chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: worst pains, years later still have it; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 months after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   The reporter considered the pain to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter told that do not get the vaccine. The patient did vaccine and 3 months later had the worst pain in his life. The 2 and half year later still had pain. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I received my 1st shot in 2019; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first shot in around 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient asked who would have the record of his/her first dose and stated that his/her healthcare professional wants the record. The patient questioned who keeps the records of who gets these shots. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The VAERS details was reported for 1st dose. Follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: malaise; muscle aches; fever; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise, muscle pain and fever. On an unknown date, the outcome of the malaise, muscle pain and fever were unknown.   It was unknown if the reporter considered the malaise, muscle pain and fever to be related to Shingrix.     Linked case(s) involving the same patient: US2023015620   Additional Information: GSK Receipt Date: 01-FEB-2023 Reporter's Comment: The case was self-reported by the patient. The patient received first dose of Shingrix and developed malaise, muscle aches and fever several months ago reporting. Nothing else was reported. The reporter did not consent to follow up. Additional Supportive Information: For tolerance of 2nd dose, refer case US2023015620, reported by same reporter.; Sender's Comments:  US-GSK-US2023015620:Same reporter/Same patient
Sex: U
Vaccine: HEP, HEP
Symptoms: Accidental underdose
Clinical narrative: adult was administered a pediatric 1st dose; adult was administered a pediatric 1st dose; adult was administered a pediatric 1st dose; adult was administered a pediatric 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B pediatric) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 2nd dose of Engerix B pediatric .5 ml, Engerix B Pre-Filled Syringe Device, the 1st dose of Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device and not applicable after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced accidental underdose, adult use of a child product, accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose, adult use of a child product, accidental underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2023AMR011504   Additional Information: GSK Receipt Date: 25-JAN-2023 Reporter's Comments: RPH reported an Adult patient was inadvertently administered a Engerix Pediatric dose for a first dose and a pediatric dose for the second dose of Engerix Pediatric last year (2022). RPH unable to provide any vaccine or patient details. The pharmacist inquired how to proceed. The reporter consented to follow up. Additional Supportive Information: The patient received first and second dose as Engerix Pediatric, which led to accidental underdose and adult use of a child product.; Sender's Comments:  US-GSK-US2023AMR011504:same reporter - 2nd dose
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Electric shock sensation, Hypoaesthesia, Injected limb mobility decreased, Loss of personal independence in daily activities
Clinical narrative: Ulna nerve pain down into finger (OT / brace); Feels like an electric shock; Still painful; Extraordinarily uncomfortable; Hard to do things, affects daily activities; Numbness in finger tip; Not much use of pinky finger; This case was reported by a consumer via call center representative and described the occurrence of neuralgia in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2022, the patient received the 1st dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced neuralgia, electric shock sensation, pain, discomfort, activities of daily living impaired, numbness in fingers and injected limb mobility decreased. On an unknown date, the outcome of the neuralgia, electric shock sensation, pain, discomfort, activities of daily living impaired, numbness in fingers and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the neuralgia, electric shock sensation, pain, discomfort, activities of daily living impaired, numbness in fingers and injected limb mobility decreased to be related to Shingrix.     Additional Information: GSK receipt date: 26-JAN-2023 Reporter comment: The reporter was a patient. The patient about 3 to 4 days after receiving the first dose of Shingrix, the patient reports that she had ulna nerve pain in her right arm, which is the arm she received the vaccine in, down into her pinky finger.  The Patient reports that the pain "feels like an electric shock going down her arm like hitting your funny bone". The Patient reports it is now 5 months later after receiving the first dose of Shingrix and it is still painful, extraordinarily uncomfortable, it is hard to do things, she has numbness in her fingertip, she does not have much use of her pinky finger on her right hand, (Multiple AE's Filed), and if affects her daily activities. The patient has seen her PCP (primary care physician) and a hand specialist.  The hand specialist sent her to occupational therapy where she received a brace to wear, which she says helps, and was also given exercises to do. The reporter did not consent to follow up Note: TTO for all event conservatively capture as a 3 days because as a same pain which is described as origin of pain is further elaborated as nerve pain can cause numbness also query raised for the same.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Orthosis user, Pain
