chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: At time of wrong injection and while in office for two hours no reaction to patient.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Haematoma, Headache, Pyrexia, Skin discolouration
Clinical narrative: headache; fatigue; fever; He had a hematoma on his upper leg which was black and blue; slight temperature; This spontaneous case was reported by a patient and describes the occurrence of HAEMATOMA (He had a hematoma on his upper leg which was black and blue), PYREXIA (slight temperature), HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (fever) in a 53-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     The patient's past medical history included Accident (hit by an 18 wheeler, Damage to upper and lower back, and both knees.) in 1991, Staphylococcal infection and Knee replacement in 1999. Concomitant products included MORPHINE, PARACETAMOL (TYLENOL) and OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for an unknown indication.   On 26-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Apr-2023 at 10:00 AM, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. In April 2023, the patient experienced HAEMATOMA (He had a hematoma on his upper leg which was black and blue) and PYREXIA (slight temperature). On an unknown date, the patient experienced HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (fever). On 24-Apr-2023, HAEMATOMA (He had a hematoma on his upper leg which was black and blue) and PYREXIA (slight temperature) had resolved. At the time of the report, HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (fever) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No treatment medication details was reported.  It was reported that the 1st Bivalent and 2nd Bivalent, felt positive outcomes of euphoria and absence of pain for 1st 6 hours. Felt that temperature was lightly elevated with a mild headache and fatigue til 3rd day. After First bivalent got euphoric pain lessening for 6 hours. After the second bivalent Patient had no pain within 30 minutes of receiving that vaccine. Patient also had a staff infection during this hospital visit. Patient also reported that bedwritten for almost 5 days/ It's like someone shut the valve off to the pain center of my brain.   This case was linked to MOD-2023-721104 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after 30-day Use by Date to 7 patients; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 23-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients).    No concomitant medication details was reported. No treatment medication details was reported.  This case contains information for the 3rd patient out of 7 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721391 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721391:Patient 1 out of 7 patients
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after 30-day Use by Date; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 23-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date).    No concomitant medications were provided. No treatment medication was provided. This case contains information for the 4th of 11 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721391 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721391:Patient 1 out of 7 patients
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after 30-day Use by Date to 7 patients; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 23-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients).    Concomitant medication details not reported by the reporter. It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment details was not reported by the reporter. This case contains information for the 5th of 7 patients described by the reporter    This case was linked to US-MODERNATX, INC.-MOD-2023-721391 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721391:Patient 1 out of 7 patients
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after 30-day Use by Date to patient; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to patient) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine and also unknown if had any of the medical history or condition.     On 23-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 23-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to patient).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported. Treatment medications were not provided.  This case was reported for patient 6 out of 7.   This case was linked to US-MODERNATX, INC.-MOD-2023-721391 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721391:Patient 1 out of 7 patients
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after 30-day Use by Date to 7 patients; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 23-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients).    No concomitant medications were reported.  No treatment information was provided.  This case was reported for patient 7 of 7 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-721391 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721391:Patient 1 out of 7 patients
