chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: improperly stored vaccine; This spontaneous report was received from a medical student referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 03-JAN-2022, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (strength, dose and route of administration were not provided; lot #T034380, expiration date not reported, but upon internal validation established as 08-JAN-2022) for prophylaxis (product storage error). The administered dose of the vaccine experienced a temperature excursion in 66.66 Fahrenheit degrees (F) for 14 hours and 30 minutes. There were multiple previous temperature excursions.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Pericarditis
Clinical narrative: MYOCARDITIS; PERICARDITIS; This spontaneous report received from a parent via a company representative via social media concerned a 19 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin and batch number and expiry date were not reported) dose was not reported, 1 total (first dose), administered on an unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number and expiry were not reported) dose, 1 total start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced myocarditis, and pericarditis (dose number in series 2) due to which patient was hospitalized for an unspecified number of days. Reporter stated that "My healthy 19-year-old son was just recently hospitalized because of your booster. Both myocarditis and pericarditis. Tell me again how safe this was? Is he going to have life-long issues now? Oh, and he only got the booster because his college held his education over his head unless he got the booster. And yes it was J and J not the others". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the myocarditis and pericarditis was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220253441-COVID-19 VACCINE AD26.COV2.S-Myocarditis, Pericarditis. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Unevaluable event
Clinical narrative: STROKE; HAD NOT BEEN SAME SINCE; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s(suspension for injection, route of administration was not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total administered on unspecified date (therapy start date and therapy end date were not provided) for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient had stroke, and had not been same since. It was reported that "a good friend who after shot stroked hasn't been same since, doctors even told him It was a adverse side affect from shot not to take anymore ". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke and had not been same since was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220256199-COVID-19 VACCINE AD26.COV2.S-Stroke. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: First dose of vaccine administered after excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (First dose of vaccine administered after excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported by reporter. No treatment medication reported by reporter.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 9 patients received expired vaccine in November and December; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccine in November and December) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 038C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccine in November and December). At the time of the report, EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccine in November and December) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment drugs were reported. 9 patients received Moderna COVID-19 vaccine last year in November and December On 17-Feb-2022 the case ID- MOD-2022-486834 has been made invalid as it contains 9 patients with no patient identifier. Expired vaccine was given with no adverse reaction reported.   This case was linked to MOD-2022-493795 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2022: Follow up received: Received patient information due to which case was valid in FU version.Added patient details, dose 1 and dose 2 detals, event start date and information updated in inarrative.
Sex: U
Vaccine: COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: Vaccine breakthrough infection; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Feb-2022 and was forwarded to Moderna on 23-Feb-2022.    This literature-non-study case was reported in a literature article and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Privacy    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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) (seriousness criterion medically significant). At the time of the report, VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) to be related.    No concomitant and treatment medications were reported by the reporter.  Company comment: This literature case concerns a  patient of unknown age and gender with no relevant medical history, who experienced the serious unexpected events of vaccine breakthrough infection. The events occurred on an unknown date following an unspecified dose of mRNA-1273 vaccine. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing infection. The rechallenge was unknown as the dosages and time of event onset were not reported. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-491471, MOD-2022-491472, MOD-2022-491473, MOD-2022-491474, MOD-2022-491475, MOD-2022-491476, MOD-2022-491477, MOD-2022-491478, MOD-2022-491479, MOD-2022-491379, MOD-2022-491481 (Patient Link).; Sender's Comments: This literature case concerns a  patient of unknown age and gender with no relevant medical history, who experienced the serious unexpected events of vaccine breakthrough infection. The events occurred on an unknown date following an unspecified dose of mRNA-1273 vaccine. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing infection. The rechallenge was unknown as the dosages and time of event onset were not reported. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: Vaccine breakthrough infection; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Feb-2022 and was forwarded to Moderna on 23-Feb-2022.    