chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer Inc) concerned a 53 year old female. Initial information was processed along with additional information was received on 29-JUN-2022 The patient's height, and weight were not reported. The patient's concurrent conditions included: high cholesterol, and unspecified allergy. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered to left arm on 13-MAR-2021 for prophylactic vaccination. Age at time of vaccination 52 years old. The batch number was not reported and has been requested. Concomitant medications included hydroxyzine for drug used for unknown indication. The patient was prescribed with non-company drug Paxlovid (form of admin and route of admin were not reported, batch number: GA1513 and expiry: unknown) dose was not reported, administered first dose on 10-JUN-2022 and last dose on 14-JUN-2022 for covid-19 treatment. On an unspecified date, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection. On 16-JUN-2022 at 06:00, Paxlovid stopped the symptoms right away but after 2 days of the last dose of Paxlovid, the patient started experiencing dry cough. Treatment medications (dates unspecified) included: benzonatate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000238638.; Sender's Comments: V0:20220657667-covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: ANAPHYLAXIS; This solicited report received from a consumer concerned a 53 year old male of an unspecified race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that eleven days after vaccination, the patient started experiencing body itching which he thought was due to being outside in a wooded area and getting bit by something. The itching got better about 3 days later, but then got much worse and eventually led to lip swelling. It was stated under assessment plan that patient had allergic angioedema (recurrent episodes of urticaria and angioedema, with swelling of lips (subsumed under anaphylaxis)). The patient had no swelling of tongue or sensation of throat closing, trigger was unclear and needed referral to an allergist for allergy testing. It was also reported that prednisone, Zyrtec, complete blood count (CBC) and comprehensive metabolic panel (CMP) were all ordered for the patient.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of anaphylaxis was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and anaphylaxis as related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220657833-covid-19 vaccine ad26.cov2.s-Anaphylaxis. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other company (Pfizer) concerned a 61 year old male. Initial information was processed along with the additional information received on 29-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, 1 in total was administered on 01-APR-2021 to left arm for prophylactic vaccination. Age at time of vaccination 60 years old. Concomitant medications included levothyroxine.  The patient additionally received non-company suspect vaccine tozinameran (Pfizer vaccine) (dose number in series 2) (form of admin, route of admin were not reported, batch number: 3198, expiry: UNKNOWN) dose was not reported, administered on 03-JAN-2022 to left arm for prophylactic vaccination.  On 31-MAY-2022, after suffering from a high fever for 36 hours, the patient tested positive for COVID-19 on 02-JUN-2022 which was coded as confirmed covid-19 infection (dose number in series 2) which led to confirmed clinical vaccination failure (dose number in series 1). On 02-JUN-2022 at morning, the patient received non-company suspect drug Paxlovid (form of admin, route of administration, batch number and expiry were not reported) dose and frequency were not reported administered for covid-19 treatment and completed prescription on 06-JUN-2022. On 06-JUN-2022, after administration of last dose of Paxlovid, the patient felt nearly 100 percent cured, except for some minor wheezing (dose number in series 2). On 10-JUN-2022 14:15, the patient redeveloped a fever (dose number in series 2). On 11-JUN-2022, the patient felt worse as his cough increased in his chest, and his head congestion also increased which was followed by a clogged eustachian tube that past week and fatigue (dose number in series 2). On 17-JUN-2022, the patient again tested positive for Covid. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000238666.; Sender's Comments: V0: 20220658513-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via another manufacturer (Pfizer) concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and amoxicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported and expiry: unknown) dose was not reported, 1 total administered on 13-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 31 years old. The patient additionally received Spikevax (elasomeran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported and expiry: unknown) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination. Age at time of vaccination 31 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 symptoms (confirmed covid-19 infection) (dose number in series 2). On an unspecified date in JUN-2022,  tested positive (confirmed clinical vaccination failure) (dose number in series 1). On an unspecified date in JUN-2022, covid-19 symptoms and positive test recurred after 6 days of negative test following getting covid and taking paxlovid. Patient was treated with Paxlovid (Nirmatrelvir/ritonavir) on 01-JUN-2022 for treatment of covid-19 and last administration was on 05-JUN-2022. Laboratory data included: COVID-19 virus test Positive. Laboratory data (dates unspecified) included: COVID-19 virus test Negative. