chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Diarrhoea, Feeding disorder
Clinical narrative: patient could only eat a little bit of food; diarrhea; very weak walking to the bathroom floor, had to sit on the bathroom floor for a few hours; woke up with no appetite; in bed until 2:30PM as she was so lethargic.; Patient woke up with a dull headache; nausea; muscle aches; Got chills at 10:15 PM, could not get warm; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (patient could only eat a little bit of food), DIARRHOEA (diarrhea), ASTHENIA (very weak walking to the bathroom floor, had to sit on the bathroom floor for a few hours), DECREASED APPETITE (woke up with no appetite) and LETHARGY (in bed until 2:30PM as she was so lethargic.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 017B21A and 014M2CA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced CHILLS (Got chills at 10:15 PM, could not get warm). On an unknown date, the patient experienced FEEDING DISORDER (patient could only eat a little bit of food), DIARRHOEA (diarrhea), ASTHENIA (very weak walking to the bathroom floor, had to sit on the bathroom floor for a few hours), DECREASED APPETITE (woke up with no appetite), LETHARGY (in bed until 2:30PM as she was so lethargic.), HEADACHE (Patient woke up with a dull headache), NAUSEA (nausea) and MYALGIA (muscle aches). At the time of the report, FEEDING DISORDER (patient could only eat a little bit of food), DIARRHOEA (diarrhea), ASTHENIA (very weak walking to the bathroom floor, had to sit on the bathroom floor for a few hours), DECREASED APPETITE (woke up with no appetite), LETHARGY (in bed until 2:30PM as she was so lethargic.), CHILLS (Got chills at 10:15 PM, could not get warm), HEADACHE (Patient woke up with a dull headache), NAUSEA (nausea) and MYALGIA (muscle aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment Information was provided by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Myalgia, Nausea
Clinical narrative: patient could only eat a little bit of food; diarrhea; very weak walking to the bathroom floor, had to sit on the bathroom floor for a few hours; woke up with no appetite; in bed until 2:30PM as she was so lethargic.; Patient woke up with a dull headache; nausea; muscle aches; Got chills at 10:15 PM, could not get warm; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (patient could only eat a little bit of food), DIARRHOEA (diarrhea), ASTHENIA (very weak walking to the bathroom floor, had to sit on the bathroom floor for a few hours), DECREASED APPETITE (woke up with no appetite) and LETHARGY (in bed until 2:30PM as she was so lethargic.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 017B21A and 014M2CA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced CHILLS (Got chills at 10:15 PM, could not get warm). On an unknown date, the patient experienced FEEDING DISORDER (patient could only eat a little bit of food), DIARRHOEA (diarrhea), ASTHENIA (very weak walking to the bathroom floor, had to sit on the bathroom floor for a few hours), DECREASED APPETITE (woke up with no appetite), LETHARGY (in bed until 2:30PM as she was so lethargic.), HEADACHE (Patient woke up with a dull headache), NAUSEA (nausea) and MYALGIA (muscle aches). At the time of the report, FEEDING DISORDER (patient could only eat a little bit of food), DIARRHOEA (diarrhea), ASTHENIA (very weak walking to the bathroom floor, had to sit on the bathroom floor for a few hours), DECREASED APPETITE (woke up with no appetite), LETHARGY (in bed until 2:30PM as she was so lethargic.), CHILLS (Got chills at 10:15 PM, could not get warm), HEADACHE (Patient woke up with a dull headache), NAUSEA (nausea) and MYALGIA (muscle aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment Information was provided by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in the ear when lay down it's when I lay down; This spontaneous case was reported by an other health care professional and describes the occurrence of TINNITUS (ringing in the ear when lay down it's when I lay down) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077021D, 010A21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Ringing in ears.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (ringing in the ear when lay down it's when I lay down). At the time of the report, TINNITUS (ringing in the ear when lay down it's when I lay down) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Influenza, Vaccination complication
Clinical narrative: flu symptoms; she felt sick; patient had cold in the body; fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Nov-2021 and was forwarded to Moderna on 07-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu symptoms), VACCINATION COMPLICATION (she felt sick), FEELING COLD (patient had cold in the body) and FATIGUE (fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, HYDRALAZINE, FLUOXETINE HYDROCHLORIDE (PROZAC) and LORAZEPAM for an unknown indication.    On 02-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 INFLUENZA (flu symptoms), VACCINATION COMPLICATION (she felt sick), FEELING COLD (patient had cold in the body) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA (flu symptoms), VACCINATION COMPLICATION (she felt sick), FEELING COLD (patient had cold in the body) and FATIGUE (fatigue) was resolving.            Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired doses administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. The patient did not receive any treatment medication.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (expired doses administered to patients) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 041C21A) for COVID-19 immunization. No medical history reported. On Nov 5, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 5, 2021, patient administered expired product (expired doses administered to patients). On Nov 5, 2021, administered expired product (expired doses administered to patients) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired doses administered to patients; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Malaise
