chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.75
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; The patient received Moderna Covid-19 vaccine lot number AS1420B expiration date February 21, 2023. The patient received the dose on February 23, 2023.; More than 35 days in between doses of the primary series; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine lot number AS1420B expiration date February 21, 2023. The patient received the dose on February 23, 2023.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between doses of the primary series) and NO ADVERSE EVENT (No adverse event) in a 21-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1420B and AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Oct-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2023, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine lot number AS1420B expiration date February 21, 2023. The patient received the dose on February 23, 2023.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between doses of the primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine lot number AS1420B expiration date February 21, 2023. The patient received the dose on February 23, 2023.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between doses of the primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine lot number AS1420B expiration date February 21, 2023. The patient received the dose on February 23, 2023.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between doses of the primary series).    No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Myalgia
Clinical narrative: muscle pain; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (muscle pain) 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.     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 MYALGIA (muscle pain). At the time of the report, MYALGIA (muscle pain) 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.   No concomitant medication was reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Feb-2023: Non-significant follow up received.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Fatigue, Inappropriate schedule of product administration
Clinical narrative: slight fatigue/ little bit of fatigue; More than 35 days in between doses of the primary; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (slight fatigue/ little bit of fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between doses of the primary) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02M20A, 012M20A and AS7146B) for COVID-19 prophylaxis.     Patient reported no chronic medical conditions. The patient reported that she does not take any medications. The patient has never had Covid-19 and the patient was not diagnosed with Myocarditis or Pericarditis.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between doses of the primary). On an unknown date, the patient experienced FATIGUE (slight fatigue/ little bit of fatigue). At the time of the report, FATIGUE (slight fatigue/ little bit of fatigue) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between doses of the primary) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. After first dose, patient reported ADR of slight fatigue lasting about 24 hours. Patient did not have any ADRs after second dose. After the first booster dose, patient reported ADR of a little bit of fatigue for a couple of hours. No treatment medications were reported.   This case was linked to MOD-2023-713038 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Arthralgia, Asthenia, Cardiac flutter, Fatigue
Clinical narrative: slight fatigue/ little bit of fatigue; More than 35 days in between doses of the primary; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (slight fatigue/ little bit of fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between doses of the primary) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02M20A, 012M20A and AS7146B) for COVID-19 prophylaxis.     Patient reported no chronic medical conditions. The patient reported that she does not take any medications. The patient has never had Covid-19 and the patient was not diagnosed with Myocarditis or Pericarditis.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between doses of the primary). On an unknown date, the patient experienced FATIGUE (slight fatigue/ little bit of fatigue). At the time of the report, FATIGUE (slight fatigue/ little bit of fatigue) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between doses of the primary) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. After first dose, patient reported ADR of slight fatigue lasting about 24 hours. Patient did not have any ADRs after second dose. After the first booster dose, patient reported ADR of a little bit of fatigue for a couple of hours. No treatment medications were reported.   This case was linked to MOD-2023-713038 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; a 40-year-old patient received Pediatric monovalent Moderna COVID-19 vaccine NDC# 80777-0275-05 (Lot# 068A22A & Exp. Date:21MAR2023) instead of adult 2nd primary dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (a 40-year-old patient received Pediatric monovalent Moderna COVID-19 vaccine NDC# 80777-0275-05 (Lot# 068A22A & Exp. Date:21MAR2023) instead of adult 2nd primary dose) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068A22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE.    On 27-Feb-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (a 40-year-old patient received Pediatric monovalent Moderna COVID-19 vaccine NDC# 80777-0275-05 (Lot# 068A22A & Exp. Date:21MAR2023) instead of adult 2nd primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (a 40-year-old patient received Pediatric monovalent Moderna COVID-19 vaccine NDC# 80777-0275-05 (Lot# 068A22A & Exp. Date:21MAR2023) instead of adult 2nd primary dose) 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 (a 40-year-old patient received Pediatric monovalent Moderna COVID-19 vaccine NDC# 80777-0275-05 (Lot# 068A22A & Exp. Date:21MAR2023) instead of adult 2nd primary dose).    No concomitant medication details was reported. No treatment medication details was reported.   Patient received first primary monovalent dose at a different facility on unknown date and Lot number, expiry date was unknown.
