chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: received a 5th booster by mistake/received 5th Moderna dose as a booster; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (received a 5th booster by mistake/received 5th Moderna dose as a booster) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059A22A, 014M20A and 026B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 23-Jun-2022, the patient experienced EXTRA DOSE ADMINISTERED (received a 5th booster by mistake/received 5th Moderna dose as a booster). At the time of the report, EXTRA DOSE ADMINISTERED (received a 5th booster by mistake/received 5th Moderna dose as a booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. The patient had received 4 Moderna vaccines and she received a fifth Moderna dose as a booster by mistake on 23-Jun-2022. No treatment drug details was reported.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Needle issue, Wrong technique in product usage process
Clinical narrative: Needle bent while receiving the Moderna Covid 19 vaccine; pharmacist bent the needle in his left tight; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NEEDLE ISSUE (Needle bent while receiving the Moderna Covid 19 vaccine) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (pharmacist bent the needle in his left tight) in a 3-year-old male patient who received mRNA-1273 (Spikevax) (batch no. A51416B) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jun-2022, the patient experienced NEEDLE ISSUE (Needle bent while receiving the Moderna Covid 19 vaccine) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (pharmacist bent the needle in his left tight). At the time of the report, NEEDLE ISSUE (Needle bent while receiving the Moderna Covid 19 vaccine) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (pharmacist bent the needle in his left tight) outcome was unknown.            No allergies was not reported by the reporter. Concomitant medication details were not reported by the reporter.  when the patient received vaccine, the pharmacist bent the needle in his left tight. The mother had now doubts and was worried because she was not sure if patient received the correct vaccine and dosage for his age group. The mother asked the pharmacist if she had administered the 30 mg of the vaccine and the Pharmacist said yes, But the mother was not sure if pharmacist was really paying attention. She was panicked because she did not know if the dosage of patient was received correct. The pharmacist said that the patient was able to receive the full dose, even though the needle bent.  Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered expired vaccine to the patients with the lot number 067F21A; The vaccine expired in the freezer on 6Apr2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patients with the lot number 067F21A) and PRODUCT STORAGE ERROR (The vaccine expired in the freezer on 6Apr2022) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 prophylaxis.     Allergies of the patient were unknown. It was unknown if the patient had ever had COVID + test or diagnosis.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patients with the lot number 067F21A) and PRODUCT STORAGE ERROR (The vaccine expired in the freezer on 6Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patients with the lot number 067F21A) and PRODUCT STORAGE ERROR (The vaccine expired in the freezer on 6Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. It was reported that the vaccine expired in the freezer on 6-Apr-2022. The vial was initially stored in the refrigerator on 28-Apr-2022 and 04-Apr-2022. The vaccines were administered on the following days :18-Apr-2022, 26-Apr-2022, 25-Apr-2022, 16-May-2022 and 17-May-2022. The patient received second booster dose. The vial did not undergo any temperature excursions. It was unknown if other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Treatment information was not provided.   This case was linked to MOD-2022-593844, MOD-2022-593857, MOD-2022-593856 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st booster dose administered before 5 months from 2nd dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster dose administered before 5 months from 2nd dose) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 037F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 25-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster dose administered before 5 months from 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster dose administered before 5 months from 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: first booster was a full dose but she was not really immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OVERDOSE (first booster was a full dose but she was not really immunocompromised) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 32L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Asthma. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Asthma.   On 04-Feb-2011, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 OVERDOSE (first booster was a full dose but she was not really immunocompromised). At the time of the report, OVERDOSE (first booster was a full dose but she was not really immunocompromised) outcome was unknown.            Treatment details was not reported by the reporter.   This case was linked to MOD-2022-593848 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Musculoskeletal stiffness
Clinical narrative: FELT STIFFNESS IN MORNING LATELY DUE TO LACK OF HUMIRA INACTIVITY; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (FELT STIFFNESS IN MORNING LATELY DUE TO LACK OF HUMIRA INACTIVITY) and FATIGUE (Fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Sep-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) .4 milliliter. On 20-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (FELT STIFFNESS IN MORNING LATELY DUE TO LACK OF HUMIRA INACTIVITY). On 22-May-2022, FATIGUE (Fatigue) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (FELT STIFFNESS IN MORNING LATELY DUE TO LACK OF HUMIRA INACTIVITY) had not resolved.            No concomitant medications was provided by the reporter. Patient felt stiffness laterly due to lack of Humira activity. Patient had Lack of drug effect for Humira where the outcome was unknown. The reported causality of Humira for event such Early morning stiffness, lack of drug effect and fatigue was reported as not related. No treatment medications were reported