This literature-non-study case was reported in a literature article and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: (Privacy)    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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) (seriousness criterion medically significant). At the time of the report, VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) to be related.    Treatment and concomitant medications  were not reported  Company comments: This literature case concerns a  patient of unknown age and gender with no relevant medical history, who experienced the serious unexpected events of vaccine breakthrough infection. The events occurred on an unknown date following an unspecified dose of mRNA-1273 vaccine. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing infection. The rechallenge was unknown as the dosages and time of event onset were not reported. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-491471, MOD-2022-491472, MOD-2022-491473, MOD-2022-491474, MOD-2022-491475, MOD-2022-491476, MOD-2022-491477, MOD-2022-491478, MOD-2022-491479, MOD-2022-491480, MOD-2022-491379 (Patient Link).; Sender's Comments: This literature case concerns a  patient of unknown age and gender with no relevant medical history, who experienced the serious unexpected events of vaccine breakthrough infection. The events occurred on an unknown date following an unspecified dose of mRNA-1273 vaccine. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing infection. The rechallenge was unknown as the dosages and time of event onset were not reported. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 3:57 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 3:57 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   Expiration date was 12Jan2022. The patient was given dose from vial that were stored in an ultracold freezer which was colder than they should have been. The facility had a temperature excursion for the Moderna COVID-19 vaccine and the patient was administered the vaccine underwent temperature excursion.  The facility had a temperature excursion for the Moderna Covid-19 vaccine. Excursion duration was 1 month. On 19-Nov-2021, the vial moved from super cold freezer to the refrigerator, 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator, no vaccine state changes were noticed, none of the vials were punctured and no previous temperature excursions.  The patient was given doses from a vial that were stored in an ultracold freezer which is colder than the standard storage conditions.   No treatment information was provided by the reporter.   This case was linked to MOD-2021-402935 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2022: Follow-up received contains no new information.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna vaccine was still in the fridge and expired, 5 doses had been given at that point; Moderna vaccine was still in the fridge and expired, 5 doses had been given at that point; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was still in the fridge and expired, 5 doses had been given at that point) and PRODUCT STORAGE ERROR (Moderna vaccine was still in the fridge and expired, 5 doses had been given at that point) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022 at 6:09 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Jan-2022 at 6:09 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was still in the fridge and expired, 5 doses had been given at that point). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine was still in the fridge and expired, 5 doses had been given at that point). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was still in the fridge and expired, 5 doses had been given at that point) and PRODUCT STORAGE ERROR (Moderna vaccine was still in the fridge and expired, 5 doses had been given at that point) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  On 16-Dec-2021 vial was initially stored in the refrigerator. The Moderna Covid-19 Vaccine was given past the beyond use date of 15-Jan-2022, it was brought to attention on 26 Jan 2022. Patient was notified of the error and patient denied any adverse effects.  Treatment information was not provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. adeH21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medication was not reported. The treatment medication was not reported.  On 16-Dec-2021, the Moderna vaccine pulled from freezer. On 26-Jan-2022, the staff brought to the attention that the vial was still in the fridge and expired, from which 5 doses had been given. On 31-Jan-2022, the Moderna responded of no re-vaccination and the patient had no adverse event. The dose of Moderna third vaccine was 0.5 with no units.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired - 5 doses had been given at that point.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired - 5 doses had been given at that point.) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired - 5 doses had been given at that point.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired - 5 doses had been given at that point.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication reported.  Moderna Vaccine pulled from freezer on 16-Dec-2021 beyond use date of 15-Jan-2022. On 26-Jan-2022 staff bought attention that it was still in fridge and Expired. 5 doses had been given that point. on 27-Jan-2021 Remaining sites Checked, Found same error of BUD date. On 31 Jan 2022, responded that revaccination was not required.  Paitent notified of error and that a repeat vaccine is not required. Paitent denies any adverse effect.  No Treatment medication reported.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (PCN) and Drug allergy (Amoxicillin).    On 21-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  On 16-Dec-2021 vial was initially stored in the refrigerator. The Moderna Covid-19 Vaccine was given past the beyond use date of 15-Jan-2022. Patient was notified of the error and patient denied adverse effects.  