Age: 21.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 7 doses of Moderna monovalent lot number 055A22A, expiration date 2.2.23, was administered to patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 055A22A, expiration date 2.2.23, was administered to patients.) and NO ADVERSE EVENT (No adverse event) in a 21-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 055A22A) for COVID-19 prophylaxis.     It was unknown that patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 27-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 27-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 055A22A, expiration date 2.2.23, was administered to patients.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 055A22A, expiration date 2.2.23, was administered to patients.) 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 (7 doses of Moderna monovalent lot number 055A22A, expiration date 2.2.23, was administered to patients.).    No concomitant medication details was reported. The vaccine had been frozen with no known temperature excursion before being thawed today for administration.  The vial was initially stored in the refrigerator on 27-Feb-2023. The vial did not undergo any temperature excursions. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713030 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713030:Same reporter
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: A moderna vaccine for age group age 6-11 year old was given 3 days past expiration date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A moderna vaccine for age group age 6-11 year old was given 3 days past expiration date) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) 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 (A moderna vaccine for age group age 6-11 year old was given 3 days past expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A moderna vaccine for age group age 6-11 year old was given 3 days past expiration 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 (A moderna vaccine for age group age 6-11 year old was given 3 days past expiration date).    No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
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 18-Jan-2023 and 20-Jan-2023 and administration of vaccine on 20-Feb-2023, 21-Feb-2023, 22-Feb-2023; No adverse event; Patients received the COVID vaccine a couple days after the BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received the COVID vaccine a couple days after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jan-2023 and 20-Jan-2023 and administration of vaccine on 20-Feb-2023, 21-Feb-2023, 22-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a child 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.     No Medical History information was reported.    In February 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. In February 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received the COVID vaccine a couple days after the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jan-2023 and 20-Jan-2023 and administration of vaccine on 20-Feb-2023, 21-Feb-2023, 22-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received the COVID vaccine a couple days after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jan-2023 and 20-Jan-2023 and administration of vaccine on 20-Feb-2023, 21-Feb-2023, 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 (Patients received the COVID vaccine a couple days after the BUD) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Jan-2023 and 20-Jan-2023 and administration of vaccine on 20-Feb-2023, 21-Feb-2023, 22-Feb-2023).    The concomitant medication was not reported by reporter. The three patients received the COVID vaccine a couple days after the BUD. The date of administration 21-Feb-2023, 20-Feb-2023 and 22-Feb-2023. The vial was initially stored in the fridge on 18-Jan-2023 and 20-Jan-2023. The vial did not undergo any temperature excursions. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-713020 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713020:adolescents/adults case
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose of Moderna monovalent with expiry date 02-Feb-2023 was administered on 27-Feb-2023 after expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose of Moderna monovalent with expiry date 02-Feb-2023 was administered on 27-Feb-2023 after expiry) and NO ADVERSE EVENT (No adverse event) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 055A22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 27-Feb-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 27-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose of Moderna monovalent with expiry date 02-Feb-2023 was administered on 27-Feb-2023 after expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose of Moderna monovalent with expiry date 02-Feb-2023 was administered on 27-Feb-2023 after 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose of Moderna monovalent with expiry date 02-Feb-2023 was administered on 27-Feb-2023 after expiry).    