chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nasal congestion, Pyrexia, SARS-CoV-2 test
Clinical narrative: Numbness in toes,uderside toes,both feet; chills; really tired,very fatigued; developed fever; COVID-19; COVID-19 positive after second dose; slight cough; nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), HYPOAESTHESIA (Numbness in toes,uderside toes,both feet), COUGH (slight cough), NASAL CONGESTION (nasal congestion) and DRUG INEFFECTIVE (COVID-19 positive after second dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included METHYLPHENIDATE HYDROCHLORIDE (RITALIN) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 11-Aug-2021, the patient experienced COUGH (slight cough) and NASAL CONGESTION (nasal congestion). On 13-Aug-2021, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (COVID-19 positive after second dose). On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in toes,uderside toes,both feet), CHILLS (chills), FATIGUE (really tired,very fatigued) and PYREXIA (developed fever). At the time of the report, COVID-19 (COVID-19), HYPOAESTHESIA (Numbness in toes,uderside toes,both feet), COUGH (slight cough), NASAL CONGESTION (nasal congestion), DRUG INEFFECTIVE (COVID-19 positive after second dose), CHILLS (chills), FATIGUE (really tired,very fatigued) and PYREXIA (developed fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Aug-2021, SARS-CoV-2 test: positive (Positive) Caught delta variant and tested positive for covid.         Treatment medications were not reported.   This case was linked to MOD-2021-292464 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination complication
Clinical narrative: other symptoms; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (other symptoms) and MYALGIA (arm soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 (other symptoms) and MYALGIA (arm soreness). At the time of the report, VACCINATION COMPLICATION (other symptoms) and MYALGIA (arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided treatment information was not provided
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was hurting a lot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was hurting a lot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History was provided.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METOPROLOL, RALOXIFENE and SPIRONOLACTONE for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was hurting a lot). At the time of the report, PAIN IN EXTREMITY (arm was hurting a lot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Treatment Medications were provided.   This case was linked to MOD-2021-291651 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included METHYLPHENIDATE HYDROCHLORIDE (RITALIN) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.   This case was linked to MOD-2021-292445 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rash, Vaccination site rash
Clinical narrative: same rash in the arm in the same spot in addition of one or more rashes on other parts of her body; a few rashes on her head and torso and in the injection site a large rash started hurting again; hurting rash around the injection site; soreness on her arm; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on her arm), VACCINATION SITE RASH (hurting rash around the injection site), RASH (a few rashes on her head and torso and in the injection site a large rash started hurting again), RASH (same rash in the arm in the same spot in addition of one or more rashes on other parts of her body) and PYREXIA (fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013792002 and 012m20a) for COVID-19 vaccination.     Concomitant products included RIVAROXABAN (XARELTO) and SIMVASTATIN (SIMVASTATINE) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness on her arm) and PYREXIA (fever). On 07-Mar-2021, the patient experienced VACCINATION SITE RASH (hurting rash around the injection site). On 05-Aug-2021, the patient experienced RASH (a few rashes on her head and torso and in the injection site a large rash started hurting again). On 16-Aug-2021, the patient experienced RASH (same rash in the arm in the same spot in addition of one or more rashes on other parts of her body). On 27-Feb-2021, PAIN IN EXTREMITY (soreness on her arm) and PYREXIA (fever) had resolved. On 10-Mar-2021, VACCINATION SITE RASH (hurting rash around the injection site) had resolved. On 08-Aug-2021, RASH (a few rashes on her head and torso and in the injection site a large rash started hurting again) had resolved. At the time of the report, RASH (same rash in the arm in the same spot in addition of one or more rashes on other parts of her body) had not resolved.            Treatment information was not provided. The next day after her 2nd dose patient experienced a fever and soreness on her arm which lasted a day. On the 11th day after her 2nd dose patient experienced a hurting rash around the injection site which lasted 4 days. 2 weeks ago patient started to experience a few rashes on her head and torso and in the injection site a large rash started hurting again for 4 days. Patient still has a few rashes which are large and not very itchy in other parts of her body. 3 days ago, patient experienced the same rash in the arm in the same spot in addition of one or more rashes on other parts of her body.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: arm soreness; She has 2 boys younger than 18 years old, who received their first dose of the Moderna covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (She has 2 boys younger than 18 years old, who received their first dose of the Moderna covid-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (She has 2 boys younger than 18 years old, who received their first dose of the Moderna covid-19 vaccine). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness). On 13-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (She has 2 boys younger than 18 years old, who received their first dose of the Moderna covid-19 vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. Reporter reported that the patient exercised to make the arm pain go away. No treatment information was provided
