chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date; No adverse event; Patient administered the vaccine after the 30 days by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date).    No concomitant medications were reported.  The patient received half dose of Moderna vaccine.  The vial had not undergone any temperature excursions.  The vial was initially stored in the refrigerator on 04-Jun-2022 and 35 vials were affected.  No treatment medications were reported.
Age: 78.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date; No adverse event; Patient administered the vaccine after the 30 days by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date).    No concomitant medications were reported.  The patient received half dose of Moderna vaccine.  The vial had not undergone any temperature excursions.  The vial was initially stored in the refrigerator on 04-Jun-2022 and 35 vials were affected.  No treatment medications were reported.
Age: 5.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Extra dose administered
Clinical narrative: **3:30 pm incident report: after vaccines where injected stepmother told MA that patient just recieved the MMR this morning from pharmacy. She handed her a copy of the paper. It was a form having pharmacy logo and MMR administered on 8/9/22. MOP apologized for not informing me nor corrected me when I explained to her and FOP that the patient needs catch-up for MMR (. I even went slow in saying MMR w/c is Measles, Mumps, Rubella combined with Varicella.) Varicella, DTaP and Polio, based on documentation as of 3 pm) information. FOP and stepmother agreed with all vaccines advised & offered.  Upon being informed by my MA of error, I discussed with MOP possible side effects. Will submit VAERS and report accidental receipt of MMR vaccine to Merck today and determine any more side effects known to them. Advised MOP to submit VAERs as well, reporting this incident.
Age: 48.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Soreness, heat, hard lump at injection site x7 days. Continues to be tender to palpation. Gradually improving but unusual length of time.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, Nausea, Pain in extremity
Clinical narrative: Metallic taste in mouth, sore arm, nausea, headache
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022; No adverse reaction; Dose administered after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse reaction) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A and 077C21B) for COVID-19 prophylaxis.     The patient's past medical history included Hepatobiliary disorder prophylaxis. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ESTRADIOL, PANTOPRAZOLE, LOSARTAN and ETODOLAC for an unknown indication.   On 23-Nov-2021 at 8:23 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-May-2022 at 2:19 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 2:19 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) and PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022).    Patient had not ever been diagnosed with/ tested positive for COVID-19.  The event did not cause the patient to seek medical care. It was unknown if there was any other potential causes. It was unknown if the patient experienced a similar event in the past. The vial did not undergo any temperature excursions  No treatment medications were provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, placed in the refrigerator on the same day of administration (26-May-2022)) and NO ADVERSE EVENT (No adverse event) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 034F21A, 011A21A and 031L20A) for COVID-19 prophylaxis. The patient had never been diagnosed with/ tested positive for COVID-19. Acute illnesses at the time of vaccination and up to one month before were unknown. Chronic or long-standing health conditions were unknown. Concurrent medical conditions included Penicillin allergy, Drug allergy (Aspirin) and Drug allergy (Sulfate). On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 18-Nov-2021 at 6:20 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 2:58 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 2:58 PM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, placed in the refrigerator on the same day of administration (26-May-2022)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, placed in the refrigerator on the same day of administration (26-May-2022)) 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 and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) to have an unknown relationship. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, placed in the refrigerator on the same day of administration (26-May-2022)). Concomitant product use was not provided by the reporter. The event did not cause the patient to seek medical care. It was unknown if there was any other potential causes. It was unknown if the patient experienced a similar event in the past. The vial did not undergone any temperature excursions. Treatment information was not provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Initially vial was stored in the refrigerator on 21-Jan-2022, expired on 13-May-2022 and administered on 26-May-2022.) and NO ADVERSE EVENT (no adverse event) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 031L20A, 025A21A and 051F21A) for COVID-19 prophylaxis. Acute illnesses at the time of vaccination and up to one month before were unknown. Chronic or long-standing health conditions were unknown. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 8:11 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 8:11 AM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Initially vial was stored in the refrigerator on 21-Jan-2022, expired on 13-May-2022 and administered on 26-May-2022.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Initially vial was stored in the refrigerator on 21-Jan-2022, expired on 13-May-2022 and administered on 26-May-2022.) 