Concomitant drugs were not reported.  It was reported that 7 monovalent doses were administered after expiry. The vaccine had been frozen with no known temperature excursion before being thawed for administration. The vial was initially stored in refrigerator on 27-Feb-2023. It was reported that the vial did not underwent any temperature excursion.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-713030, US-MODERNATX, INC.-MOD-2023-713149, US-MODERNATX, INC.-MOD-2023-713031, US-MODERNATX, INC.-MOD-2023-713031, US-MODERNATX, INC.-MOD-2023-713012, US-MODERNATX, INC.-MOD-2023-712974, US-MODERNATX, INC.-MOD-2023-710742 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713030:Same reporter US-MODERNATX, INC.-MOD-2023-713149:Same reporter US-MODERNATX, INC.-MOD-2023-713031:Same reporter US-MODERNATX, INC.-MOD-2023-713012:Same reporter US-MODERNATX, INC.-MOD-2023-712974:Same reporter US-MODERNATX, INC.-MOD-2023-710742:Same reporter US-MODERNATX, INC.-MOD-2023-713031:Same reporter
Age: 27.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; 7 doses of Moderna monovalent lot number 055A22A, expiration date 2.2.23, was administered to patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 055A22A, expiration date 2.2.23, was administered to patients.) and NO ADVERSE EVENT (No Adverse Event) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 055A22A) for COVID-19 prophylaxis.     The information was unknown about any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 27-Feb-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 27-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 055A22A, expiration date 2.2.23, was administered to patients.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent lot number 055A22A, expiration date 2.2.23, was administered to patients.) 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 (7 doses of Moderna monovalent lot number 055A22A, expiration date 2.2.23, was administered to patients.).    The date of last administration was 27-Feb-2023. The vaccine was frozen with no known temperature excursion before being thawed today for administration. Dose administered after manufacturer date of expiry. The vial was initially stored in the refrigerator on 27-Feb-2023. The vial had undergone no temperature excursion. 7 doses of Monovalent vaccine was administered to the patients.  The concomitant medication was not reported. The treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712698, US-MODERNATX, INC.-MOD-2023-712708, US-MODERNATX, INC.-MOD-2023-712766, US-MODERNATX, INC.-MOD-2023-712974, US-MODERNATX, INC.-MOD-2023-713012, US-MODERNATX, INC.-MOD-2023-713027, US-MODERNATX, INC.-MOD-2023-713031 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712698:Same reporter US-MODERNATX, INC.-MOD-2023-712708:Same reporter US-MODERNATX, INC.-MOD-2023-712766:Same reporter US-MODERNATX, INC.-MOD-2023-712974:Same reporter US-MODERNATX, INC.-MOD-2023-713012:Same reporter US-MODERNATX, INC.-MOD-2023-713027:Same reporter US-MODERNATX, INC.-MOD-2023-713031:Same reporter
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product label confusion
Clinical narrative: Circumstance or information capable of leading to a medication error; No adverse event; Pharmacist has vaccine for 6 to 11 year old patients The Pharmacist feels that the labeling is confusing enough that she almost made a mistake because the labeling says "booster doses" only on the box.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT LABEL CONFUSION (Pharmacist has vaccine for 6 to 11 year old patients The Pharmacist feels that the labeling is confusing enough that she almost made a mistake because the labeling says "booster doses" only on the box.), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to a medication error) and NO ADVERSE EVENT (No adverse event) in a 6-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2023, the patient experienced PRODUCT LABEL CONFUSION (Pharmacist has vaccine for 6 to 11 year old patients The Pharmacist feels that the labeling is confusing enough that she almost made a mistake because the labeling says "booster doses" only on the box.). On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to a medication error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT LABEL CONFUSION (Pharmacist has vaccine for 6 to 11 year old patients The Pharmacist feels that the labeling is confusing enough that she almost made a mistake because the labeling says "booster doses" only on the box.), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to a medication error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT LABEL CONFUSION (Pharmacist has vaccine for 6 to 11 year old patients The Pharmacist feels that the labeling is confusing enough that she almost made a mistake because the labeling says "booster doses" only on the box.) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to a medication error).    No concomitant medications were reported. Expiration date is not known. No other adverse events were reported. No treatment medications were reported.
