chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Accidentally administered 2 doses of the monovalent vaccine which was past beyond the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Accidentally administered 2 doses of the monovalent vaccine which was past beyond the published expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Feb-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Accidentally administered 2 doses of the monovalent vaccine which was past beyond the published expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Accidentally administered 2 doses of the monovalent vaccine which was past beyond the published expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Accidentally administered 2 doses of the monovalent vaccine which was past beyond the published expiration date).    The concomitant medication was not reported by reporter. Pharmacist reported that they just found out last 18-Mar-2023 that they accidentally administered 2 doses of the monovalent vaccine which was past beyond the published expiration date. They were from 2 different vials but the same lot number.  HCP worried of providing patient's details because of HIPAA.  This case contains information for the 2nd of 2 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-716518 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716518:Patient 1
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, COVID-19, SARS-CoV-2 test
Clinical narrative: covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 06SK21A, 032F21A, 030L20A and 037K20A) for COVID-19 prophylaxis.     It was reported that patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Colitis, Hashimoto's disease, Autoimmune disorder and Chronic appendicitis (10 years ago).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2022, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Aug-2022, SARS-CoV-2 test: Positive. On an unknown date, Antibody test: Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had some immunocompromising issues. Patient has an undiagnosed autoimmune disorder, colitis, Hashimoto's and some other things in background that make immunocompromised.  Patient received influenza vaccine on 14 Oct 2022.  No Concomitant medications were provided.  On 14 Oct 2022 patient received bivalent booster with lot number reported as 051D22A. It was reported that patient wanted to ask about availability. Patient got fifth shot which was the bivalent on 14 Oct 2022.  Patient sees ads on TV and messages on phone that if its been more than 6 months patient should consider getting another booster.  Patient got COVID around 21 Aug 2022 from a visitor at house. She and her husband both tested positive.  Patient wanted to get the next shot but not sure if its the same shot that patient got in October. The insurance site says you should be boosted again. You should stick with what you started with - if you got Moderna, you should stick with Moderna.  Patient wonders if they mean getting different bivalent boosters.  Within the month of first two shots in early February patient got an antibody test recommended by physician. Patient didnt have any evidence of having antibodies from the first two vaccines. Patient will try to find out the date of the antibody test and call back. The patient read about people who are autoimmune and they are not having antibodies after having both COVID and flu vaccine.   No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Mar-2023: Live Significant follow-up received included updated medical history.
Age: 71.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: temperature excursion with our Moderna Covid-19 vaccine; No adverse event; The dose was administered to the patient post excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion) and NO ADVERSE EVENT (No adverse event) in a 71-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. 045H22A) for COVID-19 prophylaxis.     The information was unknown whether the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 06-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 06-Mar-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine), POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with our Moderna Covid-19 vaccine) and POOR QUALITY PRODUCT ADMINISTERED (The dose was administered to the patient post excursion).    The temperature excursion occurred for both monovalent and bivalent. 27 total doses were administered post excursion.  The concomitant medication was not reported.  The treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715674 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715674:Master Case
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Therapeutic response unexpected
Clinical narrative: No Adevrse Event; After receiving that dose of the vaccine he has not had to receive any additional doses of Retacrit, which he used to take at a monthly dose of 2000mL.; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (After receiving that dose of the vaccine he has not had to receive any additional doses of Retacrit, which he used to take at a monthly dose of 2000mL.) and NO ADVERSE EVENT (No Adevrse Event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. Unknown) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:N-stage kidney failure, dementia, heart transplant.  The patient's past medical history included Dementia, Kidney failure and Heart transplant. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine; for Product used for unknown indication: Retacrit (monthly dose of 2000mL) and monoclonal antibody treatment. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Retacrit and monoclonal antibody treatment.    In September 2022, 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. In 2022, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (After receiving that dose of the vaccine he has not had to receive any additional doses of Retacrit, which he used to take at a monthly dose of 2000mL.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adevrse Event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (After receiving that dose of the vaccine he has not had to receive any additional doses of Retacrit, which he used to take at a monthly dose of 2000mL.) and NO ADVERSE EVENT (No Adevrse Event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   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.   Concomitant medications were not reported. Treatment medications were not reported.   On an unknown date, the reporter stated that her husband received all Moderna vaccines.  On Sep-2022, the reporter stated that her husband received a dose of the bivalent vaccine. After receiving that dose of the vaccine her husband had not had to receive any additional doses of Retacrit, which he used to take at a monthly dose of 2000mL.  The reporter added that her husband also received a monoclonal antibody treatment about 1 month before this dose and had not been diagnosed with COVID-19.
