chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: RN drew 0.4ml from bottom of one vial (037C21A) and 0.1ml from another adjacent vial (likely 024C21A) into a single syringe; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (RN drew 0.4ml from bottom of one vial (037C21A) and 0.1ml from another adjacent vial (likely 024C21A) into a single syringe) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A, 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021 at 3:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (RN drew 0.4ml from bottom of one vial (037C21A) and 0.1ml from another adjacent vial (likely 024C21A) into a single syringe). On 28-Oct-2021, PRODUCT ADMINISTRATION ERROR (RN drew 0.4ml from bottom of one vial (037C21A) and 0.1ml from another adjacent vial (likely 024C21A) into a single syringe) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was provided. No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 79-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 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED. At the time of the report, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment product use was provided by the reporter. The patient received an expire dose.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (temperature 101.5) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia (temperature 101.5). Patient treated with a dose of two Tylenol (paracetamol) for adverse event. At the time of the report, pyrexia (temperature 101.5) outcome: unknown. Diagnostic results: On an unknown date, body temperature: 101.5 (high). Concomitant product use not provided. This case linked to MOD-2021-375243 (patient link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, Product preparation error
Clinical narrative: 30 doses were drawn and administered from a 20-dose vial; 30 doses were drawn and administered from a 20-dose vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (30 doses were drawn and administered from a 20-dose vial) and PRODUCT PREPARATION ERROR (30 doses were drawn and administered from a 20-dose vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (30 doses were drawn and administered from a 20-dose vial) and PRODUCT PREPARATION ERROR (30 doses were drawn and administered from a 20-dose vial). On 04-Nov-2021, ACCIDENTAL UNDERDOSE (30 doses were drawn and administered from a 20-dose vial) and PRODUCT PREPARATION ERROR (30 doses were drawn and administered from a 20-dose vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.   This case was linked to MOD-2021-377749 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 58-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 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  Treatment information was not provided.  The patient received an expire dose.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of vaccination site swelling (developed swelling at injection site about a size of a golf ball 4 hours later) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient had vaccination site swelling (developed swelling at injection site about a size of a golf ball 4 hours later). At the time of the report, vaccination site swelling (developed swelling at injection site about a size of a golf ball 4 hours later) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 71-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 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED. At the time of the report, EXPIRED PRODUCT ADMINISTERED 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.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 23-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 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Dyspnoea, Dysuria, Headache, Hyperhidrosis
Clinical narrative: trouble urinating (painful); achy feeling like flu; headache; sweating like a dog; Cold sweats; trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating like a dog), COLD SWEAT (Cold sweats), DYSPNOEA (trouble breathing), DYSURIA (trouble urinating (painful)) and MYALGIA (achy feeling like flu) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 014M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced HYPERHIDROSIS (sweating like a dog), COLD SWEAT (Cold sweats), DYSPNOEA (trouble breathing), MYALGIA (achy feeling like flu) and HEADACHE (headache). On an unknown date, the patient experienced DYSURIA (trouble urinating (painful)). At the time of the report, HYPERHIDROSIS (sweating like a dog), COLD SWEAT (Cold sweats), DYSPNOEA (trouble breathing), DYSURIA (trouble urinating (painful)) and MYALGIA (achy feeling like flu) outcome was unknown and HEADACHE (headache) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication include diabetes medication,high blood pressure medication. Treatment information was not provided. Patient having kidney infection two and half months ago and was prescribed antibiotics, but pain was started again. Also patient has only one kidney as the other was removed  several years ago. Patient stated at the time of call temperature was 95.