Clinical narrative: not feeling too bad; lower back pain/minor lower back pain; This spontaneous case was reported by a nurse and describes the occurrence of MALAISE (not feeling too bad) and BACK PAIN (lower back pain/minor lower back pain) 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 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling too bad) and BACK PAIN (lower back pain/minor lower back pain). At the time of the report, MALAISE (not feeling too bad) and BACK PAIN (lower back pain/minor lower back pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: fever; Headache; Very tired; 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 PYREXIA (fever), HEADACHE (Headache) and FATIGUE (Very tired) 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 PYREXIA (fever), HEADACHE (Headache) and FATIGUE (Very tired). At the time of the report, PYREXIA (fever), HEADACHE (Headache) and FATIGUE (Very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided by the reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was a little sore) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was a little sore). At the time of the report, PAIN IN EXTREMITY (arm was a little sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-377133, US-MODERNATX, INC.-MOD-2021-377139 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-377139:Dose 3 case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A patient was administered an expired dose of the Moderna COVID-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine) 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 EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 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.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Hyperhidrosis, Malaise
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of malaise (feeling sick), hyperhidrosis (sweating), feeling abnormal (feeling yucky), nausea (nauseated) and chills in a  patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Nov 4, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced malaise (feeling sick), hyperhidrosis (sweating), feeling abnormal (feeling yucky), nausea (nauseated), chills and headache. At the time of the report, malaise (feeling sick), hyperhidrosis (sweating), feeling abnormal (feeling yucky), nausea (nauseated), chills and headache outcome: unknown. No concomitant medications or treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of malaise (feeling sick), hyperhidrosis (sweating), feeling abnormal (feeling yucky), nausea (nauseated) and chills in a  patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Nov 4, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced malaise (feeling sick), hyperhidrosis (sweating), feeling abnormal (feeling yucky), nausea (nauseated), chills and headache. At the time of the report, malaise (feeling sick), hyperhidrosis (sweating), feeling abnormal (feeling yucky), nausea (nauseated), chills and headache outcome: unknown. No concomitant medications or treatment information provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: On her right arm about 3 inches down from the injection site was red; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INJECTION SITE ERYTHEMA (On her right arm about 3 inches down from the injection site was red) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     The patient's past medical history included Stroke (She can't use her right arm.) in 2013.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced INJECTION SITE ERYTHEMA (On her right arm about 3 inches down from the injection site was red). At the time of the report, INJECTION SITE ERYTHEMA (On her right arm about 3 inches down from the injection site was red) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. Patient felt that the stroke could have had something to do with it (injection site red).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had covid after the second dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had covid after the second dose of the Moderna vaccine) 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 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. In June 2021, the patient experienced COVID-19 (had covid after the second dose of the Moderna vaccine). At the time of the report, COVID-19 (had covid after the second dose of the Moderna vaccine) outcome was unknown.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-377137, MOD-2021-377148 (Patient Link).; Sender's Comments: This case concerns a male patient, age unknown, with no relevant medical history, who experienced the non serious unexpected AESI of COVID-19. The event occurred at an unknown date after the second dose of Moderna COVID-19 vaccine. Information on vaccination dates was not provided. The rechallenge was not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: With the first dose had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (With the first dose had a sore arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included GABAPENTIN 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. On an unknown date, the patient experienced PAIN IN EXTREMITY (With the first dose had a sore arm). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (With the first dose had a sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-377156, MOD-2021-377159 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Vaccination site pain
Clinical narrative: Body aches; Headache; She had a sore arm for 2-3 days which was very tender; This spontaneous case was reported by another health care professional and describes the occurrence of PAIN (Body aches), HEADACHE (Headache) and VACCINATION SITE PAIN (She had a sore arm for 2-3 days which was very tender) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     The patient's past medical history included Anaphylaxis.    On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced PAIN (Body aches), HEADACHE (Headache) and VACCINATION SITE PAIN (She had a sore arm for 2-3 days which was very tender). At the time of the report, PAIN (Body aches), HEADACHE (Headache) and VACCINATION SITE PAIN (She had a sore arm for 2-3 days which was very tender) outcome was unknown.        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 concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2021-377173 (Patient Link).