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 and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) to have an unknown relationship. No further causality assessment was provided for PRODUCT STORAGE ERROR (Initially vial was stored in the refrigerator on 21-Jan-2022, expired on 13-May-2022 and administered on 26-May-2022). No concomitant medications was reported. Dose administered after 30-day use by date or after manufacturer date of expiry. The vial did not undergo any temperature excursions. The reporter thought that Moderna had an extension like Pfizer, and it would expire on the 13-Jul-2022 but it was expired on the 13-May-2022, they realize this on the 08-Jun-2022. Number of doses/vials was 5 vials. The used vial was placed in in the refrigerator on the same day of administration (26-May-2022). The event did not cause the patient to seek medical care. It was unknown if there was any other potential causes. It was unknown if the patient experienced a similar event in the past. No treatment medications were provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (no adverse event) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A and 001J21-2A) for COVID-19 prophylaxis. It was unknown if patient had acute illnesses at the time of vaccination and up to one month before. It was unknown if patient had chronic or long-standing health conditions. Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose number: 1, Batch/lot number- EW0186, 0.3 milliliter, Route of administration- intramuscular, left arm.) on 24-May-2021, Pfizer / BioNTech (Dose number- 2, Batch/lot number- EW0180, 0.3 milliliter, Route of administration- intramuscular and left arm.) on 14-Jun-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech and Pfizer / BioNTech. On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-May-2022 at 9:24 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 9:24 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) and PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 26-May-2022) to have an unknown relationship. It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event. No treatment medications was provided by the reporter. The used vials were placed in the refrigerator on the same day of administration 26-May-2022.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, placed in the refrigerator on the same day of administration (26-May-2022)) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 045C21A, 040B21A and 037A21B) for COVID-19 prophylaxis. No Medical History information was reported. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 9:06 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 9:06 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, placed in the refrigerator on the same day of administration (26-May-2022)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, placed in the refrigerator on the same day of administration (26-May-2022)) 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 and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) to have an unknown relationship. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, placed in the refrigerator on the same day of administration (26-May-2022)). It was unknown whether the patient had acute illnesses at the time of vaccination and up to one month before. It was unknown whether the patient had chronic or long-standing health conditions. It was unknown whether prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event. Concomitant product use was not provided by the reporter. The event did not cause the patient to seek medical care. It was unknown if there was any other potential causes. It was unknown if the patient experienced a similar event in the past. The vial did not undergo any temperature excursions. Treatment information was not provided. This case was linked to PR-MODERNATX, INC.-MOD-2022-585601 (E2B Linked Report). Sender's Comments: PR-MODERNATX, INC.-MOD-2022-585601: Master case (same reporter).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 045C21A, 011A21A and 016M20A) for COVID-19 prophylaxis. Patient had never been diagnosed with/ tested positive for COVID-19. No medical history was reported. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 30-Sep-2021 at 12:15 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-Jun-2022 at 2:15 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-Jun-2022 at 2:15 PM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) 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 and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) to have an unknown relationship. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, stored in refrigerator on 21-Jan-2022 and administered on 07-Jun-2022). The female patient was not pregnant. No concomitant medication was provided by the reporter. It was reported that, expired vaccine was administered to the patient; the health care professional thought that Moderna had an extension like Pfizer and assumed vaccines would expire on the 13-Jul-2022 but it was expired on the 13-May-2022, they realize this on the 08-Jun-2022. The used vials were placed refrigerator on the same day of administration (07-Jun-2022) and vials did not undergo any temperature excursion. Event did not cause the patient to seek medical care. It was unknown if there were any other potential causes or patient experience similar events in the past. No treatment medication was provided by the reporter.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 048C21A and 048C21A) for COVID-19 prophylaxis. The patient was never been diagnosed with/ tested positive for COVID-19. Concurrent medical conditions included Blood pressure high, Diabetes and Mental retardation. Concomitant products included: Lisinopril; Glimepiride; Vistaril [Hydroxyzine Embonate]) for an unknown indication. On 22-Jun-2021 at 2:02 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Jul-2021 at 2:02 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 07-Jun-2022 at 1:15 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-Jun-2022 at 1:15 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) to have an unknown relationship. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 21-Jan-2022 and administered on 07-Jun-2022). The vial did not undergo any temperature excursions. The used vial was placed in in the refrigerator on the same day of administration (07-Jun-2022). The reporter thought that Moderna had an extension like Pfizer, and it would expire on the 13-Jul-2022 but it was expired on the 13-May-2022, they realize this on the 08-Jun-2022. Event did not cause the patient to seek medical care. It was unknown if there were any other potential causes and if patient experience similar events in the past. No treatment details were reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored in the refrigerator on 21-Jan-2022 and administered on 07-Jun-2022; No adverse event; Dose administered after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A and 016C21A) for COVID-19 prophylaxis.     Patient was never been diagnosed with or tested positive for COVID-19.  Concurrent medical conditions included Hypothyroidism and Cerebral palsy. Concomitant products included MELATONIN, LEVOTHYROXINE SODIUM (SYNTHROID), DOCUSATE SODIUM, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 26-May-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 07-Jun-2022 at 3:10 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 07-Jun-2022 at 3:10 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 21-Jan-2022 and administered on 07-Jun-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) to have an unknown relationship. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 21-Jan-2022 and administered on 07-Jun-2022).    The reporter thought that Moderna had an extension like Pfizer, and they though it would expired on the 13-Jul-2022 but it was expired on the 13-May-2022, they realize that on the 08-Jun-2022.  The vial was initially stored in the refrigerator on 21-Jan-2022.  Vaccines were administered on 07-Jun-2022 after their expiration date set for 13-May-2022.  The used vials were placed in the refrigerator on the same day of administration 07-Jun-2022. The Vial did not undergo any temperature excursion  The event did not cause patient to seek medical care.  It was unknown if there were any other potential causes and if patient experienced a similar event in the past.  No treatment information was reported.
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No reaction; Per caller the patient was administered an expired dose of VARIVAX yesterday 21JUN2022; This spontaneous report was received from pharmacist concerning a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-JUN-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) with expiration date: 13-JUN-2022, administered as prophylaxis (dose, lot #, and route of administration and anatomical location were not provided). There were no temperature excursions for the vaccine.  Follow-up information has been received from a nurse practitioner on 08-AUG-2022. It was reported that the patient was a 24-year-old female patient. The information regarding the suspect therapy was updated:  On an unknown date, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided).  On 22-JUN-2022, she received the expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T020651, has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date: 16-JUN-2022 (expired product administered) for prophylaxis, which was administered for a healthcare professional. The patient did not have a response nor reaction to the vaccination and the event was not treated (no adverse event). No illness, allergies at time of vaccination were reported.  It was reported that the medication error occurred at the storage in clinical practice, dispensing, preparation for administration and administration. The vaccine was obtained from their own pharmacy just before reconstitution/administration. It was reported that the experience did not reappear after reintroduction (conflicting information). The outcome for expired product administered was reported as recovered/resolved. The action taken was reported as "monitoring", but assessed as not applicable.  This case was previously considered non-valid, but upon receipt of follow-up it was determined to be valid.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported.; VARIVAX that had undergone temperature excursion was administered to a patient; This spontaneous report was received from a Medical Assistant referringand refers to a 13-month-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions included cardiac murmur, cafe au lait spots, clubfoot, and congenital valgus foot deformity. She had no known allergies. Concomitant medications included measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (manufacturer unknown) and hepatitis a vaccine (+) inactivated (manufacturer unknown).   On 11-JUL-2022, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis, lot #U025790, expiration date: 19-AUG-2023, administered subcutaneously in the right arm for prophylaxis (strength was not provided). The varicella virus vaccine live (oka/merck)(VARIVAX) was stored in temperature of 6.4 degree Fahrenheit (F) for 1 hours 45 minutes. There was no previous temperature excursion reported.  It was reported that the patient came in for a recheck of her heart murmur and to catch up on the vaccines. Measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (manufacturer unknown), hepatitis a vaccine (+) inactivated (manufacturer unknown), varicella virus vaccine live (oka/merck) (VARIVAX) were ordered by the physician. The vaccines were drawn up and given to the patient. Later, when checking the data logger from the freezer, it was discovered that the vaccines had gone through the excursion. The manufacturer was called and it was determined that the vaccine (varicella virus vaccine live (oka/merck) (VARIVAX)) was still viable. The excursion was reported to the state system. The patient did not have an adverse reaction to the vaccine. The vaccine (varicella virus vaccine live (oka/merck) (VARIVAX)) that was kept in a freezer went under excursion because of a move to a new building. The excursion was minimal.