Treatment information was not provided.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna vaccine was still in the fridge and expired-5 doses had been given; Moderna vaccine was still in the fridge and expired-5 doses had been given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was still in the fridge and expired-5 doses had been given) and PRODUCT STORAGE ERROR (Moderna vaccine was still in the fridge and expired-5 doses had been given) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was still in the fridge and expired-5 doses had been given). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine was still in the fridge and expired-5 doses had been given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was still in the fridge and expired-5 doses had been given) and PRODUCT STORAGE ERROR (Moderna vaccine was still in the fridge and expired-5 doses had been given) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reported that the patient had Flublok lot number QFAA2127 via intramuscular route in right deltoid and dose number was one on the same day when the patient received Moderna vaccine.   On 16 Dec 2021 Moderna vaccine was pulled from freezer. Beyond use date (BUD) of 15 Jan 2022 was printed in red and taped to the top of the boxes. Patient was notified of the error and patient denied adverse effects.  Treatment information was not provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Illness
Clinical narrative: Super sick to vaccine- just feeling better; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and ILLNESS (Super sick to vaccine- just feeling better) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Topamax).    On 17-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced ILLNESS (Super sick to vaccine- just feeling better). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown and ILLNESS (Super sick to vaccine- just feeling better) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported. Moderna vaccine was pulled from freezer on 16-Dec-2021. Beyond use date of 15-Jan-2022 was printed in red and taped to the top of boxes.  On 26-Jan-2022, Staff noticed that vaccine was still in the fridge and expired and 5 doses had been given at that point. on 31-Jan-2022, Moderna confirmed that revaccination was not required.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used-beyond use date of 15 Jan 2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used-beyond use date of 15 Jan 2022) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used-beyond use date of 15 Jan 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used-beyond use date of 15 Jan 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant  medication was not reported. Moderna vaccine was pulled from freezer on 16-Dec-2021. Beyond use date of 15-Jan-2022 was printed in red and taped to the top of boxes. On 26-Jan-2022, Staff noticed that vaccine was still in the fridge and expired and 5 doses had been given at that point. On 31-Jan-2022, Moderna confirmed that revaccination was not required.  Treatment medication was not reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 17-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Moderna vaccine pulled from freezer on 16-Dec-2021 BUD date of 15-Jan-2022 printed in red and taped to the top of the boxes.  On 26-Jan-2022 staff brought it to attention that it was still in the fridge and expired 5 doses had been given at that point.  On 27-Jan-2022 Remaining sites checked. All other clinics found to have same error of not noticing the BUD date. Moderna contacted and report filed. BUD date added to the daily Covid usage and wastage report.  On 31-Jan-2022 Moderna responded revaccination Not required.  Patient notified of error and that a repeat vaccine is not required. Patient denies any adverse effects.  No concomitant medication was provided. No treatment information was provided.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Underdose
Clinical narrative: BUD date of 01/15/2022; Dose 1 of J&J and Dose 2 Moderna vaccine; Dose 2 given as 0.25 ml; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (BUD date of 01/15/2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 of J&J and Dose 2 Moderna vaccine) and UNDERDOSE (Dose 2 given as 0.25 ml) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01010H21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: janssen. Past adverse reactions to the above products included No adverse event with janssen.    On 19-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (BUD date of 01/15/2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 of J&J and Dose 2 Moderna vaccine) and UNDERDOSE (Dose 2 given as 0.25 ml). At the time of the report, EXPIRED PRODUCT ADMINISTERED (BUD date of 01/15/2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 of J&J and Dose 2 Moderna vaccine) and UNDERDOSE (Dose 2 given as 0.25 ml) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No known drug allergies were reported. No concomitant medications were reported. No treatment medications were reported. Moderna vaccine pulled from freezer on 16-Dec-2021. BUD date of 15-Jan-2022 printed in red and taped to the top of the boxes. On 26-Jan-2022, staff brought it to attention that it was still in the fridge and expired-5 doses had been given at that point. Patient notified of error and that a repeat vaccine is not required. Patient denies any adverse effects.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Underdose
