chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; THE JANSSEN COVID 19 VACCINE WAS REFROZEN AND ADMINISTERED TO PATIENT; This spontaneous report received from a health care professional concerned a 29 year old male. 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 admin not reported, batch number: 1821286, and expiry: 20-MAR-2022) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. Age at time of vaccination 29 years old. No concomitant medications were reported. On 07-JUL-2021, the patient experienced the janssen covid 19 vaccine was refrozen and administered to patient. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the janssen covid 19 vaccine was refrozen and administered to patient and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537341, 20220537683, 20220538146, 20220541180, 20220538238, 20220538297, 20220538379, 20220538428, 20220537548, 20220538480, 20220538573, 20220538693, 20220538890, 20220540420, 20220540435, 20220540474, 20220540524, 20220540536, 20220540611, 20220540642, 20220540688, 20220540765, 20220540814, 20220540816, 20220540853, 20220541085, 20220541180, 20220541401, 20220541506, 20220537507, 20220538480, 20220540324 and 20220538758.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PRODUCT STORAGE ERROR; THE JANSSEN COVID 19 VACCINE WAS REFROZEN AND ADMINISTERED TO PATIENT; This spontaneous report received from a health care professional concerned a 47 year old male. 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 not reported, batch number: 1821286, expiry: 20-MAR-2022) dose was not reported, administered on 15-AUG-2021 for prophylactic vaccination. Age at time of vaccination 47 years old. No concomitant medications were reported. On 15-AUG-2021, the patient experienced the janssen covid 19 vaccine was refrozen and administered to patient. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the janssen covid 19 vaccine was refrozen and administered to patient and product storage error was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537356, 20220537444, 20220537507, 20220537532, 20220537548, 20220537683, 20220538149, 20220538238, 20220538297, 20220538316, 20220538411, 20220538425, 20220538480, 20220538627, 20220539045, 20220540324, 20220540420, 20220540435, 20220540536, 20220540642, 20220538890, 20220538292, 20220538693, 20220537341, 20220538146, 20220538210, 20220538347, 20220538379, 20220538428, 20220538437, 20220538666, 20220538758, 20220540816, 20220540765, 20220540688, 20220538573, 20220540570, 20220540853, 20220541085, 20220541180, 20220541401, 20220541506, 20220540814 and 20220540524.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS REFROZEN; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 38 year old female. 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 admin not reported, batch number: 1821286, expiry: 20-MAR-2022) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. Age at time of vaccination 38 years old. No concomitant medications were reported. On 29-JUL-2021, the patient experienced administration of refrozen vaccine. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of refrozen vaccine and vaccine was refrozen was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537341, 20220537356, 20220537444, 20220537532, 20220537548, 20220537683, 20220537688, 20220538149, 20220538210, 20220538238, 20220538292, 20220538297, 20220538316, 20220538347, 20220538347, 20220538411, 20220538425, 20220538428, 20220538437, 20220538480, 20220538573, 20220538627, 20220538666, 20220538693, 20220538758, 20220538890, 20220539045, 20220540324, 20220540435, 20220540474, 20220540524, 20220540536, 20220540570, 20220540688, 20220540816, 20220540853, 20220541085, 20220541180, 20220541401, 20220541506, 20220537507, 20220538480, 20220540765 and 20220540814.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; VACCINE WAS REFROZEN AND ADMINISTERED TO PATIENT; This spontaneous report received from a health care professional concerned a 53 year old female. 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 admin not reported, and batch number: 1821286 expiry: 20-MAR-2022) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. Age at time of vaccination 53 years old. No concomitant medications were reported. On 02-JUN-2021, the patient experienced vaccine was refrozen and administered to patient. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was refrozen and administered to patient and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220538890, 20220540611, 20220541180, 20220537683, 20220540524, 20220537341, 20220537356, 20220537444, 20220537532, 20220537548, 20220537688, 20220538146, 20220538210, 20220538238, 20220538292, 20220538297, 20220538316, 20220538347, 20220538379, 20220538411, 20220538425, 20220538428, 20220538437, 20220538480, 20220538573, 20220538627, 20220538666, 20220538693, 20220540324, 20220540435, 20220540536, 20220540570, 20220540814, 20220540816, 20220540853, 20220541085, 20220541401, 20220541506, 20220537507, 20220538480, 20220540420, 20220540765, 20220540642, 20220540474, 20220540324 and 20220539045.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; THE JANSSEN COVID 19 VACCINE WAS REFROZEN AND ADMINISTERED TO PATIENT; This spontaneous report received from a health care professional concerned a 48 year old female. 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 admin not reported, and batch number: 1821286 expiry: 20/MAR/2022) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. Age at time of vaccination 48 years old. No concomitant medications were reported.  On 09-SEP-2021, the patient experienced the janssen covid 19 vaccine was refrozen and administered to patient. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the janssen covid 19 vaccine was refrozen and administered to patient and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220541180, 20220537683, 20220540524, 20220540688, 20220540570, 20220540324, 20220540611, 20220537341, 20220537356, 20220537444, 20220537532, 20220537548, 20220537688, 20220538149, 20220538210, 20220538238, 20220538292, 20220538297, 20220538316, 20220538411, 20220538425, 20220538428, 20220538437, 20220538480, 20220538573, 20220538666, 20220538693, 20220538758, 20220538890, 20220539045, 20220540420, 20220540435, 20220540474, 20220540536, 20220540642, 20220540816, 20220540853, 20220541506, 20220537507, 20220538480, 20220538146, 20220541085, 20220541401, 20220540765, 20220538347, 20220538379, 20220538627 and 20220540765.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS REFROZEN; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 48 year old male. 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 admin not reported, batch number: 1821286, expiry: 20-MAR-2022) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. Age at time of vaccination 48 years old. No concomitant medications were reported. On 09-JUL-2021, the patient experienced administration of refrozen vaccine. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was refrozen and administration of refrozen vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220538890, 20220540611, 20220541180, 20220537683, 20220540524, 20220539045, 20220540688, 20220537356, 20220537532, 20220538238, 20220537444, 20220537548, 20220538425, 20220538428, 20220538297, 20220538573, 20220540570, 20220540324, 20220540536, 20220540642, 20220540765, 20220540814, 20220538292, 20220538693, 20220537688, 20220538146, 20220538149, 20220538210, 20220538316, 20220538347, 20220538411, 20220538428, 20220538666, 20220540420, 20220540435, 20220540474, 20220538480, 20220540853, 20220541085, 20220537341, 20220537507, 20220538437, 20220538480, 20220538627, 20220541401 and 20220541506.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: received 3rd full dose due to his age/ he qualified as immunocompromised due to his advanced age.; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL OVERDOSE (received 3rd full dose due to his age/ he qualified as immunocompromised due to his advanced age.) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 007J21-2A, 016M20 and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (received 3rd full dose due to his age/ he qualified as immunocompromised due to his advanced age.). At the time of the report, ACCIDENTAL OVERDOSE (received 3rd full dose due to his age/ he qualified as immunocompromised due to his advanced age.) outcome was unknown.            No Concomitant product use was reported.  The patient stated that they had received 3 primary series doses, as the patient thought the patient was qualified as immunocompromised due to their advanced age. The patient also stated that the patient had now received the 1st booster dose and till date had received 4 total doses of the Moderna Covid-19 vaccine (3 full doses and 1 booster dose). The patient stated that one of the doctors on a TV program stated that there might be an added advantage to waiting more than 4 months before receiving the 2nd booster dose as it may work better.  The patient had earlier reported that the patient got the 3rd dose more or less as an accident, and the patient thought they only got it because the patient was 86 years old, but the patient didn't had any indications from their doctor.  The treatment medication information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2022: Significant Follow-up was received: The reporter occupation has been changed to patient from consumer. The patient details were updated including date of birth and age. Suspect drug dose details were updated including start dates and lot number of primary series and booster dose. Added event Accidental overdose and the case narrative was updated.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 02-Apr-2022 and vaccine removed from fridge on 18-Apr-2022; Vaccine expired on 02-Apr-2022 and vaccine administered on 18-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 02-Apr-2022 and vaccine administered on 18-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and vaccine removed from fridge on 18-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 02-Apr-2022 and vaccine administered on 18-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and vaccine removed from fridge on 18-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 02-Apr-2022 and vaccine administered on 18-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and vaccine removed from fridge on 18-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  The BUD date was reported as 02-Apr-2022.  Vaccine was removed from fridge on 18-Apr-2022.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-571103, MOD-2022-571106 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2022: Vaccine start date, expiry date and new event were added.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Paxlovid rebound 3 days after finishing treatment) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 prophylaxis. Concurrent medical conditions included Undifferentiated connective tissue disease and Allergy to plants (Allergic to wheatgrass). Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) from December 2021 to an unknown date and FLUVOXAMINE MALEATE (LUVOX CR) from 24-Apr-2022 to an unknown date for an unknown indication. On 23-Nov-2021 at 1:15 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On 02-May-2022 at 8:00 AM, the patient experienced COVID-19 (Paxlovid rebound 3 days after finishing treatment). On 11-May-2022, COVID-19 (Paxlovid rebound 3 days after finishing treatment) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient date of birth was reported as Feb 1964. It was reported that patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Treatment received second dose of Paxlovid device date on 14 May 2022. Company comment: This spontaneous case concerns a 58 year old female patient with relevant medical history of undifferentiated connective tissue disorder, who experienced the unexpected non serious AESI of COVID-19, about 5 months and 7 days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient was taking Paxlovid for COVID-19 infection However, had rebound COVID-19, 3 days after finishing treatment. No further information on details pertaining to the previous doses was available in the report. Ongoing COVID-19 pandemic and medical history of undifferentiated connective tissue disorder could be risk factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 58 year old female patient with relevant medical history of undifferentiated connective tissue disorder, who experienced the unexpected non serious AESI of COVID-19, about 5 months and 7 days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient was taking Paxlovid for COVID-19 infection However, had rebound COVID-19, 3 days after finishing treatment. No further information on details pertaining to the previous doses was available in the report. Ongoing COVID-19 pandemic and medical history of undifferentiated connective tissue disorder could be risk factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients administered expired Moderna vaccine/all doses administered more than 30 days after 11-Jan-2022) and PRODUCT STORAGE ERROR (This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, and administered on 28-Feb-2022) in a 68-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients administered expired Moderna vaccine/all doses administered more than 30 days after 11-Jan-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, and administered on 28-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients administered expired Moderna vaccine/all doses administered more than 30 days after 11-Jan-2022) and PRODUCT STORAGE ERROR (This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, and administered on 28-Feb-2022) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that reporter's team had accidentally administered expired Moderna COVID-19 vaccine to 18 patients: 9 patients on 9-May-2022 and 9 patients on 11-May-2022 (vaccine expired 5-May-2022). After further investigation it was identified that staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the EUA. This included 84 doses administered to 82 patients (as 2 patients received 2 doses from this lot more than 30 days after it was in the fridge) administered between 16-Feb-2022 and 11-May-2022. The vaccine in question did not experience any temperature excursions. No treatment information was reported.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with expired Moderna vaccine) and PRODUCT STORAGE ERROR (Vaccine Placed in refrigerator on 11-Jan-2022 and administered on 01-Mar-2022) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Pfizer (Batch no: EL9265.) on 28-Jan-2021 and Pfizer (Batch no: EL9265.) on 18-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. On 01-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with expired Moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine Placed in refrigerator on 11-Jan-2022 and administered on 01-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with expired Moderna vaccine) and PRODUCT STORAGE ERROR (Vaccine Placed in refrigerator on 11-Jan-2022 and administered on 01-Mar-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient received booster dose on 01-Mar-2022. The vaccine was  placed in the fridge on 11-Jan-2022 and doses were administered more than 30 days after 11-Jan-2022. The vial did not experience any temperature excursions. No patient had reported adverse reaction. The patient did not report adverse reaction to the reporter's knowledge. No treatment medications were reported.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 01-Mar-2022; inadvertently administered expired dose of the Moderna COVID-19 vaccine (dose administered more than 30 days after storage in fridge); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine (dose administered more than 30 days after storage in fridge)) and PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 01-Mar-2022) in a 51-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine (dose administered more than 30 days after storage in fridge)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 01-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine (dose administered more than 30 days after storage in fridge)) and PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 01-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The reporter reported that the staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 and were not in accordance with the EUA. The vaccine in question did not experience any temperature excursions.  The patient had not reported any adverse reaction.  No treatment information was provided by the reporter.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Taste disorder, Toothache