Clinical narrative: Ulna nerve pain down into finger (OT / brace); Feels like an electric shock; Still painful; Extraordinarily uncomfortable; Hard to do things, affects daily activities; Numbness in finger tip; Not much use of pinky finger; This case was reported by a consumer via call center representative and described the occurrence of neuralgia in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2022, the patient received the 1st dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced neuralgia, electric shock sensation, pain, discomfort, activities of daily living impaired, numbness in fingers and injected limb mobility decreased. On an unknown date, the outcome of the neuralgia, electric shock sensation, pain, discomfort, activities of daily living impaired, numbness in fingers and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the neuralgia, electric shock sensation, pain, discomfort, activities of daily living impaired, numbness in fingers and injected limb mobility decreased to be related to Shingrix.     Additional Information: GSK receipt date: 26-JAN-2023 Reporter comment: The reporter was a patient. The patient about 3 to 4 days after receiving the first dose of Shingrix, the patient reports that she had ulna nerve pain in her right arm, which is the arm she received the vaccine in, down into her pinky finger.  The Patient reports that the pain "feels like an electric shock going down her arm like hitting your funny bone". The Patient reports it is now 5 months later after receiving the first dose of Shingrix and it is still painful, extraordinarily uncomfortable, it is hard to do things, she has numbness in her fingertip, she does not have much use of her pinky finger on her right hand, (Multiple AE's Filed), and if affects her daily activities. The patient has seen her PCP (primary care physician) and a hand specialist.  The hand specialist sent her to occupational therapy where she received a brace to wear, which she says helps, and was also given exercises to do. The reporter did not consent to follow up Note: TTO for all event conservatively capture as a 3 days because as a same pain which is described as origin of pain is further elaborated as nerve pain can cause numbness also query raised for the same.
Age: 71.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Pediatric dose administered to an adult; Pediatric dose administered to an adult; Pediatric dose administered to an adult (27th October 2022); Pediatric dose administered to an adult (27th October 2022); This case was reported by a nurse via call center representative and described the occurrence of underdose in a 71-year-old male patient who received HBV (Engerix B pediatric) (batch number ZP72S, expiry date 15th December 2024) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) (batch number ZP72S, expiry date 15th December 2024) for prophylaxis.   On 23rd November 2022, the patient received the 2nd dose of Engerix B pediatric. On 27th October 2022, the patient received the 1st dose of Engerix B pediatric. On 27th October 2022, not applicable after receiving Engerix B pediatric and unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On 23rd November 2022, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose, adult use of a child product, underdose and adult use of a child product were unknown.     Additional Information: GSK receipt date :27 Jan 2023 Reporters comment: The nurse reported that the patient received 2 pediatric dose a month apart. Consent to follow up via email.  Additional supportive information. As an adult patient received 2 pediatric dose which led to adult use of child product and underdose.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received Hiberix 2 weeks ago and again on 26Jan2023; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 6-month-old female patient who received Hib (Hiberix) (batch number 97AP3, expiry date 9th November 2023) for prophylaxis.   Concomitant products included HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (HIBERIX).   On 26th January 2023, the patient received Hiberix. On 26th January 2023, unknown after receiving Hiberix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.      Additional Information: GSK receipt date :26 Jan 2023 Reporters comment: The employee had access to the patient's medical records. Receptionist stated that the patient received Hiberix 2 weeks ago and it was inadvertently administered again today (on the day of reporting). Reporter consented to follow up via postal.. Additional supportive information: As patient received vaccine 2 weeks ago and it was inadvertently administered again today which led to drug dose administration interval too short.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Vaccination failure, Weight decreased
Clinical narrative: received SHINGRIX prior to having shingles/suspected vaccination failure; had Shingles on inner thigh, shingles lesions reoccur; debilitating neuropathy pain; had a 50lb weight loss; pain; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included cortisone shot for post herpetic neuralgia and pain and prednisone for post herpetic neuralgia and pain.   The patient's past medical history included lung cancer.   On an unknown date, the patient received Shingrix, cortisone shot at an unknown dose and frequency and prednisone at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, post herpetic neuralgia, weight loss and pain. The patient was treated with gabapentin and morphine. The action taken with cortisone shot was unknown. The action taken with prednisone was unknown. On an unknown date, the outcome of the vaccination failure, weight loss and pain were unknown and the outcome of the shingles and post herpetic neuralgia were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia, weight loss and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comment: The reporter was the sister of the patient. About 2 years ago from reporting, the patient had shingles on his left inner thigh and the reporter believed that the patient received the Shingrix vaccine prior to this. The patient continued with debilitating neuropathy pain and shingles lesions occasionally resurface. The reporter stated that the patient had received Cortisone shots, Prednisone, and Nerve Blockers in the past and currently took Gabapentin and Morphine to control the pain. The patient had a 50 lb weight loss since having shingles. It was unknown if the reporter considered weight loss to be related to Cortisone shots, Nerve Blockers and Prednisone. The reporter did not consent to follow-up. Additional Supportive Information: 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. The case had been linked to US2023012633, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023012633:SAME REPORTER