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bowel movement irregularity, Chills, Epistaxis, Fatigue
Clinical narrative: Have not have a normal bowel movement; Random nose bleed almost dails /She stated it was horrific; Chills; Slight Fever; Fatigue; Sore arm; Weak; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Weak), BOWEL MOVEMENT IRREGULARITY (Have not have a normal bowel movement), EPISTAXIS (Random nose bleed almost dails /She stated it was horrific), CHILLS (Chills) and PYREXIA (Slight Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A22A, 939904, 036B21A and 030A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2022, the patient experienced ASTHENIA (Weak), CHILLS (Chills), PYREXIA (Slight Fever), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced BOWEL MOVEMENT IRREGULARITY (Have not have a normal bowel movement) and EPISTAXIS (Random nose bleed almost dails /She stated it was horrific). At the time of the report, ASTHENIA (Weak), BOWEL MOVEMENT IRREGULARITY (Have not have a normal bowel movement), CHILLS (Chills), PYREXIA (Slight Fever), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm) outcome was unknown and EPISTAXIS (Random nose bleed almost dails /She stated it was horrific) had not resolved.            No concomitant information was reported. Patient height was reported as 5.6 or 5.7 F. Patient was neither tested nor diagnosed with COVID and had no acute and chronic illnesses at the time of vaccination. Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient was still taking medication at the time of reporting. No treatment information was provided.   This case was linked to MOD-2022-594157 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Have not have a normal bowel movement; Random nose bleed almost dails /She stated it was horrific; Chills; Slight Fever; Fatigue; Sore arm; Weak; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Weak), BOWEL MOVEMENT IRREGULARITY (Have not have a normal bowel movement), EPISTAXIS (Random nose bleed almost dails /She stated it was horrific), CHILLS (Chills) and PYREXIA (Slight Fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A22A, 939904, 036B21A and 030A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2022, the patient experienced ASTHENIA (Weak), CHILLS (Chills), PYREXIA (Slight Fever), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced BOWEL MOVEMENT IRREGULARITY (Have not have a normal bowel movement) and EPISTAXIS (Random nose bleed almost dails /She stated it was horrific). At the time of the report, ASTHENIA (Weak), BOWEL MOVEMENT IRREGULARITY (Have not have a normal bowel movement), CHILLS (Chills), PYREXIA (Slight Fever), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm) outcome was unknown and EPISTAXIS (Random nose bleed almost dails /She stated it was horrific) had not resolved.            No concomitant information was reported. Patient height was reported as 5.6 or 5.7 F. Patient was neither tested nor diagnosed with COVID and had no acute and chronic illnesses at the time of vaccination. Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient was still taking medication at the time of reporting. No treatment information was provided.   This case was linked to MOD-2022-594157 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhagic cyst, Menstruation irregular, Ovarian cyst
Clinical narrative: Hemorrhagic cyst; New cyst on ovaries; 4 hours after vaccination had menstrual cycle 2 weeks early; This spontaneous case was reported by a patient and describes the occurrence of HAEMORRHAGIC CYST (Hemorrhagic cyst) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced HAEMORRHAGIC CYST (Hemorrhagic cyst) (seriousness criterion medically significant) and OVARIAN CYST (New cyst on ovaries). January 2021, the patient experienced MENSTRUATION IRREGULAR (4 hours after vaccination had menstrual cycle 2 weeks early). At the time of the report, HAEMORRHAGIC CYST (Hemorrhagic cyst), OVARIAN CYST (New cyst on ovaries) and MENSTRUATION IRREGULAR (4 hours after vaccination had menstrual cycle 2 weeks early) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant product was provided. It was reported that 4 hours after vaccination, the patient had her menstrual cycle 2 weeks early. Since then patient had her period every 2 weeks for over a year, as well as new cyst on ovaries and a hemorrhagic cyst as well. No treatment information was provided.  Company comment: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected serious (medically significant) event of Haemorrhagic cyst, unknown days after receiving the first dose with mRNA-1273 vaccine in the COVID-19 vaccination series. The patient also had her menstrual cycle 2 weeks early and new cyst on ovaries. No further information on risk factors, detailed clinical course and management of the event was available in the report. The event was not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-594000 (Patient Link).; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected serious (medically significant) event of Haemorrhagic cyst, unknown days after receiving the first dose with mRNA-1273 vaccine in the COVID-19 vaccination series. The patient also had her menstrual cycle 2 weeks early and new cyst on ovaries. No further information on risk factors, detailed clinical course and management of the event was available in the report. The event was not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Covid arm; the area was hot to touch; Itchy; Redness; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (the area was hot to touch), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Redness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy.    On 18-Mar-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 SITE REACTION (Covid arm), VACCINATION SITE WARMTH (the area was hot to touch), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (the area was hot to touch), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient height was 5.6 or 5.7 F.  No concomitant medications was reported. Patient was taking medications. The patient never had Covid positive test or diagnosis. The patient did not experienced history relating to mentioned AE and both acute and chronic illnesses at the time of vaccination. The patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. No treatment details was reported.   This case was linked to MOD-2022-594051 (Patient Link).
