chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Illness, Lethargy
Clinical narrative: body aches; Lethargic; Got really sick; Chills; Fever; Tired; Vomiting,couldn't keep anything down; Headaches,symptoms felt stronger when she took vaccine than when she actually had covid; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), ILLNESS (Got really sick), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Tired) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced LETHARGY (Lethargic), ILLNESS (Got really sick), CHILLS (Chills), PYREXIA (Fever), FATIGUE (Tired), VOMITING (Vomiting,couldn't keep anything down) and HEADACHE (Headaches,symptoms felt stronger when she took vaccine than when she actually had covid). On an unknown date, the patient experienced MYALGIA (body aches). At the time of the report, LETHARGY (Lethargic), ILLNESS (Got really sick), CHILLS (Chills), PYREXIA (Fever), FATIGUE (Tired), VOMITING (Vomiting,couldn't keep anything down), HEADACHE (Headaches,symptoms felt stronger when she took vaccine than when she actually had covid) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vomiting
Clinical narrative: body aches; Lethargic; Got really sick; Chills; Fever; Tired; Vomiting,couldn't keep anything down; Headaches,symptoms felt stronger when she took vaccine than when she actually had covid; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), ILLNESS (Got really sick), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Tired) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced LETHARGY (Lethargic), ILLNESS (Got really sick), CHILLS (Chills), PYREXIA (Fever), FATIGUE (Tired), VOMITING (Vomiting,couldn't keep anything down) and HEADACHE (Headaches,symptoms felt stronger when she took vaccine than when she actually had covid). On an unknown date, the patient experienced MYALGIA (body aches). At the time of the report, LETHARGY (Lethargic), ILLNESS (Got really sick), CHILLS (Chills), PYREXIA (Fever), FATIGUE (Tired), VOMITING (Vomiting,couldn't keep anything down), HEADACHE (Headaches,symptoms felt stronger when she took vaccine than when she actually had covid) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hypersomnia, Lethargy, Migraine, Pyrexia
Clinical narrative: tremendous problem breathing; slept for 12 hours; lethargic; severe migraine headaches; fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (tremendous problem breathing), HYPERSOMNIA (slept for 12 hours), LETHARGY (lethargic), MIGRAINE (severe migraine headaches) and PYREXIA (fever) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concomitant products included DICYCLOVERINE HYDROCHLORIDE (BENTYL), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), LORAZEPAM (ATIVAN), SIMVASTATIN (ZOCOR), LOSARTAN POTASSIUM (COZAAR), DULOXETINE HYDROCHLORIDE (CYMBALTA), OXYCODONE, ALLOPURINOL (ZYLOPRIM) and MESALAZINE (APRISO) for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced DYSPNOEA (tremendous problem breathing), HYPERSOMNIA (slept for 12 hours), LETHARGY (lethargic), MIGRAINE (severe migraine headaches) and PYREXIA (fever). At the time of the report, DYSPNOEA (tremendous problem breathing), HYPERSOMNIA (slept for 12 hours), LETHARGY (lethargic), MIGRAINE (severe migraine headaches) and PYREXIA (fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.   This case was linked to MOD-2021-342866 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Inappropriate schedule of product administration, Peripheral swelling, Pruritus
Clinical narrative: arm swelled up really bad; arm hot to the touch; arm was red; arm was very itchy; She received her second dose on Tuesday, 28/SEP/2021, lot 061E21A, no expiration date reported; injection site was hard; injection site was a little hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site was a little hot), PERIPHERAL SWELLING (arm swelled up really bad), FEELING HOT (arm hot to the touch), ERYTHEMA (arm was red) and PRURITUS (arm was very itchy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A and 00VF21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced VACCINATION SITE WARMTH (injection site was a little hot), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received her second dose on Tuesday, 28/SEP/2021, lot 061E21A, no expiration date reported) and VACCINATION SITE INDURATION (injection site was hard). On 02-Oct-2021, the patient experienced PERIPHERAL SWELLING (arm swelled up really bad), FEELING HOT (arm hot to the touch), ERYTHEMA (arm was red) and PRURITUS (arm was very itchy). At the time of the report, VACCINATION SITE WARMTH (injection site was a little hot), PERIPHERAL SWELLING (arm swelled up really bad), FEELING HOT (arm hot to the touch), ERYTHEMA (arm was red), PRURITUS (arm was very itchy) and VACCINATION SITE INDURATION (injection site was hard) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received her second dose on Tuesday, 28/SEP/2021, lot 061E21A, no expiration date reported) had resolved.            No Concomitant medications were reported. No treatment medications were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site warmth
