chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Limb discomfort, Peripheral swelling, Pyrexia
Clinical narrative: arm blew up; it was red; chills; 103.3 degrees F fever; tired; it kept getting redder and bigger; got really sick; 3 full 0.5 mL doses; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (it kept getting redder and bigger), ILLNESS (got really sick), INCORRECT DOSE ADMINISTERED (3 full 0.5 mL doses), LIMB DISCOMFORT (arm blew up) and ERYTHEMA (it was red) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 006M20A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 12-Oct-2021, the patient experienced INCORRECT DOSE ADMINISTERED (3 full 0.5 mL doses). On an unknown date, the patient experienced PERIPHERAL SWELLING (it kept getting redder and bigger), ILLNESS (got really sick), LIMB DISCOMFORT (arm blew up), ERYTHEMA (it was red), CHILLS (chills), PYREXIA (103.3 degrees F fever) and FATIGUE (tired). The patient was treated with CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (TYLENOL [CHLORPHENAMINE MALEATE;DEXTROMETHORPHAN HYDROBROMIDE;PARACETAMOL;PSEUDOEPHEDRINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 12-Oct-2021, INCORRECT DOSE ADMINISTERED (3 full 0.5 mL doses) had resolved. At the time of the report, PERIPHERAL SWELLING (it kept getting redder and bigger), ILLNESS (got really sick), LIMB DISCOMFORT (arm blew up), ERYTHEMA (it was red), CHILLS (chills), PYREXIA (103.3 degrees F fever) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.3 (abnormal) degree Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient taking inhaler as a concomitant medication for COPD. Doctor told her to take Tylenol, antihistamine and to put ice on it.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The HCP administered an expired Moderna Vaccine to the patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 046A21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-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 14-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided by the reporter. No treatment information provided.  Nurse administered an expired dose of the Moderna Vaccine to 8 patients. Lot number 049E21A, number of doses/vials 8 doses o The vial was initially stored in the refrigerator on 08 Sep 2021 and the vaccine was administered on 14 Oct 2021. The vial did not undergone any temperature excursions.   This case was linked to MOD-2021-366988, MOD-2021-367143, MOD-2021-367474 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 022M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Immunocompromised. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 26-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            No treatment medication was reported. Doctor told patient to receive only half a dose as he was doing fine and his laboratory results were good.   This case was linked to MOD-2021-367663 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: They gave 81 doses of the Moderna Covid-19 Vaccine (all from lot 939902) after the vials were; 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 (they gave 81 doses of the Moderna Covid-19 Vaccine (all from lot 939902) after the vials were) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (they gave 81 doses of the Moderna Covid-19 Vaccine (all from lot 939902) after the vials were). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (they gave 81 doses of the Moderna Covid-19 Vaccine (all from lot 939902) after the vials were) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided.  Concomitant medication was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received dose from vial punctured more than 12 hours ago; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vial punctured more than 12 hours ago) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vial punctured more than 12 hours ago). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vial punctured more than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with an expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizures; 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 SEIZURE (seizures) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SEIZURE (seizures) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizures) outcome was unknown.            Concomitant medications was not provided by the reporter.  Treatment information was not provided.  Company comment: This case concerns a patient of an unknown age and gender with no previous relevant medical history reported, who experienced the unexpected event of seizure. The events occurred on an unknown number of days after the second dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender with no previous relevant medical history reported, who experienced the unexpected event of seizure. The events occurred on an unknown number of days after the second dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore injection site left arm,; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site left arm,) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS and Lung disorder NOS. Concomitant products included ALBUTEROL [SALBUTAMOL] for Lung disorder NOS.    In February 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 PAIN (sore injection site left arm,). At the time of the report, VACCINATION SITE PAIN (sore injection site left arm,) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medication reported.   This case was linked to MOD-2021-368036 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling
Clinical narrative: spot is hot to the touch; arm started to swell / left arm is (swole up) swollen; arm started  red; she's got a fever in it too.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (spot is hot to the touch), PERIPHERAL SWELLING (arm started to swell / left arm is (swole up) swollen), ERYTHEMA (arm started  red) and FEELING HOT (she's got a fever in it too.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced FEELING HOT (spot is hot to the touch), PERIPHERAL SWELLING (arm started to swell / left arm is (swole up) swollen), ERYTHEMA (arm started  red) and FEELING HOT (she's got a fever in it too.). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING HOT (spot is hot to the touch), PERIPHERAL SWELLING (arm started to swell / left arm is (swole up) swollen), ERYTHEMA (arm started  red) and FEELING HOT (she's got a fever in it too.) outcome was unknown.            No concomitant medication was given by reporter.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: unable to walk; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (unable to walk) in a 65-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (unable to walk). At the time of the report, GAIT INABILITY (unable to walk) outcome was unknown. Not Provided          No concomitant medication was reported. No treatment medication was reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Headache, Nasopharyngitis
