chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine Administered at Inappropriate Route; This non-serious case was reported by a consumer via call center representative and described the occurrence of intramuscular formulation administered by other route in a 52-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 22-JUN-2023, the patient received Boostrix (intravenous). On 22-JUN-2023, an unknown time after receiving Boostrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Vaccine Administered at Inappropriate Route). The outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-JUN-2023 The reporter was a pharmacy student. The reporter called on behalf of healthcare professional to inquire that for Boostrix, anything to look for and it did need to be re-administered. The reporter was unable to provide vaccine Lot number or expiration date. The reporter did not consent to follow-up. The reporter reported that a patient was inadvertently administered a Boostrix vaccine given IV instead of Intramuscularly, which led to intramuscular formulation administered by other route.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Product Storage Error; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 48-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 55RY7, expiry date 17-OCT-2025) for prophylaxis.   On 26-JUN-2023, the patient received the 2nd dose of Boostrix (left deltoid). On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Product Storage Error). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 26-JUN-2023 Vaccine Coordinator stated that Boostrix was exposed to 15.6 F and administered to a patient.  The reporter requested to follow up via email as he/she did not verify the correct mailing address.  The reporter did call back to try and get it but unable to reach HCP. The reporter consented to follow up. The nurse reported a patient was inadvertently administered the Boostrix vaccine following a temperature excursion, which led to incorrect storage of drug. This case was found as duplicate of case US2023088673. All the information from the case US2023088673 was merged into this case. The case US2023088673 was deleted and this case stand as case of record for this patient.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, MENB, MNQ, RV1, TDAP
Symptoms: Product storage error
Clinical narrative: patients received vaccines after exposure at low temperature; This non-serious case was reported by a physician via call center representative and described the occurrence of incorrect product storage in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis, HBV (Engerix B) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis and Rota (Rotarix liquid formulation) for prophylaxis.   On an unknown date, the patient received Bexsero, Boostrix, Engerix B, Havrix, Infanrix, Kinrix, Menveo, Pediarix and Rotarix liquid formulation. On an unknown date, an unknown time after receiving Bexsero, Boostrix, Engerix B, Havrix, Infanrix, Kinrix, Menveo, Pediarix and Rotarix liquid formulation, the patient experienced incorrect product storage (Verbatim: patients received vaccines after exposure at low temperature). The outcome of the incorrect product storage was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-JUN-2023 The physician reported that the patients received Bexsero, Boostrix, Engerix B, Havrix, Infanrix, Kinrix, Menveo (2 vials), Pediarix and Rotarix (reconstituted) after below temperature excursion, temperature was minus 0.1-degree C. The reporter did not had data on the patients or vaccines administrated. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. The patients received vaccines after exposure at low temperature, which led to incorrect product storage.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix sometime last year and has not yet received a second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of shingrix sometime last year).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first dose of Shingrix sometime last year and has not yet received a second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 27 June 2023 The reporter stated patient was around 80 something years old, exact age and initials not available at time of reporting. The pharmacist stated that the patient received first dose of Shingrix sometime last year and had not yet received a second dose.  The pharmacist did not know exact date of initial dose, or lot number / expiration date information.  The reporter consented to follow up.  Till the time of reporting the patient did not received 2nd dose of shingrix which led to incomplete course of vaccination.
Age: 62.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: pediatric dose of Havrix was administered to an adult patient; pediatric dose of Havrix was administered to an adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 62-year-old male patient who received HAV (Havrix pediatric) (batch number 9R5LC, expiry date 02-NOV-2024) for prophylaxis.   On 27-JUN-2023, the patient received the 1st dose of Havrix pediatric. On 27-JUN-2023, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: pediatric dose of Havrix was administered to an adult patient) and underdose (Verbatim: pediatric dose of Havrix was administered to an adult patient). The outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK receipt date: 27 June 2023 Nurse called to report a pediatric dose of Havrix was administered to an adult patient. The reporter did not consent to follow-up. No follow up because reporter stated did not have email address. The adult patient received pediatric dose of Havrix  which led adult use of a child product and underdose.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: accidentally received an adult dose of Engerix-B instead of a pediatric dose; accidentally received an adult dose of Engerix-B instead of a pediatric dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 18-year-old female patient who received HBV (Engerix B pediatric) (batch number XS27B) for prophylaxis.   On 28-JUN-2023, the patient received the 1st dose of Engerix B pediatric. On 28-JUN-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: accidentally received an adult dose of Engerix-B instead of a pediatric dose) and adult use of a child product (Verbatim: accidentally received an adult dose of Engerix-B instead of a pediatric dose). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Jun-2023 The nurse wished to know how to proceed. Information about vaccines, event and patients were collected. The vaccine administration facility was the same as primary reporter. The call escalated to second line. The reporter consented to follow-up. A patient accidentally received an adult dose of Engerix-B instead of a pediatric dose, which led to underdose and adult use of a child product.