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: trouble urinating (painful); achy feeling like flu; headache; sweating like a dog; Cold sweats; trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating like a dog), COLD SWEAT (Cold sweats), DYSPNOEA (trouble breathing), DYSURIA (trouble urinating (painful)) and MYALGIA (achy feeling like flu) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 014M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced HYPERHIDROSIS (sweating like a dog), COLD SWEAT (Cold sweats), DYSPNOEA (trouble breathing), MYALGIA (achy feeling like flu) and HEADACHE (headache). On an unknown date, the patient experienced DYSURIA (trouble urinating (painful)). At the time of the report, HYPERHIDROSIS (sweating like a dog), COLD SWEAT (Cold sweats), DYSPNOEA (trouble breathing), DYSURIA (trouble urinating (painful)) and MYALGIA (achy feeling like flu) outcome was unknown and HEADACHE (headache) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication include diabetes medication,high blood pressure medication. Treatment information was not provided. Patient having kidney infection two and half months ago and was prescribed antibiotics, but pain was started again. Also patient has only one kidney as the other was removed  several years ago. Patient stated at the time of call temperature was 95.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: 13 year old received a Moderna shot; Received a booster dose as a second shot; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old received a Moderna shot) and ACCIDENTAL UNDERDOSE (Received a booster dose as a second shot) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old received a Moderna shot) and ACCIDENTAL UNDERDOSE (Received a booster dose as a second shot). On 04-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old received a Moderna shot) and ACCIDENTAL UNDERDOSE (Received a booster dose as a second shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided  Patient was supposed to received Pfizer vaccine but instead he received Moderna vaccine as booster dose.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neuralgia, Pain, Pain in extremity, Tenderness
Clinical narrative: A little tenderness/tender to touch; Radiating leg pain; Shooting pain; Like nerve pain (not muscle pain); A little pain at injection site, only if she touches it; Super slight headache; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (A little tenderness/tender to touch), PAIN IN EXTREMITY (Radiating leg pain), PAIN (Shooting pain), NEURALGIA (Like nerve pain (not muscle pain)) and VACCINATION SITE PAIN (A little pain at injection site, only if she touches it) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 immunisation: J&J (Batch Number-1805022) on 11-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J.  On 03-Nov-2021 at 4:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (A little tenderness/tender to touch), PAIN IN EXTREMITY (Radiating leg pain), PAIN (Shooting pain), NEURALGIA (Like nerve pain (not muscle pain)), VACCINATION SITE PAIN (A little pain at injection site, only if she touches it) and HEADACHE (Super slight headache). At the time of the report, TENDERNESS (A little tenderness/tender to touch), PAIN IN EXTREMITY (Radiating leg pain), PAIN (Shooting pain), NEURALGIA (Like nerve pain (not muscle pain)), VACCINATION SITE PAIN (A little pain at injection site, only if she touches it) and HEADACHE (Super slight headache) outcome was unknown.      No concomitant medications were reported.  No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: A little tenderness/tender to touch; Radiating leg pain; Shooting pain; Like nerve pain (not muscle pain); A little pain at injection site, only if she touches it; Super slight headache; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (A little tenderness/tender to touch), PAIN IN EXTREMITY (Radiating leg pain), PAIN (Shooting pain), NEURALGIA (Like nerve pain (not muscle pain)) and VACCINATION SITE PAIN (A little pain at injection site, only if she touches it) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 immunisation: J&J (Batch Number-1805022) on 11-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J.  On 03-Nov-2021 at 4:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (A little tenderness/tender to touch), PAIN IN EXTREMITY (Radiating leg pain), PAIN (Shooting pain), NEURALGIA (Like nerve pain (not muscle pain)), VACCINATION SITE PAIN (A little pain at injection site, only if she touches it) and HEADACHE (Super slight headache). At the time of the report, TENDERNESS (A little tenderness/tender to touch), PAIN IN EXTREMITY (Radiating leg pain), PAIN (Shooting pain), NEURALGIA (Like nerve pain (not muscle pain)), VACCINATION SITE PAIN (A little pain at injection site, only if she touches it) and HEADACHE (Super slight headache) outcome was unknown.      No concomitant medications were reported.  No treatment information was provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 46-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 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (administration of an expired vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient administered expired product (administration of an expired vaccine). At the time of the report, administered expired product (administration of an expired vaccine) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. The patient received an expired dose. This case linked to MOD-2021-369083 (patient link).
