chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029H21B, 047C21A and 041C21A) for COVID-19 vaccination.     The patient had no allergies. The patient never had COVID positive test or diagnosis.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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 relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2022-537607, MOD-2022-537958 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was refrigerated on 17-Feb-2022, expired on 01-Apr-2022 and later on administered on 05-Apr-2022; 21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety) and PRODUCT STORAGE ERROR (Vaccine was refrigerated on 17-Feb-2022, expired on 01-Apr-2022 and later on administered on 05-Apr-2022) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was refrigerated on 17-Feb-2022, expired on 01-Apr-2022 and later on administered on 05-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety) and PRODUCT STORAGE ERROR (Vaccine was refrigerated on 17-Feb-2022, expired on 01-Apr-2022 and later on administered on 05-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The vial was stored in refrigerator on 17-Feb-2022 at 10 am. The vial did not undergo any temperature excursion. The reporter stated that patients did not experience any adverse events. No treatment medication were provided. The analysis of the vials associated with storage excursion was completed and it was reported that the vaccine administered on 05-Apr-2022, 06-Apr-2022 and 07-Apr-2022, from lot number 026L21B likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow up contains significant information. The narrative was updated.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered/Expiration date: 23Mar2022, Administration date: 06Apr2022; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered/Expiration date: 23Mar2022, Administration date: 06Apr2022) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029H21B and 041C21A) for COVID-19 vaccination.     It was unknown if the patient ever had COVID + test or diagnosis.  The patient had no Acute and Chronic illnesses at the time of vaccination.  It was unknown if the patient was given any other vaccines within 1 month prior to Moderna COVID-19 vaccine.    On 01-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered/Expiration date: 23Mar2022, Administration date: 06Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered/Expiration date: 23Mar2022, Administration date: 06Apr2022) 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.  It was reported that the patient received dose from an expired vial of the Moderna Covid-19 Vaccine. This was the booster dose for the patient. The expiration date of the vaccine was 23-Mar-2022. The reporter was not aware if the patient was experiencing any symptoms after the administration of the vaccine.  The dose was administered after 30-day Use by date or after manufacturer date of expiry. The date the vial was initially stored in the refrigerator was unknown.  No treatment information was provided.   This case was linked to MOD-2022-537958 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored on 17-Feb-2022, expired on 01-Apr-2022 and administered on 05-Apr-2022; 21 patients administered with expired vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored on 17-Feb-2022, expired on 01-Apr-2022 and administered on 05-Apr-2022) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored on 17-Feb-2022, expired on 01-Apr-2022 and administered on 05-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored on 17-Feb-2022, expired on 01-Apr-2022 and administered on 05-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported  Date when vaccine was initially stored in refrigerator on 17-Feb-2022 No temperature excursions reported No adverse reactions reported after the vaccination No Treatment medication reported   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow up received contains No NewInformation
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (sick) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced ILLNESS (sick). At the time of the report, ILLNESS (sick) had resolved.            Patient took usual medication that patient was taking for years. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up received contains no new information
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received 0.5ml dose instead of 0.25mL for their 2nd booster dose (4th dose); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.5ml dose instead of 0.25mL for their 2nd booster dose (4th dose)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Received 0.5ml dose instead of 0.25mL for their 2nd booster dose (4th dose)). At the time of the report, ACCIDENTAL OVERDOSE (Received 0.5ml dose instead of 0.25mL for their 2nd booster dose (4th dose)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. The Reporter stated that a 0.5mL dose from a red cap and a label with a light border was administered as patient 2nd booster dose (4th dose) instead of 0.25mL.The patient was not immunocompromised. Treatment information was not provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had covid after receiving dose 1 & 2; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had covid after receiving dose 1 & 2) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bronchiectasis and Hypertension.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced COVID-19 (had covid after receiving dose 1 & 2). The patient was treated with MONOCLONAL ANTIBODIES, GRANULOCYTE for Bronchiectasis, at a dose of 4 shots in the stomach.. At the time of the report, COVID-19 (had covid after receiving dose 1 & 2) outcome was unknown.            