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000239139; Sender's Comments: V0: 20220658724-Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE provided; Nurse calling states she inadvertently administered expired VAQTA to a patient.; This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The medical history, concurrent conditions, drug reactions or allergies and concomitants therapies were not mentioned.  On 20-JUN-2022, the patient was vaccinated inadvertently with an expired dose of Hepatitis A Vaccine, inactivated (VAQTA) (Expired vaccine used), formulation: intramuscular injection, dose: 0.5 milliliter, batch # U003450 expiration date: 02-MAY-2022, (strength, vaccination schedule, and anatomical site of administration  were not reported).   It was stated that the vaccine had been stored at the appropriate storage condition, specified in the product label, through the date of administration. No additional adverse event details provided.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: No additional adverse event; Caller stated the patient received two administrations of PNEUMOVAX 23- one on 4/22/2022 and the next on 5/5/2022.; This spontaneous report was received from a nurse concerning a patient (gender and age were not reported). Patient's medical history, concurrent conditions and concomitant therapies were not reported.    On 22-APR--2022, the patient was vaccinated with the first dose of pneumococcal vaccine polyvalent (PNEUMOVAX-23) pre-filled syringe, 0.5 milliliter (route of administration and anatomical location were not provided), lot#U027357, expiration date reported as 18-AUG-2023, but upon internal review it was established as 25-MAY-2023 (conflicting information), as prophylaxis. Later in 05-MAY-2022 the patient was revaccinated with another dose of pneumococcal vaccine polyvalent (PNEUMOVAX-23) pre-filled syringe, 0.5 milliliter (route of administration and anatomical location were not provided), lot#U027357, expiration date 25-MAY-2023 (extra dose administered) as prophylaxis. The reported stated there were no know adverse events related to the double administration (no adverse event).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Imaging procedure, Laboratory test, Pain, Peripheral swelling
Clinical narrative: Peripheral swelling behind both knees that cause pain when I?m working my PCP did multiple tests and imaging and they said if it does not go away I?m going to need surgery
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine expired in the freezer on 06-Apr-2022 and administered on 17-May-2022; Administer  expired vaccine to a 100 patients/information on only 4 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer  expired vaccine to a 100 patients/information on only 4 patients) and PRODUCT STORAGE ERROR (The vaccine expired in the freezer on 06-Apr-2022 and administered on 17-May-2022) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 prophylaxis.     Patient did not had any allergies. It is unknown whether the patient had tested or diagnosed for COVID- 19. Patient did not had Acute and Chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: pfizer (Pfizer primary series.) and Pfizer (Pfizer primary series.). Past adverse reactions to the above products included No adverse event with Pfizer and pfizer.    On 17-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer  expired vaccine to a 100 patients/information on only 4 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine expired in the freezer on 06-Apr-2022 and administered on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer  expired vaccine to a 100 patients/information on only 4 patients) and PRODUCT STORAGE ERROR (The vaccine expired in the freezer on 06-Apr-2022 and administered on 17-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  Patient received second booster dose. The vial was initially stored in the refrigerator on 28-Apr-2022 and 04-Apr-2022. Patient did not receive any other vaccines  within 1 month prior to Moderna COVID-19 vaccine   No treatment drug details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Myalgia
Clinical narrative: I was sick as a dog/It was Horrific; terrible body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (I was sick as a dog/It was Horrific) and MYALGIA (terrible body aches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had no history of Covid-19 vaccine, Osteoarthritis in fingers and trigger fingers.  The patient's past medical history included Cataract (Cataract implants). Concurrent medical conditions included Diabetic, Hypertension, Arthritis, Thyroid disorder and Hair loss (hair loss for a long time).   On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, the patient experienced ILLNESS (I was sick as a dog/It was Horrific) and MYALGIA (terrible body aches). At the time of the report, ILLNESS (I was sick as a dog/It was Horrific) and MYALGIA (terrible body aches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not reported.  Treatment information was not reported.   This case was linked to MOD-2022-594629 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     It was unknown whether the patient was ever diagnosed/tested positive for COVID-19.   It was unknown whether the patient had any acute illness at the time of vaccination and up to one month before it. It was unknown whether the patient had any chronic or long-standing health conditions.     On 17-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 26 years and 4 months.  Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination was unknown  The vaccines were administered beyond use date after the thaw process. The patient did not had any adverse reactions and no reports of any reactions after the administration of these vaccines.   