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Wrong dose
Clinical narrative: Received the second dose twice; He received 0.25 ml twice, according to the nurse; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received the second dose twice) and WRONG DOSE (He received 0.25 ml twice, according to the nurse) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 0.25 mL twice. On 05-Nov-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Received the second dose twice) and WRONG DOSE (He received 0.25 ml twice, according to the nurse). On 05-Nov-2021, INCORRECT DOSE ADMINISTERED (Received the second dose twice) and WRONG DOSE (He received 0.25 ml twice, according to the nurse) had resolved.      No Concomitant medications were reported. No Treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses were administered from a vial that was punctured more than 20 times; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered from a vial that was punctured more than 20 times) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered from a vial that was punctured more than 20 times). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered from a vial that was punctured more than 20 times) 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: Severe vertigo on left side; Severe vomiting,Had to lay down because at upright position she was vomiting;; This spontaneous case was reported by a physician and describes the occurrence of VERTIGO (Severe vertigo on left side) and VOMITING (Severe vomiting,Had to lay down because at upright position she was vomiting;) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 026L20A and 026L20A) for COVID-19 vaccination.     No medical history was reported.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced VERTIGO (Severe vertigo on left side) and VOMITING (Severe vomiting,Had to lay down because at upright position she was vomiting;). The patient was treated with MECLIZINE [MECLOZINE] for Vertigo, at an unspecified dose and frequency. On 04-Nov-2021, VOMITING (Severe vomiting,Had to lay down because at upright position she was vomiting;) had resolved. At the time of the report, VERTIGO (Severe vertigo on left side) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: arm is still itching where needle went in; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 046A21A, and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS. At the time of the report, VACCINATION SITE PRURITUS outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 2 patients received full dose Moderna Covid-19 vaccine when they should have received the booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (2 patients received full dose Moderna Covid-19 vaccine when they should have received the booster dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE NRVV AD26 (JNJ 78436735) in March 2021.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 05-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (2 patients received full dose Moderna Covid-19 vaccine when they should have received the booster dose). On 05-Nov-2021, ACCIDENTAL OVERDOSE (2 patients received full dose Moderna Covid-19 vaccine when they should have received the booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided. The patient has subsequently received a full 0.5 ml (100 mcg) as the Pharmacy thought they were receiving first dose in their Moderna COVID-19 series.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation, Mass, Swelling, Tenderness
Clinical narrative: large inflammation between my shoulder and the base of my neck/ shoulder; very tender; It's soft, and it looks like a mass area; Shoulder pain; pain in the arm where I had the injection; in the area of her clavicle bone almost, the base of her neck to the begging of her shoulder, it's very very swollen. It's significantly swollen.; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (large inflammation between my shoulder and the base of my neck/ shoulder), TENDERNESS (very tender), SWELLING (in the area of her clavicle bone almost, the base of her neck to the begging of her shoulder, it's very very swollen. It's significantly swollen.), MASS (It's soft, and it looks like a mass area) and ARTHRALGIA (Shoulder pain) in a 55-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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, the patient experienced SWELLING (in the area of her clavicle bone almost, the base of her neck to the begging of her shoulder, it's very very swollen. It's significantly swollen.). On an unknown date, the patient experienced INFLAMMATION (large inflammation between my shoulder and the base of my neck/ shoulder), TENDERNESS (very tender), MASS (It's soft, and it looks like a mass area), ARTHRALGIA (Shoulder pain) and VACCINATION SITE PAIN (pain in the arm where I had the injection). At the time of the report, INFLAMMATION (large inflammation between my shoulder and the base of my neck/ shoulder), TENDERNESS (very tender), SWELLING (in the area of her clavicle bone almost, the base of her neck to the begging of her shoulder, it's very very swollen. It's significantly swollen.), MASS (It's soft, and it looks like a mass area), ARTHRALGIA (Shoulder pain) and VACCINATION SITE PAIN (pain in the arm where I had the injection) outcome was unknown.            The patient had pain in the arm where had the injection she expected that. On Saturday morning, in the area of her clavicle bone almost, the base of her neck to the begging of her shoulder. it was significantly swollen. It looks soft like a mass area were  tender. Concomitant and Treatment medications details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2021: F/U received on 08-NOV-2021: New events added, patient demographics updated.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: large inflammation between my shoulder and the base of my neck/ shoulder; very tender; It's soft, and it looks like a mass area; Shoulder pain; pain in the arm where I had the injection; in the area of her clavicle bone almost, the base of her neck to the begging of her shoulder, it's very very swollen. It's significantly swollen.; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (large inflammation between my shoulder and the base of my neck/ shoulder), TENDERNESS (very tender), SWELLING (in the area of her clavicle bone almost, the base of her neck to the begging of her shoulder, it's very very swollen. It's significantly swollen.), MASS (It's soft, and it looks like a mass area) and ARTHRALGIA (Shoulder pain) in a 55-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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, the patient experienced SWELLING (in the area of her clavicle bone almost, the base of her neck to the begging of her shoulder, it's very very swollen. It's significantly swollen.). On an unknown date, the patient experienced INFLAMMATION (large inflammation between my shoulder and the base of my neck/ shoulder), TENDERNESS (very tender), MASS (It's soft, and it looks like a mass area), ARTHRALGIA (Shoulder pain) and VACCINATION SITE PAIN (pain in the arm where I had the injection). At the time of the report, INFLAMMATION (large inflammation between my shoulder and the base of my neck/ shoulder), TENDERNESS (very tender), SWELLING (in the area of her clavicle bone almost, the base of her neck to the begging of her shoulder, it's very very swollen. It's significantly swollen.), MASS (It's soft, and it looks like a mass area), ARTHRALGIA (Shoulder pain) and VACCINATION SITE PAIN (pain in the arm where I had the injection) outcome was unknown.            