chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis
Clinical narrative: Dermatitis; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DERMATITIS (Dermatitis) in an 18-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    MEDICAL HISTORY (Parent): Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    MEDICAL HISTORY (Patient): The patient's past medical history included Maternal exposure during pregnancy.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) 1 dosage form. On an unknown date, the patient experienced DERMATITIS (Dermatitis). At the time of the report, DERMATITIS (Dermatitis) had not resolved.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Patient mother was given 2 Moderna Covid-19 shots plus whatever suggested she got. Reporter does not exactly know which dose patient mother was given at that time. Reporter does not have vaccination record so cannot provide the specific dates when these were administered and the corresponding lot numbers. Patient had dermatitis that never gets away.   This case was linked to US-MODERNATX, INC.-MOD-2023-716923 (Parent-Child Link).   See case US-MODERNATX-MOD-2023-716923 for details regarding the child case.
Sex: U
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received two bivalent vaccine; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received two bivalent vaccine) 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. ASKU) for COVID-19 prophylaxis.     The patient had no medical history/conditions, allergy, concomitant diseases and risk factor.    On an unknown date, 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 an unknown date, received 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. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Patient received two bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient received two bivalent vaccine) 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 EXTRA DOSE ADMINISTERED (Patient received two bivalent vaccine).    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.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 27-Feb-2023; No adverse event; Dose administered after manufacturer date of expiry(12-Mar-2023); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry(12-Mar-2023)), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry(12-Mar-2023)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry(12-Mar-2023)), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-Feb-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry(12-Mar-2023)) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-Feb-2023).    Concomitant medication was not provided.  It was reported that the vial was 1 dose. The vial was initially stored in refrigerator on 27-Feb-2023. The vial did not undergo any temperature excursion. Treatment information was not provided.   Reporter did not allow further contact
Age: 53.0
Sex: F
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 pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 53-year-old female patient 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.     Patient did not list an allergy.  Concurrent medical conditions included Immunocompromised.    On 20-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 20-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). 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).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications was reported.  Dosage text was reported as Initial Booster.  No treatment medications was reported.
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received Moderna Covid-19 Bivalent instead of second dose of monovalent; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Moderna Covid-19 Bivalent instead of second dose of monovalent) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.   No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Moderna Covid-19 Bivalent instead of second dose of monovalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Moderna Covid-19 Bivalent instead of second dose of monovalent) 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 WRONG PRODUCT ADMINISTERED (Patient received Moderna Covid-19 Bivalent instead of second dose of monovalent).    No concomitant medications were reported.  Both my children were given Moderna Covid-19 Bivalent instead of 2nd dose of monovalent.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-716989 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716989:same reporter
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received Moderna Covid-19 Bivalent instead of second dose of monovalent; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Moderna Covid-19 Bivalent instead of second dose of monovalent) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.   No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Moderna Covid-19 Bivalent instead of second dose of monovalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Moderna Covid-19 Bivalent instead of second dose of monovalent) 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 WRONG PRODUCT ADMINISTERED (Patient received Moderna Covid-19 Bivalent instead of second dose of monovalent).    No concomitant medications were reported.  Both my children were given Moderna Covid-19 Bivalent instead of 2nd dose of monovalent.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-716989 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716989:same reporter