Sex: M
Vaccine: COVID19
Symptoms: Carpal tunnel syndrome, Paralysis
Clinical narrative: FOOT AND HAND GOT PARALYZED; CARPEL TUNNEL; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total was administered on AUG-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced foot and hand got paralyzed, and carpel tunnel. Patient reported as, he had surgery for carpel tunnel but it came back and was unable to use hand or feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from foot and hand got paralyzed, and carpel tunnel. This report was serious (Other Medically Important Condition). This case is a duplicate.  Additional information was received from patient on 22-JUN-2023. It was determined that Manufacturer Case Number was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number; Sender's Comments: V0: Foot got paralyzed, hand got paralyzed, carpel tunnel. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via (Pfizer Inc.) concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node 3 weeks later under the opposite arm; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node 3 weeks later under the opposite arm) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (Swollen lymph node 3 weeks later under the opposite arm). At the time of the report, LYMPHADENOPATHY (Swollen lymph node 3 weeks later under the opposite arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. The patient received the injection in right arm at D0. No other symptoms were reported. No treatment medications were reported.
Age: 38.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23; Patient received Moderna Bivalent vaccine after temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine after temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 38-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 05D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine after temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine after temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine after temperature excursion).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730480 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730480:Same reporter
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.; Patient received Moderna Bivalent vaccine after temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine after temperature excursion) and NO ADVERSE EVENT (No adverse event) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 05D22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Age-related macular degeneration.    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 PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine after temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine after temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine after temperature excursion).    Concomitant Medication use information was not provided by reporter.  It was unknown that if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23. No confirmation was provided on viability of vaccine vails and as a result office continued to perform vaccination with vials until 5-30-23. Up to 14 vaccination were administered within this time line.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730480 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730480:Same reporter
Sex: U
Vaccine: COVID19-2
Symptoms: Bell's palsy, Eye haemorrhage, Tooth loss
Clinical narrative: broken blood vessels around eye; bells palsy on the side of their face and broken blood vessels around the eye; loss of two teeth; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (broken blood vessels around eye) and BELL'S PALSY (bells palsy on the side of their face and broken blood vessels around the eye) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE HAEMORRHAGE (broken blood vessels around eye) (seriousness criterion medically significant), BELL'S PALSY (bells palsy on the side of their face and broken blood vessels around the eye) (seriousness criterion medically significant) and TOOTH LOSS (loss of two teeth). At the time of the report, EYE HAEMORRHAGE (broken blood vessels around eye), BELL'S PALSY (bells palsy on the side of their face and broken blood vessels around the eye) and TOOTH LOSS (loss of two teeth) had resolved.            Concomitant medication details was not reported. Treatment details was not reported.  Company Comment: This spontaneous case concerns an unknown-years-old-patient, with  no medical history reported who experienced the  expected seriousness criterion medically significant AESI of  Bell´s palsy; the unexpected events of eye haemorrhage  (seriousness criterion medically significant), and tooth loss unknown days after a  dose of  mRNA- 1273 bivalent vaccine. Concomitant medication details nor Treatment details were reported The benefit-risk relationship of mRNA-1273 bivalent vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.   This case was linked to US-MODERNATX, INC.-MOD-2023-727542 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727542:Same reporter
