chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in refrigerator (lot number: 069H22a) on 18-Apr-2023 and vaccine was administered on 19-May-2023; no adverse event; 10 patients received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot number 069H22A; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot number 069H22A), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: 069H22a) on 18-Apr-2023 and vaccine was administered on 19-May-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. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-May-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot number 069H22A). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: 069H22a) on 18-Apr-2023 and vaccine was administered on 19-May-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 patients received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot number 069H22A), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: 069H22a) on 18-Apr-2023 and vaccine was administered on 19-May-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 (10 patients received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot number 069H22A) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: 069H22a) on 18-Apr-2023 and vaccine was administered on 19-May-2023).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This case contains information about patient 2nd out of 10 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-728204 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728204:Master case
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Nasopharyngitis, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: While I was overseas, I experienced the slow onset of cold-like symptoms that included mild head congestion and slightly runny nose. The symptoms were most apparent outdoors, where the weather was cold and damp. When we got back home, the symptoms continued, but I was still able to function. However, I decided to take a home antigen test for the sake of preventing the possible spread of COVID-19, and I got a positive result on 5/23/2023. I had a telehealth visit with my doctor the same day and was prescribed Paxlovid, which I began taking that same day. The symptoms were probably gone within 24 hours, and I felt 100% better when I woke up the morning of 5/24/2023. I took the Paxlovid during the recommended five-day course. I also followed CDC guidance and isolated for five days and then masked in public for five plus days afterwards.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient received the HepB Adult dose instead of the HepB pediatric dose.  As of 5:20pm 6/12/2023 patient had not had any adverse effects according to patient's father.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: high blood pressure
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in refrigerator (lot number: AS7173B) on 06-Mar-2023 and vaccine was administered on 10-Apr-2023.; no adverse event; Patient received vaccine that was stored in the refrigerator 3 days past 30-day storage mark; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator 3 days past 30-day storage mark), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: AS7173B) on 06-Mar-2023 and vaccine was administered on 10-Apr-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. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Apr-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator 3 days past 30-day storage mark). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: AS7173B) on 06-Mar-2023 and vaccine was administered on 10-Apr-2023.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator 3 days past 30-day storage mark), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: AS7173B) on 06-Mar-2023 and vaccine was administered on 10-Apr-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 (Patient received vaccine that was stored in the refrigerator 3 days past 30-day storage mark) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: AS7173B) on 06-Mar-2023 and vaccine was administered on 10-Apr-2023.).    No concomitant medications were provided. Dosage text reported as unknown. The vial was initially stored in the refrigerator on 06-Mar-2023. The vial did not undergo any temperature excursions. No treatment medication was provided. This case contains information for the 4th of 10 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-728204 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728204:Master case
Age: 0.67
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: No adverse event to report. Pt. receive Monovalent Pfizer for 2nd dose 4/21/2023. MTF did not receive notification to use only Bivalent booster until 4/24/23 via program
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: monovalent given instead of bivalent.  manufacturer sent wrong one and they both have gray caps
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: monovalent given instead of bivalent. manufacture sent wrong one and both have gray caps
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: HCP confirms that 10 patients received vaccine that was stored in the refrigerator past 30-day storage mark; no adverse event; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT STORAGE ERROR (HCP confirms that 10 patients received vaccine that was stored in the refrigerator past 30-day storage mark) 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. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Apr-2023, 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 11-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (HCP confirms that 10 patients received vaccine that was stored in the refrigerator past 30-day storage mark) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT STORAGE ERROR (HCP confirms that 10 patients received vaccine that was stored in the refrigerator past 30-day storage mark) 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 (Expired vaccine used) and PRODUCT STORAGE ERROR (HCP confirms that 10 patients received vaccine that was stored in the refrigerator past 30-day storage mark).    No concomitant medication was reported. The vial was initially stored in the refrigerator on 06-MAR-2023. The vial did not undergo any temperature excursion.  No treatment information was reported.  This case contains information for patient 5 out of 10.   This case was linked to US-MODERNATX, INC.-MOD-2023-728204 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728204:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in refrigerator (lot number: AS7173B) on 06-Mar-2023 and vaccine was administered on 14-Apr-2023.; No adverse event; Patient received vaccine that was stored in the refrigerator 7 days past 30-day storage mark; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator 7 days past 30-day storage mark), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: AS7173B) on 06-Mar-2023 and vaccine was administered on 14-Apr-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. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Apr-2023, 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 14-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator 7 days past 30-day storage mark). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: AS7173B) on 06-Mar-2023 and vaccine was administered on 14-Apr-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator 7 days past 30-day storage mark), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: AS7173B) on 06-Mar-2023 and vaccine was administered on 14-Apr-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 (Patient received vaccine that was stored in the refrigerator 7 days past 30-day storage mark) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: AS7173B) on 06-Mar-2023 and vaccine was administered on 14-Apr-2023.).    No concomitant medications were provided. Dosage text reported as unknown. The vial was initially stored in the refrigerator on 06-Mar-2023. The vial did not undergo any temperature excursions. No treatment medication was provided. This case contains information for the 9th of 10 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-728204 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728204:Master case  Patient no-1
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 06-Mar-2023 and was administered on 14-Apr-2023; No adverse event; Patient received vaccine that was stored in the refrigerator 7 days past 30-day storage mark; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator 7 days past 30-day storage mark), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Mar-2023 and was administered on 14-Apr-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. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Apr-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator 7 days past 30-day storage mark). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Mar-2023 and was administered on 14-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator 7 days past 30-day storage mark), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Mar-2023 and was administered on 14-Apr-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 (Patient received vaccine that was stored in the refrigerator 7 days past 30-day storage mark) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Mar-2023 and was administered on 14-Apr-2023).    No concomitant medications were provided. Dosage text reported as unknown. The vial was initially stored in the refrigerator on 06-Mar-2023. The vial did not undergo any temperature excursions. No treatment medication was provided. This case contains information for the 10th of 10 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-728204 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728204:Master case Patient no-1
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 06-Mar-2023 and was administered on 10-Apr-2023; no adverse event; Patient received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot AS7173B; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot AS7173B), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Mar-2023 and was administered on 10-Apr-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. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Apr-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 10-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot AS7173B). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Mar-2023 and was administered on 10-Apr-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot AS7173B), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Mar-2023 and was administered on 10-Apr-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 (Patient received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot AS7173B) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Mar-2023 and was administered on 10-Apr-2023).    Concomitant medication details not reported by the reporter. Dosage text was reported as Unknown. Batch number was reported as 069H22a and AS7173B. Vial with batch number 069H22a was initially stored in refrigerator on 18-APR-2023 and vial with batch number AS7173B initially stored in refrigerator on 06-MAR-2023. Vial did not undergo temperature excursion. Treatment details was not reported by the reporter. This case conatins information of 3rd patient out of 10 patient.   This case was linked to US-MODERNATX, INC.-MOD-2023-728204 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728204:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccines administered past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date) 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 no. 060H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date) 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 (Vaccines administered past the expiration date).    This case contains information for the 08th of 13 patients described by the reporter.  No concomitant medications were reported.   As per the provider the vaccines were stored in a standard freezer (15°C to -25°C). Their temperatures at max. was -24C and min. was -23C.  On 27-Dec-2020, Moderna COVID-19 vaccine was received with expiration date as 28-Mar-2022.  On 11-Apr-2022, 13 doses were administered.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-728240 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2023: Follow-up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728240:Master Case (Patient 1)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccines administered past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date) 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 no. 060H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date) 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 considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date).    This case was created for the first patient of the 13 patients involved.  Concomitant medication was not provided. It was reported that as per the provider the vaccines were stored in a standard freezer (15°C to -25°C). Their temperatures were Max: -24C and Min: -23C. It was reported that Moderna COVID-19 Vaccine with Lot number: 060H21A was received on 27-Dec-2020 with expiration date as 28-Mar-2022 but the Date of administration was 11-Apr-2022 with 13 doses being administered. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-728240 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2023: Follow-up received and had no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728240:Master case (Patient no. 01 case)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; vaccines administered past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date) 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 no. 060H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date) 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 (vaccines administered past the expiration date).    Concomitant medication was not reported. As per the provider the vaccines were stored in a standard freezer (15°C to -25°C). Their temperatures were Max: -24°C and Min: -23°C. vaccines were received on 27-Dec-2020. Treatment medication was not reported.  This case contains information for the 9th of 13 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-728240 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2023: Non-significant follow up.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728240:Master Case(Patient 1)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccine administered past the expired date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered past the expired date) 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 no. 060H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered past the expired date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered past the expired date) 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 considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered past the expired date).    This case was created for the 12th patient of the 13 patients involved.  Concomitant medication was not provided. It was reported that as per the provider the vaccines were stored in a standard freezer (15°C to -25°C). Their temperatures were Max: -24C and Min: -23C. It was reported that Moderna COVID-19 Vaccine with Lot number: 060H21A was received on 27-Dec-2020 with expiration date as 28-Mar-2022 but the Date of administration was 11-Apr-2022 with doses of 13. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-728240 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2023: Follow-up received and had no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728240:Master Case(Patient 1)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccines administered past the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date.) 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 no. 060H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date.) 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 considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date.).    This case was created for the 6th patient of the 13 patients involved.  Concomitant medication was not provided. It was reported that as per the provider the vaccines were stored in a standard freezer (15°C to -25°C). Their temperatures were Max: -24C and Min: -23C. It was reported that Moderna COVID-19 Vaccine with Lot number: 060H21A was received on 27-Dec-2020 with expiration date as 28-Mar-2022 but the Date of administration was 11-Apr-2022 with doses of 13. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-728240 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2023: Follow-up received and had no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728240:Master Case (Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received Moderna Bivalent Covid-19 vaccine that expired on May 30, 2023; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent Covid-19 vaccine that expired on May 30, 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. 020H22A) for COVID-19 prophylaxis.     It was reported that patient did not have information about previous COVID-19 vaccination doses.     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 (Patient received Moderna Bivalent Covid-19 vaccine that expired on May 30, 2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent Covid-19 vaccine that expired on May 30, 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent Covid-19 vaccine that expired on May 30, 2023).    No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-728286 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728286:Master case
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Diagnosed with/tested positive for COVID-19 on 2/2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Diagnosed with/tested positive for COVID-19 on 2/2022) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A, 021B21A and 094F23A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypercholesterolemia since 2000 and Hypertension since 2000. Concomitant products included SIMVASTATIN for Hypercholesterolemia, LOSARTAN for Hypertension.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022, the patient experienced COVID-19 (Diagnosed with/tested positive for COVID-19 on 2/2022). At the time of the report, COVID-19 (Diagnosed with/tested positive for COVID-19 on 2/2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received dose 4 of Moderna Vaccine on 09-Jul-2022 with Batch no. being reported as 017B22A.   Treatment information was not reported.   This case was linked to MOD-2023-725105 (Patient Link).
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: On the beginning of covid he got 3 to 4 vaccine of moderna vaccine he got on both arms he started to feel pain from both arms and then they both started hurting to an extent of fingers and wrist pain to this day he has pain; On the beginning of covid he got 3 to 4 vaccine of moderna vaccine he got on both arms he started to feel pain from both arms and then they both started hurting to an extent of fingers and wrist pain to this day he has pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (On the beginning of covid he got 3 to 4 vaccine of moderna vaccine he got on both arms he started to feel pain from both arms and then they both started hurting to an extent of fingers and wrist pain to this day he has pain) and ARTHRALGIA (On the beginning of covid he got 3 to 4 vaccine of moderna vaccine he got on both arms he started to feel pain from both arms and then they both started hurting to an extent of fingers and wrist pain to this day he has pain) 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. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (On the beginning of covid he got 3 to 4 vaccine of moderna vaccine he got on both arms he started to feel pain from both arms and then they both started hurting to an extent of fingers and wrist pain to this day he has pain) (seriousness criterion medically significant) and ARTHRALGIA (On the beginning of covid he got 3 to 4 vaccine of moderna vaccine he got on both arms he started to feel pain from both arms and then they both started hurting to an extent of fingers and wrist pain to this day he has pain) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (On the beginning of covid he got 3 to 4 vaccine of moderna vaccine he got on both arms he started to feel pain from both arms and then they both started hurting to an extent of fingers and wrist pain to this day he has pain) and ARTHRALGIA (On the beginning of covid he got 3 to 4 vaccine of moderna vaccine he got on both arms he started to feel pain from both arms and then they both started hurting to an extent of fingers and wrist pain to this day he has pain) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported.   This case was linked to MOD-2023-727745 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: The caller's boyfriend caught Covid-19 a few weeks ago; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (The caller's boyfriend caught Covid-19 a few weeks ago) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (2nd dose), COVID-19 Vaccine (Dose 4), COVID-19 Vaccine (Dose 3) and PFIZER BIONTECH COVID-19 VACCINE (1st dose). Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine, COVID-19 Vaccine, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    In 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 May 2023, the patient experienced COVID-19 (The caller's boyfriend caught Covid-19 a few weeks ago). At the time of the report, COVID-19 (The caller's boyfriend caught Covid-19 a few weeks ago) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. It was reported that patient had received 5 Covid -19 Vaccinations and was not sure about the third and fourth Covid-19 vaccines. Patient caught Covid-19 a few weeks ago. No treatment information was provided.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No AEs were reported; A total of 13 doses were administered after the excursion happened; Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 during 50 minute; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 during 50 minute), POOR QUALITY PRODUCT ADMINISTERED (A total of 13 doses were administered after the excursion happened) and NO ADVERSE EVENT (No AEs were reported) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7184B) for COVID-19 prophylaxis.     Patient  relevant medical history/conditions, allergy, concomitant diseases and risk factor was unknown.     On 09-May-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 04-May-2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 during 50 minute). On 09-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (A total of 13 doses were administered after the excursion happened). On an unknown date, the patient experienced NO ADVERSE EVENT (No AEs were reported). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 during 50 minute), POOR QUALITY PRODUCT ADMINISTERED (A total of 13 doses were administered after the excursion happened) and NO ADVERSE EVENT (No AEs were reported) 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 AEs were reported) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 during 50 minute) and POOR QUALITY PRODUCT ADMINISTERED (A total of 13 doses were administered after the excursion happened).    No concomitant medication was reported.  HCP stated 10 frozen unpunctured vials of Moderna COVID-19 Vaccine Bivalent experienced a temperature excursion on 04MAY2023 during 50 minutes. Maximum temperature reached was 10.5°F. A second excursion happened a couple hours later during 15 minutes and maximum temperature reached was 9.3°F. A total of 13 doses were administered after the excursion happened. No treatment information was reported.      This case was linked to US-MODERNATX, INC.-MOD-2023-728417 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728417:
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; accidentally administered dose on 01-JUN-2023 after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (accidentally administered dose on 01-JUN-2023 after the expiration date) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057A22A) for COVID-19 prophylaxis.     It was unknown if patient had any relevant medical history, conditions, allergy, concomitant diseases or risk factor. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 01-Jun-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 01-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (accidentally administered dose on 01-JUN-2023 after the 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 dose on 01-JUN-2023 after the 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 (accidentally administered dose on 01-JUN-2023 after the expiration date).    Dosage text for suspect product was reported as unknown. Concomitant drugs were not reported. It was reported that it was unknown when the 5.5 ml size vial was initially stored in refrigerator. The vial was not exposed to temperature excursion as per HCP's knowledge.  No other adverse events were reported. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-728180 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728180:same reporter
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in refrigerator (lot number: as7173B) on 06-Mar-2023 and vaccine was administered on 12-Apr-2023; no adverse event; 10 patients received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot number as7173B and 069H22a.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot number as7173B and 069H22a.), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: as7173B) on 06-Mar-2023 and vaccine was administered on 12-Apr-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. as7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2023, 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 12-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot number as7173B and 069H22a.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: as7173B) on 06-Mar-2023 and vaccine was administered on 12-Apr-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 patients received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot number as7173B and 069H22a.), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: as7173B) on 06-Mar-2023 and vaccine was administered on 12-Apr-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 (10 patients received vaccine that was stored in the refrigerator past 30-day storage mark, from vaccine Lot number as7173B and 069H22a.) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator (lot number: as7173B) on 06-Mar-2023 and vaccine was administered on 12-Apr-2023).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This case contains information about patient 6th out of 10 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-728204 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728204: case