chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-1 test, Streptococcus test, X-ray limb
Clinical narrative: 102 fever; aches,pain; chills; headache; very very cold; uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (102 fever), PAIN (aches,pain), CHILLS (chills), HEADACHE (headache) and FEELING COLD (very very cold) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement (Two knee replacements). Concurrent medical conditions included Osteoarthritis. Concomitant products included MELOXICAM for Osteoarthritis.    On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (102 fever), PAIN (aches,pain), CHILLS (chills), HEADACHE (headache), FEELING COLD (very very cold) and DISCOMFORT (uncomfortable). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) at a dose of Extra strength and DOXYCYCLINE for Adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (102 fever), PAIN (aches,pain), CHILLS (chills), HEADACHE (headache), FEELING COLD (very very cold) and DISCOMFORT (uncomfortable) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Influenza virus test: negative (Negative) Negative. On an unknown date, SARS-CoV-1 test: negative (Negative) Negative. On an unknown date, Streptococcus test: negative (Negative) Negative. On an unknown date, X-ray limb: not measured not measured.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient put herself on doxycycline treatment for one week, All Those events lasted for a day and a half.   This case was linked to MOD-2021-023532, MOD-2022-468649 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Moderna Covid-19 vaccine past it's beyond use date  administered to four patients/First Patient; Dose-1 22-DEC-2021 and Dose-2 31-JAN-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine past it's beyond use date  administered to four patients/First Patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 22-DEC-2021 and Dose-2 31-JAN-2022) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A and 067H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine past it's beyond use date  administered to four patients/First Patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 22-DEC-2021 and Dose-2 31-JAN-2022). On 31-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine past it's beyond use date  administered to four patients/First Patient) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 22-DEC-2021 and Dose-2 31-JAN-2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported.   Reporter had stated that the 4 doses 1 vial, vaccines were past their beyond use date of 26JAN2022 in the refrigerator and the vial did not undergone any temperature excursions and the vial was initially stored in the refrigerator was 27DEC2021.  Patient received her both doses in her left arm shoulder deltoid muscle and did not complain of any other Adverse events. No treatment information was reported.   This case was linked to MOD-2022-468655 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2022: Follow up contains no new information.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: something keeps moving around the area of injection after booster/it is a feeling inside, he describes it like a worm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (something keeps moving around the area of injection after booster/it is a feeling inside, he describes it like a worm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A WA64340 and 017C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE for Hypertension, METFORMIN and ATORVASTATIN for an unknown indication.   On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, 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 COMPLICATION (something keeps moving around the area of injection after booster/it is a feeling inside, he describes it like a worm). At the time of the report, VACCINATION COMPLICATION (something keeps moving around the area of injection after booster/it is a feeling inside, he describes it like a worm) outcome was unknown.            Patient states that he was taking medications for high blood pressure and other. He has been on these for 2-3 years now No treatment was provided by the reporter.   This case was linked to MOD-2022-468618 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 4th full dose of 0.5 mL given to patient; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (4th full dose of 0.5 mL given to patient) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Patient is actively receiving cancer treatment.) and Immunocompromised. Concomitant products included TRAMETINIB DIMETHYL SULFOXIDE (MEKINIST) for Cancer (NOS).   On 26-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 01-Feb-2022, the patient experienced ACCIDENTAL OVERDOSE (4th full dose of 0.5 mL given to patient). On 01-Feb-2022, ACCIDENTAL OVERDOSE (4th full dose of 0.5 mL given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Muscle aches after 1st dose; Headache after 1st dose; Fatigue after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches after 1st dose), HEADACHE (Headache after 1st dose) and FATIGUE (Fatigue after 1st dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced MYALGIA (Muscle aches after 1st dose), HEADACHE (Headache after 1st dose) and FATIGUE (Fatigue after 1st dose). On 01-Mar-2021, MYALGIA (Muscle aches after 1st dose), HEADACHE (Headache after 1st dose) and FATIGUE (Fatigue after 1st dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The  concomitant medications on use were not provided. No treatment information was provided.  Patient was not under any regular or concomitant medication and stated she had no allergies history.   This case was linked to MOD-2022-468796, MOD-2022-468797 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Mechanical urticaria, Myalgia