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; patient was given the wrong dose of vaccine. Was given the blue cap instead of the pink cap.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient was given the wrong dose of vaccine. Was given the blue cap instead of the pink cap.) and NO ADVERSE EVENT (No adverse event) in an infant 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. as7643e) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jun-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 23-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (patient was given the wrong dose of vaccine. Was given the blue cap instead of the pink cap.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient was given the wrong dose of vaccine. Was given the blue cap instead of the pink cap.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient was given the wrong dose of vaccine. Was given the blue cap instead of the pink cap.).    Concomitant product use was not provided by the reporter.  It was reported that this was patient's first bivalent dose. The patient received 2 doses of monovalent spikevax in the past.  Treatment information was not provided.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: On 30-05-2023 lowest temp was recorded at 35.8F) , and on 05-06-2023 the lowest temp. was 33.7 F); After excursion vaccine was administered to patient; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (On 30-05-2023 lowest temp was recorded at 35.8F) , and on 05-06-2023 the lowest temp. was 33.7 F)), POOR QUALITY PRODUCT ADMINISTERED (After excursion vaccine was administered to patient) and NO ADVERSE EVENT (No adverse event) in an elderly 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. AS7180B) 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) .05 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (On 30-05-2023 lowest temp was recorded at 35.8F) , and on 05-06-2023 the lowest temp. was 33.7 F)), POOR QUALITY PRODUCT ADMINISTERED (After excursion vaccine was administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (On 30-05-2023 lowest temp was recorded at 35.8F) , and on 05-06-2023 the lowest temp. was 33.7 F)), POOR QUALITY PRODUCT ADMINISTERED (After excursion vaccine was administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (On 30-05-2023 lowest temp was recorded at 35.8F) , and on 05-06-2023 the lowest temp. was 33.7 F)) and POOR QUALITY PRODUCT ADMINISTERED (After excursion vaccine was administered to patient).    No concomitant information was reported. It was reported that department of health advised vaccine specific refrigerator needed to be used, instead of the dorm-style fridge on site. The vial sat at room temp for 15 mins before admin and then discarded at the end of the day. No treatment information was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: On 30-05-2023 Lowest temp was recorded at 35.8F) , and on 05-06-2023 the lowest 33.7 F). The vial sat at room temp for 15 mins; After excursion vaccine was administered to patient; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (On 30-05-2023 Lowest temp was recorded at 35.8F) , and on 05-06-2023 the lowest 33.7 F). The vial sat at room temp for 15 mins), POOR QUALITY PRODUCT ADMINISTERED (After excursion vaccine was administered to patient) and NO ADVERSE EVENT (No adverse event) in an elderly 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. AS7180B) 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) .05 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (On 30-05-2023 Lowest temp was recorded at 35.8F) , and on 05-06-2023 the lowest 33.7 F). The vial sat at room temp for 15 mins), POOR QUALITY PRODUCT ADMINISTERED (After excursion vaccine was administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (On 30-05-2023 Lowest temp was recorded at 35.8F) , and on 05-06-2023 the lowest 33.7 F). The vial sat at room temp for 15 mins), POOR QUALITY PRODUCT ADMINISTERED (After excursion vaccine was administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (On 30-05-2023 Lowest temp was recorded at 35.8F) , and on 05-06-2023 the lowest 33.7 F). The vial sat at room temp for 15 mins) and POOR QUALITY PRODUCT ADMINISTERED (After excursion vaccine was administered to patient).    No concomitant information was reported. It was reported that department of health advised vaccine specific refrigerator needed to be used, instead of the dorm-style fridge on site. The vial sat at room temp for 15 mins before admin and then discarded at the end of the day. No treatment information was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: On 30-05-2023 Lowest temp was recorded at 35.8F) , and on 05-06-2023 the lowest 33.7 F). The vial sat at room temp for 15 mins; After excursion vaccine was administered to patient; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (On 30-05-2023 Lowest temp was recorded at 35.8F) , and on 05-06-2023 the lowest 33.7 F). The vial sat at room temp for 15 mins), POOR QUALITY PRODUCT ADMINISTERED (After excursion vaccine was administered to patient) and NO ADVERSE EVENT (no adverse event) in an elderly 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. AS7180B) 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)) (Intramuscular) .05 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (On 30-05-2023 Lowest temp was recorded at 35.8F) , and on 05-06-2023 the lowest 33.7 F). The vial sat at room temp for 15 mins), POOR QUALITY PRODUCT ADMINISTERED (After excursion vaccine was administered to patient) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (On 30-05-2023 Lowest temp was recorded at 35.8F) , and on 05-06-2023 the lowest 33.7 F). The vial sat at room temp for 15 mins), POOR QUALITY PRODUCT ADMINISTERED (After excursion vaccine was administered to patient) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (On 30-05-2023 Lowest temp was recorded at 35.8F) , and on 05-06-2023 the lowest 33.7 F). The vial sat at room temp for 15 mins) and POOR QUALITY PRODUCT ADMINISTERED (After excursion vaccine was administered to patient).    No concomitant information was reported. It was reported that department of health advised vaccine specific refrigerator needed to be used, instead of the dorm-style fridge on site. The vial sat at room temp for 15 mins before admin and then discarded at the end of the day. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730748, US-MODERNATX, INC.-MOD-2023-730773 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730748:same reporter US-MODERNATX, INC.-MOD-2023-730773:same reporter