Clinical narrative: COVID-19; Teeth pain; Terrible taste disturbance; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), TOOTHACHE (Teeth pain) and TASTE DISORDER (Terrible taste disturbance) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sarcoidosis and Drug allergy (Unknown historical drug). Concomitant products included SIMVASTATIN from April 2022 to 12-May-2022 and BUPROPION HYDROCHLORIDE (WELLBUTRIN XL) from April 2022 to 10-May-2022 for an unknown indication.    On 20-Apr-2022 at 9:30 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022 at 10:00 AM, the patient experienced TOOTHACHE (Teeth pain) and TASTE DISORDER (Terrible taste disturbance). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown and TOOTHACHE (Teeth pain) and TASTE DISORDER (Terrible taste disturbance) had not resolved.            The patient received unspecified Pfizer drug as treatment for COVID-19. Treatment started on 10-May-2022 and ended on 13-May-2022. Batch number was reported as FY7031.  Device date was reported as 16-May-2022.  Company Comment: This spontaneous case concerns a 55-year-old female patient, with relevant medical history of Sarcoidosis, who experienced the unexpected events of COVID-19, Toothache and Taste disorder. The events occurred approximately 23 days after receiving the fourth dose of mRNA-1273 Vaccine. The patient also received unspecified Pfizer drug as treatment for COVID-19 on the same day as the occurrence of the events. The outcome of the events was reported as not resolved. The patient's medical history of Sarcoidosis and the unspecified Pfizer drug  for COVID-19 treatment, remain as confounders for the occurrence of the event Taste disorder.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 55-year-old female patient, with relevant medical history of Sarcoidosis, who experienced the unexpected events of COVID-19, Toothache and Taste disorder. The events occurred approximately 23 days after receiving the fourth dose of mRNA-1273 Vaccine. The patient also received unspecified Pfizer drug as treatment for COVID-19 on the same day as the occurrence of the events. The outcome of the events was reported as not resolved. The patient's medical history of Sarcoidosis and the unspecified Pfizer drug  for COVID-19 treatment, remain as confounders for the occurrence of the event Taste disorder.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Doses were administered after 30-day Use By Date after being thawed/Vial was initially stored in the refrigerator on 07-Apr-2022 and administered on 10-May-2022 or 11-May-2022; Doses were administered after 30-day Use By Date after being thawed; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after 30-day Use By Date after being thawed) and PRODUCT STORAGE ERROR (Doses were administered after 30-day Use By Date after being thawed/Vial was initially stored in the refrigerator on 07-Apr-2022 and administered on 10-May-2022 or 11-May-2022) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after 30-day Use By Date after being thawed). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Doses were administered after 30-day Use By Date after being thawed/Vial was initially stored in the refrigerator on 07-Apr-2022 and administered on 10-May-2022 or 11-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after 30-day Use By Date after being thawed) and PRODUCT STORAGE ERROR (Doses were administered after 30-day Use By Date after being thawed/Vial was initially stored in the refrigerator on 07-Apr-2022 and administered on 10-May-2022 or 11-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported.   The vial did not undergo any temperature excursions.  The patient received second Moderna booster dose either on 10-May-2022 or on 11-May-2022.  No treatment information was provided.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Epiglottitis
Clinical narrative: Supraglottitis secondary to SARS-CoV-2; Supraglottitis secondary to SARS-CoV-2; This literature-non-study case was reported in a literature article and describes the occurrence of EPIGLOTTITIS (Supraglottitis secondary to SARS-CoV-2) in a 50-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.       No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EPIGLOTTITIS (Supraglottitis secondary to SARS-CoV-2) (seriousness criterion medically significant) and COVID-19 (Supraglottitis secondary to SARS-CoV-2). At the time of the report, EPIGLOTTITIS (Supraglottitis secondary to SARS-CoV-2) and COVID-19 (Supraglottitis secondary to SARS-CoV-2) outcome was unknown. Related      For mRNA-1273 (Spikevax) (Unknown), the reporter considered EPIGLOTTITIS (Supraglottitis secondary to SARS-CoV-2) and COVID-19 (Supraglottitis secondary to SARS-CoV-2) to be related.    Treatment and concomitant medications were not reported. Company comment This literature-non-study case concerns a 50-year-old male patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of EPIGLOTTITIS and the unexpected non-serious AESI of COVID-19, which occurred after receiving a dose of mRNA-1273 vaccine. Onset date of vaccination and date of event were not provided; hence, latency cannot be assessed. Interval between doses was not reported. It was reported that patient experienced Supraglottitis secondary to SARS-CoV-2. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This literature-non-study case concerns a 50-year-old male patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of EPIGLOTTITIS and the unexpected non-serious AESI of COVID-19, which occurred after receiving a dose of mRNA-1273 vaccine. Onset date of vaccination and date of event were not provided; hence, latency cannot be assessed. Interval between doses was not reported. It was reported that patient experienced Supraglottitis secondary to SARS-CoV-2. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slightly sore right arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (slightly sore right arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to antibiotics (fluoroquinolones and various antibiotics), Sulfonamide allergy (sulfa) and Pre-diabetic.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (slightly sore right arm). At the time of the report, VACCINATION SITE PAIN (slightly sore right arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient had never been diagnosed with/ tested positive for COVID-19.  On 04-Apr-2022, the patient received on Shingles vaccine.  The patient received the first Moderna dose on 08-Feb-2021 and experienced a slightly sore right arm.   Concomitant medication included Shingles vaccine on 04-Apr-2021.  No treatment drug details was reported.