Clinical narrative: Muscle aches after 1st dose; Headache after 1st dose; Fatigue after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches after 1st dose), HEADACHE (Headache after 1st dose) and FATIGUE (Fatigue after 1st dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced MYALGIA (Muscle aches after 1st dose), HEADACHE (Headache after 1st dose) and FATIGUE (Fatigue after 1st dose). On 01-Mar-2021, MYALGIA (Muscle aches after 1st dose), HEADACHE (Headache after 1st dose) and FATIGUE (Fatigue after 1st dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The  concomitant medications on use were not provided. No treatment information was provided.  Patient was not under any regular or concomitant medication and stated she had no allergies history.   This case was linked to MOD-2022-468796, MOD-2022-468797 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Patient experienced dermatographia: she broke up in constant hives; Muscle aches after Booster dose; Headache after booster dose; Fatigue after booster dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches after Booster dose), HEADACHE (Headache after booster dose), FATIGUE (Fatigue after booster dose) and MECHANICAL URTICARIA (Patient experienced dermatographia: she broke up in constant hives) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 028A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-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) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced MYALGIA (Muscle aches after Booster dose), HEADACHE (Headache after booster dose) and FATIGUE (Fatigue after booster dose). On 09-Nov-2021, the patient experienced MECHANICAL URTICARIA (Patient experienced dermatographia: she broke up in constant hives). The patient was treated with FEXOFENADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA-D [FEXOFENADINE;PSEUDOEPHEDRINE HYDROCHLORIDE]) for Antihistamine therapy and Dermatographia, at an unspecified dose and frequency. On 31-Oct-2021, MYALGIA (Muscle aches after Booster dose), HEADACHE (Headache after booster dose) and FATIGUE (Fatigue after booster dose) had resolved. At the time of the report, MECHANICAL URTICARIA (Patient experienced dermatographia: she broke up in constant hives) had not resolved.            Concomitant medication of the patient was not reported .   This case was linked to MOD-2022-468796, MOD-2022-468718 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Mechanical urticaria, Myalgia
Clinical narrative: Patient experienced dermatographia: she broke up in constant hives; Muscle aches after Booster dose; Headache after booster dose; Fatigue after booster dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches after Booster dose), HEADACHE (Headache after booster dose), FATIGUE (Fatigue after booster dose) and MECHANICAL URTICARIA (Patient experienced dermatographia: she broke up in constant hives) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 028A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-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) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced MYALGIA (Muscle aches after Booster dose), HEADACHE (Headache after booster dose) and FATIGUE (Fatigue after booster dose). On 09-Nov-2021, the patient experienced MECHANICAL URTICARIA (Patient experienced dermatographia: she broke up in constant hives). The patient was treated with FEXOFENADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA-D [FEXOFENADINE;PSEUDOEPHEDRINE HYDROCHLORIDE]) for Antihistamine therapy and Dermatographia, at an unspecified dose and frequency. On 31-Oct-2021, MYALGIA (Muscle aches after Booster dose), HEADACHE (Headache after booster dose) and FATIGUE (Fatigue after booster dose) had resolved. At the time of the report, MECHANICAL URTICARIA (Patient experienced dermatographia: she broke up in constant hives) had not resolved.            Concomitant medication of the patient was not reported .   This case was linked to MOD-2022-468796, MOD-2022-468718 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine in a vial punctured more than 12 hours ago administered; Vaccine in a vial improperly stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine in a vial punctured more than 12 hours ago administered) and PRODUCT STORAGE ERROR (Vaccine in a vial improperly stored) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021 at 2:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine in a vial punctured more than 12 hours ago administered) and PRODUCT STORAGE ERROR (Vaccine in a vial improperly stored). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine in a vial punctured more than 12 hours ago administered) and PRODUCT STORAGE ERROR (Vaccine in a vial improperly stored) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  No other adverse reactions were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2022: Follow-up received contains patient identifiers, dose number, administration site details added and narrative updated (No adverse reaction).