Age: 1.5
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 18 month child inadvertently received the booster from 0.25mL from the Blue cap with grey border instead of the Pink cap; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (18 month child inadvertently received the booster from 0.25mL from the Blue cap with grey border instead of the Pink cap) and NO ADVERSE EVENT (No adverse event) in an 18-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Spikevax (LOT-AS1414B , Dose 1) on 05-Jul-2022, Spikevax (LOT -AS1414B and Dose 2) on 02-Aug-2022. Past adverse reactions to the above products included No adverse event with Spikevax and Spikevax.    On 26-Jun-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) .25 milliliter. On 26-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (18 month child inadvertently received the booster from 0.25mL from the Blue cap with grey border instead of the Pink cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (18 month child inadvertently received the booster from 0.25mL from the Blue cap with grey border instead of the Pink cap) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (18 month child inadvertently received the booster from 0.25mL from the Blue cap with grey border instead of the Pink cap).    No concomitant information was reported. It was reported that HCP stated that they've determined that the child received a higher dose and didn't need any additional assistance. No treatment information was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; Since after June 1 multiple temperature excursions; 6 doses administered since June 1 after multiple temperature excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Since after June 1 multiple temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (6 doses administered since June 1 after multiple temperature excursions) 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.    In June 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In June 2023, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Since after June 1 multiple temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (6 doses administered since June 1 after multiple temperature excursions). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Since after June 1 multiple temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (6 doses administered since June 1 after multiple temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Since after June 1 multiple temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (6 doses administered since June 1 after multiple temperature excursions).    No concomitant medication was reported.  No treatment information was reported.
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 0.2ml was given IM from vial with dark pink cap instead of 0.25ml from vial with blue cap; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (0.2ml was given IM from vial with dark pink cap instead of 0.25ml from vial with blue cap) and NO ADVERSE EVENT (No adverse event) in a 5-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .2 milliliter. On 12-Jun-2023, the patient experienced WRONG PRODUCT ADMINISTERED (0.2ml was given IM from vial with dark pink cap instead of 0.25ml from vial with blue cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (0.2ml was given IM from vial with dark pink cap instead of 0.25ml from vial with blue cap) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (0.2ml was given IM from vial with dark pink cap instead of 0.25ml from vial with blue cap).    Concomitant medication was not provided. Treatment information was not reported.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in the refrigerator on 25 May 2023, vaccine was expired on 08 Jun 2023 and administer on 27 Jun 2023; No adverse event; Patient received an expired dose from lot number 043H22A; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose from lot number 043H22A), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 25 May 2023, vaccine was expired on 08 Jun 2023 and administer on 27 Jun 2023) and NO ADVERSE EVENT (No adverse event) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 043H22A and AS7144B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 27-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Jun-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 27-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose from lot number 043H22A). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 25 May 2023, vaccine was expired on 08 Jun 2023 and administer on 27 Jun 2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose from lot number 043H22A), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 25 May 2023, vaccine was expired on 08 Jun 2023 and administer on 27 Jun 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 an expired dose from lot number 043H22A) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 25 May 2023, vaccine was expired on 08 Jun 2023 and administer on 27 Jun 2023).    Concomitant medication not reported. The vial did not undergo any temperature excursions. Vial size was 2.5 ml Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730851 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730851:same reporter with diffrent patient