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (left arm red), PAIN IN EXTREMITY (left arm sore), HEADACHE (headache), PYREXIA (light fever) and CHILLS (chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031L20A) for COVID-19 vaccination. No medical history was provided. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced ERYTHEMA (left arm red), PAIN IN EXTREMITY (left arm sore), HEADACHE (headache), PYREXIA (light fever) and CHILLS (chills). On 09-Mar-2021, ERYTHEMA (left arm red), PAIN IN EXTREMITY (left arm sore), HEADACHE (headache), PYREXIA (light fever) and CHILLS (chills) had resolved. Treatment information was not provided. This case was linked to MOD-2021-292499.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Your vaccine messed me up; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Your vaccine messed me up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Your vaccine messed me up). At the time of the report, FEELING ABNORMAL (Your vaccine messed me up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: found that other people experienced this / Some people had reactions 8-10 days later; 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 (found that other people experienced this / Some people had reactions 8-10 days later) 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 (found that other people experienced this / Some people had reactions 8-10 days later). At the time of the report, VACCINATION COMPLICATION (found that other people experienced this / Some people had reactions 8-10 days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.  It was stated that the patient did some research, and patient found that other people experienced this, they talked about a reaction after 10 days of receiving the Moderna Vaccine. Some people had reactions 8-10 days later.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Feeling hot, Peripheral swelling, Pyrexia
Clinical narrative: chills; fever; arm is red; arm is swollen; arm is warm to the touch; I continue to have redness around my injection site and down my arm.; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm is red), PERIPHERAL SWELLING (arm is swollen), FEELING HOT (arm is warm to the touch), VACCINATION SITE ERYTHEMA (I continue to have redness around my injection site and down my arm.) and CHILLS (chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 17-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced ERYTHEMA (arm is red), PERIPHERAL SWELLING (arm is swollen), FEELING HOT (arm is warm to the touch) and VACCINATION SITE ERYTHEMA (I continue to have redness around my injection site and down my arm.). On 18-Aug-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). On 18-Aug-2021, CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, ERYTHEMA (arm is red), PERIPHERAL SWELLING (arm is swollen), FEELING HOT (arm is warm to the touch) and VACCINATION SITE ERYTHEMA (I continue to have redness around my injection site and down my arm.) outcome was unknown.            It was reported that the patient had received a booster dose on 17-AUG-2021.   patient received first dose on 08-FEB-2021 and second dose on 08-MAR-2021.  No treatment information was provided.   This case was linked to MOD-2021-292485 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: chills; fever; arm is red; arm is swollen; arm is warm to the touch; I continue to have redness around my injection site and down my arm.; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm is red), PERIPHERAL SWELLING (arm is swollen), FEELING HOT (arm is warm to the touch), VACCINATION SITE ERYTHEMA (I continue to have redness around my injection site and down my arm.) and CHILLS (chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 17-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced ERYTHEMA (arm is red), PERIPHERAL SWELLING (arm is swollen), FEELING HOT (arm is warm to the touch) and VACCINATION SITE ERYTHEMA (I continue to have redness around my injection site and down my arm.). On 18-Aug-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). On 18-Aug-2021, CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, ERYTHEMA (arm is red), PERIPHERAL SWELLING (arm is swollen), FEELING HOT (arm is warm to the touch) and VACCINATION SITE ERYTHEMA (I continue to have redness around my injection site and down my arm.) outcome was unknown.            It was reported that the patient had received a booster dose on 17-AUG-2021.   patient received first dose on 08-FEB-2021 and second dose on 08-MAR-2021.  No treatment information was provided.   This case was linked to MOD-2021-292485 (Patient Link).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain, Swelling
Clinical narrative: sweating more; swelling; pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating more), SWELLING (swelling) and PAIN (pain) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939676) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating more), SWELLING (swelling) and PAIN (pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, HYPERHIDROSIS (sweating more), SWELLING (swelling) and PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was not reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Severe Wheezing; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Severe Wheezing) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included Prostate cancer (several years ago). Concurrent medical conditions included COPD (Chronic obstructive pulmonary disease). Concomitant products included AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOXICILLIN/CLAVULANIC ACID) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced WHEEZING (Severe Wheezing). At the time of the report, WHEEZING (Severe Wheezing) outcome was unknown.            The treatment history was not provided.  Patient had no events after first dose of COVID-19 vaccine, after second dose 4 weeks later experienced severe wheezing. The patient had Prostrate Cancer several years ago and  wants to know if patient should take a booster dose vaccine.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: put on about 5lbs/all the weight's gone to my waist/130 to 135 lbs; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (put on about 5lbs/all the weight's gone to my waist/130 to 135 lbs) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WEIGHT INCREASED (put on about 5lbs/all the weight's gone to my waist/130 to 135 lbs). At the time of the report, WEIGHT INCREASED (put on about 5lbs/all the weight's gone to my waist/130 to 135 lbs) outcome was unknown.            No Concomitant medications were provided. No treatment medications were provided. The patient tried to cut down on what she's been eating recently.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Lymphoedema