Clinical narrative: arm swelled up really bad; arm hot to the touch; arm was red; arm was very itchy; She received her second dose on Tuesday, 28/SEP/2021, lot 061E21A, no expiration date reported; injection site was hard; injection site was a little hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site was a little hot), PERIPHERAL SWELLING (arm swelled up really bad), FEELING HOT (arm hot to the touch), ERYTHEMA (arm was red) and PRURITUS (arm was very itchy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A and 00VF21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced VACCINATION SITE WARMTH (injection site was a little hot), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received her second dose on Tuesday, 28/SEP/2021, lot 061E21A, no expiration date reported) and VACCINATION SITE INDURATION (injection site was hard). On 02-Oct-2021, the patient experienced PERIPHERAL SWELLING (arm swelled up really bad), FEELING HOT (arm hot to the touch), ERYTHEMA (arm was red) and PRURITUS (arm was very itchy). At the time of the report, VACCINATION SITE WARMTH (injection site was a little hot), PERIPHERAL SWELLING (arm swelled up really bad), FEELING HOT (arm hot to the touch), ERYTHEMA (arm was red), PRURITUS (arm was very itchy) and VACCINATION SITE INDURATION (injection site was hard) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She received her second dose on Tuesday, 28/SEP/2021, lot 061E21A, no expiration date reported) had resolved.            No Concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus/noise in their heads; 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 TINNITUS (tinnitus/noise in their heads) 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 TINNITUS (tinnitus/noise in their heads). At the time of the report, TINNITUS (tinnitus/noise in their heads) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. No Treatment Information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-150248 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-150248:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 04-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication listed.   No treatment information provided.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of rash (rash on torso, back, stomach and chest), erythema (redness on torso, back, stomach, chest) and pruritus (itchiness on torso, back, stomach, chest) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 052E21A) for COVID-19 immunization. No medical history reported. On Sep 20, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced rash (rash on torso, back, stomach and chest), erythema (redness on torso, back, stomach, chest) and pruritus (itchiness on torso, back, stomach, chest). Patient treated with prednisone for itching, at an unspecified dose and frequency. At the time of the report, rash (rash on torso, back, stomach and chest), erythema (redness on torso, back, stomach, chest) and pruritus (itchiness on torso, back, stomach, chest): not resolved. Patient said about 10 days after he received his 3rd shot he developed a rash, itchiness and redness on his torso (back, stomach and chest). Patient doctor prescribed him prednisone to relieve the itchiness. And patient asked how long should this last. No concomitant medications mentioned.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received dose from a vial that was punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from a vial that was punctured for more than 12 hours) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from a vial that was punctured for more than 12 hours). On 04-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient received dose from a vial that was punctured for more than 12 hours) 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: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for COVID after receiving vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID after receiving vaccine) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID after receiving vaccine). At the time of the report, COVID-19 (Tested positive for COVID after receiving vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was given by reporter. No treatment medication was given by reporter Caller stated that her son who has been vaccinated tested positive for COVID 19 vaccine on 2OCT2021. She does not have his vaccination information.  She gave safety consent to follow-up with her. Filing AE with limited information. She thought she was calling her vaccination facility, she did not realized that she called Moderna until towards the end of the call.; Sender's Comments: This case concerns a 51-year-old male patient with unknown medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred 18 days after receiving the Moderna mRNA-1273 vaccine. The rechallenge is not applicable as the details only one dose was provided. The benefit-risk relationship of mRNA-1273 vaccine in not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Fatigue, Gait disturbance, Lip swelling, Pharyngeal swelling