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; They administered one expired dose of the Moderna COVID-19 vaccine to one patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They administered one expired dose of the Moderna COVID-19 vaccine to one patient) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-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) 1 dosage form. On 17-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 (They administered one expired dose of the Moderna COVID-19 vaccine to one patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They administered one expired dose of the Moderna COVID-19 vaccine to one 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 (They administered one expired dose of the Moderna COVID-19 vaccine to one patient).    No concomitant medications were provided. The vaccine got expired on 12-Mar-2023 and was administered on 17-Mar-2023. No treatment medication was provided.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 14-Jan-2023, Dose was administered on 22-FEB-2023) and NO ADVERSE EVENT (no adverse event) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis.  No Medical History information was reported. On 22-Feb-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 22-Feb-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). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 14-Jan-2023, Dose was administered on 22-FEB-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 14-Jan-2023, Dose was administered on 22-FEB-2023) 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 (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 14-Jan-2023, Dose was administered on 22-FEB-2023). No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on 14-Jan-2023. The vial did not undergo any temperature excursions. No treatment information was reported. This case is for patient 2 of 3. This case was linked to US-MODERNATX, INC.-MOD-2023-716921, US-MODERNATX, INC.-MOD-2023-716965 (E2B Linked Report). Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716921:Patient 1. US-MODERNATX, INC.-MOD-2023-716965:Patient 3.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; she inadvertently gave a 19 yr old patient a pediatric dose of 0.5mL instead of the 0.5 mL of the adult Moderna Bivalent dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (she inadvertently gave a 19 yr old patient a pediatric dose of 0.5mL instead of the 0.5 mL of the adult Moderna Bivalent dose) and NO ADVERSE EVENT (No adverse event) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1903B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1, Lot EL3302) on 10-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 2 and Lot EP7533) on 07-Apr-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 23-Mar-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Mar-2023, the patient experienced WRONG PRODUCT ADMINISTERED (she inadvertently gave a 19 yr old patient a pediatric dose of 0.5mL instead of the 0.5 mL of the adult Moderna Bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (she inadvertently gave a 19 yr old patient a pediatric dose of 0.5mL instead of the 0.5 mL of the adult Moderna Bivalent dose) 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 inadvertently gave a 19 yr old patient a pediatric dose of 0.5mL instead of the 0.5 mL of the adult Moderna Bivalent dose).    It was reported that patient had received another dose of vaccine in past but was unsure of lot number. No concomitant medications were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (Child was given Moderna Covid-19 Bivalent instead of 2nd dose of monovalent.) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Child was given Moderna Covid-19 Bivalent instead of 2nd dose of monovalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Child was given Moderna Covid-19 Bivalent instead of 2nd dose of monovalent.) 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 WRONG PRODUCT ADMINISTERED (Child was given Moderna Covid-19 Bivalent instead of 2nd dose of monovalent.). No concomitant information was reported. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2023-716914 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2023-716914:same reporter.
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (Child was given Moderna Covid-19 Bivalent instead of 2nd dose of monovalent.) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Child was given Moderna Covid-19 Bivalent instead of 2nd dose of monovalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Child was given Moderna Covid-19 Bivalent instead of 2nd dose of monovalent.) 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 WRONG PRODUCT ADMINISTERED (Child was given Moderna Covid-19 Bivalent instead of 2nd dose of monovalent.). No concomitant information was reported. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2023-716914 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2023-716914:same reporter.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator on 14-Jan-2023, Dose was administred on 22-FEB-2023; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 14-Jan-2023, Dose was administred on 22-FEB-2023) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 22-Feb-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). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 14-Jan-2023, Dose was administred on 22-FEB-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 14-Jan-2023, Dose was administred on 22-FEB-2023) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 14-Jan-2023, Dose was administred on 22-FEB-2023).    Concomitant medication details not reported by the reporter. Vial size was reported as 2.5 ml. Vial was initially stored in the refrigerator on 14-JAN-2023. Vial did not undergo any temperature excursions. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716944, US-MODERNATX, INC.-MOD-2023-716965 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716944:Patient 2 US-MODERNATX, INC.-MOD-2023-716965:Patient 3
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Dyspnoea, Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (breathing problems), AMNESIA (I lost my memory) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 08-MAY-2021 and 2nd Primary monovalent dose on 09-AUG-2021) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS7140C, 052E21A and 027C21A) for COVID-19 prophylaxis. No Medical History information was reported. On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced DYSPNOEA (breathing problems) and AMNESIA (I lost my memory). On 09-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 08-MAY-2021 and 2nd Primary monovalent dose on 09-AUG-2021). The patient was treated with OXYGEN at an unspecified dose and frequency. At the time of the report, DYSPNOEA (breathing problems) and AMNESIA (I lost my memory) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Primary monovalent dose on 08-MAY-2021 and 2nd Primary monovalent dose on 09-AUG-2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported.    It was reported that after each shot, he went to the hospital with breathing problems. He went to Emergency room 3 times. He was using oxygen all the time now. Patient had lost his memory.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Ultrasound scan
