chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Carbon dioxide decreased, Chills, Haematocrit normal, Intensive care, Procalcitonin
Clinical narrative: 74-year-old gentleman received COVID19  booster dose today at dialysis appointment, sometime around 1300 hours.  Experienced rigors afterwards.  Admitted to the emergency department tonight, and subsequently to ICU in shock state requiring vasopressors.  Admission to the hospital approximately 12 hours after administration of vaccine.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Shock, White blood cell count increased
Clinical narrative: 74-year-old gentleman received COVID19  booster dose today at dialysis appointment, sometime around 1300 hours.  Experienced rigors afterwards.  Admitted to the emergency department tonight, and subsequently to ICU in shock state requiring vasopressors.  Admission to the hospital approximately 12 hours after administration of vaccine.
Age: 31.0
Sex: F
Vaccine: TYP
Symptoms: Expired product administered, Medication error
Clinical narrative: 31 year old female patient received expired dose of Typhim VI vaccine with no reported adverse event; Initial information received on 10-Nov-2021 regarding an unsolicited valid non-serious case from a pharmacist via non-healthcare professional via Global Medical Information (Reference number- 00852442).  This case involves a 31-year-old female patient who received expired dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI], (expired product administered).  The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot number not reported and expiry date: 11-Oct-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was reported "Caller states that a doctor's office contacted them today (11/10/2021) because they had administered Typhim VI which expired a month ago (10/11/2021) to a 31 year-old female patient. Pharmacist has no other information about patient or event. Pharmacist states that the doctor's office administered the immunization, but vaccine was expired when this pharmacy dispensed it".   It was not reported if the patient received a corrective treatment.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: MNQ
Symptoms: Presyncope
Clinical narrative: almost fell on the floor; Initial information received on 10-Nov-2021 regarding an unsolicited valid non-serious case received from other healthcare professional and non-healthcare professional via phone. This case involves a child of unknown gender patient who almost fell on the floor (presyncope) when received vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious almost fell on the floor (presyncope) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the event.  At the time of reporting, the outcome was unknown for the event (presyncope).  There will be no information available on the batch number for this case.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Exposure during pregnancy
Clinical narrative: expired dose of Fluzone Quadrivalent was administered with no reported adverse event; a pregnant patient received an expired dose of Fluzone Quadrivalent with no reported adverse event; Initial information received on 10-Nov-2021 regarding an unsolicited valid non-serious case from a consumer or other nonprofessional via Global Media information (under the reference 00852655).  This case involves a 25-year-old female patient receiving expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and a pregnant patient received an expired dose of fluzone quadrivalent (maternal exposure during pregnancy).  Data regarding this pregnancy were received prospectively.  At unknown gestation period and the patient was exposed to INFLUENZA QUADRIVAL A-B VACCINE at 13 weeks of pregnancy, during first pregnancy trimester for INFLUENZA QUADRIVAL A-B VACCINE.  The date of last menstrual period was reported as 27-Aug-2021.  The estimated due date was not reported.  The actual date of delivery was not reported.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Nov-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [Once, lot UT700CA, expiry date: 30-Jun-2021] via intramuscular route in the left deltoid for prophylactic vaccination.  This case is medication error due to expired vaccine used (latency same day).  It was the case of vaccine exposure during pregnancy (latency same day). The patient was pregnant when she received FLUZONE QUADRIVALENT.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out by the regulatory authority. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse events; VARIVAX was administered after improperly stored; This spontaneous report as received from a medical assistant refers to a 15 months old patient of unknown gender. On 23-SEP-2021, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T027303 exp date 12-AUG-2022) (route not reported) after improperly stored. The temperature of excursion was 6°F to 14°F (8.5F) for 0 hours 18 minutes and 0 seconds, 6°F to 14°F (11.9F) for 1 hour 0 minutes and 0 seconds. Cumulative timeframe 1 hour and 18 minutes. There was no previous temperature excursion.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccine still got shingles/Suspected vaccination failure; Shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included cold sores (had cold sores all his/her life).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported that he/she never had chicken pox but had cold sores all his/her life. The patient got Shingles vaccine and still got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Dyspnoea, Herpes zoster, Neuralgia, Rash