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 4 years ago, 2nd never; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose at least 4 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 27-Jan-2023 Reporter's comment: The pharmacist called due to an immunocompetent patient who never received second dose. The reporter consented to follow-up by email. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Chest X-ray, Echocardiogram, Laboratory test, Myocarditis
Clinical narrative: SUSPECTED COVID-19 INFECTION; MYOCARDITIS; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via another pharmaceutical company (Pfizer) concerned a 65 year old female of an unspecified ethnicity. The patient's weight was 58.06 kilograms, and height was 163 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at the time of vaccination 64 year old. No concomitant medications were reported.  It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). Patient reported that she had a good night's sleep and was fine after Janssen vaccine.  The patient additionally received non-company suspect vaccine Pfizer Biontech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin and route of admin were not reported, batch number: EW0186 expiry: unknown) dose was not reported, administered on 20-NOV-2021 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2).  On 25-NOV-2021, 5 days after Pfizer booster vaccine the patient experienced myocarditis (dose number in series 2). She went to the doctor, had a number of tests then went to the cardiologist and had a number of tests. Patient had some chest pain. She mentioned that after 5 weeks she was fine. Cardiologist read all the results and told her even though she did not fit in the demographic that he believed she had myocarditis and it passed. Patient did not receive any treatment for myocarditis. On an unspecified date, patient had a chest X-ray, echocardiogram and a lunar nuclear stress test for which results were not reported. On 31-DEC-2022, the patient experienced covid-19 (suspected covid-19 infection, dose number in series 2). Patient still had some effect and had not received any treatment for covid-19. On the day of reporting, the patient said that she will be tested tomorrow for covid. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient recovered from myocarditis on JAN-2022, had not recovered from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20230203582- Myocarditis. The event has an compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered related.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan myocardial perfusion, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; MYOCARDITIS; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via another pharmaceutical company (Pfizer) concerned a 65 year old female of an unspecified ethnicity. The patient's weight was 58.06 kilograms, and height was 163 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at the time of vaccination 64 year old. No concomitant medications were reported.  It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). Patient reported that she had a good night's sleep and was fine after Janssen vaccine.  The patient additionally received non-company suspect vaccine Pfizer Biontech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin and route of admin were not reported, batch number: EW0186 expiry: unknown) dose was not reported, administered on 20-NOV-2021 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2).  On 25-NOV-2021, 5 days after Pfizer booster vaccine the patient experienced myocarditis (dose number in series 2). She went to the doctor, had a number of tests then went to the cardiologist and had a number of tests. Patient had some chest pain. She mentioned that after 5 weeks she was fine. Cardiologist read all the results and told her even though she did not fit in the demographic that he believed she had myocarditis and it passed. Patient did not receive any treatment for myocarditis. On an unspecified date, patient had a chest X-ray, echocardiogram and a lunar nuclear stress test for which results were not reported. On 31-DEC-2022, the patient experienced covid-19 (suspected covid-19 infection, dose number in series 2). Patient still had some effect and had not received any treatment for covid-19. On the day of reporting, the patient said that she will be tested tomorrow for covid. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient recovered from myocarditis on JAN-2022, had not recovered from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20230203582- Myocarditis. The event has an compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered related.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines) and NO ADVERSE EVENT (No adverse event) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 025L20A, 030L20A and 014F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 04-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines).    Concomitant Medication use information was not provided by reporter.  A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines.   It was unknown that the patient ever been diagnosed with/tested positive for COVID-19  It was unknown that the patient had acute illness at the time of vaccination and up to one month before.  It was unknown that the patient had any chronic or long-standing health conditions.  It was unknown that the patient was prescribed OTC medications, dietary supplements or herbal remedies being taken at the time of vaccination and/or at the time of adverse event.  Treatment Medication use information was not provided by reporter.   This case was linked to MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2023: Follow up received that contains significant information includes added reporter details, updated age of patient, added suspect product of the 4th dose route of administration and location of vaccination, added event start date and updated I narrative information.; Sender's Comments:  MODERNATX, INC.-MOD-2023-704260:Master Case
