chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: breakthrough Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (breakthrough Covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 29-Sep-2021, the patient experienced COVID-19 (breakthrough Covid). At the time of the report, COVID-19 (breakthrough Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.  company comment: non-serious unexpected event of special interest (AESI) COVID-19. The event occurred unspecified time after unspecified dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was not applicable since due to nature of the event, unknown outcome and lack of information on number of doses administered, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient with no relevant medical history reported, who experienced non-serious unexpected event of special interest (AESI) COVID-19. The event occurred unspecified time after unspecified dose of the Moderna COVID-19 Vaccine (mRNA-1273). Rechallenge was not applicable since due to nature of the event, unknown outcome and lack of information on number of doses administered, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pruritus (itching chest and neck) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunisation. Co-suspect product included Tyvaso (treprostinil sodium) inhalation gas for secondary pulmonary arterial hypertension. Concurrent medical conditions included secondary pulmonary arterial hypertension. Concomitant products included Adempas (riociguat), Eliquis (apixaban) and Opsumit (macitentan) for an unknown indication. On Nov 11, 2019, patient started Tyvaso (treprostinil sodium), unknown route at an unspecified dose, four times per day. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pruritus (itching chest and neck). At the time of the report, pruritus (itching chest and neck) outcome: unknown. No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Included patient details updated
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Error resulting in administration of expired vaccine; Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        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.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Included updated Patient initials.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: error resulting in administration of expired vaccine; Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment details were reported.   This case was linked to MOD-2021-395451, MOD-2021-395366, MOD-2021-395445, MOD-2021-395489, MOD-2021-395550, MOD-2021-395452, MOD-2021-395490, MOD-2021-395485, MOD-2021-395486 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Patient details added
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: temperature of 102 (2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (temperature of 102 (2nd dose)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (temperature of 102 (2nd dose)). At the time of the report, PYREXIA (temperature of 102 (2nd dose)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102.         On 02-Nov-2021, the patient received her booster dose of the Moderna COVID-19 vaccine.  No concomitant medications reported by reporter No treatment medications provided by the reporter.     This case was linked to MOD-2021-392266 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Hypersomnia, Pyrexia
Clinical narrative: I had lots of sleep; HA fevers; Severe underarm pain 8/10; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (I had lots of sleep), PYREXIA (HA fevers), AXILLARY PAIN (Severe underarm pain 8/10) and FATIGUE (Extreme fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Nov-2021 at 3:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced PYREXIA (HA fevers), AXILLARY PAIN (Severe underarm pain 8/10) and FATIGUE (Extreme fatigue). On an unknown date, the patient experienced HYPERSOMNIA (I had lots of sleep). At the time of the report, HYPERSOMNIA (I had lots of sleep), PYREXIA (HA fevers), AXILLARY PAIN (Severe underarm pain 8/10) and FATIGUE (Extreme fatigue) outcome was unknown.            Patient did not take any medications and missed work due to symptoms but did not need to seek care.  No relevant concomitant product were reported.  Company comment:This case concerns a female patient with no reported medical history, who experienced the unexpected, non-serious and AESI event of Hypersomnia.  The event occurred on an unknown date after third dose of mRNA-1273 vaccine. The rechallenge was not applicable,  as event date was not reported and no additional dose is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient with no reported medical history, who experienced the unexpected, non-serious and AESI event of Hypersomnia.  The event occurred on an unknown date after third dose of mRNA-1273 vaccine. The rechallenge was not applicable,  as event date was not reported and no additional dose is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cold sweat, Headache, Myalgia