Sex: M
Vaccine: COVID19
Symptoms: Impaired quality of life, Mental disorder, Muscle atrophy, SARS-CoV-2 test, Weight decreased
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of MENTAL DISORDER (he is having mental problems), MUSCLE ATROPHY (lost 40 pounds, he is losing muscle mass) and IMPAIRED QUALITY OF LIFE (literally deteriorating, his body is going down to nothing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Post-traumatic stress disorder. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENTAL DISORDER (he is having mental problems), MUSCLE ATROPHY (lost 40 pounds, he is losing muscle mass) and IMPAIRED QUALITY OF LIFE (literally deteriorating, his body is going down to nothing). At the time of the report, MENTAL DISORDER (he is having mental problems), MUSCLE ATROPHY (lost 40 pounds, he is losing muscle mass) and IMPAIRED QUALITY OF LIFE (literally deteriorating, his body is going down to nothing) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative. On an unknown date, Weight decreased: decreased (Low) He has lost 40 pounds or more. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant drug was reported. The patient received Moderna vaccine 8 months ago. The patient wanted to talk to someone, and that he did not wanted to put his side effects online. The patient had mental problems, he wanted to speak with someone immediately. The patient had spoken with his therapist. No treatment drug was reported. It was reported that every time patient had visited hospital tested negative for COVID, everything had come back clear.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Dysgeusia, Fatigue, Feeling abnormal, Inappropriate schedule of product administration
Clinical narrative: Fatigue; muscle aches; fever again; I had a horrendous taste in my mouth throughout treatment, some combo of citric acid and metallic; hard to sleep; it was so awful; cough; stuffy nose; Patient recieved primary dose of Pfizer and then received moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (I had a horrendous taste in my mouth throughout treatment, some combo of citric acid and metallic), INSOMNIA (hard to sleep), FEELING ABNORMAL (it was so awful), COUGH (cough) and NASAL CONGESTION (stuffy nose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Anatomical site reported Left Arm.) on 14-Apr-2021 and PFIZER BIONTECH COVID-19 VACCINE (Anatomical site reported Left Arm.) on 05-May-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and Pfizer / BioNTech. Concurrent medical conditions included Drug allergy.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved primary dose of Pfizer and then received moderna vaccine). On 04-May-2022, the patient experienced DYSGEUSIA (I had a horrendous taste in my mouth throughout treatment, some combo of citric acid and metallic), INSOMNIA (hard to sleep), FEELING ABNORMAL (it was so awful), COUGH (cough), NASAL CONGESTION (stuffy nose) and PYREXIA (fever again). On an unknown date, the patient experienced FATIGUE (Fatigue) and MYALGIA (muscle aches). At the time of the report, DYSGEUSIA (I had a horrendous taste in my mouth throughout treatment, some combo of citric acid and metallic), INSOMNIA (hard to sleep), FEELING ABNORMAL (it was so awful), COUGH (cough), NASAL CONGESTION (stuffy nose) and PYREXIA (fever again) had not resolved and FATIGUE (Fatigue), MYALGIA (muscle aches) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved primary dose of Pfizer and then received moderna vaccine) outcome was unknown.            No concomitant drug reported.  Patient received some unknown suspect medication with start date 4-MAY-2022 and end date 9-MAY-2022 for the treatment of COVID-19.  Also patient reported  never would have taken Paxlovid.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Nasal congestion, Pyrexia
Clinical narrative: Fatigue; muscle aches; fever again; I had a horrendous taste in my mouth throughout treatment, some combo of citric acid and metallic; hard to sleep; it was so awful; cough; stuffy nose; Patient recieved primary dose of Pfizer and then received moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (I had a horrendous taste in my mouth throughout treatment, some combo of citric acid and metallic), INSOMNIA (hard to sleep), FEELING ABNORMAL (it was so awful), COUGH (cough) and NASAL CONGESTION (stuffy nose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Anatomical site reported Left Arm.) on 14-Apr-2021 and PFIZER BIONTECH COVID-19 VACCINE (Anatomical site reported Left Arm.) on 05-May-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and Pfizer / BioNTech. Concurrent medical conditions included Drug allergy.