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in the refrigerator on 25 May 2023, vaccine was expired on 08 Jun 2023 and administer on 27 Jun 2023; No adverse event; Patient received an expired dose from lot number 043H22A; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose from lot number 043H22A), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 25 May 2023, vaccine was expired on 08 Jun 2023 and administer on 27 Jun 2023) and NO ADVERSE EVENT (No adverse event) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 043H22A and AS7144B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 27-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Jun-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 27-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose from lot number 043H22A). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 25 May 2023, vaccine was expired on 08 Jun 2023 and administer on 27 Jun 2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose from lot number 043H22A), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 25 May 2023, vaccine was expired on 08 Jun 2023 and administer on 27 Jun 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 an expired dose from lot number 043H22A) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 25 May 2023, vaccine was expired on 08 Jun 2023 and administer on 27 Jun 2023).    Concomitant medication not reported. The vial did not undergo any temperature excursions. Vial size was 2.5 ml Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730860 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730860:same reporter with diffrent patient
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram, Osteoarthritis, Therapeutic response unexpected
Clinical narrative: Osteoarthritis came back; Patient was cured of osteoarthritis, was walking very well started running again, felt light it was wonderful; This spontaneous case was reported by a patient and describes the occurrence of OSTEOARTHRITIS (Osteoarthritis came back) and THERAPEUTIC RESPONSE UNEXPECTED (Patient was cured of osteoarthritis, was walking very well started running again, felt light it was wonderful) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Knee osteoarthritis. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (2 times). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    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 OSTEOARTHRITIS (Osteoarthritis came back) and THERAPEUTIC RESPONSE UNEXPECTED (Patient was cured of osteoarthritis, was walking very well started running again, felt light it was wonderful). At the time of the report, OSTEOARTHRITIS (Osteoarthritis came back) and THERAPEUTIC RESPONSE UNEXPECTED (Patient was cured of osteoarthritis, was walking very well started running again, felt light it was wonderful) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: osteoarthritis came back.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Pain, Pyrexia
Clinical narrative: aches; fever; We had an incident where we gave a covid vaccine 14 hours after BUD on June 16, 2023; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (aches), PYREXIA (fever) and EXPIRED PRODUCT ADMINISTERED (We had an incident where we gave a covid vaccine 14 hours after BUD on June 16, 2023) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Jun-2023, the patient experienced PAIN (aches) and PYREXIA (fever). 16-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We had an incident where we gave a covid vaccine 14 hours after BUD on June 16, 2023). At the time of the report, PAIN (aches), PYREXIA (fever) and EXPIRED PRODUCT ADMINISTERED (We had an incident where we gave a covid vaccine 14 hours after BUD on June 16, 2023) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Dose was moved from the freezer to the refrigerator on 16-MAY-2023. It was unknown that patient took any medications or treatments to try and help with those symptoms.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: Patient received dose of monovalent Pfizer after 4/18 when the FDA stopped use of the monovalent vaccines.    We have outreached to patient to get him scheduled to receive the BIVALENT dose due now
Age: 0.92
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: Patient received dose of monovalent Pfizer after 4/18 when the FDA stopped use of the monovalent vaccines.    Patient seen for q12 month WCC and decided to wait til next visit for the BIVALENT>
Age: 0.83
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: Patient received dose of monovalent Pfizer after 4/18 when the FDA stopped use of the monovalent vaccines.    Patient has upcoming appt on 7/11/23 and BIVALENT dose will be offered at that time.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: Patient received dose of monovalent Pfizer after 4/18 when the FDA stopped use of the monovalent vaccines.    We have outreached to patient to get him scheduled to receive the BIVALENT dose due now
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: A dose of Moderna Covid19 Vaccine Bivalent Booster 3-5 LOT 215K22A, Exp: 8/19/2023 (0.2 ml) was administered to patient on 6/23//23. It was noticed after the administration of the vaccine that the beyond use date was not recorded on the vial when it was stored in the refrigerator after removing from the freezer, indicating that the vial was stored in refrigerator for more than 30 days.