Age: 22.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was first punctured on 19-Apr-2023 and admnistered on 25-apr-2023 and stored in fridge post puncture.; No adverse event; Bivalent Vaccine that was punctured 19Apr2023 and administered on 25-Apr-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Vaccine that was punctured 19Apr2023 and administered on 25-Apr-2023), PRODUCT STORAGE ERROR (The vial was first punctured on 19-Apr-2023 and admnistered on 25-apr-2023 and stored in fridge post puncture.) and NO ADVERSE EVENT (No adverse event) in a 22-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7072B) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 25-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Vaccine that was punctured 19Apr2023 and administered on 25-Apr-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was first punctured on 19-Apr-2023 and admnistered on 25-apr-2023 and stored in fridge post puncture.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Vaccine that was punctured 19Apr2023 and administered on 25-Apr-2023), PRODUCT STORAGE ERROR (The vial was first punctured on 19-Apr-2023 and admnistered on 25-apr-2023 and stored in fridge post puncture.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent Vaccine that was punctured 19Apr2023 and administered on 25-Apr-2023) and PRODUCT STORAGE ERROR (The vial was first punctured on 19-Apr-2023 and admnistered on 25-apr-2023 and stored in fridge post puncture.).    No concomitant medications was reported. It was individual vial, size of the vial was 2.5 ml.  The vial was initially stored in refrigerator on 19-Apr-2023. The vaccine was administered on 25-Apr-2023 at approximately 2.25 pm and 4.19 pm. The vial was stored in fridge post puncture. The vial did not undergone any temperature excursion. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was less than 10 minutes. No treatment drug details was reported. This case contain information of 2nd patient out of 2 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721458 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721458:Patient 1
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; She states the monovalent was 0.25 ml/A nurse gave 0.25 ml instead of the 0.5 ml today 26Apr2023; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (She states the monovalent was 0.25 ml/A nurse gave 0.25 ml instead of the 0.5 ml today 26Apr2023) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (She states the monovalent was 0.25 ml/A nurse gave 0.25 ml instead of the 0.5 ml today 26Apr2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (She states the monovalent was 0.25 ml/A nurse gave 0.25 ml instead of the 0.5 ml today 26Apr2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (She states the monovalent was 0.25 ml/A nurse gave 0.25 ml instead of the 0.5 ml today 26Apr2023).    The patient was over 65 years old.  No concomitant medications were reported.     No treatment medications were reported.  This case contains information for the 2nd of 6 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721461 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721461:Patient 1
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; A nurse gave monovalent Moderna vaccine to patient 0.25 ml instead of the 0.5 ml; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (A nurse gave monovalent Moderna vaccine to patient 0.25 ml instead of the 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (A nurse gave monovalent Moderna vaccine to patient 0.25 ml instead of the 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A nurse gave monovalent Moderna vaccine to patient 0.25 ml instead of the 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (A nurse gave monovalent Moderna vaccine to patient 0.25 ml instead of the 0.5 ml).    No concomitant information was reported. Suspect product dosage text was reported as unknown. This case is reported for patient 4 out of 6 patients. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-721461 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721461:Patient 1
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Nurse gave 0.25 ml instead of the 0.5 ml today 26-Apr-2023; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Nurse gave 0.25 ml instead of the 0.5 ml today 26-Apr-2023) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Nurse gave 0.25 ml instead of the 0.5 ml today 26-Apr-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Nurse gave 0.25 ml instead of the 0.5 ml today 26-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Nurse gave 0.25 ml instead of the 0.5 ml today 26-Apr-2023).    No concomitant medications were reported.  No treatment information was provided.  This case was reported for patient  5 of 6 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-721461 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721461:Patient 1
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; She states the monovalent was 0.25 ml/A nurse gave 0.25 ml instead of the 0.5 ml today 26-Apr-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (She states the monovalent was 0.25 ml/A nurse gave 0.25 ml instead of the 0.5 ml today 26-Apr-2023) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (She states the monovalent was 0.25 ml/A nurse gave 0.25 ml instead of the 0.5 ml today 26-Apr-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (She states the monovalent was 0.25 ml/A nurse gave 0.25 ml instead of the 0.5 ml today 26-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (She states the monovalent was 0.25 ml/A nurse gave 0.25 ml instead of the 0.5 ml today 26-Apr-2023).    No concomitant medications was reported. No treatment drug details was reported. This case belongs to 6th out of 6 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721461 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721461:Patient 1