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered with vaccine that was beyond use date after the thaw process; This spontaneous case was reported by an HCP and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the age of patient was 31 years 7 months. No concomitant medications were reported On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines. Patient had reported no adverse reactions after the administration of vaccine. Treatment details were not reported by the reporter. Vaccine Ndc Code was reported as 80777-0273-99.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered beyond use date after the thaw process; This spontaneous case was reported by an HCP and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's age was reported as 66 years 2 months.  No concomitant medications were reported. Vaccine Ndc Code was reported as 80777-0273-99. On 10-Jun-2022, medical was notified of an audit that was done and then were made aware of vaccines that were administered beyond use date after the thaw process. It was reported that there were no patients that had any adverse reactions and no reports of any reactions after the administration of the vaccine. No treatment information was reported.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered beyond use date after the thawprocess; This spontaneous case was reported by an HCP and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thawprocess) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thawprocess). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thawprocess) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 22 years and 4 months.  Concomitant medication of the patient was not reported.  The patient did not experience any adverse reactions after the administration of vaccine.  On 10-Jun-2022 the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code 80777027399. Patient requested Pfizer-BioNTech COVID-19 Vaccine (12 plus).  No treatment information was provided by the reporter.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered beyond use date after the thaw process; This spontaneous case was reported by an HCP and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     It was unknown if the patient had ever been diagnosed or tested positive for COVID-19. It was reported, acute illness at the time of vaccination and up to one month before and chronic or long-standing health conditions were unknown.     On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's age was reported as 59 years 7 months.  No concomitant medications were provided by the reporter.  No adverse reactions were reported by the patient after the administration of vaccine. Vaccine Ndc code  was reported as 80777-0273-99.  No treatment medications were provided by the reporter.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: beyond use date of somelot numbers for moderna that were administered to patients; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (beyond use date of somelot numbers for moderna that were administered to patients) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (beyond use date of somelot numbers for moderna that were administered to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (beyond use date of somelot numbers for moderna that were administered to patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 51 years 1 month. Concomitant products were not provided.  It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19, nor if patient had chronic or long lasting health conditions.  It was reported that patient had no adverse reactions after the administration of vaccine. Patient got Moderna.   Treatment medications were not reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administrated after the beyond use date after the thawprocess; This spontaneous case was reported by an HCP and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administrated after the beyond use date after the thawprocess) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown whether the patient had chronic or long lasting health conditions. It was unknown whether the patient had ever been diagnosed or tested with positive for COVID-19.     On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administrated after the beyond use date after the thawprocess). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administrated after the beyond use date after the thawprocess) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19. There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  Treatment medications were not reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The reporter informed that, the vaccine was used beyond use date of some lot numbers for Moderna that were administered to patients. There was no adverse reaction noted or reported to the reporter ever regarding after administration of vaccine.  It was unknown if the patient was tested positive or diagnosed with COVID-19. It was unknown if acute illnesses at the time of vaccination and up to one month before. And it was unknown if chronic or long-standing health conditions.  No treatment drug details was reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 71 years 6 months.   No concomitant medication information was provided.  It was reported that the vaccines were administered beyond use date after the thaw process. Patient got Moderna. Reporter stated that there were no reports of any reactions after the administration of vaccines.  No treatment medication were provided.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by an HCP and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     It was unknown if patient was diagnosed/tested positive for COVID-19, had acute illness at the time of vaccination and up to one month before, or had chronic or long-lasting illness.  It was unknown if patient had taken any prescriptions, over the counter medication, dietary supplements or herbal remedies at the time of vaccination.     On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The age of the patient was reported as 28 years 11 months.  No concomitant medications were reported.  The patient had no adverse reaction after the vaccine administration.  No treatment medications were reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccines were administered beyond use date after the thawprocess; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines were administered beyond use date after the thawprocess) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if patient was tested with COVID-19 positive, unknown whether patient had acute illness at the time of vaccination or chronic illness.     