chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Leukaemia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LEUKAEMIA (A young man who received the Moderna Covid-19 vaccine and developed Leukemia) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced LEUKAEMIA (A young man who received the Moderna Covid-19 vaccine and developed Leukemia) (seriousness criterion medically significant). At the time of the report, LEUKAEMIA (A young man who received the Moderna Covid-19 vaccine and developed Leukemia) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were provided. No treatment medications were reported. Company comment: This spontaneous case concerns a male patient with no reported medical history, who experienced the unexpected, serious medically significant event of leukaemia. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. The report stated that a young man who received an unspecified dose of mRNA-1273 vaccine, developed leukemia. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a male patient with no reported medical history, who experienced the unexpected, serious medically significant event of leukaemia. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. The report stated that a young man who received an unspecified dose of mRNA-1273 vaccine, developed leukemia. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vail was initially stored in the refrigerator on 16-Dec-2021 and administered on 21-Jan-2022; Administered expired Moderna COVID-19 vaccine to several patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine to several patients) and PRODUCT STORAGE ERROR (Vail was initially stored in the refrigerator on 16-Dec-2021 and administered on 21-Jan-2022) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine to several patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vail was initially stored in the refrigerator on 16-Dec-2021 and administered on 21-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine to several patients) and PRODUCT STORAGE ERROR (Vail was initially stored in the refrigerator on 16-Dec-2021 and administered on 21-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported. No treatment medications were provided.  Vial did not undergo any temperature excursions.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: felt the injection needle pinch his arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (felt the injection needle pinch his arm.) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced VACCINATION SITE PAIN (felt the injection needle pinch his arm.). At the time of the report, VACCINATION SITE PAIN (felt the injection needle pinch his arm.) outcome was unknown.            No Concomitant information was reported. No Treatment information was reported.   This case was linked to MOD-2022-509755, MOD-2022-509786 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Hypoacusis, Muscle strain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (hearing loss in right ear) and MUSCLE STRAIN (neck strain) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 011J20A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Flu vaccine (Possibly Flu shot before receiving the 1st dose of Moderna COVID-19 vaccine). Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Drug allergy (Allergic to Codeine derivatives). Concomitant products included LOSARTAN, WARFARIN, PRAVASTATIN, OMEPRAZOLE, GABAPENTIN and CLONAZEPAM (Klonopin) for an unknown indication. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In February 2021, the patient experienced HYPOACUSIS (hearing loss in right ear). On 22-Feb-2021, the patient experienced MUSCLE STRAIN (neck strain). At the time of the report, HYPOACUSIS (hearing loss in right ear) had not resolved and MUSCLE STRAIN (neck strain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) Patient was diagnosed with hearing loss. The patient started to experience hearing loss 2-3 days after receiving the second dose. The patient was told by the physician that patient would recovered after 3 months, but the event was not recovered at time of report. The Patient was using hearing aid. The patient stated that the event hearing loss worsened. The patient was told to not receive the booster dose of COVID-19 vaccine due to this reaction. Treatment information was not provided.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered expired Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired Moderna COVID-19 vaccine) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.  No Medical History information was reported.  On 04-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired Moderna COVID-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired Moderna COVID-19 vaccine) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication of the patient was not reported.  The vaccine was administered after 30-day use by date. Date the vial was initially stored in the refrigerator was approximately 26-Dec-2021 and the vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.
Age: 86.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Initially stored in refrigerator in December 2021 and administered vaccine on 4 mar 2022; administered expired Moderna Covid-19 vaccine to several patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine to several patients.) and PRODUCT STORAGE ERROR (Initially stored in refrigerator in December 2021 and administered vaccine on 4 mar 2022) in an 86-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine to several patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Initially stored in refrigerator in December 2021 and administered vaccine on 4 mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine to several patients.) and PRODUCT STORAGE ERROR (Initially stored in refrigerator in December 2021 and administered vaccine on 4 mar 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Vial was initially stored in the refrigerator approximately 26 DEC2021, actually 16 DEC 2021 and administered booster vaccine. The vial did not undergo any temperature excursions.   Treatment information was not reported.
