chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability
Clinical narrative: he couldn't work for 3 days after taking the Moderna booster dose; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED WORK ABILITY (he couldn't work for 3 days after taking the Moderna booster dose) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMPAIRED WORK ABILITY (he couldn't work for 3 days after taking the Moderna booster dose). At the time of the report, IMPAIRED WORK ABILITY (he couldn't work for 3 days after taking the Moderna booster dose) had resolved.            Concomitant medications were not reported. Treatment medications were not reported
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (fever) 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 PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown. Not Provided      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.   She was currently taking 3 a day every 8hs, 1 hidoxicin at night before sleeping and pepsomodisin. She was also given a decadron shoot when she first went to the emergency room.  No concomitant medication was reported.   This case was linked to MOD-2022-438651, MOD-2022-436323 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever) and CHILLS (chills) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The patient had fever and chills only the day after the vaccination.  No treatment information was provided by the reporter.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients were administered doses from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment reported   This case was linked to MOD-2022-438672, MOD-2022-438670, MOD-2022-438673, MOD-2022-438676 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients were administered doses from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2022-438672, MOD-2022-438670, MOD-2022-438673, MOD-2022-438676, MOD-2022-438675 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients were administered doses from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 03 Jan 2022.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2022-438672, MOD-2022-438657, MOD-2022-438669, MOD-2022-438671, MOD-2022-438673, MOD-2022-438674, MOD-2022-438675, MOD-2022-438676, MOD-2022-438677 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients were administered doses from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial) 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 provided.  It was reported that dose was administered after 30-day Use By date or after manufacturer date of expiry Vial was initially stored in the refrigerator on 03 Jan 2022. That was kept in freezer since arrival until today before use. Vial did not undergo any temperature excursions.   This case was linked to MOD-2022-438672, MOD-2022-438670, MOD-2022-438673, MOD-2022-438676 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered dose from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered dose from an expired vial) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered dose from an expired vial). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Patient was administered dose from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.  The reporter later realized that the vial from where the vaccine was administered was found to be expired after administration.  The vial had not undergone through a temperature excursion and was initially stored in the refrigerator on 03-Jan-2022 and kept in freezer since arrival until the day of use.   This case was linked to MOD-2022-438672, MOD-2022-438670, MOD-2022-438657, MOD-2022-438669, MOD-2022-438671, MOD-2022-438674, MOD-2022-438675, MOD-2022-438676, MOD-2022-438677 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients were administered doses from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial) 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 mediations were reported.   This case was linked to MOD-2022-438672, MOD-2022-438670, MOD-2022-438673, MOD-2022-438676 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients were administered doses from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  The vial was initially stored in the refrigerator on 03 Jan 2022. They were kept in freezer since arrival until 03 Jan 2022 before use. The vial did not undergone any temperature excursions.   This case was linked to MOD-2022-438672, MOD-2022-438670, MOD-2022-438673, MOD-2022-438676, MOD-2022-438657, MOD-2022-438669, MOD-2022-438671, MOD-2022-438674, MOD-2022-438677 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered 10 doses of Moderna as a booster and later realized the vial was expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 03 Jan 2022. Concomitant medications were not reported. Treatment medications were not provided.   This case was linked to MOD-2022-438672, MOD-2022-438670, MOD-2022-438673, MOD-2022-438657, MOD-2022-438669, MOD-2022-438671, MOD-2022-438674, MOD-2022-438675, MOD-2022-438677 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients were administered doses from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Patients were administered doses from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment details were reported.   This case was linked to MOD-2022-438672, MOD-2022-438670, MOD-2022-438673, MOD-2022-438676, MOD-2022-438675 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 102.4 Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102.4 Fahrenheit) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Asthma and Drug allergy (Lot of allergies to prescription medications). Concomitant products included ROSUVASTATIN, HYDROCHLOROTHIAZIDE (HCTZ), SPIRONOLACTONE, COLECALCIFEROL (VITAMIN D3) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced PYREXIA (Fever of 102.4 Fahrenheit). In February 2021, PYREXIA (Fever of 102.4 Fahrenheit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 102.4 (High) 102.4 Fahrenheit.         No treatment medications were reported.   This case was linked to MOD-2022-438642, MOD-2022-438684 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ran a fever of 101.9 Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (ran a fever of 101.9 Fahrenheit) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 024M20A and 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Asthma and Drug allergy (she has a lot of allergies to prescription medications but did not list the names of the medications). Concomitant products included ROSUVASTATIN, HYDROCHLOROTHIAZIDE (HCTZ), SPIRONOLACTONE, COLECALCIFEROL (VITAMIN D3) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced PYREXIA (ran a fever of 101.9 Fahrenheit). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 26-Nov-2021, PYREXIA (ran a fever of 101.9 Fahrenheit) had resolved.            This case was linked to MOD-2022-438683, MOD-2022-438642 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Malaise, Pain, Pain in extremity
