chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: UNK
Symptoms: Pain, Pyrexia, Vomiting, Wheezing
Clinical narrative: injection site sore, left arm; and hours later she experienced wheezing; congestion getting better/Nasal congestion; Headache is better now but still remains.; Feels achy; Feels weak; now has diarrhea; Fever 101-104.5; threw up; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of adverse reaction (had a reaction to the Flu shot when patient was 11). Concurrent medical conditions included multiple allergies.   On 31st October 2022, the patient received the 1st dose of Fluarix Quadrivalent 2022-2023 season (intramuscular) and Fluarix Tetra Pre-Filled Syringe Device. On 31st October 2022, less than a day after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vomiting and fever. On 2nd November 2022, the patient experienced diarrhea. On an unknown date, the patient experienced injection site pain, wheezing, nasal congestion, headache, pain and feelings of weakness. The patient was treated with benadryl allergy (nos) (Benadryl Allergy), epinephrine (Epi Pen) and paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain was unknown and the outcome of the wheezing and nasal congestion were recovering/resolving and the outcome of the headache, diarrhea, pain and feelings of weakness were not recovered/not resolved and the outcome of the vomiting and fever were recovered/resolved.   It was unknown if the reporter considered the injection site pain, wheezing, nasal congestion, headache, vomiting, diarrhea, pain, feelings of weakness and fever to be related to Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 02-NOV-2022 Reporters comment:  The reporter reported left arm a little sore at injection site and hours later she experienced wheezing. She took Benadryl ( allergies)  and carried an EPI Pen. The patient was still wheezing and congestion getting better. Headache was better now but still remained. She reported she threw up the night of vaccine and now had diarrhea. She felt achy and weak. On the date of reporting, she reported fever was 101 degree F which had been higher, with the highest temperature recorded hours after vaccine and fever was 104.5 degree F. She had been taking Tylenol for the fever and aches. No other information provided.  Consented to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: missed the 21-30 day dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX) and HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On an unknown date, the patient did not receive the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-Nov-2022 Reporter's comment: The pharmacist stated that a patient who was between 55 to 65 years of age, was doing the accelerated dosing schedule and missed the 21-30 day dose.   The reporter consented to follow-up via email. Additional supportive information: Till the time of reporting the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Menveo reconstituted with different diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA748A, expiry date 30th November 2023) for prophylaxis.   On 3rd November 2022, the patient received Menveo. On 3rd November 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 3-Nov-2022 Reporter's comment: The nurse called to ask for information about the administration of Menveo which was reconstituted with a different diluent than the supplied meningococcal CYW-135 (MenCYW-135) liquid conjugate. The reporter asked how to proceed with patient vaccination. Did not consent to follow-up. Additional supportive information; The patient received Menveo vaccine which was reconstituted with a different diluent, which led to wrong solution used in drug reconstitution.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only the diluent; Administered only the diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA677A, expiry date 30th March 2024) for prophylaxis.   On 2nd November 2022, the patient received the 1st dose of Menveo. On 2nd November 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 3-Nov-2022 Reporter's comment: The reporter consented to follow-up by email. Additional supportive information: The patient was vaccinated with only the diluent of Menveo, which led to
Age: 87.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2018, the patient received the 2nd dose of Shingrix. In May 2018, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 04-Nov-2022 Reporter's Comments: The patient self-reported this case. The patient stated that he had shingles but had no pain with his case of shingles. The reporter did not consent to follow-up. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue, Wrong product administered
Clinical narrative: This spontaneous case was reported by another health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), WRONG PRODUCT ADMINISTERED (Patient received 611-year-old Moderna COVID-19 vaccine instead of the 12+ Moderna COVID-19 vaccine/ Received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), WRONG PRODUCT ADMINISTERED (Patient received 611-year-old Moderna COVID-19 vaccine instead of the 12+ Moderna COVID-19 vaccine/ Received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), POOR QUALITY      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna COVID-19 Vaccine Monovalent and Bivalent after a temperature excursion) and WRONG PRODUCT ADMINISTERED (Patient received 611-year-old Moderna COVID-19 vaccine instead of the 12+ Moderna COVID-19 vaccine/ Received the Monovalent Moderna COVID-19 vaccine instead of the Bivalent Moderna COVID-19 vaccine).    Concomitant product use was not provided by the reporter.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, COVID-19 immunisation, Hypersensitivity
Clinical narrative: ANAPHYLACTIC REACTION; ALLERGIC; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total, first dose administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date following vaccination with first dose of covid-19 vaccine ad26.cov2.s, the patient experienced anaphylactic reaction (Dose number in series: 1). The patient received non-company suspect vaccine covid-19 vaccine (Unspecified manufacturer) (Dose number in series: 2) (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, first booster administered for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series: 2). On an unspecified date following vaccination with covid-19 vaccine (Unspecified manufacturer), the patient experienced allergic (Dose number in series: 2). The patient additionally received non-company suspect vaccine covid-19 vaccine (Unspecified manufacturer) (Dose number in series: 3) (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, second booster administered for covid-19 prophylaxis. On an unspecified date following vaccination with covid-19 vaccine (Unspecified manufacturer), the patient again experienced allergic (Dose number in series: 3). The action taken with covid-19 vaccine ad26.cov2.s, covid-19 vaccine, and covid-19 vaccine was not applicable. The outcome of the anaphylactic reaction, allergic and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:   20221109010-Anaphylactic reaction. The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT PRODUCT STORAGE; ADMINISTERED VACCINE STORED AT A MINIMUM TEMPERATURE OF (PLUS) 40.6 DEGREES FAHRENHEIT TO A MAXIMUM TEMPERATURE OF (PLUS) 48.7 DEGREES FAHRENHEIT FOR 32 MINUTES; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202F21A expiry: 07-FEB-2023) dose was not reported, administered on 03-NOV-2022 for covid-19 prophylaxis. The drug was associated with Medication error. No concomitant medications were reported. On 03-NOV-2022, the patient experienced administered vaccine stored at a minimum temperature of (plus) 40.6 degrees fahrenheit to a maximum temperature of (plus) 48.7 degrees fahrenheit for 32 minutes. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered vaccine stored at a minimum temperature of (plus) 40.6 degrees fahrenheit to a maximum temperature of (plus) 48.7 degrees fahrenheit for 32 minutes and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20221118522.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via a company representative via media concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 01 total start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died from unknown cause. It was unknown whether the autopsy was performed. It was reported that, " I have seen a few healthy people who was vexed with their plandemic who either died.... " The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20221118918.; Sender's Comments: V0- 20221118772-Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: General physical condition abnormal
Clinical narrative: HEALTH ISSUES; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced health issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of health issues was not reported. This report was non-serious. This case, from the same reporter is linked to 20221118772.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINE FAILURE; CONFIRMED COVID-19 INFECTION / RECURRENCE OF ILLNESS AFTER RECOVERY, TESTED POSITIVE FOR COVID AGAIN; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included: neutropenia, and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient had no known drug allergy. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, 01 total administered at left arm on 30-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 58 years old. No concomitant medications were reported. The patient additionally received non-company suspect vaccine included: tozinameran (Pfizer/ BioNTech) (Dose number in series 2) (form of admin, route of admin were not reported, batch number: PE3590 expiry: UNKNOWN) dose was not reported, administered at right arm on 24-OCT-2021 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 2). On an unspecified date in OCT-2022 patient had illness and patient tested positive for which patient received non company suspect Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered from 17-OCT-2022 till 22-OCT-2022 for treatment of Covid-19. On 26-OCT-2022 08:00, the patient experienced recurrence of illness after recovery. Tested positive for Covid again (confirmed covid-19 infection). Laboratory data included: COVID-19 virus test Positive again (Dose number in series 2) which resulted to confirmed clinical vaccine failure (Dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; with tozinameran was not reported; and action taken with paxlovid was drug discontinued on 22-OCT-2022. The patient had not recovered from confirmed covid-19 infection / recurrence of illness after recovery, tested positive for covid again, and the outcome of confirmed clinical vaccine failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint. This report was associated with product quality complaint: 90000258779.; Sender's Comments: V0: 20221118958-confirmed clinical vaccine failure. The event 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. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEAD IN SLEEP; This spontaneous report received from a consumer via a company representative through media concerned a 26 year old male of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. Age at time of vaccination 3 decade old. No concomitant medications were reported.  On an unspecified date, two weeks after Janssen vaccine, the patient died in his sleep. It was reported that "My 26 year old nephew dead in his sleep 2 weeks after J and J jab". On an unspecified date, the patient died from an unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221119726-Dead in sleep. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Rash
Clinical narrative: This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 in total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  Patient was not having any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). Patient received non-company suspect vaccine included: tozinameran (Pfizer vaccine) (Dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported), dose, start therapy date were not reported for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 2).  On an unspecified date, the patient experienced rash for 2 months following vaccination with tozinameran (Pfizer vaccine) (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash for 2 months after a pfizer booster, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nervous system disorder
Clinical narrative: NEUROLOGICAL ISSUES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the patient experienced neurological issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neurological issues. This report was non-serious. This case, from the same reporter is linked to 20221122808.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; expired dose administered (Expiration Date: Oct 11, 2021 and January 13, 2022); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered (Expiration Date: Oct 11, 2021 and January 13, 2022)) and NO ADVERSE EVENT (No adverse event) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 prophylaxis.     None allergies to medications, food and other products. Patient never diagnosed with or tested positive for COVID-19. Patient had no acute illness at the time of vaccination and up to one month before. Patient had no chronic or longstanding health conditions.    On 22-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered (Expiration Date: Oct 11, 2021 and January 13, 2022)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered (Expiration Date: Oct 11, 2021 and January 13, 2022)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (expired dose administered (Expiration Date: Oct 11, 2021 and January 13, 2022)) and NO ADVERSE EVENT (No adverse event) to be not related.    No concomitant information was reported. It was reported that No adverse reaction reported. Patient didn't experience any side effects. The event did not cause the patient to seek medical care. There were no other potential causes. Patient had not experienced similar event in the past. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: received the Moderna Monovalent Booster instead of the bivalent vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     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 INCORRECT DOSE ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         Concomitant product use was not provided by the reporter.  