chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) 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 (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that the patient was administered booster shot from the vial which was expired on 3-Apr-2022. No side effects were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) 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 (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that vaccine was administered to total of 24 patients including 15 males and 9 females and were mostly for booster shots. No side effects was reported No concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) 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 (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Expired vaccine was administered to total of 24 patients including 15 males and 9 females. It was reported administrations were mostly for booster shots. No side effects were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) 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 (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment information was reported It was reported that vaccine administered to total of 24 patients including 15 males and 9 females. HCP reports administrations were mostly for booster shots. No side effects was reported. .
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) 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 (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No side effects was reported. No treatment medication was reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I TESTED AT HOME COVID POSITIVE ON 25-May-2022; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I TESTED AT HOME COVID POSITIVE ON 25-May-2022) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Patient had allergy to unknown drug.).    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2022, the patient experienced COVID-19 (I TESTED AT HOME COVID POSITIVE ON 25-May-2022). On 31-May-2022, COVID-19 (I TESTED AT HOME COVID POSITIVE ON 25-May-2022) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 31-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 06-Jun-2022, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. COVID-19 treatment included Pfzer product from 26-May-2022 to 30-May-2022. On 04June2022, the patient had nasal congestion, running nose, sneezing, slight chills, and then a positive Covid test again. Device date was reported as 04-Jun-2022  Company Comment: This is a spontaneous case concerning a 71-year-old male patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 5 months after receiving a dose of mRNA-1273 vaccine. The patient was given COVID-19 treatment for 5 days and tested negative. The patient reported nasal congestion, running nose, sneezing, chills with positive test for COVID 5 days after completing the treatment. The event had not resolved at the time of report. It should be noted that the dose was reported as third dose however, there were no information regarding the previous 2 doses of COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 71-year-old male patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 5 months after receiving a dose of mRNA-1273 vaccine. The patient was given COVID-19 treatment for 5 days and tested negative. The patient reported nasal congestion, running nose, sneezing, chills with positive test for COVID 5 days after completing the treatment. The event had not resolved at the time of report. It should be noted that the dose was reported as third dose however, there were no information regarding the previous 2 doses of COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038b21a and 060h21a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.   On 12-Apr-2021 at 8:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022 at 1:00 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 23-May-2022 to 28-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.            Company comment: This is a spontaneous case concerning a 36-year-old male  patient with no relevant medical history, who experienced the non-serious unexpected event of COVID-19 (AESI), more than 4 months after receiving an unspecified dose of mRNA-1273 vaccine. Clinical course and diagnostic test were not provided. Patient was treated with Paxlovid for 5 days, and one week after finishing it got fever, chills and congestion. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   No concomitant medications were reported.  The patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment. On 2-JUN-2022 08:00  One week after finishing paxlovid series got a fever, chills, and congestion with Outcome of reaction as unknown.  Device Date :03-Jun-2022.; Sender's Comments: Company comment: This is a spontaneous case concerning a 36-year-old male  patient with no relevant medical history, who experienced the non-serious unexpected event of COVID-19 (AESI), more than 4 months after receiving an unspecified dose of mRNA-1273 vaccine. Clinical course and diagnostic test were not provided. Patient was treated with Paxlovid for 5 days, and one week after finishing it got fever, chills and congestion. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I started paxlovid the day I tested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I started paxlovid the day I tested positive) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Paroxysmal atrial fibrillation, Degenerative disc disease (degeneration of spinal discs), Latex allergy, Sulfonamide allergy (allergy to sulfa) and Silicone allergy. Concomitant products included GABAPENTIN from 15-Sep-2016 to an unknown date, MELOXICAM from 15-Sep-2016 to an unknown date, SOTALOL from 15-May-2018 to an unknown date, FAMOTIDINE from 01-Sep-2021 to an unknown date and ROSUVASTATIN from 10-Mar-2022 to an unknown date for an unknown indication.    On 13-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2022, the patient experienced COVID-19 (I started paxlovid the day I tested positive). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 21-May-2022 to 25-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (I started paxlovid the day I tested positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2022, SARS-CoV-2 test: positive (Positive) Tested Positive on the day patient took paxlovid. On 03-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive.         Patient tested positive on day 14 at the second time after taking Paxlovid, on 04-Jun 2022. Recurrence of Covid symptoms happened 14 days after first positive test on 04-Jun-2022 which was not recovered.  Patient previously received a COVID-19 Vaccine. Device date was reported as 05-Jun-2022  Company comment: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred 8 days after the administration of fourth dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) for the treatment of COVID-19 from 21-May to 25-May. Patient tested positive again for COVID 19 on day 14 of starting the treatment. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred 8 days after the administration of fourth dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) for the treatment of COVID-19 from 21-May to 25-May. Patient tested positive again for COVID 19 on day 14 of starting the treatment. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient had 2 Moderna shot, never got the booster, and had COVID.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Jun-2022 and was forwarded to Moderna on 07-Jun-2022.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient had 2 Moderna shot, never got the booster, and had COVID.) in a female 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 second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient had 2 Moderna shot, never got the booster, and had COVID.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient had 2 Moderna shot, never got the booster, and had COVID.) outcome was unknown.            No concomitant medication information was provided.   On an unknown date, the patient received unspecified medication as a co-suspect product (unknown route) at an unspecified dose with unknown batch number, and action taken was given as (unknown). COMPANY COMMENT: This is an spontaneous case concerning an unknown-year-old female patient with medical history of PAXLOVID treatment at an unspecified dose and frequency who experienced the unexpected  AESI event of COVID-19 unknown days after  1st. dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an unknown-year-old female patient with medical history of PAXLOVID treatment at an unspecified dose and frequency who experienced the unexpected  AESI event of COVID-19 unknown days after  1st. dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: The initial infection was mild; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (The initial infection was mild) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Ulcerative colitis. Concomitant products included BALSALAZIDE from January 2010 to an unknown date for an unknown indication.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (The initial infection was mild). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 21-May-2022 to 25-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. In May 2022, COVID-19 (The initial infection was mild) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive (on day 9 and began testing positive ).         Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. On 30-May-2022, patient started with rebound symptoms and repeat COVID test was positive. It was stated that the initial infection was mild and took a 5-day course of Paxlovid. Tested negative on day 6 of Paxlovid treatment. Symptoms returned on day 9 of Paxlovid treatment and began testing positive again with much stronger symptoms and more persistent. Patient was still testing strongly positive 5 days later.  Company comment: This is a spontaneous case concerning a 39-year-old male  patient with Ulcerative colitis, who experienced the non-serious unexpected event of COVID-19 (AESI), approximately 6 months after receiving the third dose of mRNA-1273 vaccine. Clinical course  were not provided. It was reported that the initial infection was mild and patient was treated with Paxlovid for 5 days. On day 9 symptoms returned and SARS-CoV-2 test was positive again. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 39-year-old male  patient with Ulcerative colitis, who experienced the non-serious unexpected event of COVID-19 (AESI), approximately 6 months after receiving the third dose of mRNA-1273 vaccine. Clinical course  were not provided. It was reported that the initial infection was mild and patient was treated with Paxlovid for 5 days.  On day 9 symptoms returned and SARS-CoV-2 test was positive again. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (unspecified drug).    On 24-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-May-2022 to 28-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.            No concomitant medications were reported. . On 01-Jun-2022, patient experienced Covid rebound.   The Covid rebound occurred five days after ending Paxlovid treatment.  Device Date- 03Jun2022. COMPANY COMMENT: This is an spontaneous case concerning an unknown-year-old patient with medical history of Drug allergy, Concomitant products included PAXLOVID from 24-May-2022 to 28-May-2022 for COVID-19 treatment who experienced the unexpected  event of COVID-19 (AESI) 251 days after  3rd. dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an unknown-year-old patient with medical history of Drug allergy, Concomitant products included PAXLOVID from 24-May-2022 to 28-May-2022 for COVID-19 treatment who experienced the unexpected  event of COVID-19 (AESI) 251 days after  3rd. dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID 19) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039d21a) for COVID-19 vaccination.     Concurrent medical conditions included Sleep apnea, Blood pressure high and Drug allergy (Unspecified historical drug.).    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID 19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID 19) had resolved.            No concomitant medications were reported.  It was reported that, the patient had rebound COVID after the Paxlovid treatment and no treatment details were provided for the rebound of COVID.  Company Comment: This is a Spontaneous case concerning a 48-year-old male patient, with medical history of Sleep apnea, Blood pressure high and Drug allergy, RITONAVIR as Treatment of COVID-19, unspecified dose and frequency who experienced the non-serious unexpected AESI of COVID-19  in an unknown date in the context of the administration of the 3rd. dose of the mRNA-1273 vaccine (in an unknown dose and schedule of administration). Very limited information is available regarding diagnostic work-up to support the current diagnosis of COVID-19, severity and treatment received. No information regarding relevant lab data and treatment details was provided at this time. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a 48-year-old male patient, with medical history of Sleep apnea, Blood pressure high and Drug allergy, RITONAVIR as Treatment of COVID-19, unspecified dose and frequency who experienced the non-serious unexpected AESI of COVID-19  in an unknown date in the context of the administration of the 3rd. dose of the mRNA-1273 vaccine (in an unknown dose and schedule of administration). Very limited information is available regarding diagnostic work-up to support the current diagnosis of COVID-19, severity and treatment received. No information regarding relevant lab data and treatment details was provided at this time. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose received greater than 36 days from the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received greater than 36 days from the 1st dose) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received greater than 36 days from the 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received greater than 36 days from the 1st dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant included Blood pressure medication. Reporter reported that patient had not received any treatment.   This case was linked to MOD-2022-584523 (Patient Link).