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Muscle aches after 2nd dose; Headache after 2nd dose; Fatigue after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches after 2nd dose), HEADACHE (Headache after 2nd dose) and FATIGUE (Fatigue after 2nd dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced MYALGIA (Muscle aches after 2nd dose), HEADACHE (Headache after 2nd dose) and FATIGUE (Fatigue after 2nd dose). On 29-Mar-2021, MYALGIA (Muscle aches after 2nd dose), HEADACHE (Headache after 2nd dose) and FATIGUE (Fatigue after 2nd dose) had resolved.            Patient was not under any regular or concomitant medication, and stated that patient had no allergies history. Treatment medications were not reported.   This case was linked to MOD-2022-468797 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis contact, Inappropriate schedule of product administration, Influenza like illness, Pain in extremity, Pruritus
Clinical narrative: Allergic reaction to the laundry detergent; Sore arm; mild flu like symptoms; A mild rash/hives; Moderate itching; A mild rash/hives; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), INFLUENZA LIKE ILLNESS (mild flu like symptoms), URTICARIA (A mild rash/hives), DERMATITIS CONTACT (Allergic reaction to the laundry detergent) and PRURITUS (Moderate itching) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Crohns disease aggravated (in the mid to late 1990's), Heart attack on 30-Mar-2020, Stroke on 12-May-2012 and CPAP. Concurrent medical conditions included Blood pressure high (currently under control), Sleep apnea syndrome and Immunocompromised. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), ISOSORBIDE for Chest pain, ATORVASTATIN for Cholesterol, TERAZOSIN for Prostate infection, THIAMINE for Vitamin B1 deficiency, ACETYLSALICYLIC ACID (ASPIRIN N) and METOPROLOL.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced URTICARIA (A mild rash/hives), PRURITUS (Moderate itching), RASH (A mild rash/hives) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), INFLUENZA LIKE ILLNESS (mild flu like symptoms) and DERMATITIS CONTACT (Allergic reaction to the laundry detergent). On 07-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) and INFLUENZA LIKE ILLNESS (mild flu like symptoms) had resolved and URTICARIA (A mild rash/hives), DERMATITIS CONTACT (Allergic reaction to the laundry detergent), PRURITUS (Moderate itching) and RASH (A mild rash/hives) had not resolved.            Patient had sore arm and mild flu like symptoms for 2 days. Within 12 hours of receiving the shot patient had hives, rash and moderate itching. The symptoms persisted on a daily basis up until received 3rd dose.  Treatment medication was reported.   This case was linked to MOD-2022-468607, MOD-2022-468891 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Allergic reaction to the laundry detergent; Sore arm; mild flu like symptoms; A mild rash/hives; Moderate itching; A mild rash/hives; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), INFLUENZA LIKE ILLNESS (mild flu like symptoms), URTICARIA (A mild rash/hives), DERMATITIS CONTACT (Allergic reaction to the laundry detergent) and PRURITUS (Moderate itching) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Crohns disease aggravated (in the mid to late 1990's), Heart attack on 30-Mar-2020, Stroke on 12-May-2012 and CPAP. Concurrent medical conditions included Blood pressure high (currently under control), Sleep apnea syndrome and Immunocompromised. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), ISOSORBIDE for Chest pain, ATORVASTATIN for Cholesterol, TERAZOSIN for Prostate infection, THIAMINE for Vitamin B1 deficiency, ACETYLSALICYLIC ACID (ASPIRIN N) and METOPROLOL.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced URTICARIA (A mild rash/hives), PRURITUS (Moderate itching), RASH (A mild rash/hives) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), INFLUENZA LIKE ILLNESS (mild flu like symptoms) and DERMATITIS CONTACT (Allergic reaction to the laundry detergent). On 07-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) and INFLUENZA LIKE ILLNESS (mild flu like symptoms) had resolved and URTICARIA (A mild rash/hives), DERMATITIS CONTACT (Allergic reaction to the laundry detergent), PRURITUS (Moderate itching) and RASH (A mild rash/hives) had not resolved.            Patient had sore arm and mild flu like symptoms for 2 days. Within 12 hours of receiving the shot patient had hives, rash and moderate itching. The symptoms persisted on a daily basis up until received 3rd dose.  Treatment medication was reported.   This case was linked to MOD-2022-468607, MOD-2022-468891 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine in a vial punctured more than 12 hours ago and improperly stored administered to 3; Vaccine in a vial punctured more than 12 hours ago and improperly stored administered to 3; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine in a vial punctured more than 12 hours ago and improperly stored administered to 3) and PRODUCT STORAGE ERROR (Vaccine in a vial punctured more than 12 hours ago and improperly stored administered to 3) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021 at 9:19 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine in a vial punctured more than 12 hours ago and improperly stored administered to 3). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine in a vial punctured more than 12 hours ago and improperly stored administered to 3). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine in a vial punctured more than 12 hours ago and improperly stored administered to 3) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Vaccine in a vial punctured more than 12 hours ago and improperly stored administered to 3) 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. No other adverse reactions that reporter was aware of.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site pain