The patient got Moderna with vaccine Ndc code 80777027399.  No treatment medications were reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     It was unknown if patient ever had tested or diagnosed positive for COVID. It was unknown if patient had Acute or Chronic/ long-standing illnesses at the time of vaccination or up to 1 month prior to vaccination. Information about other vaccines given within 1 month prior to Moderna COVID-19 vaccine was unknown.     On 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 18-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age reported in the source document as 66 years 10 months. No concomitant medication information was provided. On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process.  Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines. Vaccine NDC code- 80777-0273-99  No treatment medication was provided.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after thaw process) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patients age was reported as 19 years 2 months.  Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and/or at the time of adverse event was unknown.  On 10-Jun-2022, the vaccination facility was notified of an audit that was done and it was informed that vaccines were administered beyond use date after the thaw process.  There was no patient that had any adverse reactions and no reports of any reactions after the administration of these vaccines. The patient got Moderna vaccine with NDC code: 80777-0273-99.  It was unknown whether the patient was ever diagnosed/tested positive for COVID-19.  It was unknown whether the patient had any acute illness at the time of vaccination and up to one month before it. It was unknown whether the patient had any chronic or long-standing health conditions.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-542869.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-542869:Crosslink case
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that was administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that was administered beyond use date after thaw process) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 18-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that was administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that was administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 28 years and 08 months.  No concomitant medications were reported.  On 10-Jun-2022, the vaccine facility staff was notified of an audit that was done and they were made aware of vaccines that were administered beyond use date after the thaw process. Patient had not reported any adverse reactions after the administration of the vaccine.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-542869 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-542869:Master case
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccines were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines were administered beyond use date after thaw process) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 72 years and 6 months. No concomitant medications were reported. On 10-Jun-2022, the vaccination facility was notified of an audit that was done and it was informed that vaccines were administered beyond use date after the thaw process.  There was no patient that had any adverse reactions and no reports of any reactions after the administration of these vaccines. The patient got Moderna with vaccine Ndc code 80777027399.  It was unknown whether the patient was ever diagnosed/tested positive for COVID-19.  It was unknown whether the patient had any acute illness at the time of vaccination and up to one month before it. It was unknown whether the patient had any chronic or long-standing health conditions. Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and/or at the time of adverse event was unknown. No treatment medications were reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vials of lot number 027L21A was initially stored in the refrigerator on 08-Mar-2022.; Vaccine were administered after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine were administered after the 30 day beyond use date) and PRODUCT STORAGE ERROR (vials of lot number 027L21A was initially stored in the refrigerator on 08-Mar-2022.) in a 35-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-May-2022 at 3:00 PM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 20-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine were administered after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials of lot number 027L21A was initially stored in the refrigerator on 08-Mar-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine were administered after the 30 day beyond use date) and PRODUCT STORAGE ERROR (vials of lot number 027L21A was initially stored in the refrigerator on 08-Mar-2022.) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not provided. Patient neither diagnosed with COVID-19 nor tested positive.  Six vials of lot number 027L21A was initially stored in the refrigerator on 08-Mar-2022. The vials did not undergo any temperature excursions.  The patient had not reported any symptoms.   Treatment medications were not reported.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient recieved dose from a vial which was initially stored in the refrigerator 08-Mar-2022 and administered to patient on 16 May 2022 after 30-day Use By Date; The patient administered the vaccine after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Patient recieved dose from a vial which was initially stored in the refrigerator 08-Mar-2022 and administered to patient on 16 May 2022 after 30-day Use By Date) and EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 day beyond use date) in an 18-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027121A) for COVID-19 prophylaxis.     