Clinical narrative: Low-grade fever/ (98.8); Body aches; Headache; Chills; Cold sweats; This spontaneous case was reported by an other health care professional and describes the occurrence of COLD SWEAT (Cold sweats), PYREXIA (Low-grade fever/ (98.8)), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) in a 31-year-old female 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: Flu shot (Left arm) on 02-Nov-2021, Pfizer (Dose 2) and Pfizer (Dose 2). Past adverse reactions to the above products included Headache with Pfizer; Low grade fever with Pfizer; and No adverse reaction with Flu shot. Concurrent medical conditions included Anxiety and Acne. Concomitant products included SPIRONOLACTONE from 15-Oct-2020 to an unknown date for Acne, ESCITALOPRAM OXALATE (LEXAPRO) from 15-Oct-2020 to an unknown date for Anxiety, LEVONORGESTREL (MIRENA) from 23-Nov-2018 to an unknown date for an unknown indication.    On 20-Nov-2021 at 10:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 microgram. On 20-Nov-2021 at 5:00 PM, the patient experienced COLD SWEAT (Cold sweats), CHILLS (Chills) and HEADACHE (Headache). On 20-Nov-2021 at 7:00 PM, the patient experienced PYREXIA (Low-grade fever/ (98.8)) and MYALGIA (Body aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) from 20-Nov-2021 to 21-Nov-2021 for Adverse event, at an unspecified dose and frequency. On 21-Nov-2021 at 11:00 AM, COLD SWEAT (Cold sweats), PYREXIA (Low-grade fever/ (98.8)), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2021, Body temperature: 98.8 (High) Low grade fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PYREXIA (Low-grade fever/ (98.8)), MYALGIA (Body aches) and HEADACHE (Headache) to be probably related. No further causality assessments were provided for COLD SWEAT (Cold sweats) and CHILLS (Chills).    Reporter stated that her race was also   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Patient's demographics, Historical vaccines, Patient's medical history, Concomitant and Treatment medications, Vaccine start date, Time and Batch number, Reporter's causality were updated.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low-grade fever/ (98.8); Body aches; Headache; Chills; Cold sweats; This spontaneous case was reported by an other health care professional and describes the occurrence of COLD SWEAT (Cold sweats), PYREXIA (Low-grade fever/ (98.8)), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) in a 31-year-old female 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: Flu shot (Left arm) on 02-Nov-2021, Pfizer (Dose 2) and Pfizer (Dose 2). Past adverse reactions to the above products included Headache with Pfizer; Low grade fever with Pfizer; and No adverse reaction with Flu shot. Concurrent medical conditions included Anxiety and Acne. Concomitant products included SPIRONOLACTONE from 15-Oct-2020 to an unknown date for Acne, ESCITALOPRAM OXALATE (LEXAPRO) from 15-Oct-2020 to an unknown date for Anxiety, LEVONORGESTREL (MIRENA) from 23-Nov-2018 to an unknown date for an unknown indication.    On 20-Nov-2021 at 10:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 microgram. On 20-Nov-2021 at 5:00 PM, the patient experienced COLD SWEAT (Cold sweats), CHILLS (Chills) and HEADACHE (Headache). On 20-Nov-2021 at 7:00 PM, the patient experienced PYREXIA (Low-grade fever/ (98.8)) and MYALGIA (Body aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) from 20-Nov-2021 to 21-Nov-2021 for Adverse event, at an unspecified dose and frequency. On 21-Nov-2021 at 11:00 AM, COLD SWEAT (Cold sweats), PYREXIA (Low-grade fever/ (98.8)), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2021, Body temperature: 98.8 (High) Low grade fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PYREXIA (Low-grade fever/ (98.8)), MYALGIA (Body aches) and HEADACHE (Headache) to be probably related. No further causality assessments were provided for COLD SWEAT (Cold sweats) and CHILLS (Chills).    Reporter stated that her race was also   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Patient's demographics, Historical vaccines, Patient's medical history, Concomitant and Treatment medications, Vaccine start date, Time and Batch number, Reporter's causality were updated.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vials were used to provide 38 doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vials were used to provide 38 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vials were used to provide 38 doses). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vials were used to provide 38 doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported. No treatment medication information was reported.  It was reported that no excursion occurred. The Moderna vials were taken out of the freezer, thawed and administered as instructed. No delays occurred in administration of Moderna vaccine. On 12 Nov 2021 all vaccines were administered within 2 hrs.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow-up received includes updated Second reporter Information.