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We've administered expired Moderna Covid-19 vaccine to several patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was stored in the refrigerator on approximately 26 Dec 2021 and not undergone temperature excursion. Patient was administered with booster 1/2 dose. No concomitant medication were provided. No treatment information were given.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered expired Moderna COVID-19 vaccine; Vial was initially stored in refrigerator on 16Dec2021 and administered on 04 Mar 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 16Dec2021 and administered on 04 Mar 2022) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 16Dec2021 and administered on 04 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 16Dec2021 and administered on 04 Mar 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant product use was provided.  Date the vial was initially stored in the refrigerator was 16-Dec-2021 and the vial did not undergo any temperature excursions.  No treatment medication was provided.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vail was stored in the fridge approximately 26/11/21 or 16/12/21; Administered expired Moderna Covid-19 vaccine to several patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Covid-19 vaccine to several patients.) and PRODUCT STORAGE ERROR (Vail was stored in the fridge approximately 26/11/21 or 16/12/21) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Covid-19 vaccine to several patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vail was stored in the fridge approximately 26/11/21 or 16/12/21). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Covid-19 vaccine to several patients.) and PRODUCT STORAGE ERROR (Vail was stored in the fridge approximately 26/11/21 or 16/12/21) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that there were no temperature excursion.  Treatment information was not reported.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered expired Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired Moderna COVID-19 vaccine) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.  No Medical History information was reported.  On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired Moderna COVID-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired Moderna COVID-19 vaccine) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was approximately 26-Dec-2021 and the vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy, Magnetic resonance imaging
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (I got Bell's palsy in the first 48 hours of vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (I got Bell's palsy in the first 48 hours of vaccination) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (I got Bell's palsy in the first 48 hours of vaccination) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: results not reported Results not reported. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication details was provided. No treatment medication details was provided. Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (medically significant) expected event Bell´s palsy, approximately 2 days after an unspecified dose of mRNA-1273.  MR imaging was performed without reported results. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the serious (medically significant) expected event Bell´s palsy, approximately 2 days after an unspecified dose of mRNA-1273. MR imaging was performed without reported results. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We've administered expired Moderna Covid-19 vaccine to several patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.) outcome was unknown.        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.
Age: 69.0
Sex: U
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 (administered expired Moderna Covid-19 vaccine to several patients) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator- 16Dec2022) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine to several patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator- 16Dec2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine to several patients) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator- 16Dec2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided. Date the vial was initially stored in the refrigerator was approximately 26-Dec-2021 and the vial did not undergo any temperature excursions. Treatment information was not provided.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 16-DEC-2022 and administered on 28-JAN-2022; We've administered expired Moderna Covid-19 vaccine to several patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 16-DEC-2022 and administered on 28-JAN-2022) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 16-DEC-2022 and administered on 28-JAN-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 16-DEC-2022 and administered on 28-JAN-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  Patient was administered half dose booster dose. It was reported that there were no temperature excursion.  No treatment medication information provided
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired Moderna Covid-19 vaccine to several patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Covid-19 vaccine to several patients) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Covid-19 vaccine to several patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Covid-19 vaccine to several patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on approximately 16Dec2021 and the vial did not undergo any temperature excursions. No treatment medications was reported.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vail was stored in the fridge approximately 26/11/21 or 16/12/21; We've administered expired Moderna Covid-19 vaccine to several patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.) and PRODUCT STORAGE ERROR (Vail was stored in the fridge approximately 26/11/21 or 16/12/21) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vail was stored in the fridge approximately 26/11/21 or 16/12/21). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.) and PRODUCT STORAGE ERROR (Vail was stored in the fridge approximately 26/11/21 or 16/12/21) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. Patient was administered 1/2 dose booster dose.It was reported that there were no temperature excursion. No treatment medication information provided.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator was approximately 16-Dec-2021 and administered on 28-JAN-2022; We've administered expired Moderna Covid-19 vaccine to several patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator was approximately 16-Dec-2021 and administered on 28-JAN-2022) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator was approximately 16-Dec-2021 and administered on 28-JAN-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator was approximately 16-Dec-2021 and administered on 28-JAN-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Booster dose given as 1/2 dose. Expiry date of vaccine was 07-APR-2022.  