Concomitant medication included  blood pressure pill and other medications patient was taking but  reporter did not knew the names of them. It was reported by the reporter that both she and her husband had COVID -19 infection in mid -Nov-2021.It was reported that patient was given monoclonal antibody infusion, 4 shots in the stomach. t was reported that patient was fully vaccinated from  moderna with dose 1 and dose 2.It was reported by the reporter that her husband did not had COVID as bad as she had.It was further stated that patient would be seeing  his family care doctor that thursday because of the booster dose. It was reported that patient was given monoclonal antibody infusion, 4 shots in the stomach as a treatment medication for underlying pulmonary issues like Bronchiectasis.  COMPANY COMMENT : This spontaneous case concerns 61 years old male patient with no relevant medical history, who experienced unexpected non serious AESI event of COVID-19, which occurred on unspecified days after second dose of mRNA-1273. It is reported that patient was given monoclonal antibody infusion as a treatment medication for underlying medical condition Bronchiectasis. Current ongoing pandemia remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow up received includes no new information.; Sender's Comments: This spontaneous case concerns 61 years old male patient with no relevant medical history, who experienced unexpected non serious AESI event of COVID-19, which occurred on unspecified days after second dose of mRNA-1273. It is reported that patient was given monoclonal antibody infusion as a treatment medication for underlying medical condition Bronchiectasis. Current ongoing pandemia remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Herpes virus infection, Pollakiuria
Clinical narrative: frequent urination; discomfort; herpes; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (frequent urination), DISCOMFORT (discomfort) and HERPES VIRUS INFECTION (herpes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POLLAKIURIA (frequent urination), DISCOMFORT (discomfort) and HERPES VIRUS INFECTION (herpes). At the time of the report, POLLAKIURIA (frequent urination), DISCOMFORT (discomfort) and HERPES VIRUS INFECTION (herpes) outcome was unknown.            It was reported that patient previously received other doses of Moderna COVID-19 vaccine and recently prescribed an anti viral drug for herpes due to frequent urination and discomfort and she reported that she started experiencing these symptoms after vaccination and she thinks there is no connection but was not sure and also wants to get second booster of the Moderna COVID-19 vaccine. No concomitant medications were reported. Treatment medicine included anti- viral drug for herpes.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm) 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 first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm). At the time of the report, VACCINATION SITE REACTION (COVID arm) outcome was unknown. mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged. No concomitant medication was provided No treatment information reported. It was reported that the patient was ready to take the 2nd booster. This case was linked to MOD-2022-537748, MOD-2022-537749 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I tested positive for Covid-19, 3 months after my 2nd dose.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I tested positive for Covid-19, 3 months after my 2nd dose.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (I tested positive for Covid-19, 3 months after my 2nd dose.). At the time of the report, COVID-19 (I tested positive for Covid-19, 3 months after my 2nd dose.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) tested positive for Covid-19.         No concomitant medications were reported. No treatment information was provided. The AE caused patient to seek medical care (office visit, Urgent care, ER, hospitalized).  Company comment:This spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected non serious AESI of COVID 19, about 3 months after receiving the second dose of mRNA-1273 vaccine. The interval between the first and the second doses was approximately 1 month. The patient tested positive for COVID 19. The COVID 19 pandemic could be a confounder for the event COVID 19. 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 reported medical history, who experienced the unexpected non serious AESI of COVID 19, about 3 months after receiving the second dose of mRNA-1273 vaccine. The interval between the first and the second doses was approximately 1 month. The patient tested positive for COVID 19. The COVID 19 pandemic could be a confounder for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 17-FEB-2022, expired on 01-APR-2022 and administered on 05-APR-2022; 21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-FEB-2022, expired on 01-APR-2022 and administered on 05-APR-2022) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-FEB-2022, expired on 01-APR-2022 and administered on 05-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/25 Patients Identifiers Update for Safety) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-FEB-2022, expired on 01-APR-2022 and administered on 05-APR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. Date the vial was initially stored in refrigerator: 17-Feb-2022 10:00 AM and vial didn't undergo any temperature excursion. Patient didn't had adverse events. It was reported that the vaccine administered on April 5, 2022 from lot number 026L21B likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up contain non-significant information.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Rash pruritic