Age: 4.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product temperature excursion issue
Clinical narrative: Lot numbers AS1903B; 045H22A; 074B22A were involved in a temperature excursion that to place at HCP office on 13-Feb-23.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Lot numbers AS1903B; 045H22A; 074B22A were involved in a temperature excursion that to place at HCP office on 13-Feb-23.) and NO ADVERSE EVENT (No adverse event) in a 4-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1903B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Lot numbers AS1903B; 045H22A; 074B22A were involved in a temperature excursion that to place at HCP office on 13-Feb-23.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Lot numbers AS1903B; 045H22A; 074B22A were involved in a temperature excursion that to place at HCP office on 13-Feb-23.) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Lot numbers AS1903B; 045H22A; 074B22A were involved in a temperature excursion that to place at HCP office on 13-Feb-23.).    No concomitant medications were reported. Lot numbers AS1903B; 045H22A; 074B22A were involved in a temperature excursion that to place at HCP office on 13-Feb-23. Vials from documented lot numbers were used. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716063, US-MODERNATX, INC.-MOD-2023-716061, US-MODERNATX, INC.-MOD-2023-716062, US-MODERNATX, INC.-MOD-2023-716039 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2023: Non-Significant Follow-up appended: No new information On 16-Mar-2023: Live Significant follow-up appended: Patient details updated, Onset date of vaccine updated, and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716061:Patient US-MODERNATX, INC.-MOD-2023-716062:Patient US-MODERNATX, INC.-MOD-2023-716039:Patient US-MODERNATX, INC.-MOD-2023-716063:Patient
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; A pediatrician reports that they inadvertently administered the bivalent dose instead of the monovalent dose for the primary series (2 as 2nd doses and 1 as 1st dose); This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (A pediatrician reports that they inadvertently administered the bivalent dose instead of the monovalent dose for the primary series (2 as 2nd doses and 1 as 1st dose)) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 216K22A and 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 15-Feb-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Mar-2023, received second 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 15-Mar-2023, the patient experienced WRONG PRODUCT ADMINISTERED (A pediatrician reports that they inadvertently administered the bivalent dose instead of the monovalent dose for the primary series (2 as 2nd doses and 1 as 1st dose)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A pediatrician reports that they inadvertently administered the bivalent dose instead of the monovalent dose for the primary series (2 as 2nd doses and 1 as 1st dose)) 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 (A pediatrician reports that they inadvertently administered the bivalent dose instead of the monovalent dose for the primary series (2 as 2nd doses and 1 as 1st dose)).    Concomitant medication not reported. Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716005 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2023: Significant Live follow up appended : Patient and Dosage information Updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716005:1st infant patient
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: No adverse event; they had their 1st dose of the Moderna Covid-19 vaccine in Sep2021 and were at a pharmacy at the time of the call (16Mar2023) to get the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (they had their 1st dose of the Moderna Covid-19 vaccine in Sep2021 and were at a pharmacy at the time of the call (16Mar2023) to get the 2nd dose) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and unknown) for COVID-19 prophylaxis.     No Medical History information was reported.   In September 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 16-Mar-2023, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2023, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (they had their 1st dose of the Moderna Covid-19 vaccine in Sep2021 and were at a pharmacy at the time of the call (16Mar2023) to get the 2nd dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (they had their 1st dose of the Moderna Covid-19 vaccine in Sep2021 and were at a pharmacy at the time of the call (16Mar2023) to get the 2nd dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported No concomitant medications were reported  Caller stated that they had their 1st dose of the Moderna Covid-19 vaccine in Sep2021 and were at a pharmacy at the time of the call (16Mar2023) to get the 2nd dose. They were told that they need to redo the 1st dose. They want to know if this is true. Agent asked if caller is able to provide their contact details 1st before proceeding to assist them but call got disconnected. Callback cannot be made as phone number had not been obtained. Submitting AE with limited information. Country chosen as the default country of occurrence as agent did not have ample time to confirm this.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Moderna Covid-19 Vaccine, "We gave it to 2 of our patients yesterday; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 Vaccine, "We gave it to 2 of our patients yesterday) 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.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:HCP declined to provide DOB.     On 16-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 Vaccine, "We gave it to 2 of our patients yesterday) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 Vaccine, "We gave it to 2 of our patients yesterday) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported No concomitant medications were reported   This case was linked to US-MODERNATX, INC.-MOD-2023-715996 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715996:same reporter
Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; that the second dose was given 2 weeks early-2nd dose 17-Mar-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (that the second dose was given 2 weeks early-2nd dose 17-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 19-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (that the second dose was given 2 weeks early-2nd dose 17-Mar-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (that the second dose was given 2 weeks early-2nd dose 17-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (that the second dose was given 2 weeks early-2nd dose 17-Mar-2023).    The concomitant medication was not reported.  The second vaccine was administered 2 weeks early. The treatment medication was not reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient receive a pediatric monovalent dose for 6 years to 11 years instead of the primary dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient receive a pediatric monovalent dose for 6 years to 11 years instead of the primary dose) and NO ADVERSE EVENT (No adverse event) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient did not experienced any relevant medical history or conditions, allergy, concomitant diseases and risk factor.     On 17-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Patient receive a pediatric monovalent dose for 6 years to 11 years instead of the primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient receive a pediatric monovalent dose for 6 years to 11 years instead of the primary 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 (Patient receive a pediatric monovalent dose for 6 years to 11 years instead of the primary dose).    No concomitant medications was provided. No treatment medications was provided.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine administered after 30 day use by date and manufacturer date of expiry; No adverse event; Vaccine with lot 015B22A was given to patient after expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine with lot 015B22A was given to patient after expiration date), PRODUCT STORAGE ERROR (Vaccine administered after 30 day use by date and manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 24-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine with lot 015B22A was given to patient after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after 30 day use by date and manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine with lot 015B22A was given to patient after expiration date), PRODUCT STORAGE ERROR (Vaccine administered after 30 day use by date and manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine with lot 015B22A was given to patient after expiration date) and PRODUCT STORAGE ERROR (Vaccine administered after 30 day use by date and manufacturer date of expiry).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine was unknown. Concomitant medications details were not reported by the reporter. They had the date written down as March and they found out it expired in February. Caller wanted to check and make sure there was no extension to the expiration date. Vial was initially stored in the refrigerator on 09-Feb-2023.  Vial did not undergo any temperature excursions. Treatment details was not reported by the reporter.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; A patient was administered a second dose of the vaccine after the published expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was administered a second dose of the vaccine after the published expiration date) and NO ADVERSE EVENT (No adverse event) in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 17-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 17-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient was administered a second dose of the vaccine after the published expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient was administered a second dose of the vaccine after the published expiration date) 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 EXPIRED PRODUCT ADMINISTERED (A patient was administered a second dose of the vaccine after the published expiration date).    No concomitant medications were reported. No treatment medications were reported.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Pruritus
Clinical narrative: Patient had skin issues 3 days after the vaccine, extremely itchy spots on the body, Unbearably itchy. Not always the same area, different areas at different times. Hands, feet, legs, torso.; The area is also very red.; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Patient had skin issues 3 days after the vaccine, extremely itchy spots on the body, Unbearably itchy. Not always the same area, different areas at different times. Hands, feet, legs, torso.) and ERYTHEMA (The area is also very red.) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 3), PFIZER BIONTECH COVID-19 VACCINE (Dose 1) and PFIZER BIONTECH COVID-19 VACCINE (Dose 2). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 17-Jan-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 20-Jan-2023, the patient experienced PRURITUS (Patient had skin issues 3 days after the vaccine, extremely itchy spots on the body, Unbearably itchy. Not always the same area, different areas at different times. Hands, feet, legs, torso.) and ERYTHEMA (The area is also very red.). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Patient had skin issues 3 days after the vaccine, extremely itchy spots on the body, Unbearably itchy. Not always the same area, different areas at different times. Hands, feet, legs, torso.) and ERYTHEMA (The area is also very red.) had not resolved.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No medical history, concomitant disease, or risk factors were reported  It was reported that patient never had an issue with the first three doses of Pfizer vaccine. The patient did not experience any additional symptoms or events. The patient was using topical steroid on the areas and taking Zyrtec which seems to be help. But once stop taking the medication again the itchiness was appearing. No lab data or results were reported. No treatment medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     The patient had no medical conditions.   On 19-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (covid 19). On 16-Dec-2022, COVID-19 (covid 19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2022, SARS-CoV-2 test: Negative.  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 concomitant medications were reported.  The patient received 1st dose on 05-Feb-2021, lot no. 010M20A, 2nd dose on 04-Mar-2021, lot no. 014M20A and 1st booster on 01-Apr-2021, lot no. 048L21A.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient experienced chills, achiness, headache, congestion of nose, cough, nasal drip, and got diarrhea during approximately 2 weeks, it was not too bad but she got dehydrated.   No treatment was given.   This case was linked to MOD-2021-304545 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Herpes zoster, Pain, Skin mass
Clinical narrative: There are no more blisters but there are still bumps.; The pain inside his head is still excruciating and it radiates to the right eye and ear.; The pain inside his head is still excruciating and it radiates to the right eye and ear.; severe, severe case of shingles; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HERPES ZOSTER (severe, severe case of shingles), SKIN MASS (There are no more blisters but there are still bumps.), PAIN (The pain inside his head is still excruciating and it radiates to the right eye and ear.) and HEADACHE (The pain inside his head is still excruciating and it radiates to the right eye and ear.) in an 82-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 prophylaxis.     The patient had no medical history/conditions, allergy, concomitant diseases or risk factor.  Previously administered products included for Product used for unknown indication: Flu vaccine on 26-Sep-2022. Past adverse reactions to the above products included No adverse event with Flu vaccine.    On 27-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced HERPES ZOSTER (severe, severe case of shingles). On an unknown date, the patient experienced SKIN MASS (There are no more blisters but there are still bumps.), PAIN (The pain inside his head is still excruciating and it radiates to the right eye and ear.) and HEADACHE (The pain inside his head is still excruciating and it radiates to the right eye and ear.). At the time of the report, HERPES ZOSTER (severe, severe case of shingles) and HEADACHE (The pain inside his head is still excruciating and it radiates to the right eye and ear.) had not resolved and SKIN MASS (There are no more blisters but there are still bumps.) and PAIN (The pain inside his head is still excruciating and it radiates to the right eye and ear.) outcome was unknown.        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 concomitant medications were reported.     The patient had received the other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient received the Moderna COVID-19 vaccine 1st dose  on 06-Mar-2021 (lot number - 036A21A), 2nd dose on 03-Apr-2021 (lot number - 026B21A), 3rd dose on 24-Oct2-021 (lot number - 004F21A) and 4th dose on  04-Apr-2022 (lot number - 083J21A). The reporter stated that within2 weeks after getting the bivalent booster dose on 27-Sep-222 her husband had severe shingles. It was on patient's forehead and eye all the was to his head. The patient was given various shingles meds and patient was now on the 3rd pain medication but it was not helping.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error, Wrong product administered
Clinical narrative: Patient received updated booster on 03/11 instead of second dose; The second dose given incorrectly but was expired, refrigerated for more than 30 days; Vaccine was expired and refrigerated for more than 30 days; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received updated booster on 03/11 instead of second dose), EXPIRED PRODUCT ADMINISTERED (The second dose given incorrectly but was expired, refrigerated for more than 30 days), PRODUCT STORAGE ERROR (Vaccine was expired and refrigerated for more than 30 days) 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. 062F22A) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received updated booster on 03/11 instead of second dose), EXPIRED PRODUCT ADMINISTERED (The second dose given incorrectly but was expired, refrigerated for more than 30 days), PRODUCT STORAGE ERROR (Vaccine was expired and refrigerated for more than 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received updated booster on 03/11 instead of second dose), EXPIRED PRODUCT ADMINISTERED (The second dose given incorrectly but was expired, refrigerated for more than 30 days), PRODUCT STORAGE ERROR (Vaccine was expired and refrigerated for more than 30 days) 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 WRONG PRODUCT ADMINISTERED (Patient received updated booster on 03/11 instead of second dose), EXPIRED PRODUCT ADMINISTERED (The second dose given incorrectly but was expired, refrigerated for more than 30 days) and PRODUCT STORAGE ERROR (Vaccine was expired and refrigerated for more than 30 days).    