chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 23-Oct2021, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 23rd October 2021 batch number 9435L and expiry date 8th April 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.    Additional Information: GSK Receipt Date: 20-JAN-2023 Reporter's comments:  The pharmacist was asking information about the validity of the first dose as the patient wished to receive the second dose. Information about the vaccine and patient given. The Vaccine Administration Facility was the same as primary reporter. Reporter consented to follow up. Additional supportive information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The details were reported corresponding to the 1st dose as the 2nd dose was not administered yet.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Second Boostrix on 20Jan2023; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 32-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number HX952, expiry date 4th May 2025) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX).   On 20th January 2023, the patient received Boostrix. On 20th January 2023, unknown after receiving Boostrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 20-JAN-2023 Reporter's Comment: The nurse reported that patient received the first dose on 28 December 2022 and second Boostrix vaccine on 20th January 2023. The reporter consent to follow up. Additional supportive information: The patient received 2nd dose of boostrix, which led to extra dose administered.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only the diluent; Administered only the diluent; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number 5392T, expiry date 31st August 2023) for prophylaxis.   On 4th January 2023, the patient received the 1st dose of Shingrix. On 4th January 2023, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date: 20-JAN-2023 Reporter's Comment: The registered nurse called to inquire that how to proceed and should the dose been repeated. The nurse reported that the patient was inadvertently administered the Shingrix diluent (AS01b) only without the lyophilized component. The reporter did not consent to follow up. Additional Supportive Information: The patients received Shingrix vaccines with only the diluent component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1-dose on 2021, not received 2nd dose; This 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 (had received first dose of Shingrix on 22 November 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 23-JAN-2023 Reporter's comment: The pharmacist had reported that, a patient had received first dose of Shingrix, and had not received a second dose yet at the time of reporting. The vaccine administration facility was the same as primary reporter. The reporter had consented to follow-up. Additional supportive information: Additional supportive information: until the time of reporting, the patient did not receive the second dose of Shingrix, which had led to incomplete course of vaccination. The provided corresponded to the first dose of Shingrix as the second dose was not administered yet.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 1st polio dose and 2nd dtap dose; Kinrix after 7 years old; This case was reported by a physician via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 7-year-old female patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th January 2023, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 18th January 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate schedule of vaccine administered and inappropriate age at vaccine administration 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: 23-JAN-2023 Reporter's Comment: The reporter was a physician. The reporter reported that the patient received Kinrix vaccine 13 days after her 7th birthday. The reporter stated that the patient received Kinrix vaccine as 1st dose of polio and 2nd dose DTaP. Additional supportive information: The patient received Kinirix who was older than the indicated age which led to inappropriate age at vaccine administration. The patient received Kinrix vaccine as 1st dose of polio and 2nd dose DTaP schedule, which led to Inappropriate schedule of vaccine administered
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose before pandemic, 2nd dose 02Nov2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 9CR25, expiry date 24th September 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received right before the pandemic).   On 2nd November 2022, the patient received the 2nd dose of Shingrix. On 2nd November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 23-JAN-2023 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the patient received first dose of Shingrix vaccine right  before the pandemic and the exact date was unknown.   The reporter stated that the patient did not receive the second dose until 02nd November 2022.   The reporter did not have the exact date or lot number information for the first dose.   The reporter did consent to follow up. Additional supportive information: The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Administered after temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 47-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number H242K, expiry date 9th June 2025) for prophylaxis.   On 23rd January 2023, the patient received Boostrix. On 23rd January 2023, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 23-JAN-2023 Reporter's Comment: The physician called to report that the Boostrix was out of normal temperature range and then was administered to a female patient. The HCP (health care professional) reported data logger mark out of range, but temperature was unknown, after that it was administer to patient. The reporter consent to follow up. Additional supportive information: The vaccine was out of normal temperature range, which led to Incorrect storage of drug.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyschromatopsia, Electrocardiogram, Fatigue, Headache
Clinical narrative: SYNCOPE; RAINBOW VISION; COUPLE OF NEAR SYNCOPE EPISODES; VERY FATIGUED; HEADACHES; This spontaneous report received from a physician concerned a 32 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypohidrosis, and occasional light headed bouts, and other pre-existing medical conditions included: The patient was a Pilot, very active and runs 2-3 miles a day.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered on MAR-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 4 decade old. No concomitant medications were reported.  On an unspecified date, the patient experienced couple of near syncope episode has not had a tilt test or anything in the past. The patient had a couple of frank syncopal episodes over the last several months, one with a documented blood pressure of 60. No injuries. The patient also experienced fatigue and headaches. The patient did not have that problem at all. One of the things the patient was complaining about was rainbow vision, that periodically comes and goes. 3 weeks ago, the patient had an episode (of syncope) out of nowhere and went for cardiovascular evaluation. The physician exercised the patient for 20 minutes, no chest pain, and had an essentially normal electrocardiogram. At the time of this report the reporter thought patient might have some underlying autonomic dysregulation that tripped the patient over into becoming more dysregulated in syncope. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the syncope, rainbow vision, very fatigued, headaches and couple of near syncope episodes was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230144279-Syncope. The event has a 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 Causality is considered indeterminate. The company causality is considered unassessable.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Syncope