Clinical narrative: Allergic reaction; Rash over trunk area / Rash flare/broke into rashes; Broke into rashes and its itching; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash over trunk area / Rash flare/broke into rashes), RASH PRURITIC (Broke into rashes and its itching) and HYPERSENSITIVITY (Allergic reaction) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to animal (Takes Claritin for Cat allergy). Concomitant products included LORATADINE (CLARITINE ALLERGY) for Allergy to animal.    On 28-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced RASH (Rash over trunk area / Rash flare/broke into rashes) and RASH PRURITIC (Broke into rashes and its itching). On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction). At the time of the report, RASH (Rash over trunk area / Rash flare/broke into rashes), RASH PRURITIC (Broke into rashes and its itching) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown.            Patient had no problems while breathing was reported. Treatment included: Montelukast and Benadryl for Allergic reaction.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: a patient that received 0.5mL for their 1st booster dose from a previous vaccinator, instead of 0.25mL.; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (a patient that received 0.5mL for their 1st booster dose from a previous vaccinator, instead of 0.25mL.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Apr-2022, the patient experienced ACCIDENTAL OVERDOSE (a patient that received 0.5mL for their 1st booster dose from a previous vaccinator, instead of 0.25mL.). At the time of the report, ACCIDENTAL OVERDOSE (a patient that received 0.5mL for their 1st booster dose from a previous vaccinator, instead of 0.25mL.) 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.  It was reported that a patient received 0.5mL for their 1st booster dose from a previous vaccinator, instead of 0.25mL.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm) 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 VACCINATION SITE REACTION (COVID arm). At the time of the report, VACCINATION SITE REACTION (COVID arm) outcome was unknown.            No concomitant medication was reported. Patient developed COVID arm in all 3 shots and she was ready to take the 2nd booster. No treatment medications was reported.   This case was linked to MOD-2022-537673, MOD-2022-537749 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm). At the time of the report, VACCINATION SITE REACTION (COVID arm) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-537673, MOD-2022-537748 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passed out from the Moderna shot the next day and took about 5 minutes to come to; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out from the Moderna shot the next day and took about 5 minutes to come to) 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 dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out from the Moderna shot the next day and took about 5 minutes to come to) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out from the Moderna shot the next day and took about 5 minutes to come to) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported. No treatment drug detail was reported.  Patient took about 5 minutes to come to after passing out from Moderna shot. Company Comment This Spontaneous case reported by a consumer, concerns a female patient of unknown age, with no medical history reported, who experienced the unexpected, serious (Medically significant) event of Loss of consciousness (Passed out from the Moderna shot the next day and took about 5 minutes to come to) which occurred unknown days after an unknown dose of mRNA1273 vaccine. Patient took about 5 minutes to come to, after passing out from Moderna shot. No other information regarding the clinical course, other symptoms, lab test results and treatment details were provided. The event had resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness was assessed as per Medical Judgement.   This case was linked to MOD-2022-537798 (Patient Link).; Sender's Comments: This Spontaneous case reported by a consumer, concerns a female patient of unknown age, with no medical history reported, who experienced the unexpected, serious (Medically significant) event of Loss of consciousness (Passed out from the Moderna shot the next day and took about 5 minutes to come to) which occurred unknown days after an unknown dose of mRNA1273 vaccine. Patient took about 5 minutes to come to, after passing out from Moderna shot. No other information regarding the clinical course, other symptoms, lab test results and treatment details were provided. The event had resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness was assessed as per Medical Judgement.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Report Adverse Event Yes) 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 VACCINATION COMPLICATION (Report Adverse Event Yes). At the time of the report, VACCINATION COMPLICATION (Report Adverse Event Yes) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant product use was reported. No treatment information was provided. Reporter did not allow further contact.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received second booster dose from a vial that was already expired.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received second booster dose from a vial that was already expired.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received second booster dose from a vial that was already expired.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received second booster dose from a vial that was already expired.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Patient received second booster dose on 11-APR-2022. HCP explained that all the previous doses that the patient received were from Moderna and that the patient had not reported any side effects. Treatment details was not reported by the reporter.