Age: 1.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP stated they administered a 1st dose of Moderna COVID-19 Vaccine to a 16 months old patient on 28-FEB-2023 but they just realized the vaccine expired on 02-FEB-2023; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they administered a 1st dose of Moderna COVID-19 Vaccine to a 16 months old patient on 28-FEB-2023 but they just realized the vaccine expired on 02-FEB-2023) and NO ADVERSE EVENT (No adverse event) in a 1-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they administered a 1st dose of Moderna COVID-19 Vaccine to a 16 months old patient on 28-FEB-2023 but they just realized the vaccine expired on 02-FEB-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they administered a 1st dose of Moderna COVID-19 Vaccine to a 16 months old patient on 28-FEB-2023 but they just realized the vaccine expired on 02-FEB-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they administered a 1st dose of Moderna COVID-19 Vaccine to a 16 months old patient on 28-FEB-2023 but they just realized the vaccine expired on 02-FEB-2023).    No concomitant medication was reported.    HCP stated they administered a 1st dose of Moderna COVID-19 Vaccine to a 16 months old patient on 28-FEB-2023 but they just realized the vaccine expired on 02-FEB-2023. No treatment information was reported.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; The vaccination card states that the patient received a Bivalent booster dose for the first primary Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (The vaccination card states that the patient received a Bivalent booster dose for the first primary Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown whether patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 31-Jan-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 31-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (The vaccination card states that the patient received a Bivalent booster dose for the first primary Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The vaccination card states that the patient received a Bivalent booster dose for the first primary Moderna COVID-19 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 WRONG PRODUCT ADMINISTERED (The vaccination card states that the patient received a Bivalent booster dose for the first primary Moderna COVID-19 vaccine).    No concomitant medications were provided. No treatment medication was provided.   Reporter did not allow further contact
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 7 doses of Moderna monovalent vaccine administered after expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent vaccine administered after expiry) and NO ADVERSE EVENT (No adverse event) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 055A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 27-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent vaccine administered after expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent vaccine administered after 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna monovalent vaccine administered after expiry).    It was unknown if the patient received any other vaccines 4 weeks prior to COVID-19 vaccine.  No concomitant medications was reported.  The vaccine had been frozen with no known temperature excursion before being thawed today for administration. The vial was initially stored in the refrigerator on 27-Feb-2023.  No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713030, US-MODERNATX, INC.-MOD-2023-713031, US-MODERNATX, INC.-MOD-2023-713012, US-MODERNATX, INC.-MOD-2023-712974, US-MODERNATX, INC.-MOD-2023-710742, US-MODERNATX, INC.-MOD-2023-713027 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713030:Same reporter US-MODERNATX, INC.-MOD-2023-713031:Same reporter US-MODERNATX, INC.-MOD-2023-713012:Same reporter US-MODERNATX, INC.-MOD-2023-712974:Same reporter US-MODERNATX, INC.-MOD-2023-710742:Same reporter US-MODERNATX, INC.-MOD-2023-713027:Same reporter
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; First dose of Primary vaccine series administered today after the published expiration date of 26-FEB-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (First dose of Primary vaccine series administered today after the published expiration date of 26-FEB-2023) and NO ADVERSE EVENT (No adverse event) in a 27-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.   Patient did not have any relevant medical history or conditions, allergy, concomitant diseases and risk factor.     On 28-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 28-Feb-2023,after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (First dose of Primary vaccine series administered today after the published expiration date of 26-FEB-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (First dose of Primary vaccine series administered today after the published expiration date of 26-FEB-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 EXPIRED PRODUCT ADMINISTERED (First dose of Primary vaccine series administered today after the published expiration date of 26-FEB-2023).    No concomitant medications were reported.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19.  No treatment information was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator 26Jan2023; No adverse event; Bivalent vaccine was administered to a patient after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was administered to a patient after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 26Jan2023) 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. 019H22A) for COVID-19 prophylaxis.     It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 27-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) .5 milliliter. On 27-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was administered to a patient after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 26Jan2023). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was administered to a patient after 30-day Use By Date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 26Jan2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was administered to a patient after 30-day Use By Date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 26Jan2023).    No concomitant medications were reported.  There was Individual Vial of size 2.5 ml.  The vial was initially stored in the refrigerator on 26-Jan-2023. The vial did not undergo any temperature excursions.  No treatment details were reported.