Sex: F
Vaccine: COVID19, UNK
Symptoms: Antiphospholipid antibodies, Antiphospholipid antibodies positive
Clinical narrative: Lupus anticoagulant positive/Tested positive to Lupus; This spontaneous case was reported by a consumer and describes the occurrence of ANTIPHOSPHOLIPID ANTIBODIES POSITIVE (Lupus anticoagulant positive/Tested positive to Lupus) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced ANTIPHOSPHOLIPID ANTIBODIES POSITIVE (Lupus anticoagulant positive/Tested positive to Lupus). At the time of the report, ANTIPHOSPHOLIPID ANTIBODIES POSITIVE (Lupus anticoagulant positive/Tested positive to Lupus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antiphospholipid antibodies: positive (Positive) Positive.         No concomitant medication was provided by the reporter No treatment medication was provided by the reporter.
Age: 50.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Cough, Lethargy, Paranasal sinus hypersecretion, Pyrexia, Seasonal allergy
Clinical narrative: Slight fever; Cough from sinus drainage; Nasal sinus discharge; Allergies/ Allergy season was really bad; Lethargic; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), COUGH (Cough from sinus drainage), PARANASAL SINUS HYPERSECRETION (Nasal sinus discharge), SEASONAL ALLERGY (Allergies/ Allergy season was really bad) and PYREXIA (Slight fever) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    The patient's past medical history included Root canal procedure (Recovering/Resolving). Concurrent medical conditions included Hidradenitis suppurativa (Moderate to severe hidradenitis suppurativa).   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form once a day. In 2021, the patient experienced LETHARGY (Lethargic). In May 2022, the patient experienced COUGH (Cough from sinus drainage), PARANASAL SINUS HYPERSECRETION (Nasal sinus discharge) and SEASONAL ALLERGY (Allergies/ Allergy season was really bad). On 01-Jun-2022, the patient experienced PYREXIA (Slight fever). On 02-Jun-2022, PYREXIA (Slight fever) had resolved. At the time of the report, LETHARGY (Lethargic), COUGH (Cough from sinus drainage) and PARANASAL SINUS HYPERSECRETION (Nasal sinus discharge) outcome was unknown and SEASONAL ALLERGY (Allergies/ Allergy season was really bad) was resolving.     No concomitant medications were reported. No treatment medications were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Influenza like illness, Migraine, Psoriasis, Visual impairment
Clinical narrative: Flu like symptoms; Psoriasis; Dose 1 administared on Apr-2021 and dose 2 on Oct-2021; Vision issue; Migraine; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Vision issue), MIGRAINE (Migraine), INFLUENZA LIKE ILLNESS (Flu like symptoms), PSORIASIS (Psoriasis) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administared on Apr-2021 and dose 2 on Oct-2021) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VISUAL IMPAIRMENT (Vision issue) and MIGRAINE (Migraine). In October 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administared on Apr-2021 and dose 2 on Oct-2021). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and PSORIASIS (Psoriasis). At the time of the report, VISUAL IMPAIRMENT (Vision issue), MIGRAINE (Migraine), INFLUENZA LIKE ILLNESS (Flu like symptoms), PSORIASIS (Psoriasis) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administared on Apr-2021 and dose 2 on Oct-2021) outcome was unknown.            No concomitant medications was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event's of VISION ISSUE, MIGRAINE, FLU LIKE SYMPTOMS and PSORIASIS was not provided for Humira. No treatment drug details was reported.