The patient had no known allergy. The patient did not had chronic or long-standing health conditions.     On 16-May-2022 at 11:30 AM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 16-May-2022 at 11:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient recieved dose from a vial which was initially stored in the refrigerator 08-Mar-2022 and administered to patient on 16 May 2022 after 30-day Use By Date). At the time of the report, PRODUCT STORAGE ERROR (Patient recieved dose from a vial which was initially stored in the refrigerator 08-Mar-2022 and administered to patient on 16 May 2022 after 30-day Use By Date) and EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Prescriptions, over the counter medication, dietary supplement or herbal remedies at the time of vaccination were reported as none.  The patient had not ever tested positive for COVID-19. It was unknown if patient had acute illness at the time of vaccination and up to 1 month before.  Six (6) vials of lot number 027L21A was initially stored in the refrigerator on 08-Mar-2022.  The vials did not undergo any temperature excursions.  The patients had not reported symptoms.  No additional doses, medications or treatments had been administered.   This case was linked to MOD-2022-583062 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial initially stored in refrigerator on 08-Mar-2022 and vaccine administered on 20-May-2022; Dose administered after 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 08-Mar-2022 and vaccine administered on 20-May-2022) in a 66-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 prophylaxis.     It was reported that patient had been neither diagnosed nor tested COVID-19 test positive. No chronic or long standing health conditions were reported.     On 20-May-2022 at 10:30 AM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 20-May-2022 at 10:30 AM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 08-Mar-2022 and vaccine administered on 20-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 08-Mar-2022 and vaccine administered on 20-May-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.  No. of doses/vials were 6 vials. The vial was initially stored in the refrigerator on 08-Mar-2022.  No the vial did not undergo any temperature excursions.  No treatment medications were reported by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator from the freezer on 08-Mar-2022 and the doses were administered on 16-May-2022; Administered with vaccine that is past beyond the 30 day use; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 08-Mar-2022 and the doses were administered on 16-May-2022) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 prophylaxis.     Patient was not tested positive or was not diagnosed with COVID-19.     On 16-May-2022 at 1:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 16-May-2022 at 1:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 08-Mar-2022 and the doses were administered on 16-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine that is past beyond the 30 day use) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator from the freezer on 08-Mar-2022 and the doses were administered on 16-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug information was provided. It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions. It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event.  Administered vaccine after the BUD from 08-Mar-2022 to 2-Jun-2022.   Number of Vials where 6 vials, the vial was initially stored in refrigerator was 08-MAr- 2022. The vial did not undergo the temperature excursion. Patient had no reported symptoms. No treatment medications were provided.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine were stored more than 30 days in a refrigerator; The patient administered the vaccine after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 day beyond use date) and PRODUCT STORAGE ERROR (Vaccine were stored more than 30 days in a refrigerator) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-May-2022 at 11:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 24-May-2022 at 11:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine were stored more than 30 days in a refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 day beyond use date) and PRODUCT STORAGE ERROR (Vaccine were stored more than 30 days in a refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had no known allergy. No concomitant medications were reported. The patient had not ever tested positive for COVID-19, and had not taken any prescriptions, over the counter medication, dietary supplement or herbal remedies at the time of vaccination and also not had any acute illness at the time of vaccination and up to 1 month before. Six (6) vials of lot number 027L21A was initially stored in the refrigerator on 08-Mar-2022. The vials did not undergo any temperature excursions. The patients had not reported symptoms.  No additional doses, medications, or treatments had been administered.   This case was linked to MOD-2022-583062 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine stored in refrigerator on 08-Mar-2022/Vaccine administered on 16-May-2022; Patient received vaccine after the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the beyond use date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 08-Mar-2022/Vaccine administered on 16-May-2022) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 prophylaxis.     