chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old  patient  was administered moderna covid-19 vaccine) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old  patient  was administered moderna covid-19 vaccine). On 29-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old  patient  was administered 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 provided. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect) 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 VACCINATION COMPLICATION (Side effect). At the time of the report, VACCINATION COMPLICATION (Side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: severe arm pain in the arm that he got the injection/ left arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (severe arm pain in the arm that he got the injection/ left arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A, 029A21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (severe arm pain in the arm that he got the injection/ left arm). At the time of the report, VACCINATION SITE PAIN (severe arm pain in the arm that he got the injection/ left arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Treatment details was not reported by the reporter.  It was reported that patient still has the pain even though it is 2 months out
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Disorganised speech, Pyrexia, Tremor
Clinical narrative: Shaking like a leaf; Dry cough; He can't talk right; Chills; Fever; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking like a leaf), COUGH (Dry cough), DISORGANISED SPEECH (He can't talk right), CHILLS (Chills) and PYREXIA (Fever) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 030M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Dec-2021, the patient experienced TREMOR (Shaking like a leaf), COUGH (Dry cough), DISORGANISED SPEECH (He can't talk right), CHILLS (Chills), PYREXIA (Fever) and VOMITING (Throwing up). At the time of the report, TREMOR (Shaking like a leaf), COUGH (Dry cough), DISORGANISED SPEECH (He can't talk right), CHILLS (Chills), PYREXIA (Fever) and VOMITING (Throwing up) outcome was unknown.            The patient also stated that 3 dose shot was worst shot he ever had.  The patient was administrating his medications.  No treatment information was reported.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Shaking like a leaf; Dry cough; He can't talk right; Chills; Fever; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking like a leaf), COUGH (Dry cough), DISORGANISED SPEECH (He can't talk right), CHILLS (Chills) and PYREXIA (Fever) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 030M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Dec-2021, the patient experienced TREMOR (Shaking like a leaf), COUGH (Dry cough), DISORGANISED SPEECH (He can't talk right), CHILLS (Chills), PYREXIA (Fever) and VOMITING (Throwing up). At the time of the report, TREMOR (Shaking like a leaf), COUGH (Dry cough), DISORGANISED SPEECH (He can't talk right), CHILLS (Chills), PYREXIA (Fever) and VOMITING (Throwing up) outcome was unknown.            The patient also stated that 3 dose shot was worst shot he ever had.  The patient was administrating his medications.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Patient had a reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient had a reaction) 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 VACCINATION COMPLICATION (Patient had a reaction). At the time of the report, VACCINATION COMPLICATION (Patient had a reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis, Paranasal sinus discomfort, Rhinorrhoea
Clinical narrative: down with a bad cold; Runny nose; Sinus pressure; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (down with a bad cold), RHINORRHOEA (Runny nose) and PARANASAL SINUS DISCOMFORT (Sinus pressure) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (down with a bad cold), RHINORRHOEA (Runny nose) and PARANASAL SINUS DISCOMFORT (Sinus pressure). At the time of the report, NASOPHARYNGITIS (down with a bad cold), RHINORRHOEA (Runny nose) and PARANASAL SINUS DISCOMFORT (Sinus pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient is scheduling for second dose.  No concomitant medications were reported. No treatment information was provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Feeling abnormal, Mobility decreased
Clinical narrative: He was hit hard & the last several days he has been flat on his back & can barely move; started feeling off/wasn't myself; had no appetite; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (started feeling off/wasn't myself), DECREASED APPETITE (had no appetite) and MOBILITY DECREASED (He was hit hard & the last several days he has been flat on his back & can barely move) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 037C21A and 042B21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis, Raynaud's disease and Lyme disease (Chronic). Concomitant products included ETANERCEPT (ENBREL) for an unknown indication.   On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Dec-2021, the patient experienced FEELING ABNORMAL (started feeling off/wasn't myself) and DECREASED APPETITE (had no appetite). On 26-Dec-2021, the patient experienced MOBILITY DECREASED (He was hit hard & the last several days he has been flat on his back & can barely move). At the time of the report, FEELING ABNORMAL (started feeling off/wasn't myself), DECREASED APPETITE (had no appetite) and MOBILITY DECREASED (He was hit hard & the last several days he has been flat on his back & can barely move) had not resolved.            No Treatment information was provided.  On 26Dec2021 he was hit hard & the last several days he has been flat on his back & can barely move. He has periodic flare ups from the Chronic Lyme & Psoriatic Arthritis that usually last 48 to 72 hours, but this has been going on the last several days. He made an appointment with his doctor, then canceled it after reading online there is nothing that can be done for him. He also called a local ER that told him that he could come in but there is nothing that they could do for him. He feels it is just a waiting game now.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Her itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Her itchy rash) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Her itchy rash). At the time of the report, RASH PRURITIC (Her itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Patient is scheduled for her second dose on February 24, 2021. Dermatologist prescribed Anitibiotics for itchy rash. Patient was asking  whether she is allowed to take this medication on 20-FEB-2021.