Clinical narrative: Felt like a head cold; Fatigue; Chills; Tested positive for COVID-19; Soreness in arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19), NASOPHARYNGITIS (Felt like a head cold), VACCINATION SITE PAIN (Soreness in arm), HEADACHE (Headache) and FATIGUE (Fatigue) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL and HYDROCHLOROTHIAZIDE for Blood pressure, TESTOSTERONE for an unknown indication.    On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced HEADACHE (Headache). On 09-Oct-2021, the patient experienced VACCINATION SITE PAIN (Soreness in arm). On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced NASOPHARYNGITIS (Felt like a head cold), FATIGUE (Fatigue) and CHILLS (Chills). On 08-Oct-2021, HEADACHE (Headache) had resolved. On 13-Oct-2021, VACCINATION SITE PAIN (Soreness in arm) had resolved. At the time of the report, COVID-19 (Tested positive for COVID-19), NASOPHARYNGITIS (Felt like a head cold), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Oct-2021, SARS-CoV-1 test: negative (Negative) Negative. On 25-Oct-2021, SARS-CoV-1 test: positive (Positive) positive.     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.   Patient taking testosterone injection for Low testosterone. No treatment information was provided. Patient scheduled second dose of Moderna vaccine On 5-Nov-2021
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-1 test, Vaccination site pain
Clinical narrative: Felt like a head cold; Fatigue; Chills; Tested positive for COVID-19; Soreness in arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19), NASOPHARYNGITIS (Felt like a head cold), VACCINATION SITE PAIN (Soreness in arm), HEADACHE (Headache) and FATIGUE (Fatigue) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL and HYDROCHLOROTHIAZIDE for Blood pressure, TESTOSTERONE for an unknown indication.    On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced HEADACHE (Headache). On 09-Oct-2021, the patient experienced VACCINATION SITE PAIN (Soreness in arm). On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced NASOPHARYNGITIS (Felt like a head cold), FATIGUE (Fatigue) and CHILLS (Chills). On 08-Oct-2021, HEADACHE (Headache) had resolved. On 13-Oct-2021, VACCINATION SITE PAIN (Soreness in arm) had resolved. At the time of the report, COVID-19 (Tested positive for COVID-19), NASOPHARYNGITIS (Felt like a head cold), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Oct-2021, SARS-CoV-1 test: negative (Negative) Negative. On 25-Oct-2021, SARS-CoV-1 test: positive (Positive) positive.     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.   Patient taking testosterone injection for Low testosterone. No treatment information was provided. Patient scheduled second dose of Moderna vaccine On 5-Nov-2021
Sex: F
Vaccine: COVID19
Symptoms: Rib fracture, Vaccination site erythema, Vaccination site mass
Clinical narrative: She had a lump in her left arm; Redness; Broker her ribs; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (she had a lump in her left arm), RIB FRACTURE (Broker her ribs) and VACCINATION SITE ERYTHEMA (redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced RIB FRACTURE (Broker her ribs). On 22-Sep-2021, the patient experienced VACCINATION SITE MASS (she had a lump in her left arm) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE MASS (she had a lump in her left arm), RIB FRACTURE (Broker her ribs) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient thought on the second day after vaccination, had a lump in left arm and redness. Also stated did not remember but broke her ribs, and was taking muscle relaxer for the same.  No concomitant medications were reported.   This case was linked to MOD-2021-367645 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I had typical side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had typical side effects) 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 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced VACCINATION COMPLICATION (I had typical side effects). At the time of the report, VACCINATION COMPLICATION (I had typical side effects) outcome was unknown.            No concomitant medication were reported. No treatment information was reported.   This case was linked to MOD-2021-035647 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: went to get a booster dose but was given a 3rd dose (0.5ml) for the immunocompromised instead; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (went to get a booster dose but was given a 3rd dose (0.5ml) for the immunocompromised instead) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included Cyst removal (In July she had a knot in her shoulder area on top of the cephalic vein under her collar bone surgically removed.). Concurrent medical conditions included Systemic lupus erythematosis.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 28-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (went to get a booster dose but was given a 3rd dose (0.5ml) for the immunocompromised instead). On 28-Oct-2021, ACCIDENTAL OVERDOSE (went to get a booster dose but was given a 3rd dose (0.5ml) for the immunocompromised instead) had resolved.            No concomitant medications were reported.  No treatment medications were reported.    In Jul 2021 she had a knot in her shoulder area on top of the cephalic vein under her collar bone surgically removed. It was a lymph node. She states that it was huge & that it was about the size of a bird's egg. She states that she had other lymph nodes in her arm near her elbow that were enlarged but not removed. They did not find anything wrong with the removed lymph node.   This case was linked to MOD-2021-368093 (Patient Link).