Clinical narrative: Really fatigued; Seizure for 15 minutes; Puffiness in lip; Puffiness in throat; Uncontrollable jerking  for 15 minutes; Could not walk; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure for 15 minutes) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Seizure. Concurrent medical conditions included Allergy. Concomitant products included CLONIDINE, ROSUVASTATIN, LEVOTHYROXINE, PANTOPRAZOLE, ACETYLSALICYLIC ACID (BABY ASPIRIN), ALBUTEROL [SALBUTAMOL], FLUTICASONE, MULTIVITAMIN [VITAMINS NOS], APOAEQUORIN (PREVAGEN [APOAEQUORIN]) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.  On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, the patient experienced SEIZURE (Seizure for 15 minutes) (seriousness criterion medically significant), LIP SWELLING (Puffiness in lip), PHARYNGEAL SWELLING (Puffiness in throat), DYSKINESIA (Uncontrollable jerking  for 15 minutes) and GAIT DISTURBANCE (Could not walk). On 19-Sep-2021, the patient experienced FATIGUE (Really fatigued). At the time of the report, SEIZURE (Seizure for 15 minutes) and DYSKINESIA (Uncontrollable jerking  for 15 minutes) had resolved, LIP SWELLING (Puffiness in lip), PHARYNGEAL SWELLING (Puffiness in throat) and GAIT DISTURBANCE (Could not walk) outcome was unknown and FATIGUE (Really fatigued) was resolving.      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.   Concomitant products included cavatelli 25mg.  Treatment information was not provided.  Company Comment - This case concerns a 74-year-old, female patient with relevant medical history of drug allergy and seizure, who experienced the unexpected event of Seizure. The event occurred approximately 1 day after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. However, patient's medical history remains a contributory factor. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 74-year-old, female patient with relevant medical history of drug allergy and seizure, who experienced the unexpected event of Seizure. The event occurred approximately 1 day after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. However, patient's medical history remains a contributory factor. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Really fatigued; Seizure for 15 minutes; Puffiness in lip; Puffiness in throat; Uncontrollable jerking  for 15 minutes; Could not walk; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure for 15 minutes) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Seizure. Concurrent medical conditions included Allergy. Concomitant products included CLONIDINE, ROSUVASTATIN, LEVOTHYROXINE, PANTOPRAZOLE, ACETYLSALICYLIC ACID (BABY ASPIRIN), ALBUTEROL [SALBUTAMOL], FLUTICASONE, MULTIVITAMIN [VITAMINS NOS], APOAEQUORIN (PREVAGEN [APOAEQUORIN]) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.  On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, the patient experienced SEIZURE (Seizure for 15 minutes) (seriousness criterion medically significant), LIP SWELLING (Puffiness in lip), PHARYNGEAL SWELLING (Puffiness in throat), DYSKINESIA (Uncontrollable jerking  for 15 minutes) and GAIT DISTURBANCE (Could not walk). On 19-Sep-2021, the patient experienced FATIGUE (Really fatigued). At the time of the report, SEIZURE (Seizure for 15 minutes) and DYSKINESIA (Uncontrollable jerking  for 15 minutes) had resolved, LIP SWELLING (Puffiness in lip), PHARYNGEAL SWELLING (Puffiness in throat) and GAIT DISTURBANCE (Could not walk) outcome was unknown and FATIGUE (Really fatigued) was resolving.      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.   Concomitant products included cavatelli 25mg.  Treatment information was not provided.  Company Comment - This case concerns a 74-year-old, female patient with relevant medical history of drug allergy and seizure, who experienced the unexpected event of Seizure. The event occurred approximately 1 day after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. However, patient's medical history remains a contributory factor. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 74-year-old, female patient with relevant medical history of drug allergy and seizure, who experienced the unexpected event of Seizure. The event occurred approximately 1 day after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. However, patient's medical history remains a contributory factor. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (noise in my head/tinnitus) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A/049C21A and 007C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DICYCLOVERINE HYDROCHLORIDE (BENTYL), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), LORAZEPAM (ATIVAN), SIMVASTATIN (ZOCOR), LOSARTAN POTASSIUM (COZAAR), DULOXETINE HYDROCHLORIDE (CYMBALTA), OXYCODONE, ALLOPURINOL (ZYLOPRIM) and MESALAZINE (APRISO) for an unknown indication.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jun-2021, the patient experienced TINNITUS (noise in my head/tinnitus). At the time of the report, TINNITUS (noise in my head/tinnitus) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided.   