It was reported that patient received the first vaccine on 02-Aug.  No concomitant information was reported. No treatment information was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 19-Dec-2022 and was administered on 03-Feb-2023, 10-Feb-2023 and 11-Mar-2023; No adverse event; Patient received dose after its BUD date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose after its BUD date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19-Dec-2022 and was administered on 03-Feb-2023, 10-Feb-2023 and 11-Mar-2023) 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. AS7171B) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 03-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 03-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose after its BUD date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19-Dec-2022 and was administered on 03-Feb-2023, 10-Feb-2023 and 11-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose after its BUD date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19-Dec-2022 and was administered on 03-Feb-2023, 10-Feb-2023 and 11-Mar-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 (Patient received dose after its BUD date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 19-Dec-2022 and was administered on 03-Feb-2023, 10-Feb-2023 and 11-Mar-2023).    No concomitant medications were provided. It was reported that 3 Patients received doses after its BUD date on 03-Feb-2023, 10-Feb-2023 and 11-Mar-2023. The vial did not undergo any temperature excursions. No treatment medication was provided. This case contains information for the 1st of 3 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716134, US-MODERNATX, INC.-MOD-2023-716130 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716134:case for adult patient 3 out of 3 patients US-MODERNATX, INC.-MOD-2023-716130:case for adult patient 2 out of 3 patients
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: bivalent vaccine was administered to patient which was beyond the BUD; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (bivalent vaccine was administered to patient which was beyond the BUD) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    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, the patient experienced EXPIRED PRODUCT ADMINISTERED (bivalent vaccine was administered to patient which was beyond the BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (bivalent vaccine was administered to patient which was beyond the BUD) 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 (bivalent vaccine was administered to patient which was beyond the BUD).    Dosage text for suspect product was reported as initial booster.  Concomitant drugs were not reported.  It was reported that unknown bivalent vaccine was administered to patient which was beyond the BUD. No other symptoms were reported.  Treatment medications were not provided.
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: bivalent vaccines was administered the vaccine was beyond the BUD.; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (bivalent vaccines was administered the vaccine was beyond the BUD.) and NO ADVERSE EVENT (no adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    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, the patient experienced EXPIRED PRODUCT ADMINISTERED (bivalent vaccines was administered the vaccine was beyond the BUD.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (bivalent vaccines was administered the vaccine was beyond the BUD.) 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 (bivalent vaccines was administered the vaccine was beyond the BUD.).    No concomitant medications was reported.  Bivalent vaccines was administered. The vaccine was beyond the BUD. No reported symptoms.  No treatment medications was reported.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 2, 4 year old twin female patients who had their 2 primary series, inadvertently got a 3rd primary dose instead of the Moderna Bivalent booster today, 17May2023; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (2, 4 year old twin female patients who had their 2 primary series, inadvertently got a 3rd primary dose instead of the Moderna Bivalent booster today, 17May2023) and NO ADVERSE EVENT (No adverse event) in a 4-year-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 17-Mar-2023, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (2, 4 year old twin female patients who had their 2 primary series, inadvertently got a 3rd primary dose instead of the Moderna Bivalent booster today, 17May2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (2, 4 year old twin female patients who had their 2 primary series, inadvertently got a 3rd primary dose instead of the Moderna Bivalent booster today, 17May2023) 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 (2, 4 year old twin female patients who had their 2 primary series, inadvertently got a 3rd primary dose instead of the Moderna Bivalent booster today, 17May2023).    No concomitant medications were reported. Patient had received 2 primary series dose. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-716158 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716158:2nd Child Female Twin Patient