Clinical narrative: Vaccine beyond Use Date 15012022 and administer on 17012022/Expired doses had been given; Dose 2 given as 0.25; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine beyond Use Date 15012022 and administer on 17012022/Expired doses had been given) and UNDERDOSE (Dose 2 given as 0.25) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine beyond Use Date 15012022 and administer on 17012022/Expired doses had been given) and UNDERDOSE (Dose 2 given as 0.25). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine beyond Use Date 15012022 and administer on 17012022/Expired doses had been given) and UNDERDOSE (Dose 2 given as 0.25) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported Moderna vaccine pulled from freezer on 16 DEC 2021. Beyond Use Date (BUD) Of 15 JAN 2022 printed in red and taped to the top of the boxes. On 26 JAN 2022, staff brought it to attention that it was still in the fridge and expired 5 doses had been given at that point. Patient notified regarding error and that a repeat vaccine is not required and denied any adverse effects. Treatment medications were not reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: still in fridge and expired/ 5 doses had been given at that point; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (still in fridge and expired/ 5 doses had been given at that point) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (still in fridge and expired/ 5 doses had been given at that point). At the time of the report, EXPIRED PRODUCT ADMINISTERED (still in fridge and expired/ 5 doses had been given at that point) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Moderna vaccine was pulled from freezer on 16-DEC-2021. BUD date of 15-JAN-2022 was printed in red.  No concomitant medications were reported. No treatment medications were reported.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flublok (First dose given through Intramuscular route in Right Deltoid with Batch no: QFAA2127). Past adverse reactions to the above products included No adverse event with Flublok.    On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  On 16-Dec-2021 vial was initially stored in the refrigerator. 5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date of 15-Jan-2022. Patient was notified of the error and patient denied adverse effects.  Treatment information was not provided.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna vaccine was still in the fridge and expired-5 doses had been given; Moderna vaccine was still in the fridge and expired-5 doses had been given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was still in the fridge and expired-5 doses had been given) and PRODUCT STORAGE ERROR (Moderna vaccine was still in the fridge and expired-5 doses had been given) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was still in the fridge and expired-5 doses had been given). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine was still in the fridge and expired-5 doses had been given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was still in the fridge and expired-5 doses had been given) and PRODUCT STORAGE ERROR (Moderna vaccine was still in the fridge and expired-5 doses had been given) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  On 16 Dec 2021 Moderna vaccine was pulled from the freezer. Beyond use date (BUD) of 15 Jan 2022 printed in red and taped to the top of the boxes. On 26 Jan 2022, it was still in the fridge and expired - 5 doses had been given at that point.  Treatment information was not provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The vial did not undergone any temperature excursions and Vaccine beyond use date was 16-Jan-2022. The vial was initially stored in the refrigerator was 17-Dec-2021.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  BUD was reported as 16-Jan-2022
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain in extremity, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Pain that expands from thighs to knees/Sored thighs; Really sored right arm; Sored knees/Sored thighs; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain that expands from thighs to knees/Sored thighs), VACCINATION SITE PAIN (Really sored right arm), ARTHRALGIA (Sored knees/Sored thighs) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A and 022J21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 07-Jan-2022. Concurrent medical conditions included Blood pressure high.   On 26-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2022, the patient experienced PAIN IN EXTREMITY (Pain that expands from thighs to knees/Sored thighs), VACCINATION SITE PAIN (Really sored right arm), ARTHRALGIA (Sored knees/Sored thighs) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain that expands from thighs to knees/Sored thighs), VACCINATION SITE PAIN (Really sored right arm), ARTHRALGIA (Sored knees/Sored thighs) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.         The patient was taking medication for her high blood pressure as concomitant medication. The lot number for second dose was also reported as 022J21A.  It was mentioned that pain symptoms got better on 23 FEB 2022 when she took painkillers. The headache came back on the day of reporting. And she was feeling more pain.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Booster Doses Administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Booster Doses Administered) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007J21-2A, 036C21A and 036C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Booster Doses Administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Booster Doses Administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered after exposure to room temperature >24 hours; Administration of a dose after 12 hours the vial was first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of a dose after 12 hours the vial was first puncture) and PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature >24 hours) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Morphine and Codeine).    On 23-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of a dose after 12 hours the vial was first puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature >24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of a dose after 12 hours the vial was first puncture) and PRODUCT STORAGE ERROR (Dose administered after exposure to room temperature >24 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was unknown if the patient was on concomitant/ regular medication and if experienced any symptoms.  Treatment details was not reported by the reporter.