Clinical narrative: Diagnosed with shingles; began to experience the development of a painful rash; blisters on body, specifically chest area; Difficulty breathing; nerve pain; Permanent skin markings; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLISTER (blisters on body, specifically chest area), DYSPNOEA (Difficulty breathing), NEURALGIA (nerve pain), SKIN REACTION (Permanent skin markings) and HERPES ZOSTER (Diagnosed with shingles) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jul-2021, the patient experienced BLISTER (blisters on body, specifically chest area), DYSPNOEA (Difficulty breathing), NEURALGIA (nerve pain), SKIN REACTION (Permanent skin markings) and RASH (began to experience the development of a painful rash). On 04-Jul-2021, the patient experienced HERPES ZOSTER (Diagnosed with shingles). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Adverse event, at a dose of UNK dosage form; PREDNISONE for Adverse event, at a dose of 20 mg once a day and LIDOCAINE (LIDODERM) for Adverse event, at a dose of UNK dosage form. At the time of the report, BLISTER (blisters on body, specifically chest area), DYSPNOEA (Difficulty breathing), NEURALGIA (nerve pain), SKIN REACTION (Permanent skin markings), HERPES ZOSTER (Diagnosed with shingles) and RASH (began to experience the development of a painful rash) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. The treatment medication included OTC sprays for unknown indication. The patient visited an urgent care for treatment on 04 Jul 2021, she was diagnosed with shingles, and prescribed medications. Patient claimed she is not immunocompromised and had no other health conditions       Most recent FOLLOW-UP information incorporated above includes: On 13-Nov-2021: Event outcome updated to not resolved. Urgent case visit and indication for treatment medication was updated.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: Diagnosed with shingles; began to experience the development of a painful rash; blisters on body, specifically chest area; Difficulty breathing; nerve pain; Permanent skin markings; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLISTER (blisters on body, specifically chest area), DYSPNOEA (Difficulty breathing), NEURALGIA (nerve pain), SKIN REACTION (Permanent skin markings) and HERPES ZOSTER (Diagnosed with shingles) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jul-2021, the patient experienced BLISTER (blisters on body, specifically chest area), DYSPNOEA (Difficulty breathing), NEURALGIA (nerve pain), SKIN REACTION (Permanent skin markings) and RASH (began to experience the development of a painful rash). On 04-Jul-2021, the patient experienced HERPES ZOSTER (Diagnosed with shingles). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Adverse event, at a dose of UNK dosage form; PREDNISONE for Adverse event, at a dose of 20 mg once a day and LIDOCAINE (LIDODERM) for Adverse event, at a dose of UNK dosage form. At the time of the report, BLISTER (blisters on body, specifically chest area), DYSPNOEA (Difficulty breathing), NEURALGIA (nerve pain), SKIN REACTION (Permanent skin markings), HERPES ZOSTER (Diagnosed with shingles) and RASH (began to experience the development of a painful rash) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. The treatment medication included OTC sprays for unknown indication. The patient visited an urgent care for treatment on 04 Jul 2021, she was diagnosed with shingles, and prescribed medications. Patient claimed she is not immunocompromised and had no other health conditions       Most recent FOLLOW-UP information incorporated above includes: On 13-Nov-2021: Event outcome updated to not resolved. Urgent case visit and indication for treatment medication was updated.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna 0.25ml booster dose given 25.5 hours past initial vial puncture. No adverse effects; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna 0.25ml booster dose given 25.5 hours past initial vial puncture. No adverse effects) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 043B21A and 002B21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Influenza (Manufacturer- Fluad,  Lot Number- 312835, Route- IM and Body site- L Delt Dose number- 1). Past adverse reactions to the above products included No adverse event with Influenza. Concurrent medical conditions included Allergy to antibiotic (azithromycin), Drug allergy (gabapentin) and Penicillin allergy.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna 0.25ml booster dose given 25.5 hours past initial vial puncture. No adverse effects). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Moderna 0.25ml booster dose given 25.5 hours past initial vial puncture. No adverse effects) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Significant Follow up- Event date, dose 1 and 2 details and co-suspect details were added.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: ran over by a mac truck; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (ran over by a mac truck) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced FEELING ABNORMAL (ran over by a mac truck). In February 2021, FEELING ABNORMAL (ran over by a mac truck) had resolved.            No Concomitant medication were reported. No treatment medication were reported.   This case was linked to MOD-2021-382910 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Vaccination site erythema
Clinical narrative: left arm is hard; Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (left arm is hard) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031m21a and 038k20a) for COVID-19 vaccination.     Medical history was not reported by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced INDURATION (left arm is hard) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) in November 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, INDURATION (left arm is hard) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Redness at injection site; Swelling at injection site; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site) 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 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.            No concomitant and treatment medications were not provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: 99.8 fever; Chills after booster dose; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills after booster dose) and PYREXIA (99.8 fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced CHILLS (Chills after booster dose). On 11-Nov-2021, the patient experienced PYREXIA (99.8 fever). At the time of the report, CHILLS (Chills after booster dose) and PYREXIA (99.8 fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2021, Body temperature: 99.8 (High) High.         no concomitants were reported. no treatment medications was provided   This case was linked to MOD-2021-384037 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  It was reported that the patient had no adverse event.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow up document received contains no newinformation
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: receiving doses of the Moderna COVID19 vaccine after its expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving doses of the Moderna COVID19 vaccine after its expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving doses of the Moderna COVID19 vaccine after its expiration date). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (receiving doses of the Moderna COVID19 vaccine after its expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided. It was reported that no temperature excursion had taken place and removed from freezer and was placed in refrigerator on 3/11/2021.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow-up received on 12-Nov-2021 includes significant information where Batch number was updated. On 12-Nov-2021: Non-significant Follow-up  contains No New Information.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pain in extremity, Pruritus, Rash
Clinical narrative: Arm soreness; Breaking out since 1st dose; Unresolved Small blisters; Unresolved Itch; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Unresolved Small blisters), PRURITUS (Unresolved Itch), PAIN IN EXTREMITY (Arm soreness) and RASH (Breaking out since 1st dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003f21a, 04521a and 017b21a) for COVID-19 vaccination.     Concurrent medical conditions included Depression. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Depression.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced BLISTER (Unresolved Small blisters), PRURITUS (Unresolved Itch) and RASH (Breaking out since 1st dose). On 22-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm soreness). The patient was treated with MOMETASONE FUROATE at a dose of 1 dosage form. At the time of the report, BLISTER (Unresolved Small blisters), PRURITUS (Unresolved Itch) and RASH (Breaking out since 1st dose) outcome was unknown and PAIN IN EXTREMITY (Arm soreness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient used Mometasone Furoate cream by the dermatologist but it did not work for her as treatment.   This case was linked to MOD-2021-384243, MOD-2021-384200, MOD-2021-384243 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: vaccine given on the 21th vial puncture; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (vaccine given on the 21th vial puncture) 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 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (vaccine given on the 21th vial puncture). On 08-Nov-2021, PRODUCT ADMINISTRATION ERROR (vaccine given on the 21th vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medications were not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first 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. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Follow-up received. Contains no newinformation.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: fatigue for a day with the first 2 doses; arm soreness for a couple of days with the first 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue for a day with the first 2 doses) and VACCINATION SITE PAIN (arm soreness for a couple of days with the first 2 doses) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 007M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included VITAMINS NOS for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-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 FATIGUE (fatigue for a day with the first 2 doses) and VACCINATION SITE PAIN (arm soreness for a couple of days with the first 2 doses). At the time of the report, FATIGUE (fatigue for a day with the first 2 doses) and VACCINATION SITE PAIN (arm soreness for a couple of days with the first 2 doses) had resolved.            No treatment information provided by the reporter  It was reported that  patient had no comorbidities, no regular chronic medications.  Patient received third dose of Moderna on 08-Nov-2021, Batch number: 039F21A.   This case was linked to MOD-2021-384309, MOD-2021-384344 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Contusion, Dizziness, Fall, Fatigue
Clinical narrative: fall from bed; sustained a bruise on the side from the fall; scalp was tender; arm soreness; extreme fatigue; dizziness; loss of energy in the arms and legs/loss of energy in the lower limbs caused her to fall from bed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (loss of energy in the arms and legs/loss of energy in the lower limbs caused her to fall from bed), FALL (fall from bed), CONTUSION (sustained a bruise on the side from the fall) and PAIN OF SKIN (scalp was tender) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced DIZZINESS (dizziness), ASTHENIA (loss of energy in the arms and legs/loss of energy in the lower limbs caused her to fall from bed), PAIN OF SKIN (scalp was tender), VACCINATION SITE PAIN (arm soreness) and FATIGUE (extreme fatigue). On 10-Nov-2021, the patient experienced FALL (fall from bed) and CONTUSION (sustained a bruise on the side from the fall). The patient was treated with PARACETAMOL (TYNELOL) on 10-Nov-2021 for Pain, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) on 10-Nov-2021 for Pain, at a dose of UNK, one time dose. On 10-Nov-2021, DIZZINESS (dizziness), ASTHENIA (loss of energy in the arms and legs/loss of energy in the lower limbs caused her to fall from bed), FALL (fall from bed), PAIN OF SKIN (scalp was tender), VACCINATION SITE PAIN (arm soreness) and FATIGUE (extreme fatigue) had resolved. At the time of the report, CONTUSION (sustained a bruise on the side from the fall) outcome was unknown.            Concomitants of the patient includes only vitamins.  Patient also applied topicals to the bruise as treatment.   This case was linked to MOD-2021-384343, MOD-2021-384309 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Non significant follow up contains no new informataion
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Vaccination site pain
Clinical narrative: fall from bed; sustained a bruise on the side from the fall; scalp was tender; arm soreness; extreme fatigue; dizziness; loss of energy in the arms and legs/loss of energy in the lower limbs caused her to fall from bed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (loss of energy in the arms and legs/loss of energy in the lower limbs caused her to fall from bed), FALL (fall from bed), CONTUSION (sustained a bruise on the side from the fall) and PAIN OF SKIN (scalp was tender) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced DIZZINESS (dizziness), ASTHENIA (loss of energy in the arms and legs/loss of energy in the lower limbs caused her to fall from bed), PAIN OF SKIN (scalp was tender), VACCINATION SITE PAIN (arm soreness) and FATIGUE (extreme fatigue). On 10-Nov-2021, the patient experienced FALL (fall from bed) and CONTUSION (sustained a bruise on the side from the fall). The patient was treated with PARACETAMOL (TYNELOL) on 10-Nov-2021 for Pain, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) on 10-Nov-2021 for Pain, at a dose of UNK, one time dose. On 10-Nov-2021, DIZZINESS (dizziness), ASTHENIA (loss of energy in the arms and legs/loss of energy in the lower limbs caused her to fall from bed), FALL (fall from bed), PAIN OF SKIN (scalp was tender), VACCINATION SITE PAIN (arm soreness) and FATIGUE (extreme fatigue) had resolved. At the time of the report, CONTUSION (sustained a bruise on the side from the fall) outcome was unknown.            Concomitants of the patient includes only vitamins.  Patient also applied topicals to the bruise as treatment.   This case was linked to MOD-2021-384343, MOD-2021-384309 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: Non significant follow up contains no new informataion