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Thrombosis
Clinical narrative: blood clots; Patient received second dose 23 days apart from 1st one; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose 23 days apart from 1st one). On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criterion medically significant). On 28-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose 23 days apart from 1st one) outcome was unknown. At the time of the report, THROMBOSIS (blood clots) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications was not provided.; Sender's Comments: This case concerns a 28-year-old, male patient with no relevant medical history, who experienced the serious adverse event of special interest of Thrombosis. Inappropriate schedule of product administration was considered as an additional event. The events occurred on an unknown date after the second dose of Spikevax. The rechallenge was assessed as not applicable as the AEs occurred after the second dose. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: gave the second on the 15th day; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave the second on the 15th day) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave the second on the 15th day). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave the second on the 15th day) 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.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: little soreness where he had the shot the 3 times he received the shots; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (little soreness where he had the shot the 3 times he received the shots) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced MYALGIA (little soreness where he had the shot the 3 times he received the shots). At the time of the report, MYALGIA (little soreness where he had the shot the 3 times he received the shots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported the LOT number for first dose, but is unsure. First dose received on16February2021, Lot: 023M20 "4" (A or 4, caller is not sure). No concomitant medication details were reported. No treatment medication details were reported.   This case was linked to MOD-2021-375356, MOD-2021-375384 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 62-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 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 53-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 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported  No treatment medication information was reported
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue
Clinical narrative: Tired; COVID-19; Lack of drug effect; This spontaneous case was reported by a nurse and describes the occurrence of DRUG INEFFECTIVE (Lack of drug effect), FATIGUE (Tired) and COVID-19 (COVID-19) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (COVID-19). On an unknown date, the patient experienced FATIGUE (Tired). At the time of the report, DRUG INEFFECTIVE (Lack of drug effect) and FATIGUE (Tired) outcome was unknown and COVID-19 (COVID-19) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COVID-19 (COVID-19) to be possibly related. No further causality assessments were provided for DRUG INEFFECTIVE (Lack of drug effect) and FATIGUE (Tired).    Concomitant medications include blood pressure pills (unspecified) and cholesterol pills (unspecified).  No treatment medications provided.  This is a Spontaneous case concerning a 72-year-old, male patient with medical history of taking medication for blood pressure and cholesterol (unknown exact indication),  who experienced the unexpected non serious (AESI) event of COVID 19 and Lack of efficacy, along with the non serious expected event of fatigue. The event occurred approximately 7 months after the first dose and 8 months after the second dose of Moderna COVID 19 vaccine, received with a correct latency between doses (28 days). The rechallenge is negative for the event Fatigue. The patient´s demographics and medical history of blood pressure and cholesterol pathology could be a confounder for the event.   The benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.   This case was linked to MOD-2021-375480 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 72-year-old, male patient with medical history of taking medication for blood pressure and cholesterol (unknown exact indication),  who experienced the unexpected non serious (AESI) event of COVID 19 and Lack of efficacy, along with the non serious expected event of fatigue. The event occurred approximately 7 months after the first dose and 8 months after the second dose of Moderna COVID 19 vaccine, received with a correct latency between doses (28 days). The rechallenge is negative for the event Fatigue. The patient´s demographics and medical history of blood pressure and cholesterol pathology could be a confounder for the event.   The benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 44-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 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), 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-2021-369083 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of NAUSEA (Nausea) and VOMITING (Vomiting) 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 NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. Treatment information provided included Hydration and antiemetics.  It was reported that it was patient's second dose of Moderna vaccine, and the patient had a reaction to the vaccine which included Nausea and vomiting and visited the Emergency room for hydration and antiemetics.  The vial from which the vaccine was taken was removed from the refrigerator and administered after it was in the refrigerator for a week. The refrigerator raged from 5.2C to 6.5C while the punctured vial was in it.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: patient got full dose instead of booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (patient got full dose instead of booster dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 02-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (patient got full dose instead of booster dose). On 02-Nov-2021, ACCIDENTAL OVERDOSE (patient got full dose instead of booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Gout, Pyrexia