Age: 39.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On 13-Nov-2021, the patient received dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The other potential cause was reported as Flu vaccine which was administered the same week as that of the Moderna Vaccine.  Patient received the flu vaccine on Nov-13-2021 via injection(unknown manufacturer). Patient reported that on 20-Nov-2021, he woke up with a swollen eye and swollen half face and was later diagnosed with shingles. Patient took medication for it and the condition was slowly improving.
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: Lymph node pain, Myalgia, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: body aches; sore arm at injecti on site; swollen lymph nodes under arms on the side booster was received (left ); tender lymph nodes under arms on the side booster was received (left ); This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), VACCINATION SITE PAIN (sore arm at injection site), VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes under arms on the side booster was received (left )) and LYMPH NODE PAIN (tender lymph nodes under arms on the side booster was received (left )) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced MYALGIA (body aches), VACCINATION SITE PAIN (sore arm at injection site), VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes under arms on the side booster was received (left )) and LYMPH NODE PAIN (tender lymph nodes under arms on the side booster was received (left )). In November 2021, MYALGIA (body aches) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm at injecti on site) had not resolved and VACCINATION SITE LYMPHADENOPATHY (swollen lymph nodes under arms on the side booster was received (left )) and LYMPH NODE PAIN (tender lymph nodes under arms on the side booster was received (left )) was resolving.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Symptoms started about 4-6 hours after receiving of booster. Body aches lasted about 48 hours; lymph nodes still swollen and tender, started to decrease and arm still slightly sore.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: receiving expired vaccine/several patients received expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired vaccine/several patients received expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired vaccine/several patients received expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving expired vaccine/several patients received expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Health care professional (HCP) mentioned that several patients received expired vaccine and wanted to know how to manage those patients to revaccinate them.  Treatment information was not reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Dizzy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 031L201) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine (Dose one, injection and Left arm (body site)) on 18-Oct-2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Drug allergy (Codiene allergy), Drug allergy (All pain medications), Allergy since 01-May-2005 and Back pain since 10-Oct-2016. Concomitant products included MONTELUKAST from 05-Jan-2019 to 28-Oct-2021, MULTIVITAMIN [VITAMINS NOS] from 01-Mar-2020 to an unknown date, BIOTIN from 01-Mar-2020 to an unknown date and ELDERBERRY [SAMBUCUS NIGRA] from 01-Mar-2020 to an unknown date for an unknown indication.   On 08-Feb-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced DIZZINESS (Dizzy) and HEADACHE (Headache). In March 2021, DIZZINESS (Dizzy) and HEADACHE (Headache) had resolved.            No treatment medication were provided.   This case was linked to MOD-2021-388568, MOD-2021-388496 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      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.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported.  No treatment were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a physician, describes the occurrence of administered expired product (expired vaccine used) in a  patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 038B21A) for COVID-19 immunization. No medical history reported. On Nov 12 , 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 12 , 2021, patient administered expired product (expired vaccine used). On Nov 12 , 2021, administered expired product (expired vaccine used) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Administered with expired COVID vaccine; Error resulting in administration of expired COVID vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired COVID vaccine) and PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired COVID vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired COVID vaccine) and PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired COVID vaccine). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered with expired COVID vaccine) and PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired COVID vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  As per the reporter, there were no symptoms or quality issue to report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Expired vaccine used; Error resulting in administration of expired vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired vaccine). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Its not reported that how long the vaccine was stored at refrigerated prior to the administration.   The concomitant medications information was not reported. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      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.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were given.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided.  Concomitant medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported.  No Treatment medication information was reported.   This case was linked to MOD-2021-392458 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of expired vaccine.; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine.). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  No treatment medication information provided.   This case was linked to MOD-2021-392458 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered with expired COVID vaccine; Error resulting in administration of expired COVID vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired COVID vaccine) and EXPIRED PRODUCT ADMINISTERED (Error resulting in administration of expired COVID vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired COVID vaccine) and EXPIRED PRODUCT ADMINISTERED (Error resulting in administration of expired COVID vaccine). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered with expired COVID vaccine) and EXPIRED PRODUCT ADMINISTERED (Error resulting in administration of expired COVID vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  As per the reporter, there were no symptoms or quality issue to report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-392935 (Patient Link).