Clinical narrative: Upper arm still disconfirm; Aches in the arm or the discomfort on the arm, is minimal; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Upper arm still disconfirm) and VACCINATION SITE PAIN (Aches in the arm or the discomfort on the arm, is minimal) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included THIAMAZOLE (METHIMAZOLE) and ANASTROZOLE for an unknown indication.   On 01-Jan-2021, 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 an unknown date, the patient experienced VACCINATION SITE DISCOMFORT (Upper arm still disconfirm) and VACCINATION SITE PAIN (Aches in the arm or the discomfort on the arm, is minimal). At the time of the report, VACCINATION SITE DISCOMFORT (Upper arm still disconfirm) and VACCINATION SITE PAIN (Aches in the arm or the discomfort on the arm, is minimal) was resolving.      Treatment information was not reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine in a vial punctured more than 12 hours ago and improperly stored administered to 3 patient; Vaccine in a vial punctured more than 12 hours ago and improperly stored administered to 3 patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine in a vial punctured more than 12 hours ago and improperly stored administered to 3 patient) and PRODUCT STORAGE ERROR (Vaccine in a vial punctured more than 12 hours ago and improperly stored administered to 3 patient) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902, 046A21A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine in a vial punctured more than 12 hours ago and improperly stored administered to 3 patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine in a vial punctured more than 12 hours ago and improperly stored administered to 3 patient). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine in a vial punctured more than 12 hours ago and improperly stored administered to 3 patient) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Vaccine in a vial punctured more than 12 hours ago and improperly stored administered to 3 patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medications was reported.  No treatments medications was reported. The clinic received a shipment of Moderna vaccine on 10 AUG 2021 and placed the vaccine in the refrigerator. On 26 AUG 2022 the vial of Moderna Covid-19 vaccine was opened and was not discarded.  Patient did not had any side effects after 1 and 2 doses.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: under the age of 18 was administered moderna covid-19 vaccine as 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under the age of 18 was administered moderna covid-19 vaccine as 1st dose) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under the age of 18 was administered moderna covid-19 vaccine as 1st dose). On 07-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under the age of 18 was administered moderna covid-19 vaccine as 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Treatment medications was not provided.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Induration, Vaccination complication
Clinical narrative: experience a reaction/that side of the face slept; experience a hardness the left side of their face only/that bit by bit started to go down,; it was like a numbness/like been anesthetize; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experience a reaction/that side of the face slept), INDURATION (experience a hardness the left side of their face only/that bit by bit started to go down,) and HYPOAESTHESIA (it was like a numbness/like been anesthetize) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTIROXINA [LEVOTHYROXINE] for an unknown indication.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced INDURATION (experience a hardness the left side of their face only/that bit by bit started to go down,). 27-Jul-2021, the patient experienced HYPOAESTHESIA (it was like a numbness/like been anesthetize). On an unknown date, the patient experienced VACCINATION COMPLICATION (experience a reaction/that side of the face slept). On 27-Jul-2021, INDURATION (experience a hardness the left side of their face only/that bit by bit started to go down,) had resolved. At the time of the report, VACCINATION COMPLICATION (experience a reaction/that side of the face slept) and HYPOAESTHESIA (it was like a numbness/like been anesthetize) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided. patient want be get the Booster dose .Event like a numbness, like been anesthetize, or having that side of the face slept. Both time 20 minutes after getting the vaccine on the left  arm.   This case was linked to MOD-2022-468944 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Induration, Vaccination complication