Clinical narrative: gout flare up; loss of appetite; fatigue; chills; slight temperature; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (gout flare up), DECREASED APPETITE (loss of appetite), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (slight temperature) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 010M20A and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, the patient experienced GOUT (gout flare up), DECREASED APPETITE (loss of appetite), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (slight temperature). At the time of the report, GOUT (gout flare up) had not resolved and DECREASED APPETITE (loss of appetite), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (slight temperature) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.   This case was linked to MOD-2021-375387, MOD-2021-375399 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: Less than 6 months for administration of booster dose after 2nd dose; Swelling in right arm; Redness in right arm; Fatigue; Headache; Joint pain; Chills; Nauseousness; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 6 months for administration of booster dose after 2nd dose), VACCINATION SITE SWELLING (Swelling in right arm), VACCINATION SITE ERYTHEMA (Redness in right arm), FATIGUE (Fatigue) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 6 months for administration of booster dose after 2nd dose), VACCINATION SITE SWELLING (Swelling in right arm), VACCINATION SITE ERYTHEMA (Redness in right arm), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), CHILLS (Chills) and NAUSEA (Nauseousness). On 03-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 6 months for administration of booster dose after 2nd dose) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swelling in right arm), VACCINATION SITE ERYTHEMA (Redness in right arm), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), CHILLS (Chills) and NAUSEA (Nauseousness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications include High blood pressure medication. No Treatment information was reported.   This case was linked to MOD-2021-375447 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Less than 6 months for administration of booster dose after 2nd dose; Swelling in right arm; Redness in right arm; Fatigue; Headache; Joint pain; Chills; Nauseousness; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 6 months for administration of booster dose after 2nd dose), VACCINATION SITE SWELLING (Swelling in right arm), VACCINATION SITE ERYTHEMA (Redness in right arm), FATIGUE (Fatigue) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 6 months for administration of booster dose after 2nd dose), VACCINATION SITE SWELLING (Swelling in right arm), VACCINATION SITE ERYTHEMA (Redness in right arm), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), CHILLS (Chills) and NAUSEA (Nauseousness). On 03-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 6 months for administration of booster dose after 2nd dose) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swelling in right arm), VACCINATION SITE ERYTHEMA (Redness in right arm), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), CHILLS (Chills) and NAUSEA (Nauseousness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications include High blood pressure medication. No Treatment information was reported.   This case was linked to MOD-2021-375447 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Abdominal cramping; Diarrhea; Headache; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal cramping), DIARRHEA (Diarrhea), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced ABDOMINAL PAIN (Abdominal cramping), DIARRHEA (Diarrhea), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, ABDOMINAL PAIN (Abdominal cramping), DIARRHEA (Diarrhea), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.            Patient had received J&J vaccine for the first dose.  No concomitant product was provided by the reporter. No treatment medication was provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 59-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 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) 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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007MZ0A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, VITAMIN C [ASCORBIC ACID] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications provided.   This case was linked to MOD-2021-375409, MOD-2021-375383 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 53-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 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned.  No treatment details were reported.   This case was linked to MOD-2021-369083, MOD-2021-369095 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 65-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 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered, Occupational exposure to product
Clinical narrative: Needle or syringe popped off; Incomplete dose administered; Splashed into my face splashed into my eyes; 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 DEVICE CONNECTION ISSUE (needle or syringe popped off), INCORRECT DOSE ADMINISTERED (Incomplete dose administered) and OCCUPATIONAL EXPOSURE TO PRODUCT (splashed into my face splashed into my eyes) 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 DEVICE CONNECTION ISSUE (needle or syringe popped off), INCORRECT DOSE ADMINISTERED (Incomplete dose administered) and OCCUPATIONAL EXPOSURE TO PRODUCT (splashed into my face splashed into my eyes). At the time of the report, DEVICE CONNECTION ISSUE (needle or syringe popped off), INCORRECT DOSE ADMINISTERED (Incomplete dose administered) and OCCUPATIONAL EXPOSURE TO PRODUCT (splashed into my face splashed into my eyes) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: more than 42 days for administration of second dose after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose after 1st dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose after 1st dose). In July 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose after 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included high blood pressure medicine.  Treatment information was not provided   This case was linked to MOD-2021-375405 (Patient Link).