The nurse stated that it happened because of the monovalent vaccine with the purple border was labeled booster doses.  Treatment information was not provided.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: received the Moderna Monovalent Booster instead of the bivalent vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine).    No concomitant medications were reported.  It was reported that, the patient received the Moderna Monovalent Booster instead of the bivalent vaccine. The nurse stated that, this happened because the monovalent vaccine with purple border was labeled as booster dose.  No adverse event noted.  No treatment medications were reported.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: received the Moderna Monovalent Booster instead of the bivalent vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           No concomitant medications were reported.  It was reported that, the patient received Moderna monovalent booster instead of the bivalent vaccine. According to the nurse, this happened because the monovalent vaccine with purple border was labeled as booster dose.  No adverse event noted.  No treatment medications were reported.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received the Moderna Covid-19 vaccine monovalent instead of the bivalent vaccine for the booster dose; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine monovalent instead of the bivalent vaccine for the booster dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine monovalent instead of the bivalent vaccine for the booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine monovalent instead of the bivalent vaccine for the booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine monovalent instead of the bivalent vaccine for the booster dose).    No concomitant medications were reported.  The reporter stated that this medication error had happened because the monovalent vaccine with the purple border was labeled as booster doses.  No treatment information was provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     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 INCORRECT DOSE ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine).    Concomitant product use was not provided by the reporter.  The nurse stated that it happened because of the monovalent vaccine with the purple border was labeled booster doses.  Treatment information was not provided.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: received the Moderna Monovalent Booster instead of the bivalent vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine).    No concomitant medications were reported.  It was reported that, the patient received the Moderna Monovalent Booster instead of the bivalent vaccine. The nurse stated that, this happened because the monovalent vaccine with purple border was labeled as booster dose. No adverse event noted.  No treatment medications were reported.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine have undergone several temperature excursions and was administered to the patient), PRODUCT TEMPERATURE EXCURSION ISSUE (refrigeration excursions identified) and NO ADVERSE EVENT (No adverse event) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Aug-2022 at 4:42 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine)       Vaccination site was deltoid muscle.  The nurse reported that, Moderna Monovalent and Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back in Aug-2022. It was reported that, refrigeration excursions were identified, and state vaccines were housed in these units. The manufactures were notified, and the state department made aware of the situation. The storage condition of vial at the time of excursion was in refrigerator. The vials were not visually inspected.  No adverse reactions reported for the patient.  No treatment medications were reported.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: received the Moderna Monovalent Booster instead of the bivalent vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine).    No concomitant medications were reported. During a Moderna Covid-19 vaccine clinic patient received Moderna COVID-19 vaccine monovalent instead of the bivalent dose for their booster dose. Nurse stated this happened because the monovalent vaccine with the purple border was labeled "booster doses". No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: received the Moderna Monovalent Booster instead of the bivalent vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     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 INCORRECT DOSE ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine).    Concomitant product use was not provided by the reporter.  The nurse stated that it happened because of the monovalent vaccine with the purple border was labeled booster doses.  Treatment information was not provided.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: received the Moderna Monovalent Booster instead of the bivalent vaccine; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received the Moderna Monovalent Booster instead of the bivalent vaccine).    No concomitant medications were reported.  It was reported that, the patient received the Moderna Monovalent Booster instead of the bivalent vaccine. The nurse stated that, this happened because the monovalent vaccine with purple border was labeled as booster dose.  No adverse event noted.  No treatment medications were reported.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) in a 37-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022 at 8:58 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 26-Sep-2022 at 8:58 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: ; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccines undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 52-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.       For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccines undergone several temperature excursions and have been administered to patient).    No concomitant medication was provided.    Date vial was moved from freezer to refrigerator on 7-Sep-2022. The 2 unbroken cartons 20 vials.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. It was reported that no adverse reactions were reported to their knowledge for any patients.  Treatment medication was not provided by the reporter
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine monovalent instead of the bivalent vaccine for their booster dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine monovalent instead of the bivalent vaccine for their booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine monovalent instead of the bivalent vaccine for their booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         No concomitant medications were reported.  During a Moderna Covid-19 vaccine clinic patient received Moderna COVID-19 vaccine monovalent instead of the bivalent dose for their booster dose. Nurse stated this happened because the monovalent vaccine with the purple border was labeled "booster doses".  No treatment information was provided.