Clinical narrative: experience a reaction/that side of the face slept; experience a hardness the left side of their face only/that bit by bit started to go down/second one lasted for 6 hrs; it was like a numbness/like been anesthetize or having that side of the face slept; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experience a reaction/that side of the face slept), INDURATION (experience a hardness the left side of their face only/that bit by bit started to go down/second one lasted for 6 hrs) and HYPOAESTHESIA (it was like a numbness/like been anesthetize or having that side of the face slept) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053e21a) for COVID-19 vaccination.     Concomitant products included LEVOTIROXINA [LEVOTHYROXINE] for an unknown indication.   On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced INDURATION (experience a hardness the left side of their face only/that bit by bit started to go down/second one lasted for 6 hrs) and HYPOAESTHESIA (it was like a numbness/like been anesthetize or having that side of the face slept). On an unknown date, the patient experienced VACCINATION COMPLICATION (experience a reaction/that side of the face slept). On 24-Aug-2021, INDURATION (experience a hardness the left side of their face only/that bit by bit started to go down/second one lasted for 6 hrs) and HYPOAESTHESIA (it was like a numbness/like been anesthetize or having that side of the face slept) had resolved. At the time of the report, VACCINATION COMPLICATION (experience a reaction/that side of the face slept) outcome was unknown.            No treatment medications provided by the reporter  Patient experienced hardness the left side of their face only, that bit by bit started to go down lasted 6 hours, it was like a numbness, like been anesthetize, or having that side of the face slept. Both time 20 minutes after getting the vaccine on the left arm, and only happened in the face.   This case was linked to MOD-2022-468905 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of menstrual disorder  (patient had a full menstrual cycle in December 2021) 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 the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. December 2021, patient experienced menstrual disorder (patient had a full menstrual cycle in December 2021). At the time of the report, menstrual disorder (patient had a full menstrual cycle in December 2021) outcome: unknown. The patient had a full primary series of the Moderna COVID-19 vaccine in the spring of 2021. Patient said she has not had a cycle in 1 and ½ years. No concomitant medication or treatment information reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Hypersomnia, Post-acute COVID-19 syndrome
Clinical narrative: long hauler/She was not hospitalized then but stayed in bed for 3 weeks/her doctor she was told that; once fell asleep while driving/goes to sleep sleep sleep for 14 hours on the average; she has no sense of taste; This spontaneous case was reported by a consumer and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (long hauler/She was not hospitalized then but stayed in bed for 3 weeks/her doctor she was told that), HYPERSOMNIA (once fell asleep while driving/goes to sleep sleep sleep for 14 hours on the average) and AGEUSIA (she has no sense of taste) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 027B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (long hauler/She was not hospitalized then but stayed in bed for 3 weeks/her doctor she was told that), HYPERSOMNIA (once fell asleep while driving/goes to sleep sleep sleep for 14 hours on the average) and AGEUSIA (she has no sense of taste). At the time of the report, POST-ACUTE COVID-19 SYNDROME (long hauler/She was not hospitalized then but stayed in bed for 3 weeks/her doctor she was told that), HYPERSOMNIA (once fell asleep while driving/goes to sleep sleep sleep for 14 hours on the average) and AGEUSIA (she has no sense of taste) outcome was unknown.            Patient did not eat or drink and lost weight.   No concomitant medication was provided by reporter. No treatment medication was provided by reporter.  Company Comment: This is a Spontaneous case concerning a 72-year-old female patient, with medical history of COVID-19, who experienced the unexpected, nonserious, and AESI events of Hypersomnia and Ageusia. The events occurred on an unknown date after the second dose of mRNA-1273 vaccine. 5-6 months after second dose, patient was diagnosed as a long hauler. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a 72-year-old female patient, with medical history of COVID-19, who experienced the unexpected, nonserious, and AESI events of Hypersomnia and Ageusia. The events occurred on an unknown date after the second dose of mRNA-1273 vaccine. 5-6 months after second dose, patient was diagnosed as a long hauler. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Bleeding after menopause; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Bleeding after menopause) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Bleeding after menopause). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Bleeding after menopause) outcome was unknown.            No concomitant products were reported.  Patient states she had a coworker that experienced the same thing of her after getting the vaccine and had bleeding after menopause.  No treatment information was reported by the reporter.   This case was linked to MOD-2022-468976 (Patient Link).