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Hurts to move the arm  after 3rd shot; Left arm Injection site hurting after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Hurts to move the arm  after 3rd shot) and VACCINATION SITE PAIN (Left arm Injection site hurting after 3rd shot) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 026L20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Sep-2021, the patient experienced PAIN (Hurts to move the arm  after 3rd shot) and VACCINATION SITE PAIN (Left arm Injection site hurting after 3rd shot). At the time of the report, PAIN (Hurts to move the arm  after 3rd shot) and VACCINATION SITE PAIN (Left arm Injection site hurting after 3rd shot) had not resolved.            No concomitant medication was reported.   The treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: couple of symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (couple of symptoms) 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 VACCINATION COMPLICATION (couple of symptoms). At the time of the report, VACCINATION COMPLICATION (couple of symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Herpes zoster
Clinical narrative: severe back pain; shingle rash; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (severe back pain) and HERPES ZOSTER (shingle rash) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909, 004C21A and 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced BACK PAIN (severe back pain) and HERPES ZOSTER (shingle rash). At the time of the report, BACK PAIN (severe back pain) and HERPES ZOSTER (shingle rash) outcome was unknown.            Treatment information included pain medication.   No concomitant medication was provided by reporter.  Shingle rash was diagnosed by patient's primary care physician.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Patient wants to take Tylenol or Ibuprofen; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Patient wants to take Tylenol or Ibuprofen) 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 VACCINATION COMPLICATION (Patient wants to take Tylenol or Ibuprofen). At the time of the report, VACCINATION COMPLICATION (Patient wants to take Tylenol or Ibuprofen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: From today morning at 0430 am I am having high figure; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (From today morning at 0430 am I am having high figure) 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 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PYREXIA (From today morning at 0430 am I am having high figure). At the time of the report, PYREXIA (From today morning at 0430 am I am having high figure) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: questioning whether the vaccine was administered correctly. She is concerned that the vaccine was not injected in the muscle. She stated she found out that the injection was given in the upper arm instead of the muscle; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (questioning whether the vaccine was administered correctly. She is concerned that the vaccine was not injected in the muscle. She stated she found out that the injection was given in the upper arm instead of the muscle) 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 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (questioning whether the vaccine was administered correctly. She is concerned that the vaccine was not injected in the muscle. She stated she found out that the injection was given in the upper arm instead of the muscle). On 23-Jan-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (questioning whether the vaccine was administered correctly. She is concerned that the vaccine was not injected in the muscle. She stated she found out that the injection was given in the upper arm instead of the muscle) had resolved.            No concomitant and treatment medication details was reported. The injection was given in the upper arm instead of the muscle.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: was supposed to start an antibiotic yesterday; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (was supposed to start an antibiotic yesterday) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (was supposed to start an antibiotic yesterday). At the time of the report, VACCINATION COMPLICATION (was supposed to start an antibiotic yesterday) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was going to get the 2nd dose of the Moderna vaccine on Friday (12Feb2021) and patient was supposed to start an antibiotic yesterday.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered >12  hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12  hours post puncture) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2021 at 12:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2021 at 12:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12  hours post puncture). On 28-Dec-2021 at 12:00 PM, EXPIRED PRODUCT ADMINISTERED (Dose administered >12  hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Date and time vial was first punctured: 27-Dec-2021 at 3 PM. The vial was stored in the refrigerator post puncture for 23 hours and 45 minutes.  No treatment medication were reported.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: The caller's father reported soreness in his arm immediately for couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (The caller's father reported soreness in his arm immediately for couple of days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (The caller's father reported soreness in his arm immediately for couple of days). At the time of the report, PAIN IN EXTREMITY (The caller's father reported soreness in his arm immediately for couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: having headaches after booster dose, moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of HEADACHE (having headaches after booster dose, moderna) 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 HEADACHE (having headaches after booster dose, moderna). At the time of the report, HEADACHE (having headaches after booster dose, moderna) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: My first dose was Pfizer and my second dose was Moderna; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (My first dose was Pfizer and my second dose was Moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: pfizer. Past adverse reactions to the above products included No adverse event with pfizer.    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 INTERCHANGE OF VACCINE PRODUCTS (My first dose was Pfizer and my second dose was Moderna). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (My first dose was Pfizer and my second dose was Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant treatment was provided. No treatment medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: patient who received a booster dose towards the end of October.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (patient who received a booster dose towards the end of October.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced ACCIDENTAL UNDERDOSE (patient who received a booster dose towards the end of October.). In October 2021, ACCIDENTAL UNDERDOSE (patient who received a booster dose towards the end of October.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Reporter informed patient was immunocompromised and should have received a third full dose instead of booster dose.Also wanted to know how to manage going forward at this point since it is 2 months later.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: first two doses she had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (first two doses she had a sore arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, LOSARTAN and BUPROPION HYDROCHLORIDE (BUP) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (first two doses she had a sore arm). At the time of the report, PAIN IN EXTREMITY (first two doses she had a sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were provided.   This case was linked to MOD-2021-433312, MOD-2021-433313 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Insomnia, Myalgia, Neck pain
Clinical narrative: back hurts so bad; Can't sleep at night; neck hurts so bad; sore at the muscle and  muscle  hurts; joints huts; sore at the arm  and  arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore at the arm  and  arm hurts), BACK PAIN (back hurts so bad), INSOMNIA (Can't sleep at night), NECK PAIN (neck hurts so bad) and MYALGIA (sore at the muscle and  muscle  hurts) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Dec-2021, the patient experienced PAIN IN EXTREMITY (sore at the arm  and  arm hurts). On 20-Dec-2021, the patient experienced BACK PAIN (back hurts so bad), INSOMNIA (Can't sleep at night), NECK PAIN (neck hurts so bad), MYALGIA (sore at the muscle and  muscle  hurts) and ARTHRALGIA (joints huts). At the time of the report, PAIN IN EXTREMITY (sore at the arm  and  arm hurts), BACK PAIN (back hurts so bad), INSOMNIA (Can't sleep at night), NECK PAIN (neck hurts so bad), MYALGIA (sore at the muscle and  muscle  hurts) and ARTHRALGIA (joints huts) outcome was unknown.            Deep down in patient  joints, she had real sharp pain. No concomitant medication was provided. No treatment medication was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: back hurts so bad; Can't sleep at night; neck hurts so bad; sore at the muscle and  muscle  hurts; joints huts; sore at the arm  and  arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore at the arm  and  arm hurts), BACK PAIN (back hurts so bad), INSOMNIA (Can't sleep at night), NECK PAIN (neck hurts so bad) and MYALGIA (sore at the muscle and  muscle  hurts) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Dec-2021, the patient experienced PAIN IN EXTREMITY (sore at the arm  and  arm hurts). On 20-Dec-2021, the patient experienced BACK PAIN (back hurts so bad), INSOMNIA (Can't sleep at night), NECK PAIN (neck hurts so bad), MYALGIA (sore at the muscle and  muscle  hurts) and ARTHRALGIA (joints huts). At the time of the report, PAIN IN EXTREMITY (sore at the arm  and  arm hurts), BACK PAIN (back hurts so bad), INSOMNIA (Can't sleep at night), NECK PAIN (neck hurts so bad), MYALGIA (sore at the muscle and  muscle  hurts) and ARTHRALGIA (joints huts) outcome was unknown.            Deep down in patient  joints, she had real sharp pain. No concomitant medication was provided. No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: developed shingles after receiving second dose of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (developed shingles after receiving second dose of Moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (developed shingles after receiving second dose of Moderna). At the time of the report, HERPES ZOSTER (developed shingles after receiving second dose of Moderna) outcome was unknown. Not Provided          No concomitant medication information was provided. No treatment medication information was provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Tinnitus
Clinical narrative: Ringing in my ear; felt pretty lousy/not as bad as the second dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt pretty lousy/not as bad as the second dose) and TINNITUS (Ringing in my ear) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A, 031L20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Nov-2021, the patient experienced FEELING ABNORMAL (felt pretty lousy/not as bad as the second dose). On an unknown date, the patient experienced TINNITUS (Ringing in my ear). At the time of the report, FEELING ABNORMAL (felt pretty lousy/not as bad as the second dose) and TINNITUS (Ringing in my ear) had not resolved.        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-2021-433346 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Nightmare
Clinical narrative: Had the worst nightmare, all matters of death,Severe nightmare; This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (Had the worst nightmare, all matters of death,Severe nightmare) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0Z8AZ1A) for COVID-19 vaccination.     The patient's past medical history included Herpes infection (Herpes shingles in the right eye). Concurrent medical conditions included Post herpetic neuralgia. Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for Pain management, DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 29-Mar-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 NIGHTMARE (Had the worst nightmare, all matters of death,Severe nightmare). At the time of the report, NIGHTMARE (Had the worst nightmare, all matters of death,Severe nightmare) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication was not provided. It was reported that the patient was advised by doctor to receive booster shot because of the reactions experienced by the patient.   This case was linked to MOD-2021-433796 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: she can taste the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (she can taste the vaccine) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 047A21A and 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TASTE DISORDER (she can taste the vaccine). At the time of the report, TASTE DISORDER (she can taste the vaccine) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-433382, MOD-2021-433444 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Joint injury