On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines were administered beyond use date after the thawprocess). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines were administered beyond use date after the thawprocess) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The age of the patient was reported as 48 years 2 months.  No concomitant medications were reported by the reporter.  On 10-JUN-2022, The medical was notified of an audit that was done and were then made aware of vaccines that were administered beyond use date after the thaw process. There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  No treatment medications were reported by the reporter.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered with vaccine that was beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine that was beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the age of patient was 57  years 11 months. No concomitant medications were reported It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19, nor if patient had chronic or long lasting health conditions. Patient had reported no adverse reactions after the administration of vaccine. Treatment details was not reported by the reporter.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Age of the patient was reported as 27 year 8 months.   No concomitant drug information was provided.  The patient had received Moderna Covid-19 vaccine that were given beyond the 30 day use by date after the thaw process. No patient had any adverse reactions and no reports of any reactions after administration of the vaccine was noted.   No treatment drug information was received.   This case was linked to MOD-2022-542869 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Underdose
Clinical narrative: Vaccine that administered beyond use date after the thaw process/expired vaccine administered; First dose received 0.25ml instead of 0.5ml; This spontaneous case was reported by an HCP and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) and UNDERDOSE (First dose received 0.25ml instead of 0.5ml) in a 44-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     It was unknown if patient had acute illness at the time of vaccination and up to one month before.     On 10-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On 10-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) and UNDERDOSE (First dose received 0.25ml instead of 0.5ml). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) and UNDERDOSE (First dose received 0.25ml instead of 0.5ml) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if patient had been diagnosed with or tested positive for COVID-19, nor if patient had chronic or long lasting health conditions. It was reported that no adverse events had occurred after administration of vaccine to the patient. No treatment medications were reported. On 10-Jun-2022, the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code 80777-0273-99.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 26 years and 3 months.  No concomitant medications were reported.  On 10-Jun-2022, the vaccine facility was notified of an audit that was done and it was informed that vaccines were administered beyond use date after the thaw process. There was no patient that had any adverse reactions and no reports of any reactions after the administration of these vaccines. The patient got Moderna with vaccine Ndc code 80777027399. Patient requested Pfizer-BioNTech COVID-19 Vaccine (12 plus).  It was unknown whether the patient was ever diagnosed/tested positive for COVID-19.   It was unknown whether the patient had any acute illness at the time of vaccination and up to one month before it. It was unknown whether the patient had any chronic or long-standing health conditions.  Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and/or at the time of adverse event was unknown.  No treatment medications were reported.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that were administered beyond use date after thaw process) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 43 years 8 months.  No concomitant medications were reported. It was reported vaccine administrated beyond use date after the thaw process. There  was no adverse reaction noted or reported to us ever regarding these administration. No treatment medications were reported.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Overdose
Clinical narrative: Vaccine that administered beyond use date after the thaw process/expired vaccine administered; Third dose received 0.5 ml  instead of 0.25; This spontaneous case was reported by an HCP and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) and OVERDOSE (Third dose received 0.5 ml  instead of 0.25) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     Unknown if patient was ever been diagnosed with or tested positive for COVID-19.  Unknown if patient had acute illness at the time of vaccination and up to one month before.   On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) and OVERDOSE (Third dose received 0.5 ml  instead of 0.25). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) and OVERDOSE (Third dose received 0.5 ml  instead of 0.25) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  Treatment medications were not reported.   This case was linked to MOD-2022-542869 (Patient Link).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccines were administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines were administered beyond use date after the thaw process) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown whether the patient was ever diagnosed/tested positive for COVID-19.  It was unknown whether the patient had any acute illness at the time of vaccination and up to one month before it. It was unknown whether the patient had any chronic or long-standing health conditions.     On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines were administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines were administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's age was reported as 20 years 10 months.  It was unknown that prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and/or at the time of adverse event.  It was informed that vaccines were administered beyond use date after the thaw process.  There was no patient that had any adverse reactions and no reports of any reactions after the administration of these vaccines.  Treatment medications were not reported.