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved primary dose of Pfizer and then received moderna vaccine). On 04-May-2022, the patient experienced DYSGEUSIA (I had a horrendous taste in my mouth throughout treatment, some combo of citric acid and metallic), INSOMNIA (hard to sleep), FEELING ABNORMAL (it was so awful), COUGH (cough), NASAL CONGESTION (stuffy nose) and PYREXIA (fever again). On an unknown date, the patient experienced FATIGUE (Fatigue) and MYALGIA (muscle aches). At the time of the report, DYSGEUSIA (I had a horrendous taste in my mouth throughout treatment, some combo of citric acid and metallic), INSOMNIA (hard to sleep), FEELING ABNORMAL (it was so awful), COUGH (cough), NASAL CONGESTION (stuffy nose) and PYREXIA (fever again) had not resolved and FATIGUE (Fatigue), MYALGIA (muscle aches) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved primary dose of Pfizer and then received moderna vaccine) outcome was unknown.            No concomitant drug reported.  Patient received some unknown suspect medication with start date 4-MAY-2022 and end date 9-MAY-2022 for the treatment of COVID-19.  Also patient reported  never would have taken Paxlovid.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired on 29-Apr-2022 and was administered on 10-May-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 29-Apr-2022 and was administered on 10-May-2022) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 10-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 29-Apr-2022 and was administered on 10-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 29-Apr-2022 and was administered on 10-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the vial was initially stored in the refrigerator on the same date that the dose was administered. The vial did not undergo any temperature excursions.  No treatment medications were reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired dose administered; Vaccine expired on 29 Apr 2022 and vial was stored in the refrigerator on 17 May 2022 (expired vaccine stored and then administered); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered) and PRODUCT STORAGE ERROR (Vaccine expired on 29 Apr 2022 and vial was stored in the refrigerator on 17 May 2022 (expired vaccine stored and then administered)) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered) and PRODUCT STORAGE ERROR (Vaccine expired on 29 Apr 2022 and vial was stored in the refrigerator on 17 May 2022 (expired vaccine stored and then administered)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered) and PRODUCT STORAGE ERROR (Vaccine expired on 29 Apr 2022 and vial was stored in the refrigerator on 17 May 2022 (expired vaccine stored and then administered)) 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. It was reported that the vial was initially stored in the refrigerator at the same date that the dose was administered. The vial did not undergo any temperature excursions.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: she has bells palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (she has bells palsy) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057, 066F21A, 036D21A and 038A21A) for COVID-19 vaccination.     Patient reported that she did not test or diagnosed for COVID.  Concurrent medical conditions included Food allergy.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (she has bells palsy) (seriousness criterion medically significant). The patient was treated with PREDNISONE for Bell's palsy, at an unspecified dose and frequency and VALACYCLOVIR [VALACICLOVIR] for Bell's palsy, at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (she has bells palsy) outcome was unknown.            Patient's height was reported as 5'2". Patient had been taking concomitant medications, but did not specified them.  Company comment: This spontaneous case concerns an 86-year-old female patient with no relevant medical history, who experienced the expected serious (medically significant) AESI Bell's palsy, on an unspecified date after receiving the 4th dose of mRNA-1273 vaccine.  Patient was treated with Prednisone and Valacyclovir. The outcome was reported as unknown. Details of concurrent conditions, clinical course, and investigation reports were not provided. Previously patient was received first three doses mRNA-1273 vaccine and no information present on any adverse event.  Elderly age of the patient could be a risk factor. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns an 86-year-old female patient with no relevant medical history, who experienced the expected serious (medically significant) AESI Bell's palsy, on an unspecified date after receiving the 4th dose of mRNA-1273 vaccine.  Patient was treated with Prednisone and Valacyclovir. The outcome was reported as unknown. Details of concurrent conditions, clinical course, and investigation reports were not provided. Previously patient was received first three doses mRNA-1273 vaccine and no information present on any adverse event.  Elderly age of the patient could be a risk factor. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.