Age: 32.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Rash, Skin discharge
Clinical narrative: Skin discharge, breakout on under arms, groin and upper thigh, upper thigh open and draining; Fatigue; Skin breakout, breakout on under arms, groin and upper thigh; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCHARGE (Skin discharge, breakout on under arms, groin and upper thigh, upper thigh open and draining), FATIGUE (Fatigue) and RASH (Skin breakout, breakout on under arms, groin and upper thigh) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 10-Sep-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 10-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN DISCHARGE (Skin discharge, breakout on under arms, groin and upper thigh, upper thigh open and draining), FATIGUE (Fatigue) and RASH (Skin breakout, breakout on under arms, groin and upper thigh). At the time of the report, SKIN DISCHARGE (Skin discharge, breakout on under arms, groin and upper thigh, upper thigh open and draining), FATIGUE (Fatigue) and RASH (Skin breakout, breakout on under arms, groin and upper thigh) outcome was unknown.            No concomitant medications were reported.  Reported that On unknown dates, the patient experienced flare up or Condition aggravated, fatigue and breakout on under arms, groin and upper thigh/ upper thigh was open and draining.  The reporter causality for flare up with humira (adalimumab) was a reasonable possibility and fatigue with humira (adalimumab) was no reasonable possibility, for skin breakout and skin discharge unknown onset was not provided.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: they have a receipt that stated that they received a 0.25ml dose, but the nurse told them that she gave him the 0.5ml dosage And they believe that is correct; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT DOSE ADMINISTERED (they have a receipt that stated that they received a 0.25ml dose, but the nurse told them that she gave him the 0.5ml dosage And they believe that is correct) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 001m21a) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (they have a receipt that stated that they received a 0.25ml dose, but the nurse told them that she gave him the 0.5ml dosage And they believe that is correct). At the time of the report, INCORRECT DOSE ADMINISTERED (they have a receipt that stated that they received a 0.25ml dose, but the nurse told them that she gave him the 0.5ml dosage And they believe that is correct) outcome was unknown.            No concomitant medications was reported. It was reported that patient had a receipt that stated patient received a 0.25 ml dose, but the nurse gave the 0.5 ml dosage and nurse believe that it was correct, and that there was no problem with that vaccination. No treatment medications was reported.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 5 year old given the Moderna  vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 year old given the Moderna  vaccine) in a 5-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. On 08-Jun-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 year old given the Moderna  vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 year old given the Moderna  vaccine) 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. It was reported that patient has not reported any adverse event at the time of the call.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A, 001B21A, 022C21A and 084J21A) for COVID-19 vaccination.     The patient's past medical history included Sleep apnea. Concurrent medical conditions included Drug allergy, Sulfonamide allergy and Allergy to chemicals. Concomitant products included MIRTAZAPINE from 05-Oct-2020 to 06-Jun-2022 for an unknown indication.   On 10-Mar-2021 at 7:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021 at 5:45 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021 at 6:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021 at 11:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            The patient took other medications or products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  Patient was given PAXLOVID. After 7 days of my diagnosis and the end of the pills, my symptoms were gone although I tested positive. Two days later patient started having new symptoms, headache, nasal congestion, nausea with strong positive testing results using two different brands of home testing kits. Device Date: 06Jun2022   This case was linked to MOD-2022-585139 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   It was unknown if the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains Non significant information.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administer expired vaccine to patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.) in a 60-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses.  Dates of administration of vaccine were reported as 8Apr2022, 12Apr2022 and 13Apr2022.  The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contain Non significant information.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  The vial did not undergo any temperature excursions Total of 102 doses were given from LOT 026C21A  Treatment medication was not provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non significant follow up was received.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) in a 54-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses.   The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacture date of expiration) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported. Number of doses administered was 102 doses. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains non significant information
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired on 24-Oct-2021 and administered on 25-Oct-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021 and administered on 25-Oct-2021) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021 and administered on 25-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021 and administered on 25-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses.  The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non Significant follow up received contains Primary Reporter address updated
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Number of doses administered was 102 doses. The vial did not undergo any temperature excursions. Treatment medications was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains non significant information.