chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient received the booster on 22Dec2021 after 10-12 days he started having hives, and the itch was so bad; Patient received the booster on 22Dec2021 after 10-12 days he started having hives, and the itch was so bad; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Patient received the booster on 22Dec2021 after 10-12 days he started having hives, and the itch was so bad) and URTICARIA (Patient received the booster on 22Dec2021 after 10-12 days he started having hives, and the itch was so bad) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Dairy intolerance (he only has little issues with dairy products) and Hypercholesterolaemia (High cholesterol started before receiving the vaccines).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, the patient experienced PRURITUS (Patient received the booster on 22Dec2021 after 10-12 days he started having hives, and the itch was so bad) and URTICARIA (Patient received the booster on 22Dec2021 after 10-12 days he started having hives, and the itch was so bad). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives and Itchy, at an unspecified dose and frequency and LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) ongoing since an unknown date for Hives and Itchy, at an unspecified dose and frequency. At the time of the report, PRURITUS (Patient received the booster on 22Dec2021 after 10-12 days he started having hives, and the itch was so bad) and URTICARIA (Patient received the booster on 22Dec2021 after 10-12 days he started having hives, and the itch was so bad) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRURITUS (Patient received the booster on 22Dec2021 after 10-12 days he started having hives, and the itch was so bad) and URTICARIA (Patient received the booster on 22Dec2021 after 10-12 days he started having hives, and the itch was so bad) to be related.    Concomitant medications included medication for his high cholesterol once in a while. Patient went to the doctor and he told him his symptoms were caused by the Moderna vaccine and that they could last from 2 weeks to 2 months, patient was taking Benadryl but it did not worked, then he took Allegra and worked fine. Symptoms have improved, but patient stated that it has been more than 2 months and he is still having symptoms and taking medication. Patient was willing to help by giving his blood for research. Patient was never tested positive for COVID.   This case was linked to MOD-2022-504212, MOD-2022-504209.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Patient experienced mild symptoms after the first 2 shots; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient experienced mild symptoms after the first 2 shots) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient experienced mild symptoms after the first 2 shots). At the time of the report, VACCINATION COMPLICATION (Patient experienced mild symptoms after the first 2 shots) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had little issues with dairy products. Patient never tested positive for COVID.  Concomitant medications included medication for Cholesterol.  No treatment medications were reported.   This case was linked to MOD-2022-504212, MOD-2022-504199 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Patient received the first 2 vaccines and developed mild symptoms for a day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient received the first 2 vaccines and developed mild symptoms for a day) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Dairy intolerance (he only has little issues with dairy products) and Hypercholesteraemia (High cholesterol started before receiving the vaccines).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-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 VACCINATION COMPLICATION (Patient received the first 2 vaccines and developed mild symptoms for a day). At the time of the report, VACCINATION COMPLICATION (Patient received the first 2 vaccines and developed mild symptoms for a day) had resolved.            Treatment medication was not provided by the reporter.  Patient received the first 2 vaccines in February and March 2021 and developed mild symptoms for a day. Patient never tested positive for COVID 19. Patient had taken medication for his cholesterol once in a while. Patient also stated that he can help by giving his blood for research.   This case was linked to MOD-2022-504209, MOD-2022-504199 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in the ear after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in the ear after 2nd shot) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2021, the patient experienced TINNITUS (Ringing in the ear after 2nd shot). At the time of the report, TINNITUS (Ringing in the ear after 2nd shot) outcome was unknown.            No Concomitant Drug details were reported.  No Treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Administration after temperature excursion; In February their fridge was up and down, they have an average temperature of 31.1 degrees F; Administration after temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Administration after temperature excursion), PRODUCT STORAGE ERROR (In February their fridge was up and down, they have an average temperature of 31.1 degrees F) and POOR QUALITY PRODUCT ADMINISTERED (Administration after temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Administration after temperature excursion), PRODUCT STORAGE ERROR (In February their fridge was up and down, they have an average temperature of 31.1 degrees F) and POOR QUALITY PRODUCT ADMINISTERED (Administration after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Administration after temperature excursion), PRODUCT STORAGE ERROR (In February their fridge was up and down, they have an average temperature of 31.1 degrees F) and POOR QUALITY PRODUCT ADMINISTERED (Administration after temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No Concomitant product use was reported. The reporter who was an HCP reported that in February their fridge was up and down, they had an average temperature of 31.1 degrees F. The minimum temperature was 28.9 degrees F, and the maximum temperature was 40.4 degrees F. Reportedly, the patient administration: the reporter doesn't remember, there might have been. No treatment information was provided.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: A little ringing in the ear after 2nd Shot; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (A little ringing in the ear after 2nd Shot) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced TINNITUS (A little ringing in the ear after 2nd Shot). At the time of the report, TINNITUS (A little ringing in the ear after 2nd Shot) outcome was unknown.            No concomitant medication were provided No treatment details were provided   This case was linked to MOD-2022-504250 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in the ear 14 days after booster Shot; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in the ear 14 days after booster Shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Ringing in the ear 14 days after booster Shot). At the time of the report, TINNITUS (Ringing in the ear 14 days after booster Shot) outcome was unknown.            Concomitant medications was not provided by the reporter.  Patient stated that 14 days after the booster shot, she started with Ringing in the ear. She stated that her entire family started with ringing in the ear after Moderna COVID-19 vaccine. She complained to her family doctor, but he said lets wait and see if it goes away by itself. The doctor did not prescribe anything. She does not had her vaccination card available and does not remember the lot numbers.  Treatment information was not provided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever after first shot; Felt sore after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever after first shot) and MYALGIA (Felt sore after first shot) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced PYREXIA (Fever after first shot) and MYALGIA (Felt sore after first shot). On 16-Apr-2021, PYREXIA (Fever after first shot) and MYALGIA (Felt sore after first shot) had resolved.  mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant medications were provided. No treatment information were provided. After the first dose she had a fever and she felt sore for 1 day.  This case was linked to MOD-2022-504266, MOD-2022-504267 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: had Fever; Chills; felt sore for a couple of days.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (had Fever), CHILLS (Chills) and MYALGIA (felt sore for a couple of days.) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced PYREXIA (had Fever), CHILLS (Chills) and MYALGIA (felt sore for a couple of days.). On 16-May-2021, PYREXIA (had Fever), CHILLS (Chills) and MYALGIA (felt sore for a couple of days.) had resolved.            Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2022-504251, MOD-2022-504267 (Patient Link).
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. No Medical History information was reported.    On 29-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. Date of placed in refrigerator was on 17-Nov-2021. Vaccine did not undergone any temperature excursion. No other events were reported for patient. No Treatment information was reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.  No Medical History information was reported.  On 07-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  The reporter was infection control manager.  Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was 17-Nov-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Muscular weakness, Pain in extremity, Vaccination site pain
Clinical narrative: Weakness in hands/ it is hard to hold coffee cup; Forearm pain/ arm pain for one day; Ongoing pain for months in upper right arm/upper arm pain that goes up to top of arm from her forearm down to hands/ pain is constant; Received 2nd booster dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness in hands/ it is hard to hold coffee cup), PAIN IN EXTREMITY (Forearm pain/ arm pain for one day), VACCINATION SITE PAIN (Ongoing pain for months in upper right arm/upper arm pain that goes up to top of arm from her forearm down to hands/ pain is constant) and EXTRA DOSE ADMINISTERED (Received 2nd booster dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Levaquin), Drug allergy (steroids), Allergy to animals (cats), Allergy to animals (dogs), Drug allergy (OTC allergy) and COPD. Concomitant products included SALBUTAMOL (ALBUTEROL HFA) and IPRATROPIUM for COPD.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced MUSCULAR WEAKNESS (Weakness in hands/ it is hard to hold coffee cup), PAIN IN EXTREMITY (Forearm pain/ arm pain for one day), VACCINATION SITE PAIN (Ongoing pain for months in upper right arm/upper arm pain that goes up to top of arm from her forearm down to hands/ pain is constant) and EXTRA DOSE ADMINISTERED (Received 2nd booster dose). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 10-Nov-2021, PAIN IN EXTREMITY (Forearm pain/ arm pain for one day) had resolved. At the time of the report, MUSCULAR WEAKNESS (Weakness in hands/ it is hard to hold coffee cup) and EXTRA DOSE ADMINISTERED (Received 2nd booster dose) outcome was unknown and VACCINATION SITE PAIN (Ongoing pain for months in upper right arm/upper arm pain that goes up to top of arm from her forearm down to hands/ pain is constant) had not resolved.            The patient was taking Clor Tabs as concomitant for OTC allergy.  The patient have never tested positive for COVID-19.  Other vaccines were reported as none  Patient also had used heating pads for treatment.   This case was linked to MOD-2022-504401 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 57-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Reporter stated that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of December-2021, January-2022, and February-2022. They were filling out a temperature excursion assessment with the State currently. Also reported that no adverse reactions were experienced by any patients.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Headache, Myalgia, Pain
Clinical narrative: Ache; Body ache; Headache; She also received a 4th dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache), MYALGIA (Body ache), HEADACHE (Headache) and EXTRA DOSE ADMINISTERED (She also received a 4th dose) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 017E21A, 031L20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Myelodysplastic syndrome, Allergy to chemicals (Talcum powder Allergy (the type they use on gloves)) and Immunocompromised. Concomitant products included EPOETIN ALFA (PROCRIT) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2022, the patient experienced EXTRA DOSE ADMINISTERED (She also received a 4th dose). On an unknown date, the patient experienced PAIN (Ache), MYALGIA (Body ache) and HEADACHE (Headache). At the time of the report, PAIN (Ache), MYALGIA (Body ache) and HEADACHE (Headache) had resolved and EXTRA DOSE ADMINISTERED (She also received a 4th dose) outcome was unknown.            Patient received all the doses in her deltoid muscle. Patient never tested to positive for Covid-19 and did not received any other vaccine with in 1 month prior to Moderna. When she received the First and Second dose her hemoglobin levels went up. No treatment information details were reported.   This case was linked to MOD-2022-504269 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired vaccine used; Product storage error; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Product storage error). On 16-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported. No adverse events reported. No temperature excursion of the product was reported. Date place in refrigerator: 18-Nov-2021  .
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Vaccination site pain
Clinical narrative: pain at her left arm injection site; Moderna Covid-19 vaccine booster dose given more than 12 hours after first dose withdrawn from vial; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at her left arm injection site) and EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine booster dose given more than 12 hours after first dose withdrawn from vial) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Pfizer vaccine as her two primary series shots) on 30-Mar-2021 and Pfizer vaccine (Pfizer vaccine as her two primary series shots). Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 02-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine booster dose given more than 12 hours after first dose withdrawn from vial). On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at her left arm injection site). At the time of the report, VACCINATION SITE PAIN (pain at her left arm injection site) and EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine booster dose given more than 12 hours after first dose withdrawn from vial) outcome was unknown.            The patient reported that she saw the vial of the Moderna COVID-19 vaccine, that it first had a dose taken from the vial on 01 March 2022 and that her dose from the same vial was taken out at 7:30 AM on 02 March 2022. Patient got this information from a sticker that the provider placed on the side of the vial that her Moderna COVID-19 booster dose came from. No concomitant medications were reported.  Treatment information was not provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Rotator cuff syndrome
Clinical narrative: rotator cuff injury; This spontaneous case was reported by a consumer and describes the occurrence of ROTATOR CUFF SYNDROME (rotator cuff injury) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.  Concurrent medical conditions included Type 2 diabetes mellitus (Recent change in status: no difference) since 1996 and Heart rate abnormal (Concomitantly, took 25 mg metoprolol extended-release twice a day to help control heart rate XL). Concomitant products included METOPROLOL for Heart rate abnormal, INSULIN GLARGINE (LANTUS) and CANAGLIFLOZIN (INVOKANA [CANAGLIFLOZIN]) for an unknown indication.  On 08-Sep-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 ROTATOR CUFF SYNDROME (rotator cuff injury). The patient was treated with HYDROCORTISONE on 07-Mar-2022 at an unspecified dose and frequency. At the time of the report, ROTATOR CUFF SYNDROME (rotator cuff injury) had not resolved.  The patient had no allergies. The patient was never diagnosed with COVID positive. There were no other vaccines that the patient received within 1 month prior to Moderna COVID-19 vaccine.  The patient had a lot of shoulder problems with his rotator cuff injury. The patient received hydrocortisone shots in his shoulder for rotator cuff injury to stop the pain.   