Clinical narrative: broke her left wrist/arm is in a cast; This spontaneous case was reported by a consumer and describes the occurrence of JOINT INJURY (broke her left wrist/arm is in a cast) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT INJURY (broke her left wrist/arm is in a cast). At the time of the report, JOINT INJURY (broke her left wrist/arm is in a cast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatments medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial that was opened and not refrigerated for approximately 20 hours; vial that was opened and not refrigerated for approximately 20 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial that was opened and not refrigerated for approximately 20 hours) and PRODUCT STORAGE ERROR (vial that was opened and not refrigerated for approximately 20 hours) 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 EXPIRED PRODUCT ADMINISTERED (vial that was opened and not refrigerated for approximately 20 hours) and PRODUCT STORAGE ERROR (vial that was opened and not refrigerated for approximately 20 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vial that was opened and not refrigerated for approximately 20 hours) and PRODUCT STORAGE ERROR (vial that was opened and not refrigerated for approximately 20 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported No Treatment medications reported
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired booster shot; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster shot) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A, 040A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster shot). On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received expired booster shot) had resolved.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-434042 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects with Lot# 041L204; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (side effects with Lot# 041L204) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L204) 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 VACCINATION COMPLICATION (side effects with Lot# 041L204). At the time of the report, VACCINATION COMPLICATION (side effects with Lot# 041L204) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that the patients had side effects with Lot# 041L204.  Treatment medication was not provided by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Fatigue
Clinical narrative: mild tiredness; Received full third dose and not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (mild tiredness) and ACCIDENTAL OVERDOSE (Received full third dose and not immunocompromised) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (Received full third dose and not immunocompromised). On an unknown date, the patient experienced FATIGUE (mild tiredness). On 31-Aug-2021, ACCIDENTAL OVERDOSE (Received full third dose and not immunocompromised) had resolved. At the time of the report, FATIGUE (mild tiredness) outcome was unknown.            No concomitant medications was provided. No treatment medications was provided.
Sex: U
Vaccine: COVID19
Symptoms: Respiration abnormal
Clinical narrative: effected my friends ability to breathe immensely; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATION ABNORMAL (effected my friends ability to breathe immensely) 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 RESPIRATION ABNORMAL (effected my friends ability to breathe immensely). At the time of the report, RESPIRATION ABNORMAL (effected my friends ability to breathe immensely) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: atient with a shellfish allergy who received the vaccine and developed an allergy; This spontaneous case was reported by a physician and describes the occurrence of ALLERGY TO VACCINE (atient with a shellfish allergy who received the vaccine and developed an allergy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy.    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 ALLERGY TO VACCINE (atient with a shellfish allergy who received the vaccine and developed an allergy). At the time of the report, ALLERGY TO VACCINE (atient with a shellfish allergy who received the vaccine and developed an allergy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not reported  Treatment information was not reported   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive to COVID 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive to COVID 19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced COVID-19 (tested positive to COVID 19). At the time of the report, COVID-19 (tested positive to COVID 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that he was scheduled to receive his second shot of MODERNA COVID 19 Vaccine on 11FEB2021, but tested positive to COVID 19 on 23-JAN-2021, and was told to wait for fourteen days. No concomitant medication was provided by the reporter No treatment medication was provided by the reporter.  Company comment: This spontaneous case concerns a male patient of an unknown age with no details on medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred within the month after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding symptoms and clinical course.  The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of an unknown age with no details on medical history, who experienced the unexpected non serious event/AESI of COVID-19 after mRNA- 1273 Moderna vaccine. The event occurred within the month after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding symptoms and clinical course.  The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: it was an absolute nightmare,Severe side effects,the booster was worst than second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (it was an absolute nightmare,Severe side effects,the booster was worst than second vaccine) 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, 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 COMPLICATION (it was an absolute nightmare,Severe side effects,the booster was worst than second vaccine). At the time of the report, VACCINATION COMPLICATION (it was an absolute nightmare,Severe side effects,the booster was worst than second vaccine) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Dec-2021: Followup received contains No new information.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-423296 (Patient Link).