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Product administered to patient of inappropriate age
Clinical narrative: A 15 year old patient was administered 1st dose of Moderna vaccine/Off-label use; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Oct-2021 and was forwarded to Moderna on 29-Oct-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 year old patient was administered 1st dose of Moderna vaccine/Off-label use) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     The patient's past medical history included Painful ankle and Drug use disorder (History of Drug Use). Concurrent medical conditions included Drug allergy (Tylenol) and Obesity (on 15-02-2020 the weight was 102.4kg on 04-08-2021 the weight was 133.4kg).    On 02-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 year old patient was administered 1st dose of Moderna vaccine/Off-label use). On 02-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 year old patient was administered 1st dose of Moderna vaccine/Off-label use) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Blood pressure measurement: elevated (High) ELEVATED BLOOD PRESSURE.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medications was not reported.   This case was linked to MOD-2021-303426 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: An expired booster was given to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired booster was given to a patient) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired booster was given to a patient). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (An expired booster was given to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: adverse reactions after second shot.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse reactions after second shot.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse reactions after second shot.). At the time of the report, VACCINATION COMPLICATION (adverse reactions after second shot.) outcome was unknown.            She does not want to share any information with the safety department. She states that the side effects she has are relating to what women usually have but does not want to go into further details. No concomitant medication were provided. No treatment details were provided.   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: received booster of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (received booster of 0.5 ml) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (received booster of 0.5 ml). On 23-Oct-2021, ACCIDENTAL OVERDOSE (received booster of 0.5 ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medications was reported.  No treatments medications was reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: received booster of 0.5 ml/received a full dose as their booster instead of the half dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (received booster of 0.5 ml/received a full dose as their booster instead of the half dose) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (received booster of 0.5 ml/received a full dose as their booster instead of the half dose). On 23-Oct-2021, ACCIDENTAL OVERDOSE (received booster of 0.5 ml/received a full dose as their booster instead of the half dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Side benefits, which were good; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Side benefits, which were good) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A, 016B21 and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Poison oak rash (Skin problems on arm from poison oak scabs for 10 years.). Concurrent medical conditions included Heart disease, unspecified (Patient was bleeding all the time due to medicine for heart stuff.).   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 28-Oct-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Side benefits, which were good). On 28-Oct-2021, THERAPEUTIC RESPONSE UNEXPECTED (Side benefits, which were good) had resolved.            No treatment information was reported by the reporter. Patient took medicine for indication of heart stuff. Patient had an epidemiologist appointment to have the problem taken care of. He had his Moderna shot and now skin problems on his arm from poison oak and bleeding was all cleared up after a month.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Pain in extremity
Clinical narrative: Patient received 0.25mL booster dose instead of 0.5mL third dose; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) and ACCIDENTAL UNDERDOSE (Patient received 0.25mL booster dose instead of 0.5mL third dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 013A21A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In October 2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 25-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25mL booster dose instead of 0.5mL third dose). On 25-Oct-2021, ACCIDENTAL UNDERDOSE (Patient received 0.25mL booster dose instead of 0.5mL third dose) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was sore) outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided.  It was reported that patient got a call from her doctor saying she should have gotten the whole vaccine (third dose) instead of the booster.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Everybody I knew got tired from the Covid-19 vaccines.; 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 FATIGUE (Everybody I knew got tired from the Covid-19 vaccines.) 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 FATIGUE (Everybody I knew got tired from the Covid-19 vaccines.). At the time of the report, FATIGUE (Everybody I knew got tired from the Covid-19 vaccines.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were not reported. Reporter mentioned that one friend received Moderna Covid-19 vaccine another received Pfizer vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: kidney pains/pain from your right side; 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 RENAL PAIN (kidney pains/pain from your right side) 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 27-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RENAL PAIN (kidney pains/pain from your right side). At the time of the report, RENAL PAIN (kidney pains/pain from your right side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided by the reporter. No treatment was provided by the reporter.  It was reported that patient received a dose of the vaccine yesterday