As per the patient, the event was not related to the vaccine.   This case was linked to MOD-2021-033647 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Reporter confirmed that patients had been administered doses while the temperature excursion assessment was ongoing.; patient was administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Reporter confirmed that patients had been administered doses while the temperature excursion assessment was ongoing.) and POOR QUALITY PRODUCT ADMINISTERED (patient was administered Moderna vaccine while temperature excursion assessment was ongoing) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Reporter confirmed that patients had been administered doses while the temperature excursion assessment was ongoing.) and POOR QUALITY PRODUCT ADMINISTERED (patient was administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Reporter confirmed that patients had been administered doses while the temperature excursion assessment was ongoing.) and POOR QUALITY PRODUCT ADMINISTERED (patient was administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        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.  The reporter stated that their facility had not been able to download the digital data logger, they had been put on hold by at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 66-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.     This case was linked to MOD-2022-501575 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) outcome was unknown.        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 did not allow further contact
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported   No adverse reactions were reported by any patients.   No Treatment medication reported
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: patient then got 2 more primary series doses (18Jan2022 & 15Feb2022); This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (patient then got 2 more primary series doses (18Jan2022 & 15Feb2022)) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    In 2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2021, the patient experienced EXTRA DOSE ADMINISTERED (patient then got 2 more primary series doses (18Jan2022 & 15Feb2022)). At the time of the report, EXTRA DOSE ADMINISTERED (patient then got 2 more primary series doses (18Jan2022 & 15Feb2022)) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication were provided.  The patient had primary series doses, a 3rd dose for the immunocompromised, and a booster dose of the Moderna COVID-19 Vaccine. On an unknown date in Oct-2021, the patient then had a stem cell transplant for an unknown reason. The doctor recommended that she get all 4 doses again. The patient then got 2 more primary series doses (18-Jan-2022 and 15-Feb-2022).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was placed in the refrigerator on 17-NOV-2021.Vial did not undergo any temperature excursion. No adverse event was reported.  No treatment medications were reported.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter  It was mentioned that the vial was initially refrigerated  on 17 Nov 2021, the vial did not undergo any temperature excursion and patient did not experienced any adverse events.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) 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.   The date of vial placed in refrigerator was on 21-OCT-2021 and vaccine did not undergone any temperature excursion. Patient did not experience ant adverse event. No concomitant were reported. No treatment were reported.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there was a confusion between the expiration date printed in the carton the expiration date when the QR code was scanned. No adverse events were reported. Vial did not underwent any temperature excursion. Vial was placed in refrigerator on 29-Oct-2021.  No treatment medications were reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was placed in the refrigerator on 17-NOV-2021.Vial did not undergo any temperature excursion. No adverse event was reported.  No treatment medications were reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there was a confusion between the expiration date printed in the carton the expiration date when the QR code was scanned. No adverse events were reported. Vial did not undergo any temperature excursion. Vial was placed in refrigerator on 18-Nov-2021.  No treatment medications were reported.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The product was refrigerated on 16Oct2021 beyond exiration date 03Oct2021; The patient received expired dose beyind expiratory date 03OCT2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received expired dose beyind expiratory date 03OCT2021) and PRODUCT STORAGE ERROR (The product was refrigerated on 16Oct2021 beyond exiration date 03Oct2021) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received expired dose beyind expiratory date 03OCT2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The product was refrigerated on 16Oct2021 beyond exiration date 03Oct2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received expired dose beyind expiratory date 03OCT2021) and PRODUCT STORAGE ERROR (The product was refrigerated on 16Oct2021 beyond exiration date 03Oct2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date place stored in refrigerator was 16-Oct-2021. No temperature excursion occurred. No adverse event was reported.  No concomitant medication were provided No treatment details were provided