Clinical narrative: Lymphedema after vaccine / Lymphedema got worst after the second dose; she started the lymphedema therapy, and for her second dose; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (Lymphedema after vaccine / Lymphedema got worst after the second dose) and CONDITION AGGRAVATED (she started the lymphedema therapy, and for her second dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 030A21A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included ALPRAZOLAM (XANAX) and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-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 LYMPHOEDEMA (Lymphedema after vaccine / Lymphedema got worst after the second dose) and CONDITION AGGRAVATED (she started the lymphedema therapy, and for her second dose). At the time of the report, LYMPHOEDEMA (Lymphedema after vaccine / Lymphedema got worst after the second dose) and CONDITION AGGRAVATED (she started the lymphedema therapy, and for her second dose) outcome was unknown.            concomitant medications include - Blood pressure medication . No treatment medications provided. patient stated that- she did manual therapy after second dose, so the arm did not blow up.   This case was linked to MOD-2021-292373 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: administered Higher dose ( 1 ml ) -than-authorized dose ( 0.5 Ml ); This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (administered Higher dose ( 1 ml ) -than-authorized dose ( 0.5 Ml )) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (administered Higher dose ( 1 ml ) -than-authorized dose ( 0.5 Ml )). At the time of the report, ACCIDENTAL OVERDOSE (administered Higher dose ( 1 ml ) -than-authorized dose ( 0.5 Ml )) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided. Patient did not report any adverse effects post vaccination
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (administered Higher dose ( 1 ml ) -than-authorized dose ( 0.5 Ml )) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (administered Higher dose ( 1 ml ) -than-authorized dose ( 0.5 Ml )). At the time of the report, ACCIDENTAL OVERDOSE (administered Higher dose ( 1 ml ) -than-authorized dose ( 0.5 Ml )) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Caller stated that no side effects have been reported from the patient and had not mentioned whether it was his first or second dose. No concomitant medications were provided by reporter. No treatment medications were provided by reporter. This case was linked to MOD-2021-293191, MOD-2021-293335.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches) and PYREXIA (Fever) 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 20-Aug-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 21-Aug-2021, the patient experienced PAIN (Body aches) and PYREXIA (Fever). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN (Body aches) and PYREXIA (Fever) outcome was unknown.            Concomitant medications were not provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired 1st dose of vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired 1st dose of vaccine) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired 1st dose of vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired 1st dose of vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.  A nurse opened the vial at 10:30 AM 19-Aug-2021 and kept at refrigerated temperature.
Sex: U
Vaccine: COVID19
Symptoms: Periorbital swelling
Clinical narrative: I got puffy eyes after getting vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of PERIORBITAL SWELLING (I got puffy eyes after getting vaccinated) 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 July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced PERIORBITAL SWELLING (I got puffy eyes after getting vaccinated). At the time of the report, PERIORBITAL SWELLING (I got puffy eyes after getting vaccinated) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Consumer stated that he or she received Moderna vaccine three weeks ago. The Consumer stated that they got puffy eyes post-vaccination and it has been three weeks.  No concomitant product use was provided by the reporter.   No treatment medications were reported.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Developed covid July 25th; tested positive for Covid-19 after 2nd dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Developed covid July 25th) and DRUG INEFFECTIVE (tested positive for Covid-19 after 2nd dose of vaccine) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 25-Jul-2021, the patient experienced COVID-19 (Developed covid July 25th) and DRUG INEFFECTIVE (tested positive for Covid-19 after 2nd dose of vaccine). At the time of the report, COVID-19 (Developed covid July 25th) and DRUG INEFFECTIVE (tested positive for Covid-19 after 2nd dose of vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, SARS-CoV-2 test: negative (Negative) Tested Negative for COVID-19 last week. On 25-Jul-2021, SARS-CoV-2 test: positive (Positive) Tested Positive for COVID-19.         No Concomitant Medications were provided by the reporter. No Treatment Medications were provided by the reporter.  Based on biological implausibility, a causal relationship between the event of COVID 19 and the administration of the product is assessed as unlikely.  The event of drug ineffective is considered not applicable.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: Follow-up received and updated lab data values.; Sender's Comments: Based on biological implausibility, a causal relationship between the event of COVID 19 and the administration of the product is assessed as unlikely.  The event of drug ineffective is considered not applicable.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: more than 36 days since the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 36 days since the first dose) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (more than 36 days since the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 36 days since the first dose) had resolved.            Concomitant product was not provided by the reporter  Treatment information was not provided   Reporter did not allow further contact