Clinical narrative: Developed a DVT in Right Leg; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "DVT in Right Leg", start date: Jan2021 (unspecified if ongoing), notes: Dates when patient was in hospital for Developed a DVT in Right Leg: Jan2021 to Jan2021. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Time: Not Provided , Anatomical Site of injection: Right Arm , Route of Administration: Not Provided), administration date: Mar2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: DEEP VEIN THROMBOSIS (hospitalization, medically significant) with onset Jan2022, outcome "not recovered", described as "Developed a DVT in Right Leg". The patient was hospitalized for deep vein thrombosis (hospitalization duration: 3 day(s)). The event "developed a dvt in right leg" required emergency room visit. The patient underwent the following laboratory tests and procedures: Ultrasound scan: (Jul2022) they still see some DVT in her right leg, notes: Caller states she is still taking blood thinners and she had an ultrasound last Jul. Therapeutic measures were taken as a result of deep vein thrombosis. Clinical course: It was reported that the patient took the Covid vaccine back in 2021 and developed a DVT after patient took the vaccine. The reporter stated patient is still taking blood thinners and patient had an ultrasound last Jul, and still see some DVT in patient right leg. It was reported that patient was seen in the ER and then admitted to the hospital for 3 days. Patient received treatment with Xarelto 10mg once a Day.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 27.0
Sex: F
Vaccine: 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) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 4 (booster), single (Lot number: GJ3275) at the age of 27 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: GN6205), in right arm, on 29Mar2021 as dose 2, single (Lot number: GR8732) and on 26Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing), notes: other medical history: ADHD; "bronchiectasis" (unspecified if ongoing), notes: other medical history: bronchiectasis; "pectus excavatum" (unspecified if ongoing), notes: other medical history: pectus excavatum; "unspecified chronic lung disease" (unspecified if ongoing), notes: other medical history: unspecified chronic lung disease; "dysmenorrhea" (unspecified if ongoing), notes: other medical history: dysmenorrhea; "suspected endometriosis" (unspecified if ongoing), notes: other medical history: suspected endometriosis; "known allergies: Shellfish" (unspecified if ongoing), notes: known allergies: Shellfish. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: whistling in her head/five people off the bat that has the same experience/ocean sound in her head; ocean sound in her head making her not sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "whistling in her head/five people off the bat that has the same experience/ocean sound in her head"; SLEEP DISORDER (non-serious), outcome "unknown", described as "ocean sound in her head making her not sleep ". Additional information: patient called about an ocean sound in her head making her not sleep and not put her head down. Reporter mentioned that there is still a whistling in her head while on the phone, she did not have it before. Reporter stated that it came from the Pfizer Vaccine and knows five people off the bat that has the same experience.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300125828 same reporter, product and event, different patient;US-PFIZER INC-202300125830 same reporter, product and event, different patient;US-PFIZER INC-202300125829 same reporter, product and event, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 95-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension Cardiac" (unspecified if ongoing), notes: Hypertension Cardiac. The patient's concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "not recovered", described as "Hives". The event "hives" required physician office visit. Therapeutic measures were taken as a result of urticaria.  Additional information: Dose lot unknown reason stated as not available/provided to reporter at the time of report completion. Reporter was reporting for his/her mother. After first vaccine she started having hives. For 2 years she had dealt with this issue. Treated and seen by multiple doctors. Phototherapy was used as well as medications (multiple). Case was reported as non-serious. Known allergies included none. No COVID prior vaccination and COVID not tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300124661 same patient/event and different drug dose;
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4161263.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Batch/Lot number: unknown), on 03May2021 as dose 2, single (Batch/Lot number: unknown) and on 03Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: blood pressure [Blood pressure], 146/99. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 146/99. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient had COVID and had been prescribed Paxlovid.  The reporter's assessment of the causal relationship of "covid" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (DRUG INEFFECTIVE , COVID-19) and BNT162B2.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID test positive; COVID test positive; Vaccine brand other: Moderna Bivalent/ vaccine brand: Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Dec2020 as dose 1, single (Lot number: E1685), in left arm, on 07Jan2021 as dose 2, single (Lot number: EJ1686), in left arm, on 09Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 26May2022 as dose 4 (booster), single (Lot number: FN2908), in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 02Nov2022 as dose 5 (booster), single (Lot number: 016H22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "shrimp" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Neomycin, reaction(s): "known allergies: Neomycin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Nov2022, outcome "unknown", described as "Vaccine brand other: Moderna Bivalent/ vaccine brand: Pfizer / BioNTech"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID test positive". Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on available information, a lack of efficacy (Vaccination failure and COVID-19) under Interchange of vaccine products with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: Ocean sound in her head making her not sleep and not put her head down/ whistling in her head while on the phone.; Ocean sound in her head" making her not sleep and not put her head down.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "Ocean sound in her head making her not sleep and not put her head down/ whistling in her head while on the phone."; SLEEP DISORDER (non-serious), outcome "unknown", described as "Ocean sound in her head" making her not sleep and not put her head down.".  Additional information: Product: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent. Female patient called about an "ocean sound in her head" making her not sleep and not put her head down. Patient has consulted with a specialist who didn't see it in her ear and assessed that it was not caused by the Pfizer COVID-19 Vaccine. Caller mentioned that there is still a whistling in her head while on the phone. Caller mentioned that she did not have it before. Caller stated that it came from the Pfizer Vaccine and knows five people off the bat that has the same experience. Caller is asking for recommendations.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s): US-PFIZER INC-202101426139 same reporter, different patient and event;
Sex: U
Vaccine: COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: ocean sound in head making not sleep and not put head down/whistling in head; ocean sound in head making not sleep and not put head down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "ocean sound in head making not sleep and not put head down/whistling in head "; SLEEP DISORDER (non-serious), outcome "unknown", described as "ocean sound in head making not sleep and not put head down".  Additional information: Reporter called about an "ocean sound in their head" making them not sleep and not put their head down. Also, there was a whistling in their head while on the phone. Reporter stated that she knows five people off the bat that has the same experience.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : US-PFIZER INC-202300124718 same reporter, product and event, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: ocean sound in head making not sleep and not put head down/whistling in head; ocean sound in head making not sleep and not put head down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "ocean sound in head making not sleep and not put head down/whistling in head"; SLEEP DISORDER (non-serious), outcome "unknown", described as "ocean sound in head making not sleep and not put head down".  Additional information: Reporter called about an "ocean sound in their head" making them not sleep and not put their head down. Also, there was a whistling in their head while on the phone. Reporter stated that she knows five people off the bat that has the same experience.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : US-PFIZER INC-202300124718 same reporter, product and event, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: ocean sound in head making not sleep and not put head down/whistling in head; ocean sound in head making not sleep and not put head down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "ocean sound in head making not sleep and not put head down/whistling in head"; SLEEP DISORDER (non-serious), outcome "unknown", described as "ocean sound in head making not sleep and not put head down".  Additional information: Reporter called about an "ocean sound in their head" making them not sleep and not put their head down. Also, there was a whistling in their head while on the phone. Reporter stated that she knows five people off the bat that has the same experience.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300124718 same reporter, product and event, different patient;
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Sep2022 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Colitis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EC9266), in left arm, on 06Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 27Oct2021 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 26Jul2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "History of vsd" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing); "history of breast cancer, stage 1" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codine, reaction(s): "known allergies: Codine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: 4 days after negative test; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included PAXLOVID from 06Mar2023 to 11Mar2023. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Rash
Clinical narrative: Rash/she started getting a rash all over; Eczema; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "not recovered", described as "Rash/she started getting a rash all over"; ECZEMA (non-serious), outcome "unknown". The events "rash/she started getting a rash all over" and "eczema" required physician office visit.  Additional information: Patient was also the reporter. Patient had an issue when she received the COVID-19 Vaccine through Pfizer. Patient broke out in a rash after she got the vaccine. Caller does not provide a phone number when queried. Patient said it was ok for someone to contact her about this if need be. Patient has eczema as well. Once patient received the COVID-19 Vaccine, she started getting a rash all over. It's still ongoing, and pretty much the same. Patient has been going back and forth to the doctor. Clarified with caller that patient just happened to reach his department. Caller confirmed with the patient that she was not involved with a clinical trial. Eczema was mentioned throughout the conversation between the patient and the caller. However, patient did not clarify if her eczema began prior to or after receiving the Pfizer COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.