This case was linked to MOD-2021-342829 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered). On 04-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Reporter stated there was a box of moderna vials and marked it with the date 10.3. reporter stated that was meant to be the 30-day expiration date, but a medical assistant was not aware because it was not marked with expires on 10.3. The vaccine was administered to one male patient. Patient waited about 20 minutes after he was administered the vaccine, no adverse reactions noted. Vial was moved from freezer to refrigerator on 3-sep-2021.  No treatment information was provided.  It was analyzed, regarding the dose administered on 04-oct-2021: Moderna cannot guarantee patient received full protection against the Covid-19 virus.     Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Follow Up received: Additional information added in inarrative.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Feeling hot, Nausea
Clinical narrative: She was heating up as soon as they put it in the arm; She did not want to think about anything/she did not want to do anything/wanted to lay in bed/ does not wantded to sit up; Immediately nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (She was heating up as soon as they put it in the arm), FEELING ABNORMAL (She did not want to think about anything/she did not want to do anything/wanted to lay in bed/ does not wantded to sit up) and NAUSEA (Immediately nauseous) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced FEELING HOT (She was heating up as soon as they put it in the arm), FEELING ABNORMAL (She did not want to think about anything/she did not want to do anything/wanted to lay in bed/ does not wantded to sit up) and NAUSEA (Immediately nauseous). At the time of the report, FEELING HOT (She was heating up as soon as they put it in the arm), FEELING ABNORMAL (She did not want to think about anything/she did not want to do anything/wanted to lay in bed/ does not wantded to sit up) and NAUSEA (Immediately nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Body temperature: increased (High) Body temperature rose..         Concomitant product use was not provided.  The symptoms were worse and lasted longer compared to first shot. The paramedic made the patient to sit half and hour before she drove to home.  Treatment information was not provided.   This case was linked to MOD-2021-342936 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest discomfort, Chest pain, Pain in extremity, Rash macular
Clinical narrative: burning; big red blotchy; soreness in the arm; pain in the chest, It feels like there is something in the chest; tightening in the chest; broke out in hives, little by little there were hives in different parts of the bod; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (broke out in hives, little by little there were hives in different parts of the bod), BURNING SENSATION (burning), RASH MACULAR (big red blotchy), CHEST PAIN (pain in the chest, It feels like there is something in the chest) and CHEST DISCOMFORT (tightening in the chest) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2021, the patient experienced URTICARIA (broke out in hives, little by little there were hives in different parts of the bod). On 01-Oct-2021, the patient experienced CHEST PAIN (pain in the chest, It feels like there is something in the chest) and CHEST DISCOMFORT (tightening in the chest). On an unknown date, the patient experienced BURNING SENSATION (burning), RASH MACULAR (big red blotchy) and PAIN IN EXTREMITY (soreness in the arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, URTICARIA (broke out in hives, little by little there were hives in different parts of the bod), BURNING SENSATION (burning), RASH MACULAR (big red blotchy) and PAIN IN EXTREMITY (soreness in the arm) was resolving and CHEST PAIN (pain in the chest, It feels like there is something in the chest) and CHEST DISCOMFORT (tightening in the chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was provided by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: burning; big red blotchy; soreness in the arm; pain in the chest, It feels like there is something in the chest; tightening in the chest; broke out in hives, little by little there were hives in different parts of the bod; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (broke out in hives, little by little there were hives in different parts of the bod), BURNING SENSATION (burning), RASH MACULAR (big red blotchy), CHEST PAIN (pain in the chest, It feels like there is something in the chest) and CHEST DISCOMFORT (tightening in the chest) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2021, the patient experienced URTICARIA (broke out in hives, little by little there were hives in different parts of the bod). On 01-Oct-2021, the patient experienced CHEST PAIN (pain in the chest, It feels like there is something in the chest) and CHEST DISCOMFORT (tightening in the chest). On an unknown date, the patient experienced BURNING SENSATION (burning), RASH MACULAR (big red blotchy) and PAIN IN EXTREMITY (soreness in the arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, URTICARIA (broke out in hives, little by little there were hives in different parts of the bod), BURNING SENSATION (burning), RASH MACULAR (big red blotchy) and PAIN IN EXTREMITY (soreness in the arm) was resolving and CHEST PAIN (pain in the chest, It feels like there is something in the chest) and CHEST DISCOMFORT (tightening in the chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of COVID-19 (she knows of 4 other people who were vaccinated and got COVID-19) in a female 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 dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 4, 2021, patient experienced COVID-19 (she knows of 4 other people who were vaccinated and got COVID-19). Patient treated with remdesivir for the adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (she knows of 4 other people who were vaccinated and got COVID-19) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medications not provided. Reporter did not allow further contact. Sender's comments: This spontaneous report concerns four female patients, of unknown age, who experienced COVID-19. The event occurred after unknown duration following vaccination with mRNA-1273. The reporter stated the patients contracted COVID-19 after vaccination. The re-challenge: unknown as there is no information on the vaccine doses. The benefit-risk relationship of mRNA-1273 not affected by this report.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired dose of the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment medications were reported.    .   This case was linked to MOD-2021-342712 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis, Malaise, Thyroiditis subacute
Clinical narrative: Hashimoto's thyroiditis; Subacute thyroiditis; feeling ill; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE THYROIDITIS (Hashimoto's thyroiditis) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MALAISE (feeling ill). In June 2021, the patient experienced AUTOIMMUNE THYROIDITIS (Hashimoto's thyroiditis) (seriousness criterion medically significant) and THYROIDITIS SUBACUTE (Subacute thyroiditis). At the time of the report, AUTOIMMUNE THYROIDITIS (Hashimoto's thyroiditis), THYROIDITIS SUBACUTE (Subacute thyroiditis) and MALAISE (feeling ill) outcome was unknown.            No concomitant medication reported. No treatment information was provided.  The patient started feeling ill in Apr2021 and was diagnosed to have Hashimoto's thyroiditis and subacute thyroiditis in Jun2021. She was currently being followed up by an endocrinologist with regular ultrasound. No medications are being taken.  Company comment This case concerns a  54-year-old, female patient with no relevant medical history, who experienced the unexpected event of Hashimoto's thyroiditis. The event occurred approximately 4 months after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable since event occurred after the second dose. This patient's age and sex remains a risk factor in the reported event. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a  54-year-old, female patient with no relevant medical history, who experienced the unexpected event of Hashimoto's thyroiditis. The event occurred approximately 4 months after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable since event occurred after the second dose. This patient's age and sex remains a risk factor in the reported event. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired dose of the vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Oct-2021 and was forwarded to Moderna on 05-Oct-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) 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 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine). On 05-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and Treatment was not specified.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: I felt a little off for 2 hours; sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I felt a little off for 2 hours) and VACCINATION SITE PAIN (sore left injection site arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced FEELING ABNORMAL (I felt a little off for 2 hours) and VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, FEELING ABNORMAL (I felt a little off for 2 hours) and VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) SARS-CoV-2 antibody test- Negative.         No concomitant medication was given by reporter. No treatment medication was given by reporter.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The vaccines were applied to patients after being refrozen; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (The vaccines were applied to patients after being refrozen) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Medical history was not provided.     On 23-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (The vaccines were applied to patients after being refrozen). On 23-Jun-2021, PRODUCT STORAGE ERROR (The vaccines were applied to patients after being refrozen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow up information was received include no new information.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired dose of the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and Treatment medication were reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hypersomnia, Nausea, Pain in extremity