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: throat pain; a runny nose; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (throat pain) and RHINORRHOEA (a runny nose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (throat pain) and RHINORRHOEA (a runny nose). At the time of the report, OROPHARYNGEAL PAIN (throat pain) and RHINORRHOEA (a runny nose) outcome was unknown.            Concomitant medications included psychiatric medications (unspecified). No treatment medications were provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Headache, Hyperhidrosis, Illness
Clinical narrative: feels like I'm sweating right now; a little bit clammy; yucky; a bit tired; had a fever; really bad headache; arm got quite sore for about a day and a half; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm got quite sore for about a day and a half), HYPERHIDROSIS (feels like I'm sweating right now), COLD SWEAT (a little bit clammy), ILLNESS (yucky) and FATIGUE (a bit tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced VACCINATION SITE PAIN (arm got quite sore for about a day and a half). On 20-Aug-2021, the patient experienced HYPERHIDROSIS (feels like I'm sweating right now), COLD SWEAT (a little bit clammy), ILLNESS (yucky), FATIGUE (a bit tired), PYREXIA (had a fever) and HEADACHE (really bad headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency. On 18-Aug-2021, VACCINATION SITE PAIN (arm got quite sore for about a day and a half) had resolved. At the time of the report, HYPERHIDROSIS (feels like I'm sweating right now), COLD SWEAT (a little bit clammy), ILLNESS (yucky), FATIGUE (a bit tired), PYREXIA (had a fever) and HEADACHE (really bad headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications provided.  Patient does not have a spleen.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: feels like I'm sweating right now; a little bit clammy; yucky; a bit tired; had a fever; really bad headache; arm got quite sore for about a day and a half; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm got quite sore for about a day and a half), HYPERHIDROSIS (feels like I'm sweating right now), COLD SWEAT (a little bit clammy), ILLNESS (yucky) and FATIGUE (a bit tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced VACCINATION SITE PAIN (arm got quite sore for about a day and a half). On 20-Aug-2021, the patient experienced HYPERHIDROSIS (feels like I'm sweating right now), COLD SWEAT (a little bit clammy), ILLNESS (yucky), FATIGUE (a bit tired), PYREXIA (had a fever) and HEADACHE (really bad headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency. On 18-Aug-2021, VACCINATION SITE PAIN (arm got quite sore for about a day and a half) had resolved. At the time of the report, HYPERHIDROSIS (feels like I'm sweating right now), COLD SWEAT (a little bit clammy), ILLNESS (yucky), FATIGUE (a bit tired), PYREXIA (had a fever) and HEADACHE (really bad headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications provided.  Patient does not have a spleen.
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Pyrexia
Clinical narrative: had to take days at work; got sick with high temperature; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED WORK ABILITY (had to take days at work) and PYREXIA (got sick with high temperature) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-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 IMPAIRED WORK ABILITY (had to take days at work) and PYREXIA (got sick with high temperature). At the time of the report, IMPAIRED WORK ABILITY (had to take days at work) and PYREXIA (got sick with high temperature) outcome was unknown.            No concomitant medications reported.  Treatment information not reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Rash, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (warm to the touch), RASH (Rash on her left arm) and VACCINATION SITE PAIN (Left arm was sore) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced FEELING HOT (warm to the touch), RASH (Rash on her left arm) and VACCINATION SITE PAIN (Left arm was sore). At the time of the report, FEELING HOT (warm to the touch), RASH (Rash on her left arm) and VACCINATION SITE PAIN (Left arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were provided.  No Treatment Medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Caller received her 1st dose of the Moderna vaccine on 03May2021 and hasn't received yet the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller received her 1st dose of the Moderna vaccine on 03May2021 and hasn't received yet the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller received her 1st dose of the Moderna vaccine on 03May2021 and hasn't received yet the 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller received her 1st dose of the Moderna vaccine on 03May2021 and hasn't received yet the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was reported. The treatment information was unknown. Patient scheduled to receive her 2nd dose on 20-AUG-2021 at 2.45 PM.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 100.3F for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 100.3F for a couple of days) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced PYREXIA (Fever 100.3F for a couple of days). On 16-Mar-2021, PYREXIA (Fever 100.3F for a couple of days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment information was not provided.  Patient is healthy and does not have a history of thyroid problems.   This case was linked to MOD-2021-293023 (Patient Link).