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Atrial fibrillation; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 34-year-old male patient 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, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) had resolved.            Concomitant product use was not provided by the reporter. The patient experienced an episode of atrial fibrillation which was diagnosed in a hospital emergency room. The episode occurred about 5.5 months after second dose of Spikevax. He was observed there without drug treatment. The atrial fibrillation resolved in the emergency room on the same day. The precise duration of atrial fibrillation was not reported. The atrial fibrillation had not recurred.  Company comment: This spontaneous case concerns a 34-year-old male patient, with no medical history reported, who experienced the serious (medically significant) unexpected AESI of Atrial fibrillation, which occurred 5.5 months after the second dose of mRNA-1273. It was reported that the patient was observed without drug treatment and resolved in the emergency room on the same day. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 34-year-old male patient, with no medical history reported, who experienced the serious (medically significant) unexpected AESI of Atrial fibrillation, which occurred 5.5 months after the second dose of mRNA-1273. It was reported that the patient was observed without drug treatment and resolved in the emergency room on the same day. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mechanical urticaria, Urticaria chronic
Clinical narrative: chronic hives; dermatographia; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA CHRONIC (chronic hives) and MECHANICAL URTICARIA (dermatographia) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 013L20A and 025J20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (Patient reported that it was more than 1 month prior to the Moderna COVID-19 vaccine). Past adverse reactions to the above products included No adverse event with Flu shot. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Dec-2021, the patient experienced URTICARIA CHRONIC (chronic hives) and MECHANICAL URTICARIA (dermatographia). The patient was treated with PREDNISONE at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency; ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID F) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Chronic urticaria, at a dose of since the start of chronic hives. At the time of the report, URTICARIA CHRONIC (chronic hives) and MECHANICAL URTICARIA (dermatographia) had not resolved.            No medical history was reported.  Patient reported birth control as concomitant medication.  Patient stated that the adverse reaction had stayed the same. However, it was probably due to the medications she was taking to treat her symptoms. Patient stated that she was getting better at managing her condition. Patient felt that if not treated herself properly, condition would worsen. Patient had been seeing a Dermatologist monthly since FEB 2022, and her primary care physician twice (JAN 2022 and FEB 2022) for her condition.  Patient reported acupuncture as a treatment.   This case was linked to MOD-2022-537821 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: chronic hives; dermatographia; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA CHRONIC (chronic hives) and MECHANICAL URTICARIA (dermatographia) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 013L20A and 025J20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (Patient reported that it was more than 1 month prior to the Moderna COVID-19 vaccine). Past adverse reactions to the above products included No adverse event with Flu shot. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Dec-2021, the patient experienced URTICARIA CHRONIC (chronic hives) and MECHANICAL URTICARIA (dermatographia). The patient was treated with PREDNISONE at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency; ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID F) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Chronic urticaria, at a dose of since the start of chronic hives. At the time of the report, URTICARIA CHRONIC (chronic hives) and MECHANICAL URTICARIA (dermatographia) had not resolved.            No medical history was reported.  Patient reported birth control as concomitant medication.  Patient stated that the adverse reaction had stayed the same. However, it was probably due to the medications she was taking to treat her symptoms. Patient stated that she was getting better at managing her condition. Patient felt that if not treated herself properly, condition would worsen. Patient had been seeing a Dermatologist monthly since FEB 2022, and her primary care physician twice (JAN 2022 and FEB 2022) for her condition.  Patient reported acupuncture as a treatment.   This case was linked to MOD-2022-537821 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mechanical urticaria, Urticaria chronic