The vial was initially stored in the refrigerator was approximately 16-Dec-2021. Treatment medications were not reported.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vail was initially stored in the refrigerator on 16-Dec-2021 and administered on 28-jan-2022; We've administered expired Moderna Covid-19 vaccine to several patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.) and PRODUCT STORAGE ERROR (Vail was initially stored in the refrigerator on 16-Dec-2021 and administered on 28-jan-2022) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vail was initially stored in the refrigerator on 16-Dec-2021 and administered on 28-jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.) and PRODUCT STORAGE ERROR (Vail was initially stored in the refrigerator on 16-Dec-2021 and administered on 28-jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: They have been administering the vaccine after expiration date/30-day use by date expired vaccine was administered to several patients; They have been administering the vaccine after expiration date/30-day use by date expired vaccine was administered to several patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have been administering the vaccine after expiration date/30-day use by date expired vaccine was administered to several patients) and PRODUCT STORAGE ERROR (They have been administering the vaccine after expiration date/30-day use by date expired vaccine was administered to several patients) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have been administering the vaccine after expiration date/30-day use by date expired vaccine was administered to several patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They have been administering the vaccine after expiration date/30-day use by date expired vaccine was administered to several patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have been administering the vaccine after expiration date/30-day use by date expired vaccine was administered to several patients) and PRODUCT STORAGE ERROR (They have been administering the vaccine after expiration date/30-day use by date expired vaccine was administered to several patients) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator was on 28Jan2022.  No concomitant medication were reported.  No treatment medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial of the vaccine was initially stored in the refrigerator on 28-Jan-2022 and administered to patient on 09-Mar-2022; Expired vaccine administered to one patient after 30 days use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to one patient after 30 days use by date) and PRODUCT STORAGE ERROR (The vial of the vaccine was initially stored in the refrigerator on 28-Jan-2022 and administered to patient on 09-Mar-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to one patient after 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial of the vaccine was initially stored in the refrigerator on 28-Jan-2022 and administered to patient on 09-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to one patient after 30 days use by date) and PRODUCT STORAGE ERROR (The vial of the vaccine was initially stored in the refrigerator on 28-Jan-2022 and administered to patient on 09-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The vial had not undergone any temperature excursions. The healthcare provider wanted to get directions on what to do with the patients, and asked if they should repeat the dose of the patients.   This case was linked to MOD-2022-509838, MOD-2022-509900, MOD-2022-509902, MOD-2022-509907 (Patient Link).
Age: 84.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vail was initially stored in the refrigerator on 16-Dec-2021 and administered on 21-Jan-2022; We've administered expired Moderna Covid-19 vaccine to several patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.) and PRODUCT STORAGE ERROR (Vail was initially stored in the refrigerator on 16-Dec-2021 and administered on 21-Jan-2022) in an 84-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vail was initially stored in the refrigerator on 16-Dec-2021 and administered on 21-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We've administered expired Moderna Covid-19 vaccine to several patients.) and PRODUCT STORAGE ERROR (Vail was initially stored in the refrigerator on 16-Dec-2021 and administered on 21-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. On 16-Dec-2021, the vial was initially stored in the refrigerator.  Patient received booster half dose. The vial did not undergo any temperature excursion. No treatment drug details was reported.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine vial was stored in the refrigerator for more than 30 days; administered expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine vial was stored in the refrigerator for more than 30 days) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine vial was stored in the refrigerator for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine vial was stored in the refrigerator for more than 30 days) 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 vial was initially stored in the refrigerator on 16-Dec-2021. The vial did not undergo temperature excursion.   No treatment details were reported.
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired Moderna Covid-19 vaccine to several patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Covid-19 vaccine to several patients.) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Covid-19 vaccine to several patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Covid-19 vaccine to several patients.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medications was reported.  Date the vial was initially stored in the refrigerator was approximately 26-Dec-2021 and the vial did not undergo any temperature excursions