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Inadvertently administered improperly stored vaccine; This spontaneous report was received from a licensed practical nurse referring to an unknown gender 4-year-old patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 11-JUL-2022, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (lot #T029535, expiration date: 01-SEP-2022) with in left vasuts lateralis for prophylaxis (strength, dose, and route of administration were not reported) that after temperature excursion 33 Fahrenheit (F) for 10 hours (product storage error) with sterile diluent (MERCK STERILE DILUENT) (manufacturer unknown).The sterile diluent (MERCK STERILE DILUENT) (manufacturer unknown)was not involved in temperature excursion.  There was no previous temperature excursion. No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: HEPA, HEPA, HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional Adverse event; The medical assistant could not rule out that the imrpoperly stored vaccines, PEDAVX HIB, VAQTA and ROTATEQ were administered to patients.; This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender.  The patients medical history, concurrent conditions and concomitant therapies were not reported.   Between the week of 11-JUL-2022 and 15-JUL-2022, there was a temperature excursion with the lowest temperature at 0.92°C, of 11 hours and 30 minutes of the following vaccines: haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), lot #U024091, expiration date: 29-OCT-2023, and lot#batch# W000458, expiration date: 17-JUN-2024 administered to prevent haemophilis influenza B infection (formulation, strength, and route of administration were not provided); rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #1742419, expiration date: 23-JAN-2023, and lo#/batch# W004503, expiration date: 15-MAY-2023,  administered to prevent rotavirus infection (formulation, strength, and route of administration were not provided); hepatitis a vaccine, inactivated (VAQTA) lot #U033212, expiration date: 07-NOV-2022, administered to prevent hepatitis A infection (formulation, strength, and route of administration were not provided); and  hepatitis a vaccine, inactivated (VAQTA) lot #W002889, expiration date: 06-MAR-2023, administered to prevent hepatitis A infection (formulation, strength, and route of administration were not provided).   The reporter could not rule out that the improperly stored vaccines were administered to patients on an unknown date in July 2022. (Improper storage of product in use). There were no additional adverse events reported (no adverse event).  This is a non-valid case due to lack of patient's identifiers.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Oral mucosal eruption
Clinical narrative: Child developed a rash in their mouth; This spontaneous report was received from a registered nurse, concerning a 12-month-old patient of unknown gender. Information regarding the patient's medical history, concurrent conditions, drug reactions or allergies, and concomitant medications was not provided.  On an unknown date, the patient was vaccinated concomitantly with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection; and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, (strength, lot #, expiry date, and route of administration were not provided). Both vaccines were administered for prophylaxis at their 12-month visit.  On an unspecified date, the child developed rash in their mouth (oral mucosal eruption). At the time of reporting, the outcome of the event was unknown.  It was not confirmed if the healthcare professional was interested in requesting to obtain a sample and sending isolates for an analysis.  The causal relationship between the event of oral mucosal eruption, varicella virus vaccine live (oka/merck) (VARIVAX), and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-2208USA004153:Splitted case
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE/PQC; MMRII with a labeled expiry of 5/29/2022 was administered; This spontaneous report was received from office manager, referring to patient of unknown gender and age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an 15-JUL-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live  (recombinant human albumin) (M-M-R II) 0.5 milliliter, lot #T018669, expiration date: 29-MAY-2022 (strength, route of administration, and indication were not provided) (Expired product administered). No adverse events (AE) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA007043: US-009507513-2207USA007049: US-009507513-2207USA007188: US-009507513-2207USA006816: US-009507513-2207USA007049:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; VAQTA was administered during temperature excursion; This spontaneous report was received from medical assistant referring to a patient of unknown age and gender.   The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On 01-AUG-2022, medical assistant called for evaluation of vaccine temperature stability and reported that there was an administration of the Hepatitis A Vaccine, Inactivated (VAQTA) 0.5 ml/once (anatomical location, lot number and expiration date were not reported) as prophylaxis;  during temperature excursion (Product storage error), no additional adverse events (No adverse event).   On 01-AUG-2022, the patient received a dose of Hepatitis A Vaccine, inactivated (VAQTA) vial 25/0.5 (no units provided), 0.5 ml/once, administered as prophylaxis (route of administration, lot number and expiration date were not reported).