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Product administered to patient of inappropriate age
Clinical narrative: 16 year old boy died after receving moderna vaccine; Inappropriate age at vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (16 year old boy died after receving moderna vaccine) in a 16-year-old male 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 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 DEATH (16 year old boy died after receving moderna vaccine) (seriousness criteria death and medically significant) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment information was reported.   Reporter did not allow further contact; Reported Cause(s) of Death: unknown cause of death
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myopericarditis) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced MYOCARDITIS (Myopericarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myopericarditis) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 28 year old physical therapist dead after moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (28 year old physical therapist dead after moderna vaccine) in a 28-year-old patient of an unknown 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. Death occurred on an unknown date It is unknown if an autopsy was performed.            Treatment and concomitant drug details not reported.
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Blood disorder
Clinical narrative: Blood disorder; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD DISORDER (Blood disorder) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD DISORDER (Blood disorder). At the time of the report, BLOOD DISORDER (Blood disorder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant use were reported No Treatment were reported
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 19 year old student dies 6 weeks after her second moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (19 year old student dies 6 weeks after her second moderna COVID-19 vaccine) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date It is unknown if an autopsy was performed.            Reporter reported that 19-Year-Old student died 6 weeks after her second Moderna COVID-19 vaccine.  No concomitant medication details were provided by reporter.  No treatment medication details were provided by reporter.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: 25 Year old female suffers pericarditis after her second moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (25 Year old female suffers pericarditis after her second moderna COVID-19 vaccine) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (25 Year old female suffers pericarditis after her second moderna COVID-19 vaccine) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (25 Year old female suffers pericarditis after her second moderna COVID-19 vaccine) outcome was unknown.            No concomitant medication information was reported. No treatment medication information was reported.  Company comment: This spontaneous case concerns a 25-year-old, female patient, with no reported medical history, who experienced the expected, serious (Medically significant) AESI pericarditis. The event occurred after an unknown time of interval from receiving the second dose of mRNA-1273 vaccine, as nor vaccination or event dates were reported. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 25-year-old, female patient, with no reported medical history, who experienced the expected, serious (Medically significant) AESI pericarditis. The event occurred after an unknown time of interval from receiving the second dose of mRNA-1273 vaccine, as nor vaccination or event dates were reported. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: (Privacy) hospitalized after the moderna COVID-19 vaccine , Diagnosed with perimyocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Privacy) hospitalized after the moderna COVID-19 vaccine , Diagnosed with perimyocarditis) 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 MYOCARDITIS ((Privacy) hospitalized after the moderna COVID-19 vaccine , Diagnosed with perimyocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS ((Privacy) hospitalized after the moderna COVID-19 vaccine , Diagnosed with perimyocarditis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was reported No treatment medication information was reported  Company comment: This spontaneous case concerns a patient of an unknown age and gender with no medical history reported, who experienced the expected serious (hospitalization and medically significant) event/AESI of Myocarditis after a dose of mRNA- 1273 vaccine. Temporal association was not disclosed. No further information is available regarding clinical manifestations, diagnostic work-up and treatment provided. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no medical history reported, who experienced the expected serious (hospitalization and medically significant) event/AESI of Myocarditis after a dose of mRNA- 1273 vaccine. Temporal association was not disclosed. No further information is available regarding clinical manifestations, diagnostic work-up and treatment provided. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: RUNNIE NOSE; MORE PAIN IN A M ,AND NIGHT; headache; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (RUNNIE NOSE), PAIN (MORE PAIN IN A M ,AND NIGHT) and HEADACHE (headache) 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. In December 2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced RHINORRHOEA (RUNNIE NOSE) and PAIN (MORE PAIN IN A M ,AND NIGHT). In January 2022, HEADACHE (headache) had resolved. At the time of the report, RHINORRHOEA (RUNNIE NOSE) and PAIN (MORE PAIN IN A M ,AND NIGHT) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative.  No concomitant medications were reported.  No treatment medications were reported.