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Heart rate irregular, Hyperthyroidism, Palpitations
Clinical narrative: Went from hypothyroidism to hyperthyroidism; Fast heartbeat/Like water around the heart/Like a tunnel; Lost a lot of weight; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTHYROIDISM (Went from hypothyroidism to hyperthyroidism), PALPITATIONS (Fast heartbeat/Like water around the heart/Like a tunnel), WEIGHT DECREASED (Lost a lot of weight) and FATIGUE (Fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included Polio in 1951 and Back surgery. Concurrent medical conditions included Hashimoto's disease (30 years ago) since 1991 and Hypothyroidism. Concomitant products included WARFARIN for Clot blood, LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced PALPITATIONS (Fast heartbeat/Like water around the heart/Like a tunnel) and FATIGUE (Fatigue). 15-Mar-2021, the patient experienced WEIGHT DECREASED (Lost a lot of weight). In July 2021, the patient experienced HYPERTHYROIDISM (Went from hypothyroidism to hyperthyroidism). In April 2021, PALPITATIONS (Fast heartbeat/Like water around the heart/Like a tunnel), WEIGHT DECREASED (Lost a lot of weight) and FATIGUE (Fatigue) had resolved. At the time of the report, HYPERTHYROIDISM (Went from hypothyroidism to hyperthyroidism) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Blood pressure measurement: 160/100 (High) High and 159/58 (High) High. On 15-Mar-2021, Heart rate irregular: abnormal (abnormal) abnormal. On an unknown date, Blood pressure measurement: 120/70 (normal) Normal. On an unknown date, Renal function test: normal (normal) normal.   The patient had a heart monitor for a month. 6 weeks later, everything went back to normal without medication.  Patient had her annual check on July and doctor told to lower the dose of Synthroid down to 88 mcg from 100 mcg.  Patient was scheduled to receive the booster dose next Sunday on 14 Nov 2021.  No treatment information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Renal function test, Weight decreased
Clinical narrative: Went from hypothyroidism to hyperthyroidism; Fast heartbeat/Like water around the heart/Like a tunnel; Lost a lot of weight; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTHYROIDISM (Went from hypothyroidism to hyperthyroidism), PALPITATIONS (Fast heartbeat/Like water around the heart/Like a tunnel), WEIGHT DECREASED (Lost a lot of weight) and FATIGUE (Fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included Polio in 1951 and Back surgery. Concurrent medical conditions included Hashimoto's disease (30 years ago) since 1991 and Hypothyroidism. Concomitant products included WARFARIN for Clot blood, LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced PALPITATIONS (Fast heartbeat/Like water around the heart/Like a tunnel) and FATIGUE (Fatigue). 15-Mar-2021, the patient experienced WEIGHT DECREASED (Lost a lot of weight). In July 2021, the patient experienced HYPERTHYROIDISM (Went from hypothyroidism to hyperthyroidism). In April 2021, PALPITATIONS (Fast heartbeat/Like water around the heart/Like a tunnel), WEIGHT DECREASED (Lost a lot of weight) and FATIGUE (Fatigue) had resolved. At the time of the report, HYPERTHYROIDISM (Went from hypothyroidism to hyperthyroidism) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Blood pressure measurement: 160/100 (High) High and 159/58 (High) High. On 15-Mar-2021, Heart rate irregular: abnormal (abnormal) abnormal. On an unknown date, Blood pressure measurement: 120/70 (normal) Normal. On an unknown date, Renal function test: normal (normal) normal.   The patient had a heart monitor for a month. 6 weeks later, everything went back to normal without medication.  Patient had her annual check on July and doctor told to lower the dose of Synthroid down to 88 mcg from 100 mcg.  Patient was scheduled to receive the booster dose next Sunday on 14 Nov 2021.  No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (Patient has high blood pressure that was controlled.). Concomitant products included LISINOPRIL for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (chills). On 03-Feb-2021, PYREXIA (Fever) and CHILLS (chills) had resolved.            Patient uses concomitant drugs that was cartia, and thyroid medicine.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-384477 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Vaccination site movement impairment
