that, they are a high risk patient..  The Patient 1 stated that on 01Nov2021 they will be going to the hospital for a  procedure on their kidneys.  No concomitant medications were provided by the reporter.  Company Comment: This case concerns a 61-year-old, male patient with no relevant medical history, who experienced the serious unexpected event of Nephrolithiasis. The event occurred after unspecified time after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the event occurred after the second dose. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-055014 (Patient Link).; Sender's Comments: This case concerns a 61-year-old, male patient with no relevant medical history, who experienced the serious unexpected event of Nephrolithiasis. The event occurred after unspecified time after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the event occurred after the second dose. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Influenza like illness
Clinical narrative: One patient developed the regular mild flu-like symptoms; Patient received vaccine that may not have an extended expiration date; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (One patient developed the regular mild flu-like symptoms) and EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that may not have an extended expiration date) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) 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) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that may not have an extended expiration date). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (One patient developed the regular mild flu-like symptoms). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that may not have an extended expiration date) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (One patient developed the regular mild flu-like symptoms) outcome was unknown.        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.   Concomitant and Treatment was not specified.  vial was removed from the freezer 40 minutes before administration.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: The follow up received on 25Oct2021 contains new event of flu-like symptoms
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Dose administered after a temperature excursion; Poor quality product administered; 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) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Sep-2021, the patient 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 received second 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) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the reporter had a temperature excursion of about 20 doses of Moderna, it got down to 32°F, then went up to 34°F, then up to 36°F, then up to 37°F over the course of an hour. The doses were put in a portable transport unit and left at 32° and the transport unit was not prepared for enough time to maintain the temperature. Expiration date of the dose administered was on 30-Oct-2021.  No concomitant medication was reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired doses were administered on 20Oct2021; 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 (Expired doses were administered on 20Oct2021) 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 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses were administered on 20Oct2021). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired doses were administered on 20Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  3 doses were administered after manufacturer date of expiry. On 19-Oct-2021, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. HCP declined to report AE.   Reporter did not allow further contact