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: No adverse event, Overdose
Clinical narrative: no additional AE reported; patient received a dose of PEDVAX HIB and Pentacel on the same day; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On 03-AUG-2022, the patient was administered a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml, lot # U034519, expiration date: 28-MAR-2024 (route of administration and anatomical location were not provided) for prophylaxis and diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) (doe, lot #, expiration date, route of administration, anatomical location and indication were not provided) (overdose). No additional events were reported.
Age: 0.25
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No known patient adverse reactions or side effects; 1 dose of ROTATEQ was administered on 7/13/22 /  temperature excursion; This spontaneous report was received from an Office Manager/Vaccine Coordinator referring to a 12-week-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  The Office Manager/Vaccine Coordinator reported that there was a temperature excursion just discovered, it occurred between 11-JUL-2022 and 15-JUL-2022. Vaccines involved in the excursion were Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Captured in case # 2208USA003021). The vaccine undergo a temperature excursion of above 47 degrees Fahrenheit (F) (55.2F) for a period of 5 hours, and above 47 degrees Fahrenheit (F) (53F) for a period of 30 minutes (Product storage error). The vaccine did not underwent a previous temperature excursion.  On 13-JUL-2022, the patient was vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2ml by mouth, administered as prophylaxis, lot number was verified to be U038864 with expiration date of 22-APR-2023. There were no known patient adverse reactions or side effects (No adverse event).   An excursion on 26-JUL-2022 was already reported.  This was one of two cases from the same reporter.; Sender's Comments:  US-009507513-2208USA003021:
Age: 16.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient did not experience any adverse reactions; administration of PROQUAD to patient who was only intended to receive VARIVAX; This spontaneous report was received from a certified medical assistant concerning a 16-year-old female patient. The patient's medical history, concurrent conditions, and concomitant medication were not provided. On an unspecified date, she completed a 2-dose schedule of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II).   On 04-AUG-2022, the patient was supposed to receive a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), but instead she was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) for prophylaxis (dose, route of administration, injection anatomical location, lot # and expiration date were not reported) (Wrong product administered). The patient did not experience any adverse reactions (No adverse event).
Age: 1.0
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product preparation error
Clinical narrative: No other AE; The caller said there was a patient who received a dose of PROQUAD that was diluted with 0.9% sodium chloride. Caller said the diluent used to reconstitute was manufactured; This spontaneous report has been received form a nurse, regarding a 12-months-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 02-AUG-2022, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (recombinant human albumin (rHA) (lot number: U039258, which was determined to be valid, with an expiration date on 09-JUN-2023)  as prophylaxis (dose, route and anatomical location of administration were not reported). The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was diluted with sodium chloride (lot number: 29-203-DK, with an expiration date on 01-MAY-2023) (Wrong solution used in drug reconstitution). No other adverse event occurred.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: HCP called for temperature stability evaluation of vaccines and reported that 10 pediatric patients received PROQUAD vaccine since excursion date on 7/14/2022, no exact dates provided.; This spontaneous report was received from a medical assistant referring to a 4-year-old male patient. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.   On an unknown date in 2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin, rHA) (PROQUAD), dose of 0.5 mL, lot number: W016358, expiration date: 16-NOV-2023(dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error).   On 14-JUL-2022, the administered dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin, rHA) (PROQUAD) experienced a temperature excursion. It was unknown whether a digital data logger was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Illness, Vaccination failure
Clinical narrative: got the vaccine still got it/suspected vaccination failure; got the vaccine still got it; sick rite now; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and sickness. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 6-Aug-2022 Reporter's comment: The case was reported by the patient's sister via interactive digital media. The patient got the shot and still got them. The patient was sick right now. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.