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event; they administered the Moderna COVID-19 monovalent vaccine to 7 pediatric patients after the 30 day use by date; HCP confirms that the Moderna monovalent vaccine was administered to these patients and not bivalent; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they administered the Moderna COVID-19 monovalent vaccine to 7 pediatric patients after the 30 day use by date), WRONG PRODUCT ADMINISTERED (HCP confirms that the Moderna monovalent vaccine was administered to these patients and not bivalent) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (they administered the Moderna COVID-19 monovalent vaccine to 7 pediatric patients after the 30 day use by date) and WRONG PRODUCT ADMINISTERED (HCP confirms that the Moderna monovalent vaccine was administered to these patients and not bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they administered the Moderna COVID-19 monovalent vaccine to 7 pediatric patients after the 30 day use by date), WRONG PRODUCT ADMINISTERED (HCP confirms that the Moderna monovalent vaccine was administered to these patients and not bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (they administered the Moderna COVID-19 monovalent vaccine to 7 pediatric patients after the 30 day use by date) and WRONG PRODUCT ADMINISTERED (HCP confirms that the Moderna monovalent vaccine was administered to these patients and not bivalent).    No concomitant medication details was reported.  It was reported that doses were administered to 3 patients on 18-APR-2023, 2 patients on 20-APR-2023, and 2 patients on 25-APR-2023. No adverse reactions have been reported by the patient. Intact carton was used and vial size was 2.5 ml. The vial was initially stored in the refrigerator on 11-MAR-2023 (BUD:10-APR-2023). The vial did not undergo any temperature excursions.  No treatment medication details was reported.  This case contains information for the 6th patient out of 7 infant patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721478 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721478:(Patient no-1)(Master case)
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal
Clinical narrative: did not feel great; having no energy but not sick; This spontaneous case was reported by a non-health professional and describes the occurrence of FEELING ABNORMAL (did not feel great) and ASTHENIA (having no energy but not sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown if patient ever been diagnosed with or tested positive for COVID-19. It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before or any chronic or long-standing health conditions.     In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced FEELING ABNORMAL (did not feel great) and ASTHENIA (having no energy but not sick). In November 2021, FEELING ABNORMAL (did not feel great) and ASTHENIA (having no energy but not sick) had resolved.            No concomitant product reported by the reporter.  Patient did not felt good the next day after receive a Moderna booster. Patient described as having no energy but not sick. Symptoms lasted just one day. He felt fine the next day and considered symptoms fully resolved.  No treatment medication reported by reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after 30-day Use by Date to 7 patients; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     The patient medical history or condition was not known by he HCP.     On 23-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 23-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients).    No concomitant medications were reported.     It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medications were reported.  This case contains information for the 1st of 7 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721413, US-MODERNATX, INC.-MOD-2023-721426, US-MODERNATX, INC.-MOD-2023-721427, US-MODERNATX, INC.-MOD-2023-721428, US-MODERNATX, INC.-MOD-2023-721429, US-MODERNATX, INC.-MOD-2023-721430 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721429:Patient 6 out of 7 patients US-MODERNATX, INC.-MOD-2023-721413:Patient 2 out of 7 patients US-MODERNATX, INC.-MOD-2023-721430:Patient 7 out of 7 patients US-MODERNATX, INC.-MOD-2023-721428:Patient 5 out of 7 patients US-MODERNATX, INC.-MOD-2023-721427:Patient 4 out of 7 patients US-MODERNATX, INC.-MOD-2023-721426:Patient 3 out of 7 patients
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; administered the Monovalent on 21Apr2023 to 2 patients and on 22Apr2023 to 1 patient; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (administered the Monovalent on 21Apr2023 to 2 patients and on 22Apr2023 to 1 patient) and NO ADVERSE EVENT (No adverse event) in a 7-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. As1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Apr-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (administered the Monovalent on 21Apr2023 to 2 patients and on 22Apr2023 to 1 patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (administered the Monovalent on 21Apr2023 to 2 patients and on 22Apr2023 to 1 patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (administered the Monovalent on 21Apr2023 to 2 patients and on 22Apr2023 to 1 patient).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medication were reported. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; A nurse gave movalent moderna vaccine to patient 0.25 ml instead of the 0.5 ml; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (A nurse gave movalent moderna vaccine to patient 0.25 ml instead of the 0.5 ml) and NO ADVERSE EVENT (no adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (A nurse gave movalent moderna vaccine to patient 0.25 ml instead of the 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A nurse gave movalent moderna vaccine to patient 0.25 ml instead of the 0.5 ml) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (A nurse gave movalent moderna vaccine to patient 0.25 ml instead of the 0.5 ml).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721464, US-MODERNATX, INC.-MOD-2023-721466, US-MODERNATX, INC.-MOD-2023-721467, US-MODERNATX, INC.-MOD-2023-721468, US-MODERNATX, INC.-MOD-2023-721471 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721471:Patient 6 US-MODERNATX, INC.-MOD-2023-721468:Patient 5 US-MODERNATX, INC.-MOD-2023-721466:Patient 3 US-MODERNATX, INC.-MOD-2023-721464:Patient 2 US-MODERNATX, INC.-MOD-2023-721467:Patient 4
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Rash, Rash erythematous, SARS-CoV-2 test
Clinical narrative: The rash started about 2 yrs ago, and progressed and progressed. It's getting worse and disfiguring.; sister in law did have covid after the shot; A few weeks after the shot developed a rash on chest neck, and side of face; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (sister in law did have covid after the shot), RASH ERYTHEMATOUS (A few weeks after the shot developed a rash on chest neck, and side of face) and RASH (The rash started about 2 yrs ago, and progressed and progressed. It's getting worse and disfiguring.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced COVID-19 (sister in law did have covid after the shot) and RASH ERYTHEMATOUS (A few weeks after the shot developed a rash on chest neck, and side of face). On an unknown date, the patient experienced RASH (The rash started about 2 yrs ago, and progressed and progressed. It's getting worse and disfiguring.). At the time of the report, COVID-19 (sister in law did have covid after the shot) and RASH ERYTHEMATOUS (A few weeks after the shot developed a rash on chest neck, and side of face) had not resolved and RASH (The rash started about 2 yrs ago, and progressed and progressed. It's getting worse and disfiguring.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     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.   Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  It was reported that after a few weeks of vaccination patient had rash which was red and raw looking and would not go out in public. Patient saw a dermatologist and took several medications, but nothing worked. The doctor wanted to put patient on another medication, but patient was unwilling to take it.
Age: 1.58
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient was administered with Monovalent vaccine; This spontaneous case was reported by a medical assistant and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was administered with Monovalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 19-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 21-Apr-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 21-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Patient was administered with Monovalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was administered with Monovalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient was administered with Monovalent vaccine).    No concomitant medications was reported. It was reported that they administered the Monovalent on 21-Apr-2023 to 2 patients and on 22-Apr-2023 to 1 patient. No treatment drug details was reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: Patient received first dose more than a year ago and now coming for their 2nd dose of the primary series; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient received first dose more than a year ago and now coming for their 2nd dose of the primary series) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient received first dose more than a year ago and now coming for their 2nd dose of the primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient received first dose more than a year ago and now coming for their 2nd dose of the primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient received first dose more than a year ago and now coming for their 2nd dose of the primary series).    No concomitant medications were provided. No treatment medication was provided.   Reporter did not allow further contact
Sex: F
Vaccine: PNC13
Symptoms: Injury associated with device, Occupational exposure to product, Scratch, Syringe issue
Clinical narrative: ended up pricking herself with the needle; ended up pricking herself with the needle; a part of the needle or a part of the, what you call the vaccination two things fell apart/ The syringe, the blue part on the syringe fell off while giving vaccination; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A female patient was exposed to pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 17Apr2023 at 15:00 as dose number unknown, single (Lot number: GD1168) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious) with onset 17Apr2023 at 15:00, outcome "unknown", described as "a part of the needle or a part of the, what you call the vaccination two things fell apart/ The syringe, the blue part on the syringe fell off while giving vaccination"; INJURY ASSOCIATED WITH DEVICE (non-serious), OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious) all with onset 17Apr2023 at 15:00, outcome "unknown" and all described as "ended up pricking herself with the needle".  