Clinical narrative: wasn't feeling well; body aches; arm was sore; slight joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (wasn't feeling well), PAIN (body aches), PAIN IN EXTREMITY (arm was sore) and ARTHRALGIA (slight joint pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Shaking of hands (right arm and hand shaking,) on 04-Jan-2021.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced MALAISE (wasn't feeling well), PAIN (body aches), PAIN IN EXTREMITY (arm was sore) and ARTHRALGIA (slight joint pain). At the time of the report, MALAISE (wasn't feeling well), PAIN (body aches), PAIN IN EXTREMITY (arm was sore) and ARTHRALGIA (slight joint pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not provided Treatment medications were not provided   This case was linked to MOD-2022-438597, MOD-2022-438711 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Headache, Loss of personal independence in daily activities, Myalgia
Clinical narrative: body aches; my legs didn't want to work; was out of it, & bedridden; high temperature of 102.8F; severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (my legs didn't want to work), BEDRIDDEN (was out of it, & bedridden), PYREXIA (high temperature of 102.8F) and HEADACHE (severe headaches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Shaking of hands on 04-Jan-2021 and Numbness mouth (mouth starts getting numb, like and  been to the dentist & starting coming out of the Novocaine) on 04-Jan-2021.    On 17-Feb-2021 at 1:45 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced MYALGIA (body aches), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (my legs didn't want to work), BEDRIDDEN (was out of it, & bedridden), PYREXIA (high temperature of 102.8F) and HEADACHE (severe headaches). At the time of the report, MYALGIA (body aches), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (my legs didn't want to work), BEDRIDDEN (was out of it, & bedridden), PYREXIA (high temperature of 102.8F) and HEADACHE (severe headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 102.8 (High) high temperature of 102.8F.         Patient usually an active person and take long hikes with daughter, & I kayak.  Concomitant medications was not reported. Treatment medications was not reported.   This case was linked to MOD-2022-438710, MOD-2022-438597 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: body aches; my legs didn't want to work; was out of it, & bedridden; high temperature of 102.8F; severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (my legs didn't want to work), BEDRIDDEN (was out of it, & bedridden), PYREXIA (high temperature of 102.8F) and HEADACHE (severe headaches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Shaking of hands on 04-Jan-2021 and Numbness mouth (mouth starts getting numb, like and  been to the dentist & starting coming out of the Novocaine) on 04-Jan-2021.    On 17-Feb-2021 at 1:45 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced MYALGIA (body aches), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (my legs didn't want to work), BEDRIDDEN (was out of it, & bedridden), PYREXIA (high temperature of 102.8F) and HEADACHE (severe headaches). At the time of the report, MYALGIA (body aches), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (my legs didn't want to work), BEDRIDDEN (was out of it, & bedridden), PYREXIA (high temperature of 102.8F) and HEADACHE (severe headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 102.8 (High) high temperature of 102.8F.         Patient usually an active person and take long hikes with daughter, & I kayak.  Concomitant medications was not reported. Treatment medications was not reported.   This case was linked to MOD-2022-438710, MOD-2022-438597 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Vaccination site pain
Clinical narrative: pain in arm, both shoulders and neck; pain in arm, both shoulders and neck; pain in arm, both shoulders and neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain in arm, both shoulders and neck), VACCINATION SITE PAIN (pain in arm, both shoulders and neck) and ARTHRALGIA (pain in arm, both shoulders and neck) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (high blood pressure), Diabetes and Asthma.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced NECK PAIN (pain in arm, both shoulders and neck), VACCINATION SITE PAIN (pain in arm, both shoulders and neck) and ARTHRALGIA (pain in arm, both shoulders and neck). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, NECK PAIN (pain in arm, both shoulders and neck), VACCINATION SITE PAIN (pain in arm, both shoulders and neck) and ARTHRALGIA (pain in arm, both shoulders and neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported.  Patient takes medications for all of those unrelated to the vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jan-2022: Follow up received contains contains No New Information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine administrated / Expired vaccine >24 hours post puncture administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administrated / Expired vaccine >24 hours post puncture administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administrated / Expired vaccine >24 hours post puncture administered). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired vaccine administrated / Expired vaccine >24 hours post puncture administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was stated that a punctured vial was kept at room temperature more than 24 hours, then administered to a patient.  No concomitant medications were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jan-2022: Follow-up received with information vaccine administered to a patient and event verbatim updated.