Clinical narrative: Dose 1-Date administered:5FEB2021 , Dose 2-Date administered: 17MAR2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1-Date administered:5FEB2021 , Dose 2-Date administered: 17MAR2021) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 025J20A) for COVID-19 vaccination.     The patient's past medical history included Flu vaccination (she had received the Flu shot which was more than 1 month prior to the Moderna COVID-19 vaccine).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1-Date administered:5FEB2021 , Dose 2-Date administered: 17MAR2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1-Date administered:5FEB2021 , Dose 2-Date administered: 17MAR2021) outcome was unknown.            Patient had never tested positive for COVID-19. Concomitant medications included birth control medications and OTC multivitamins. No treatment medications were provided.   This case was linked to MOD-2022-537780 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1-Date administered:5FEB2021 , Dose 2-Date administered: 17MAR2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1-Date administered:5FEB2021 , Dose 2-Date administered: 17MAR2021) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 025J20A) for COVID-19 vaccination.     The patient's past medical history included Flu vaccination (she had received the Flu shot which was more than 1 month prior to the Moderna COVID-19 vaccine).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1-Date administered:5FEB2021 , Dose 2-Date administered: 17MAR2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1-Date administered:5FEB2021 , Dose 2-Date administered: 17MAR2021) outcome was unknown.            Patient had never tested positive for COVID-19. Concomitant medications included birth control medications and OTC multivitamins. No treatment medications were provided.   This case was linked to MOD-2022-537780 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expiration date 25Mar2022/The vial was taken freezer and placed in refrigerator on 7 April/ administered on 7 April; 4 patients administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients administered with expired vaccine) and PRODUCT STORAGE ERROR (expiration date 25Mar2022/The vial was taken freezer and placed in refrigerator on 7 April/ administered on 7 April) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expiration date 25Mar2022/The vial was taken freezer and placed in refrigerator on 7 April/ administered on 7 April). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients administered with expired vaccine) and PRODUCT STORAGE ERROR (expiration date 25Mar2022/The vial was taken freezer and placed in refrigerator on 7 April/ administered on 7 April) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was given booster dose. Concomitant medication list was not provided. The vial was taken from the freezer on the morning of 07-Apr-2022 and placed in the refrigerator for use on 07-Apr-2022. The vial did not undergo any temperature excursions. Treatment information was not provided.   This case was linked to MOD-2022-537851, MOD-2022-537863 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Live follow up received: updated reporter contact details, added patient demographics, added dose description of suspect product.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Gait disturbance
Clinical narrative: The day after her 2nd booster dose she couldn't stand up or walk; The day after her 2nd booster dose she couldn't stand up or walk; felt dizzy all day long/stayed in bed most of the day; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (The day after her 2nd booster dose she couldn't stand up or walk), DYSSTASIA (The day after her 2nd booster dose she couldn't stand up or walk) and DIZZINESS (felt dizzy all day long/stayed in bed most of the day) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048E21A, 034F21A, 017B21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, the patient experienced GAIT DISTURBANCE (The day after her 2nd booster dose she couldn't stand up or walk), DYSSTASIA (The day after her 2nd booster dose she couldn't stand up or walk) and DIZZINESS (felt dizzy all day long/stayed in bed most of the day). At the time of the report, GAIT DISTURBANCE (The day after her 2nd booster dose she couldn't stand up or walk), DYSSTASIA (The day after her 2nd booster dose she couldn't stand up or walk) and DIZZINESS (felt dizzy all day long/stayed in bed most of the day) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  Patient drank fluids. It was reported that the patient was better at the time of this report however patient was not back to 100 percent.  No Treatment information was provided.   This case was linked to MOD-2022-537825, MOD-2022-537773 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A patient that received a Moderna Covid-19 vaccine 1 day after the expiration date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient that received a Moderna Covid-19 vaccine 1 day after the expiration date) 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 EXPIRED PRODUCT ADMINISTERED (A patient that received a Moderna Covid-19 vaccine 1 day after the expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient that received a Moderna Covid-19 vaccine 1 day after the expiration date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported. HCP did not have any patient information or lot number.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was placed in refrigerator on 17-Feb-2022, expired product date on 01-Apr- 2022, administration date on 05-Apr-2022.; patient administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient administered with expired vaccine) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 17-Feb-2022, expired product date on 01-Apr- 2022, administration date on 05-Apr-2022.) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 17-Feb-2022, expired product date on 01-Apr- 2022, administration date on 05-Apr-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient administered with expired vaccine) and PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 17-Feb-2022, expired product date on 01-Apr- 2022, administration date on 05-Apr-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. The vial was initially stored in refrigerator on 17 Feb 2022 10:00 am. The vials did not undergo any temperature excursions. It was reported that no patients have come out with adverse events. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up received contains non significant information.