Age: 9.0
Sex: F
Vaccine: COVID19, FLU4, IPV, MMRV, COVID19, FLU4, IPV, MMRV
Symptoms: Product preparation issue
Clinical narrative: Inappropriate smaller amount of diluent was added leading to more concentrated dose of vaccine
Age: 9.0
Sex: F
Vaccine: COVID19, FLU4, IPV, MMRV, COVID19, FLU4, IPV, MMRV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Inappropriate smaller amount of diluent was added leading to more concentrated dose of vaccine
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain in bicep when left arm is raised. No discomfort when arm is at rest (down).
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19, FLU4
Symptoms: Product preparation issue
Clinical narrative: Inappropriate smaller amount of diluent was added leading to more concentrated dose of vaccine
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19, FLU4
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Inappropriate smaller amount of diluent was added leading to more concentrated dose of vaccine
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: Inappropriate smaller amount of diluent was added leading to more concentrated dose of vaccine
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Inappropriate smaller amount of diluent was added leading to more concentrated dose of vaccine
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Atrial flutter, Blood cholesterol increased, Blood pressure increased
Clinical narrative: Initial reaction 10/28/21  Severe joint pain, elevated heart rate, elevated blood pressure, severe swelling of hands and knuckles.  Second Reaction 12/1 Severe joint pain, elevated heart rate, elevated blood pressure, severe swelling of hands and knuckles. Subsequent steroid treatment did not improve blood inflammatory levels (3, 3 week steroid treatment cycles) Heart rate increased further after second dose, saw Cardiologist 1/11/22, cardio echo-sound performed 1/27, heart rate 150+, Atrial Flutter discovered on echo-sound/EKG, did not exist previously. Severe ongoing joint pain ? travelling throughout body with different location every few days (hands , wrist, elbows, knees, feet, chest) Repeated blood tests during steroid treatment cycles reflect elevated blood inflammatory levels continuing (as of 2/26/22). Doctor has recommended Cardiac Catheter Ablation procedure (to be scheduled on 2/28/22). Reaction has required 15+ office/ blood test visits and cardiac catheter procedure is pending. Joint pain, elevated heart rate and atrial flutter remain unresolved. Severe ongoing daily joint pain. Inflammatory Blood test levels remain high after 2 full 3-week steroid treatment cycles. (CRP Non-Cardiac 2.12mg/dl on 2/22 after 6 weeks total of Prednisone, currently on third 3-week cycle). Note I had a full physical in September 2022, No Atrial Flutter at that time, full blood panel, all blood test results were normal except slightly high cholesterol levels.  Reaction condition remains unresolved, high blood inflammatory levels, elevated heart rate and constant joint pain in new locations every day (Left hand, knuckles, wrist, left elbow is primary, with other joints variable). Rapidly losing hand strength in left hand and ability to grasp / twist objects (i.e., doorknob twist is not possible every day)