Sex: U
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This spontaneous case was reported by a nurse and describes the occurrence of SINUSITIS (sinus infection) 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 SINUSITIS (sinus infection). At the time of the report, SINUSITIS (sinus infection) 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 medications was reported. No treatment drug details was reported.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna vaccine given to a 9 years old child; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine given to a 9 years old child) in a 9-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine given to a 9 years old child). On 30-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine given to a 9 years old child) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants were provided. No treatment was provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: headache; slight tiredness; a sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (slight tiredness) and VACCINATION SITE PAIN (a sore arm at the injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced HEADACHE (headache), FATIGUE (slight tiredness) and VACCINATION SITE PAIN (a sore arm at the injection site). At the time of the report, HEADACHE (headache), FATIGUE (slight tiredness) and VACCINATION SITE PAIN (a sore arm at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported by reporter No treatment medications provided by the reporter.     This case was linked to MOD-2022-438856, MOD-2022-438857 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Ear disorder
Clinical narrative: Weird ear thing; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISORDER (Weird ear thing) 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.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EAR DISORDER (Weird ear thing). At the time of the report, EAR DISORDER (Weird ear thing) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.  The patient reported that Group of people who had hives after the COVID booster.   This case was linked to MOD22-000532 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever for 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever for 48 hours) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PYREXIA (fever for 48 hours). In April 2021, PYREXIA (fever for 48 hours) had resolved.            Concomitant drug details include none. No treatment information was provided after dose-2 events. Patient reports having allergies to tetracycline and medications allergies.   This case was linked to MOD-2022-438492, MOD-2022-438771 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Device connection issue
Clinical narrative: Caregiver possibly received a partial dose of the Moderna booster/Not sure what amount of vaccine the caregiver received; It seemed that the needle wasn't fully attached and some of the vaccine leaked out during administration; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE and DEVICE CONNECTION ISSUE (It seemed that the needle wasn't fully attached and some of the vaccine leaked out during administration) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (Not sure what amount of vaccine received) and DEVICE CONNECTION ISSUE (It seemed that the needle wasn't fully attached and some of the vaccine leaked out during administration). On 30-Dec-2021, ACCIDENTAL UNDERDOSE (not sure what amount of vaccine received) and DEVICE CONNECTION ISSUE (It seemed that the needle wasn't fully attached and some of the vaccine leaked out during administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Erythema, Pharyngeal swelling, Pyrexia, Rash erythematous
Clinical narrative: Swelling at top of throat; Big welts size of quarters/hives; Red spotty rash across body; ears are red and burning; ears are burning; fever for 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Swelling at top of throat), URTICARIA (Big welts size of quarters/hives), RASH ERYTHEMATOUS (Red spotty rash across body), ERYTHEMA (ears are red and burning) and EAR DISCOMFORT (ears are burning) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 045B21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (Tetracycline).   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PHARYNGEAL SWELLING (Swelling at top of throat), URTICARIA (Big welts size of quarters/hives), RASH ERYTHEMATOUS (Red spotty rash across body), ERYTHEMA (ears are red and burning), EAR DISCOMFORT (ears are burning) and PYREXIA (fever for 48 hours). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) for Adverse event, at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (Swelling at top of throat), URTICARIA (Big welts size of quarters/hives), RASH ERYTHEMATOUS (Red spotty rash across body), ERYTHEMA (ears are red and burning), EAR DISCOMFORT (ears are burning) and PYREXIA (fever for 48 hours) outcome was unknown.            No concomitant medications provided.   This case was linked to MOD-2022-438492, MOD-2022-438766 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Swelling at top of throat; Big welts size of quarters/hives; Red spotty rash across body; ears are red and burning; ears are burning; fever for 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Swelling at top of throat), URTICARIA (Big welts size of quarters/hives), RASH ERYTHEMATOUS (Red spotty rash across body), ERYTHEMA (ears are red and burning) and EAR DISCOMFORT (ears are burning) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 045B21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (Tetracycline).   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PHARYNGEAL SWELLING (Swelling at top of throat), URTICARIA (Big welts size of quarters/hives), RASH ERYTHEMATOUS (Red spotty rash across body), ERYTHEMA (ears are red and burning), EAR DISCOMFORT (ears are burning) and PYREXIA (fever for 48 hours). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) for Adverse event, at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (Swelling at top of throat), URTICARIA (Big welts size of quarters/hives), RASH ERYTHEMATOUS (Red spotty rash across body), ERYTHEMA (ears are red and burning), EAR DISCOMFORT (ears are burning) and PYREXIA (fever for 48 hours) outcome was unknown.            No concomitant medications provided.   This case was linked to MOD-2022-438492, MOD-2022-438766 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was not experiencing any symptoms.  No concomitant medication details was reported.  No treatment medication details was reported.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old patient was mistakenly given the Moderna COVID 19 vaccine booster; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient was mistakenly given the Moderna COVID 19 vaccine booster) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer COVID 19 vaccine and Pfizer COVID 19 vaccine. Past adverse reactions to the above products included No adverse event with Pfizer COVID 19 vaccine and Pfizer COVID 19 vaccine.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient was mistakenly given the Moderna COVID 19 vaccine booster). On 30-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient was mistakenly given the Moderna COVID 19 vaccine booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient who received Pfizer COVID 19 vaccine as primary doses was mistakenly given the Moderna COVID 19 vaccine booster.  No concomitant medication were reported.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: How long do side effects last/at what point should I call the doctor; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (How long do side effects last/at what point should I call the doctor) 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 (How long do side effects last/at what point should I call the doctor). At the time of the report, VACCINATION COMPLICATION (How long do side effects last/at what point should I call the doctor) 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 was not provided. Treatment information was not provided.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling of body temperature change, Therapeutic response unexpected
Clinical narrative: Felt hot and cold; Felt little chills; Little pain in the ankle; Chronic pain from rheumatoid arthritis pain has resolved tremendously and it made such a turn around; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold), CHILLS (Felt little chills), ARTHRALGIA (Little pain in the ankle) and THERAPEUTIC RESPONSE UNEXPECTED (Chronic pain from rheumatoid arthritis pain has resolved tremendously and it made such a turn around) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis (was disabled with the diagnosis of rheumatoid arthritis) and Chronic pain.    On 31-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Chronic pain from rheumatoid arthritis pain has resolved tremendously and it made such a turn around). On 03-Jan-2022, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold), CHILLS (Felt little chills) and ARTHRALGIA (Little pain in the ankle). On 04-Jan-2022, FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold), CHILLS (Felt little chills) and ARTHRALGIA (Little pain in the ankle) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Chronic pain from rheumatoid arthritis pain has resolved tremendously and it made such a turn around) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that before the vaccine, he felt horrible everyday. It was reported that the lot number was 028R or a K21A. No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives/Were delayed hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives/Were delayed hives) 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 URTICARIA (Hives/Were delayed hives). At the time of the report, URTICARIA (Hives/Were delayed hives) was resolving.            Concomitant medications were not provided. Treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, SARS-CoV-2 test
Clinical narrative: allergy symptoms; This spontaneous case was reported by a nurse and describes the occurrence of HYPERSENSITIVITY (allergy symptoms) 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 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (allergy symptoms). At the time of the report, HYPERSENSITIVITY (allergy symptoms) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: unknown unknown, Results Pending.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.  The patient stated that it was unknown if the Intramuscular injection was given into the Left or Right Deltoid for both the Moderna COVID-19 doses. The patient reported that she was tested for COVID-19 today out of precaution but the results were not back yet. The patient had not yet received the Moderna booster dose.   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Circumference of a softball hurt and ached for 3-4 months after; Whole arm at the injection site hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Circumference of a softball hurt and ached for 3-4 months after) and VACCINATION SITE PAIN (Whole arm at the injection site hurt) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN (Circumference of a softball hurt and ached for 3-4 months after) and VACCINATION SITE PAIN (Whole arm at the injection site hurt). At the time of the report, PAIN (Circumference of a softball hurt and ached for 3-4 months after) and VACCINATION SITE PAIN (Whole arm at the injection site hurt) outcome was unknown.            No concomitant product use was provided.  No treatment medication was provided.    This case was linked to MOD-2022-437114, MOD-2022-437218 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left arm injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm injection site arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-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 VACCINATION SITE PAIN (sore left arm injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left arm injection site arm) 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 relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-438840 (Patient Link).