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: feeling dizzy; most tired; This spontaneous case was reported by a non-health professional and describes the occurrence of DIZZINESS (feeling dizzy) and FATIGUE (most tired) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Prostate implant brachytherapy (removed implant because of cancer.), Cancer, Urine incontinence, Carpal tunnel syndrome, Knee surgery NOS (He got both Right and Left Knee Replaced.), Back surgery (five surgeries in his back), Shoulder arthroscopy (On Both Right and Left Shoulders.), Prostatectomy (Prostate removed because of cancer.), Calcaneus fracture, Stent placement, Endolymphatic shunt placement (because of inner ear problems) and Tennis elbow. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), ACETYLSALICYLIC ACID (BABY ASPIRIN), CELECOXIB, GABAPENTIN, PARACETAMOL (ACETAMINOPHEN), MULTIVITAMINS [VITAMINS NOS], EVOLOCUMAB (REPATHA), TESTOSTERONE and IRON for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced DIZZINESS (feeling dizzy) and FATIGUE (most tired). At the time of the report, DIZZINESS (feeling dizzy) and FATIGUE (most tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient got the 2nd dose on 25Feb2021 with batch number 002A21A. No treatment medications were provided by reporter.   This case was linked to MOD-2021-292919 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Hot flush
Clinical narrative: Up and down heat flashes; Extremely hyper; chills; Fatigueness or wearing down; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Up and down heat flashes), FEELING ABNORMAL (Extremely hyper), CHILLS (chills) and FATIGUE (Fatigueness or wearing down) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy, Psoriatic arthritis and Chronic migraine.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced HOT FLUSH (Up and down heat flashes), FEELING ABNORMAL (Extremely hyper), CHILLS (chills) and FATIGUE (Fatigueness or wearing down). At the time of the report, HOT FLUSH (Up and down heat flashes), FEELING ABNORMAL (Extremely hyper), CHILLS (chills) and FATIGUE (Fatigueness or wearing down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported. It was reported that the patient took second dose of Moderna vaccine on 16-APR-2021 on the right arm and the batch no was reported to be 031B21A
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: was diagnosed with COVID19 one week after receiving the first dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (was diagnosed with COVID19 one week after receiving the first dose of the vaccine) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced COVID-19 (was diagnosed with COVID19 one week after receiving the first dose of the vaccine). The patient was treated with IVERMECTIN for Adverse event, at an unspecified dose and frequency and HYDROXYCHLOROQUINE for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (was diagnosed with COVID19 one week after receiving the first dose of the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, SARS-CoV-2 test: positive (Positive) Positive.     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 provided by reporter.Treatment includes use of antibiotics. The patient was diagnosed with COVID19 one week later.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Liver function test, Lymphadenopathy, Mononucleosis heterophile test, Musculoskeletal stiffness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck), SPLENOMEGALY (spleen was enlarged), LYMPHADENOPATHY (lymph nodes are swollen) and PYREXIA (ran low grade fever, 103.5 was the highest, fever ranges from 101.8 to 103.5) 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 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck) and LYMPHADENOPATHY (lymph nodes are swollen). On 10-Aug-2021, the patient experienced PYREXIA (ran low grade fever, 103.5 was the highest, fever ranges from 101.8 to 103.5). On an unknown date, the patient experienced SPLENOMEGALY (spleen was enlarged). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck), SPLENOMEGALY (spleen was enlarged), LYMPHADENOPATHY (lymph nodes are swollen) and PYREXIA (ran low grade fever, 103.5 was the highest, fever ranges from 101.8 to 103.5) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2021, Body temperature: 103.5 (High) Ranges from 101.8 to 103.5. On 10-Aug-2021, Liver function test: elevated (High) Elevated. On 10-Aug-2021, Mononucleosis heterophile test: positive (Positive) positive. On 10-Aug-2021, Red blood cell count: low (Low) Down a little bit. On 10-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Body temperature: 101.8 (High) 101.8. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Mono test was done which came back as positive and immune system was down. No Concomitant medication information was reported. The patient started to run a low grad e fever, mother said she also had the same low grade, fever got the fever and had the fever since, 10-Aug-2021.The fever ranges from 101.8 to 103.5. The patient took Tylenol for treatment. The patient had a stiff neck and her lymph nodes was swollen, that started around 09-AUG-2021 and was scheduled for the second on 31-AUG-2021. The red blood count was down a little bit. Three Covid tests within a week and all were negative. This case was linked to MOD-2021-293008. Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: Follow-up received on 20-AUG-2021 include reporter details, patient Lab details, treatment medications updated.