Clinical narrative: SYNCOPE; RAINBOW VISION; COUPLE OF NEAR SYNCOPE EPISODES; VERY FATIGUED; HEADACHES; This spontaneous report received from a physician concerned a 32 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypohidrosis, and occasional light headed bouts, and other pre-existing medical conditions included: The patient was a Pilot, very active and runs 2-3 miles a day.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered on MAR-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 4 decade old. No concomitant medications were reported.  On an unspecified date, the patient experienced couple of near syncope episode has not had a tilt test or anything in the past. The patient had a couple of frank syncopal episodes over the last several months, one with a documented blood pressure of 60. No injuries. The patient also experienced fatigue and headaches. The patient did not have that problem at all. One of the things the patient was complaining about was rainbow vision, that periodically comes and goes. 3 weeks ago, the patient had an episode (of syncope) out of nowhere and went for cardiovascular evaluation. The physician exercised the patient for 20 minutes, no chest pain, and had an essentially normal electrocardiogram. At the time of this report the reporter thought patient might have some underlying autonomic dysregulation that tripped the patient over into becoming more dysregulated in syncope. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the syncope, rainbow vision, very fatigued, headaches and couple of near syncope episodes was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230144279-Syncope. The event has a 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 Causality is considered indeterminate. The company causality is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: HAVENT BEEN ABLE TO STOP SHAKING; This spontaneous report received from a parent via a company representative 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, 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 havent been able to stop shaking. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from havent been able to stop shaking. This report was non-serious.
Age: 72.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 72-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) 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 and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Concomitant medications were not reported.  Patient reported there was something wrong inside patient's chest and patient could only hope it was not one of those forever symptoms like (long covid).  Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  No concomitant medication was reported. No treatment medication was reported.  This case pertains to the 2nd patient of the total 190 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna monovalent vaccine was administered to approximately 20 patients instead of the Moderna bivalent booster).    Concomitant medications details were not reported by the reporter.  HCP states that they had a situation at the pharmacy where Moderna monovalent vaccine was administered to approximately 20 patients from 11-Jan-2023 to 21-Jan-2023, instead of the Moderna bivalent booster.  Treatment details were not reported by the reporter.  This report was considered for second patient out of 20 reported adult patients who received the vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-704234 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704234:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No Concomitant medication was reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER  CASE
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  No concomitant medication reported. No treatment medication reported.  This case pertains to the 04th patient of the total 190 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration. No concomitant medication reported. No treatment medication reported. This case pertains to the 39th patient of the total 190 patients.    This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant medication was provided.  It was reported that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine was unknown and reported that 190 patients (9 different lot numbers) received a vaccine past the beyond used by date.   Treatment medication was not provided by the reporter.  This case contains the information of 5th patient out of 190 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER  CASE
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant products were not provided. Unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment medication were not reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER  CASE
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; no adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 2nd of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  There were 13, 11, and 6 different doses given. The 30 patients received Monovalent Moderna Vaccine past the manufacturer's expiration date.The batch lot number was reported as 022D21A which was expired on 20 April 2022. The Lot number 033F21A which was expired on 08 April 2022. The Lot number 037C21A expired on 02 January 2022.  Treatment Medication use information was not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  No concomitant medication reported. No treatment medication reported.  This case pertains to the 40th patient of the total 190 patients.    This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; no adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.            No concomitant drug information was provided.  It was reported that there were 3 lot numbers. Lot 022D21A with expiration 20Apr2022, Lot 033F21A with expiration 08Apr2022 and Lot 037C21A with expiration 2Jan2022.  In total 30 doses were administered with 13, 11, and 6 different doses from different lot numbers.      No treatment medication information was provided.  The case was reported for 3rd out  of 30 adult patients who had received the vaccine as reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient administered vaccine after the 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jan-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the 30 day beyond use date).    This case contains information for the 2nd of 4 child patients described by the reporter.  No concomitant information was reported.  No symptoms reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704265 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704265:Master case - 1st child
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patients received Monovalent Moderna Vaccine past the manufacturers expiration date; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant drug information was provided.  It was reported that there were 3 lot numbers. Lot 022D21A with expiration 20Apr2022, Lot 033F21A with expiration 08Apr2022 and Lot 037C21A with expiration 2Jan2022.  In total 30 doses were administered with 13, 11, and 6 different doses from different lot numbers.      No treatment medication information was provided.  The case was reported for 4th out  of 30 adult patients who had received the vaccine as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-703461; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703461:master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration. No concomitant medication reported. No treatment medication reported. This case pertains to the 41th patient of the total 190 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; no adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.            This case contains information for the 29th of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter. There were 13, 11, and 6 different doses were given. The 30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date. The batch lot no 022D21A expired on 20 Apr 2022, the Lot number 033F21A expired on 08 Apr 2022 and the Lot  number 037C21A expired on 02 Jan 2022.   Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-703461 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703461:master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case included information of patient 07 th patient out of 190 reported patients. Concomitant product use was not provided by the reporter. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that 190 patients received a vaccine past the beyond use date from 9 different lot number vials.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER  CASE