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 30-day Use By Date/01Oct2021 7 doses; 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 (Dose administered after 30-day Use By Date/01Oct2021 7 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/01Oct2021 7 doses). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/01Oct2021 7 doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No Treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: they gave 81 doses of the Moderna Covid-19 Vaccine  after the vials werestored in the refrigerator for 30 days; they gave 81 doses of the Moderna Covid-19 Vaccine  after the vials werestored in the refrigerator for 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (they gave 81 doses of the Moderna Covid-19 Vaccine  after the vials werestored in the refrigerator for 30 days) and EXPIRED PRODUCT ADMINISTERED (they gave 81 doses of the Moderna Covid-19 Vaccine  after the vials werestored in the refrigerator for 30 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (they gave 81 doses of the Moderna Covid-19 Vaccine  after the vials werestored in the refrigerator for 30 days) and EXPIRED PRODUCT ADMINISTERED (they gave 81 doses of the Moderna Covid-19 Vaccine  after the vials werestored in the refrigerator for 30 days). On 18-Oct-2021, PRODUCT STORAGE ERROR (they gave 81 doses of the Moderna Covid-19 Vaccine  after the vials werestored in the refrigerator for 30 days) and EXPIRED PRODUCT ADMINISTERED (they gave 81 doses of the Moderna Covid-19 Vaccine  after the vials werestored in the refrigerator for 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant drugs were reported. no treatment drugs were reported
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; 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 (side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.            No treatment information was provided. No concomitant medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 30-day Use By Date/25Oct2021 19 booster doses; 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 (Dose administered after 30-day Use By Date/25Oct2021 19 booster doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/25Oct2021 19 booster doses). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/25Oct2021 19 booster doses) had resolved.        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.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 30-day Use By Date / 81 doses of the Moderna Covid-19 Vaccine after the vials were stored in the refrigerator for 30 days; 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 (Dose administered after 30-day Use By Date / 81 doses of the Moderna Covid-19 Vaccine after the vials were stored in the refrigerator for 30 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date / 81 doses of the Moderna Covid-19 Vaccine after the vials were stored in the refrigerator for 30 days). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date / 81 doses of the Moderna Covid-19 Vaccine after the vials were stored in the refrigerator for 30 days) had resolved.        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. Reporter reported that Last one was in the refrigerator with a label on it (not to be used in patients). Date the vial was initially stored in the refrigerator was 2Aug2021. On 03-SEP-2021 4 doses were administered. On 20-SEP-2021 4 doses were administered. On 01-OCT-2021 7 doses were administered. On 18-OCT-2021 4 doses were administered. On 25-OCT-2021 19 booster doses were administered. On 26-OCT-2021 14 booster doses were administered. On 27-OCT-2021 19 booster doses were administered.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever; Body ache; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever) and MYALGIA (Body ache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and MYALGIA (Body ache). At the time of the report, PYREXIA (Fever) and MYALGIA (Body ache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.   This case was linked to MOD-2021-315935 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: An expired 2nd dose was given to a patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired 2nd dose was given to a patient) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired 2nd dose was given to a patient). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (An expired 2nd dose was given to a patient) 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.  The vial didn't undergo any temperature excursions.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  No treatment was provided by the reporter.  Vaccine was administered on Deltoid.   This case was linked to MOD-2021-361706 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications was provided by the reporter. No Treatment medications was provided by the reporter.   This case was linked to MOD-2021-361706 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 61-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 21-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.    This case was linked to MOD-2021-361706 (Patient Link).