Clinical narrative: Could not lift her arm; Tiredness/ Staying in the bed; Arm hurting so badly; Nauseas; Chills; Head hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her arm), FATIGUE (Tiredness/ Staying in the bed), VACCINATION SITE PAIN (Arm hurting so badly), NAUSEA (Nauseas) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034f21a, 013m20a and 030a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included MONTELUKAST SODIUM (MONTELUKAST [MONTELUKAST SODIUM]), NIFEDIPINE (PROCARDIA [NIFEDIPINE]), COLECALCIFEROL (VITAMINS D3), ASPIRIN [ACETYLSALICYLIC ACID], FUROSEMIDE, IBUPROFEN (ADVIL [IBUPROFEN]) and PHENYTOIN (DILANTIN [PHENYTOIN]) for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her arm), FATIGUE (Tiredness/ Staying in the bed), VACCINATION SITE PAIN (Arm hurting so badly), NAUSEA (Nauseas), CHILLS (Chills) and HEADACHE (Head hurting). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain in arm, at a dose of 325 milligram. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her arm), FATIGUE (Tiredness/ Staying in the bed), VACCINATION SITE PAIN (Arm hurting so badly), NAUSEA (Nauseas), CHILLS (Chills) and HEADACHE (Head hurting) outcome was unknown.            Concomitant medication includes pulmonary hypertension medication  Following vaccination with the booster patient experienced the following: tiredness, could not lift her arm, arm hurting so badly, nauseas, chills, head hurting and staying in the bed.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Could not lift her arm; Tiredness/ Staying in the bed; Arm hurting so badly; Nauseas; Chills; Head hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her arm), FATIGUE (Tiredness/ Staying in the bed), VACCINATION SITE PAIN (Arm hurting so badly), NAUSEA (Nauseas) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034f21a, 013m20a and 030a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included MONTELUKAST SODIUM (MONTELUKAST [MONTELUKAST SODIUM]), NIFEDIPINE (PROCARDIA [NIFEDIPINE]), COLECALCIFEROL (VITAMINS D3), ASPIRIN [ACETYLSALICYLIC ACID], FUROSEMIDE, IBUPROFEN (ADVIL [IBUPROFEN]) and PHENYTOIN (DILANTIN [PHENYTOIN]) for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her arm), FATIGUE (Tiredness/ Staying in the bed), VACCINATION SITE PAIN (Arm hurting so badly), NAUSEA (Nauseas), CHILLS (Chills) and HEADACHE (Head hurting). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain in arm, at a dose of 325 milligram. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her arm), FATIGUE (Tiredness/ Staying in the bed), VACCINATION SITE PAIN (Arm hurting so badly), NAUSEA (Nauseas), CHILLS (Chills) and HEADACHE (Head hurting) outcome was unknown.            Concomitant medication includes pulmonary hypertension medication  Following vaccination with the booster patient experienced the following: tiredness, could not lift her arm, arm hurting so badly, nauseas, chills, head hurting and staying in the bed.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The caller also stated that her friend got expired vaccine too but had no reactions.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The caller also stated that her friend got expired vaccine too but had no reactions.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The caller also stated that her friend got expired vaccine too but had no reactions.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The caller also stated that her friend got expired vaccine too but had no reactions.) had resolved.            No concomitant medications were reported.  No treatment information was reported.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Minor receiving Moderna booster dose; Receiving booster 5 months after receiving 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Minor receiving Moderna booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receiving booster 5 months after receiving 2nd dose) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination.     Previously administered products included for COVID-19: Pfizer Vaccine (Patient received two doses of the Pfizer COVID-19 vaccine.) on 08-Jun-2021. Past adverse reactions to the above products included No adverse event with Pfizer Vaccine.    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, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Minor receiving Moderna booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receiving booster 5 months after receiving 2nd dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Minor receiving Moderna booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receiving booster 5 months after receiving 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No Treatment information was reported.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine administered expired  on 11/7/2021 10 days past the expiration date. .Vaccine administration error.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine administered expired  on 11/7/2021 10 days past the expiration date. .Vaccine administration error.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine administered expired  on 11/7/2021 10 days past the expiration date. .Vaccine administration error.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine administered expired  on 11/7/2021 10 days past the expiration date. .Vaccine administration error.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine administered expired  on 11/7/2021 10 days past the expiration date. .Vaccine administration error.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine administered expired  on 11/7/2021 10 days past the expiration date. .Vaccine administration error.