The patient had not been diagnosed/tested positive for COVID-19. It was unknown that the patient had acute illness at the time of vaccination and up to one month before. It was unknown that the patient had chronic or long-lasting illness and patient had taken any prescriptions, over the counter medication, dietary supplements or herbal remedies at the time of vaccination.     On 16-May-2022 at 11:00 AM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-May-2022 at 11:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 08-Mar-2022/Vaccine administered on 16-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the beyond use date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 08-Mar-2022/Vaccine administered on 16-May-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Total number of vials was 6. The vial was initially stored in refrigerator on 08-Mar-2022. The vial did not undergo any temperature excursion. The patient did not report any symptoms.  No treatment medications were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 prophylaxis.    No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's age was reported as 56 years 4 months.  No concomitant medications were provided by the reporter.  It was reported that vaccines were administered beyond use date after the thaw process. There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  No treatment medications were provided by the reporter.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Expired product administered
Clinical narrative: Vaccine administered beyond use date after the thaw process; Vaccine number 2nd and dose volume 0.25; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) and ACCIDENTAL UNDERDOSE (Vaccine number 2nd and dose volume 0.25) in an 18-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 030h21b) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) and ACCIDENTAL UNDERDOSE (Vaccine number 2nd and dose volume 0.25). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) and ACCIDENTAL UNDERDOSE (Vaccine number 2nd and dose volume 0.25) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   The patient age was reported as 18 years 11 months.  No concomitant medications were reported. Vaccine Ndc Code was reported as 80777-0273-99. The patient did not had any adverse reactions and no reports of any reactions after the administration of the vaccine. No treatment information was reported.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The reporter informed that, the vaccine was used beyond use date of some lot numbers for Moderna that were administered to patients. There was no adverse reaction noted or reported to the reporter ever regarding after administration of vaccine.  It was unknown if the patient was tested positive or diagnosed with COVID-19. It was unknown if acute illnesses at the time of vaccination and up to one month before. And it was unknown if chronic or long-standing health conditions.  No treatment drug details was reported.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received dose from a vial which was initially stored in the refrigerator 08-Mar-2022 and administered to patient on 20 May 2022 after 30-day Use By Date; The patient administered the vaccine after the 30 days beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days beyond use date) and PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 08-Mar-2022 and administered to patient on 20 May 2022 after 30-day Use By Date) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 prophylaxis.     Patient was not ever diagnosed with/ tested positive for Covid-19.  there were no known drug allergies of the patient to medications, food and other products.  It was unknown if patient had any acute illness at the time of vaccination or up to one month before. It was unknown if patient had any chronic or long-standing health conditions.     On 20-May-2022 at 3:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 20-May-2022 at 3:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 08-Mar-2022 and administered to patient on 20 May 2022 after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days beyond use date) and PRODUCT STORAGE ERROR (Patient received dose from a vial which was initially stored in the refrigerator 08-Mar-2022 and administered to patient on 20 May 2022 after 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if the patient had any prescriptions, over the counter medication, dietary supplements or herbal remedies taken at the time of vaccination  Vials with batch no 027L21A were initially stored in the refrigerator on 08-Mar-2022. The vials did not undergo any temperature excursions. The patients had not reported symptoms.  No additional doses, medications or treatments had been administered.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccines beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccines beyond use date after the thaw process) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 prophylaxis.     It was unknown whether the patient was diagnosed or tested positive for covid-19.  Acute illness at the time of vaccination and up to one month before was not known.  Chronic and long-standing health conditions were unknown.     On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccines beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccines beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported has 54 years 5 month.  The patient got Moderna with vaccine Ndc code 80777027399.  The medical notified of an audit that was done which made aware that some vaccines were administered beyond use date after the thaw process.  There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  Concomitant drugs were not reported.  Treatment details were not reported.   This case was linked to MOD-2022-542869 (Patient Link).