The patient had pain in the arm where had the injection she expected that. On Saturday morning, in the area of her clavicle bone almost, the base of her neck to the begging of her shoulder. it was significantly swollen. It looks soft like a mass area were  tender. Concomitant and Treatment medications details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2021: F/U received on 08-NOV-2021: New events added, patient demographics updated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Pharmacist inadvertently gave two patients booster shots at 2.5 mL instead of 0.25 mL; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Pharmacist inadvertently gave two patients booster shots at 2.5 mL instead of 0.25 mL) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     The patient's past medical history included Walker user.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2.5 ml. On 05-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Pharmacist inadvertently gave two patients booster shots at 2.5 mL instead of 0.25 mL). On 05-Nov-2021, ACCIDENTAL OVERDOSE (Pharmacist inadvertently gave two patients booster shots at 2.5 mL instead of 0.25 mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 4 patients were administered vaccines from a vial that has been punctured for greater than 12hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients were administered vaccines from a vial that has been punctured for greater than 12hours) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 045A21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-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) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients were administered vaccines from a vial that has been punctured for greater than 12hours). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (4 patients were administered vaccines from a vial that has been punctured for greater than 12hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided.   Doses were administered from the same vial which was initially punctured on 26-OCT-2021 and administered up until 3-NOV-2021.
Sex: U
Vaccine: COVID19
Symptoms: Platelet count decreased
Clinical narrative: Platelets dropped; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (Platelets dropped) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PLATELET COUNT DECREASED (Platelets dropped). At the time of the report, PLATELET COUNT DECREASED (Platelets dropped) outcome was unknown. Not Provided          No concomitant medications were provided by reporter. No treatment medications were reported.  This case concerns a patient of an unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious AESI event of platelet count decreased. The event occurred at an unknown day after the third dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since the events happened after the third dose and no additional dosing is expected. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious AESI event of platelet count decreased. The event occurred at an unknown day after the third dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since the events happened after the third dose and no additional dosing is expected. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: First punctired on Nov 1/given to patients on Nov 2, 16.5 hours later; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (First punctired on Nov 1/given to patients on Nov 2, 16.5 hours later) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) .25 ml. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (First punctired on Nov 1/given to patients on Nov 2, 16.5 hours later). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (First punctired on Nov 1/given to patients on Nov 2, 16.5 hours later) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication was provided.  Vaccine was removed from freezer to fridge on 1-Nov-2021 2:32 pm, and first punctured on 1-Nov-2021 at 5pm. Same vial vaccine was given to patients around 9:30 am on 2-Nov-2021,16.5 hours later, instead of within 12 hours. Pharmacist was confused to use within 24 hours, so pulled about 10 of 0.25 ml booster shot from the vial, and used 8 of those to patients between 9:25 to 10:00 am. No patients had any adverse effect, but  was questioned about efficacy.  Company comment: This case concerns a 74-year-old, female patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after third dose of Moderna vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of Moderna vaccine is not affected by this report.   This case was linked to MOD-2021-373479 (Patient Link).; Sender's Comments: This case concerns a 74-year-old, female patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after third dose of Moderna vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine that were stored for more than 30 days in the fridge were administered to no less than 27 patients.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine that were stored for more than 30 days in the fridge were administered to no less than 27 patients.) 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 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 (Moderna vaccine that were stored for more than 30 days in the fridge were administered to no less than 27 patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine that were stored for more than 30 days in the fridge were administered to no less than 27 patients.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Product administration error
Clinical narrative: 35 patints exposed to vaccine from which vial may have been punctured more than 20 times; Accidental underdose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) and ACCIDENTAL UNDERDOSE (Accidental underdose) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) and ACCIDENTAL UNDERDOSE (Accidental underdose). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) and ACCIDENTAL UNDERDOSE (Accidental underdose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's date of birth was reported as 1940. No concomitant medications reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We had a dose administered from a vial that was opened yesterday; 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 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 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 information was reported. This case concerns a patient unknown age and gender, with no known medical history, who experienced the non-serious event of expired product administered. The events occurred  on the same day after unspecified dose of Moderna vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccine removed from freezer 8:00 am on 11-OCT-2021.  No concomitant and treatment medication reported   This case was linked to MOD-2021-364617 (Patient Link).