Additional information: It is PREVNAR 13 vaccination and a part of the needle or a part of the, what you call the vaccination two things fell apart while giving the vaccination to a baby. It happened on 17Apr2023 at 15:00, this was the third dose of the baby. The blue portion of the syringe of the vaccine shot came off while injecting. The nurse pulled it out quickly. However, it scratched the child, and she ended up pricking herself with the needle. When probed if the needle got injected to nurse accidentally, no. The blue part on the syringe or the needle broke off while giving the vaccine to the baby. So, when she pulled it out knowing that it is already broken, ended up scratching the baby and poking herself at the same time.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300163933 Same reporter/ drug/ event, different patients;
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 00:15 as dose 4 (booster), single (Lot number: AS7163B) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (Treatment start date- 16Apr2023; Treatment stop date- 20Apr2023).; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300168413 Same patient, different product, different event;
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Vertigo
Clinical narrative: vertigo; unable to even walk unassisted for a month and also in 2021.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 28Dec2020 as dose 1, 0.3 ml single (Lot number: EJ1685, Expiration Date: 31Mar2021), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Flu vaccine (Prior Vaccinations (within 4 weeks): None, had a flu vaccine but it was at the end of Sep2020), administration date: Sep2020, for Immunization. The following information was reported: VERTIGO (non-serious) with onset 03Jan2021, outcome "recovered" (03Jan2021); GAIT INABILITY (non-serious) with onset 2021, outcome "unknown", described as "unable to even walk unassisted for a month and also in 2021". The event "vertigo" required emergency room visit.  Additional information: The report was not related to a study or programme. On 28Dec2020 he had his first vaccine and 6 days later on 03Jan2021 was when his health problems began and it was vertigo; he had to seek medical attention for that and it lasted for months and months and was actually unable to even walk unassisted for a month and also in 2021. Vertigo: actually was  resolved on 03Jan2021 and it has at this point completely resolved. The initial visit to the emergency room was for the vertigo on he went the next morning on 04Jan2021. After the emergency room visit he saw a neurologist for the symptoms. His life changed forever 6 days after the first vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300168804 Same product, patient, different AEs, different dose;US-PFIZER INC-202300168805 Same product, patient, different AEs, different dose;
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Rash pruritic
Clinical narrative: Covid toes on both feet started 1 month post vaccination; redness; blisters on first 3 toes of each feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Jul2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Is bivalent: False, Prev dose lot number: EW0185, Prev dose lot unknown: False, Prev dose administration date: 08Sep2021, Prev dose administration time: 05:45 PM, Prev dose dose number: 3), administration date: 08Sep2021, when the patient was 74-year-old, for COVID-19 immunization; Covid-19 vaccine (Primary immunization series complete; Manufacturer Unknown), for COVID-19 immunization. The following information was reported: RASH PRURITIC (non-serious) with onset 25Aug2022 at 22:30, outcome "recovered", described as "Covid toes on both feet started 1 month post vaccination"; BLISTER (non-serious) with onset 25Aug2022 at 22:30, outcome "recovered", described as "blisters on first 3 toes of each feet"; ERYTHEMA (non-serious) with onset 25Aug2022 at 22:30, outcome "recovered", described as "redness". The events "covid toes on both feet started 1 month post vaccination", "redness" and "blisters on first 3 toes of each feet" required physician office visit. Therapeutic measures were not taken as a result of rash pruritic, erythema, blister.  Additional information: It was reported, on 25Aug2022 10:30 PM Covid toes on both feet started 1 month post vaccination. Started as redness on big and gradually over days to blisters on first 3 toes of each feet. Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. AE resulted in Doctor or other healthcare professional office/clinic visit. The patient was Recovered. No treatment received. No covid prior vaccination. Covid tested post vaccination: Unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose 2 and Dose 4: Pfizer/Dose 3: Moderna/Dose 1: Jannssen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 4 (booster), single (Lot number: GH97206) at the age of 71 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Oct2021 as dose 2, single (Lot number: FF2593), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 3 (booster), single (Lot number: 065K21A), in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 03Mar2021 as dose 1, single (Lot number: 1805022), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Oct2021, outcome "unknown", described as "Dose 2 and Dose 4: Pfizer/Dose 3: Moderna/Dose 1: Jannssen"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19; patient was treated with PAXLOVID.