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; Patient received the Moderna Bivalent booster as their second dose instead of the Monovalent dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the Moderna Bivalent booster as their second dose instead of the Monovalent dose) and NO ADVERSE EVENT (no adverse event) in a 50-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 27-Feb-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 27-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the Moderna Bivalent booster as their second dose instead of the Monovalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the Moderna Bivalent booster as their second dose instead of the Monovalent 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 (Patient received the Moderna Bivalent booster as their second dose instead of the Monovalent dose).    No concomitant medications were reported.  No treatment medications were reported.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Heart rate increased, Heart rate irregular, Myocarditis
Clinical narrative: Fast Pulse rate, erratic heart rate, abnormal EKG, Did an Echo cardiogram and myocarditis and pericarditis was discovered. An EKG and Echo was done a few years prior and was perfectly normal
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Fast Pulse rate, erratic heart rate, abnormal EKG, Did an Echo cardiogram and myocarditis and pericarditis was discovered. An EKG and Echo was done a few years prior and was perfectly normal
Sex: F
Vaccine: PNC20
Symptoms: Occupational exposure to product, Wrong technique in product usage process
Clinical narrative: Prevnar 20 was accidentally sprayed into the eyes of the person that was administering the medication; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team and product quality group.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OCCUPATIONAL EXPOSURE TO PRODUCT (intervention required) with onset 20Feb2023, described as "Prevnar 20 was accidentally sprayed into the eyes of the person that was administering the medication". Clinical course: The reporter was asking what should be done if Prevnar 20 was accidentally sprayed into the eyes of the person that was administering the medication. She stated that she was not sure why it sprayed as they made sure the needle was on snugly. As of 20Feb2023, Clarified that the medication sprayed in the staff member's eye. Just happened today (20Feb2023), going on about 15 minutes ago. Staff member was not having any visual changes, not having any burning, or anything like that. Was not really sure how much she did get in her eyes.   The information on the batch/lot number for pneumococcal 20-val conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.  Follow-up (20Feb2023): This is a spontaneous follow-up report received from a contactable nurse. Upon received follow up information on 20Feb2023, this case now upgrade to serious.  Updated information: Reporter address added, patient's gender added, event onset date added, seriousness updated to intervention required, clinical course updated.    The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Occupational exposure to product via eye is an accident due to incorrect technique in administration with the suspect vaccine.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Chest discomfort, Dyspnoea, Echocardiogram, Pericarditis
Clinical narrative: CTA of the chest from 28Dec2022 suggested pericarditis; Pt developed shortness of breath; chest pressure; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "CLL" (unspecified if ongoing); "gout" (unspecified if ongoing). Concomitant medication(s) included: VENETOCLAX; OBINUTUZUMAB; QUETIAPINE; VENLAFAXINE; ULORIC; WELLBUTRIN; VITAMIN D3. Past drug history included: Allopurinol, reaction(s): "Known allergy: allopurinol". Vaccination history included: Covid-19 vaccine (Dose 3 (Booster), Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 1, Unknown manufacturer), for Covid-19 Immunization. Patient had no COVID prior vaccination and had not tested post vaccination. The following information was reported: PERICARDITIS (medically significant) with onset Dec2022, outcome "recovered", described as "CTA of the chest from 28Dec2022 suggested pericarditis"; DYSPNOEA (medically significant) with onset Dec2022, outcome "recovered", described as "Pt developed shortness of breath"; CHEST DISCOMFORT (medically significant) with onset Dec2022, outcome "recovered", described as "chest pressure". The events "cta of the chest from 28dec2022 suggested pericarditis", "pt developed shortness of breath" and "chest pressure" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Angiogram: (28Dec2022) pericarditis; Echocardiogram: (05Jan2023) negative, notes: performed after symptoms had resolved. Therapeutic measures were not taken as a result of pericarditis, dyspnoea, chest discomfort. Clinical course: Patient developed shortness of breath with chest pressure. CTA of the chest from 28Dec2022 suggested pericarditis. Echo performed on 05Jan2023 after symptoms had resolved was negative.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and possible temporal association, the contributory role of BNT162b2, BNT162b2 omi ba.4-5 to the reported Pericarditis, Dyspnoea and Chest discomfort cannot be completely excluded. Case will be further reviewed upon receipt of FU information.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Narcolepsy
Clinical narrative: one member said this/ narcolepsy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: NARCOLEPSY (medically significant), outcome "unknown", described as "one member said this/ narcolepsy". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Dec2020 as dose 1, single (Batch/Lot number: unknown) and on 11Jan2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Eosinophilic oesophagitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Feb2023) Positive, notes: Rebound - tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: Paxlovid was used for COVID 19 Treatment from 12Feb2023 to 17Feb2023. Rebound - tested positive on 23Feb2023 after becoming symptomatic - headache, myalgias, congestion.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a vaccine varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect vaccines to the reported vaccination failure and COVID-19 cannot be ruled out.