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Having severe pain in my arm since I got the second shot of Covid vaccine Moderna; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Having severe pain in my arm since I got the second shot of Covid vaccine Moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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 PAIN IN EXTREMITY (Having severe pain in my arm since I got the second shot of Covid vaccine Moderna). At the time of the report, PAIN IN EXTREMITY (Having severe pain in my arm since I got the second shot of Covid vaccine Moderna) had not resolved.            Concomitant medications details were not reported by the reporter.  It was reported that patient had this pain over 3 months and developed severe pain that feels like if someone put a dagger in arm. Patient did not have a doctor now and was hoping it would get better but it was still there and the patient was worried now.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Mar-2022: Follow-up document contains no additional information.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Joint swelling, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: Knee swelling/knees swelled significantly; Patients hands were swollen to the point that he was unable to dress unassisted; Diminished mobility; Patient had such extreme symptions and pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Knee swelling/knees swelled significantly), PERIPHERAL SWELLING (Patients hands were swollen to the point that he was unable to dress unassisted), MOBILITY DECREASED (Diminished mobility) and PAIN (Patient had such extreme symptions and pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Adult onset Still's disease (After Moderna patient experienced significant swelling and pain that patient never experienced before) since August 2000.   On 19-Feb-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced JOINT SWELLING (Knee swelling/knees swelled significantly), PERIPHERAL SWELLING (Patients hands were swollen to the point that he was unable to dress unassisted), MOBILITY DECREASED (Diminished mobility) and PAIN (Patient had such extreme symptions and pain). The patient was treated with PREDNISONE ongoing from June 2021 for Swelling and Pain, at a dose of 60-mg-5mg and CANAKINUMAB (ILARIS) from 28-Sep-2021 to 14-Jan-2022 for Autoimmune disorder, at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Knee swelling/knees swelled significantly), PERIPHERAL SWELLING (Patients hands were swollen to the point that he was unable to dress unassisted), MOBILITY DECREASED (Diminished mobility) and PAIN (Patient had such extreme symptions and pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, C-reactive protein: 189 C-Reactive Protein- 189. In 2021, Red blood cell sedimentation rate: 80 SED rate was 80. In 2021, White blood cell count: 17.2 WBC -17.2.         No concomitant medications were reported.  Patient was unable to make a twisting movement such as to remove a water bottle lid and patient had to hold their coffee cup with 2 hands. Patient started Ilaris injections on 28-Sep-2021 and had a positive response from this medication.   This case was linked to MOD-2022-452278, MOD-2022-510055 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate, White blood cell count
Clinical narrative: Knee swelling/knees swelled significantly; Patients hands were swollen to the point that he was unable to dress unassisted; Diminished mobility; Patient had such extreme symptions and pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Knee swelling/knees swelled significantly), PERIPHERAL SWELLING (Patients hands were swollen to the point that he was unable to dress unassisted), MOBILITY DECREASED (Diminished mobility) and PAIN (Patient had such extreme symptions and pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Adult onset Still's disease (After Moderna patient experienced significant swelling and pain that patient never experienced before) since August 2000.   On 19-Feb-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced JOINT SWELLING (Knee swelling/knees swelled significantly), PERIPHERAL SWELLING (Patients hands were swollen to the point that he was unable to dress unassisted), MOBILITY DECREASED (Diminished mobility) and PAIN (Patient had such extreme symptions and pain). The patient was treated with PREDNISONE ongoing from June 2021 for Swelling and Pain, at a dose of 60-mg-5mg and CANAKINUMAB (ILARIS) from 28-Sep-2021 to 14-Jan-2022 for Autoimmune disorder, at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Knee swelling/knees swelled significantly), PERIPHERAL SWELLING (Patients hands were swollen to the point that he was unable to dress unassisted), MOBILITY DECREASED (Diminished mobility) and PAIN (Patient had such extreme symptions and pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, C-reactive protein: 189 C-Reactive Protein- 189. In 2021, Red blood cell sedimentation rate: 80 SED rate was 80. In 2021, White blood cell count: 17.2 WBC -17.2.         No concomitant medications were reported.  Patient was unable to make a twisting movement such as to remove a water bottle lid and patient had to hold their coffee cup with 2 hands. Patient started Ilaris injections on 28-Sep-2021 and had a positive response from this medication.   This case was linked to MOD-2022-452278, MOD-2022-510055 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Joint swelling, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Knee swelling/My knees swelled significantly; Patient had such extreme symptions and pain.; My hands were swollen to the point that I was unable to dress; Diminished my mobility; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Knee swelling/My knees swelled significantly), PAIN IN EXTREMITY (Patient had such extreme symptions and pain.), PERIPHERAL SWELLING (My hands were swollen to the point that I was unable to dress) and MOBILITY DECREASED (Diminished my mobility) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Still's disease adult onset (Significant swelling, pain that patient never experienced prior to Moderna) since August 2000.    On 19-Feb-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced JOINT SWELLING (Knee swelling/My knees swelled significantly), PAIN IN EXTREMITY (Patient had such extreme symptions and pain.), PERIPHERAL SWELLING (My hands were swollen to the point that I was unable to dress) and MOBILITY DECREASED (Diminished my mobility). The patient was treated with PREDNISONE ongoing from June 2021 for Swelling and Pain, at a dose of 60-mg-5mg. At the time of the report, JOINT SWELLING (Knee swelling/My knees swelled significantly), PAIN IN EXTREMITY (Patient had such extreme symptions and pain.), PERIPHERAL SWELLING (My hands were swollen to the point that I was unable to dress) and MOBILITY DECREASED (Diminished my mobility) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: 189 C-Reactive Protein- 189. On an unknown date, Red blood cell sedimentation rate: 80 SED rate was 80. On an unknown date, White blood cell count: 17.2 WBC -17.2.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient was unable to make a twisting movement such as to remove a water bottle lid and patient had to hold their coffee cup with 2 hands. Patient started Prednisone after receiving Moderna. The patient had never experienced such intense pain, swelling. No concomitant medications was provided by the reporter.   This case was linked to MOD-2022-510038, MOD-2022-452278 (Patient Link).