Clinical narrative: She didn't have a whole lot of energy; Pain to the arm, the night after she got the shot; She was fatigue, really fatigue; Nausea for a couple of days/some nausea; went to take a nap for 28 minutes but woke up 5 hours later, never does that; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (went to take a nap for 28 minutes but woke up 5 hours later, never does that), ASTHENIA (She didn't have a whole lot of energy), PAIN IN EXTREMITY (Pain to the arm, the night after she got the shot), FATIGUE (She was fatigue, really fatigue) and NAUSEA (Nausea for a couple of days/some nausea) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced ASTHENIA (She didn't have a whole lot of energy), PAIN IN EXTREMITY (Pain to the arm, the night after she got the shot), FATIGUE (She was fatigue, really fatigue) and NAUSEA (Nausea for a couple of days/some nausea). In April 2021, the patient experienced HYPERSOMNIA (went to take a nap for 28 minutes but woke up 5 hours later, never does that). At the time of the report, HYPERSOMNIA (went to take a nap for 28 minutes but woke up 5 hours later, never does that), ASTHENIA (She didn't have a whole lot of energy), PAIN IN EXTREMITY (Pain to the arm, the night after she got the shot), FATIGUE (She was fatigue, really fatigue) and NAUSEA (Nausea for a couple of days/some nausea) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.    This case was linked to MOD-2021-342868, MOD-2021-343171, MOD-2021-343138 (Patient Link).; Sender's Comments: This case concerns an 46-year-old female patient with unknown medical history, who experienced the unexpected non-serious events of hypersomnia, asthenia, pain in extremity, fatigue and nausea. The event occurred between 1 to 3 days after receiving the first dose of Moderna mRNA-1273 vaccine. The rechallenge is not applicable as only first dose details were provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (patient received a dose of Moderna vaccine from a vial punctured and used for more than 12 hours) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037F21A) for COVID-19 immunization. No medical history reported. On Oct 4, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. Oct 4, 2021, patient administered expired product (patient received a dose of Moderna vaccine from a vial punctured and used for more than 12 hours). At the time of the report, administered expired product (patient received a dose of Moderna vaccine from a vial punctured and used for more than 12 hours): resolved. The reporter did not provide any causality assessments, concomitant medications or treatment information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients received a dose of the vaccine from a vials stored in the refrigerator beyond 30 days.; 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 EXPIRED PRODUCT ADMINISTERED (patients received a dose of the vaccine from a vials stored in the refrigerator beyond 30 days.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) 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 (patients received a dose of the vaccine from a vials stored in the refrigerator beyond 30 days.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received a dose of the vaccine from a vials stored in the refrigerator beyond 30 days.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. On 16-Aug-2021, the Vaccine was initially stored in the refrigerator. The vaccines was administered to several patients beyond this date (16-Sep-2021). The vaccines were administered on several dates to several patients. No treatment information was provided
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site pain, Wrong technique in product usage process
Clinical narrative: flu-like symptoms; soreness in the injection site; vial turned upside down 5-6 times/vial may have been shaken; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), INJECTION SITE PAIN (soreness in the injection site) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vial turned upside down 5-6 times/vial may have been shaken) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), INJECTION SITE PAIN (soreness in the injection site) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vial turned upside down 5-6 times/vial may have been shaken). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) and INJECTION SITE PAIN (soreness in the injection site) outcome was unknown and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vial turned upside down 5-6 times/vial may have been shaken) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Follow-up document received contains new events- soreness in the injection site and flu-like symptoms added.