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022) and NO ADVERSE EVENT (No adverse event) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 32030BD, EN6203 and EN6198) for COVID-19 prophylaxis.     Acute illness at the time of vaccination, chronic illness or if patient has ever been diagnosed with COVID-19 was unknown.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (reported that they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022 Date of administration of vaccines were on 26Jul2022).    No concomitant product reported by reporter.  Pharmacy staff reported that they inadvertently administered 51 doses of the monovalent vaccines. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). No treatment medication was reported.   This case was linked to MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2023: Significant follow up received. Route of administration for 4th vaccine and narrative was updated.; Sender's Comments:  MODERNATX, INC.-MOD-2023-704260:(Master case)
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Administred Dose 1 on  28-Jan-2021 and Dose 2 on 11-Mar-2021; No adverse event; they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administred Dose 1 on  28-Jan-2021 and Dose 2 on 11-Mar-2021) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 027A21A and 030L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administred Dose 1 on  28-Jan-2021 and Dose 2 on 11-Mar-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administred Dose 1 on  28-Jan-2021 and Dose 2 on 11-Mar-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 40 doses of the monovalent vaccines/ expiration date 13Jul2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administred Dose 1 on  28-Jan-2021 and Dose 2 on 11-Mar-2021).    No concomitant product reported by reporter.  Pharmacy staff reported that they inadvertently administered 40 doses of the monovalent vaccines.  No treatment medication was reported.   This case was linked to MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2023: Significant Follow-Up information received: Reporter details, suspect's dosing details, route of administration, event verbatim and narrative updated. Sender's Comments:  MODERNATX, INC.-MOD-2023-704260:Master Case
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No Adverse event) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 014F21A, 030L20A and 025L20A) for COVID-19 prophylaxis.     It was not given if the patient was allergic to medications, food, and other products. It was unknown if the patient ever been diagnosed with or tested positive for covid-19. It was unknown if patient has illnesses at the time of vaccination and up to one month before. It was unknown if patient has chronic or long-standing health conditions. It was unknown if the patient was taken over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and or at the time of adverse event.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-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 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Concomitant product use was not provided by the reporter. Patient received 2nd and 1st booster dose.  Pharmacy staff reported that they inadvertently administered 51 doses of the monovalent vaccines. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2023: Follow up has significant information which included reporter detail, patient note, vaccine Information (suspect product route of administration, dose) and i-narrative supplement were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master case
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No Adverse event) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     It was unknown if the patient had any acute illness, chronic or long standing health or was taking prescription, over the counter medication, dietary supplements, or herbal remedies at the time of vaccination.  Previously administered products included for Product used for unknown indication: Pfizer (FIRST DOSE) on 27-Feb-2021, Pfizer (SECOND DOSE) on 27-Mar-2021 and Pfizer (FIRST BOOSTER) on 02-Dec-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 26-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022).    It was unknown if the patient was diagnosed with or had any COVID-19 positive test previously.   No concomitant medications was reported.  No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2023: Follow-up received, updated suspect drug information and I narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master case
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Aug-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 19-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022).    No concomitant medicine were reported.  It was unknown patient was ever been diagnosed with or tested positive for COVID-19. It was unknown if patient had acute illness at the time of vaccination and up to one month before and about chronic or long standing health conditions. It was unknow if patient took prescription, over the counter medications, dietary supplements or herbal remedies being taken at time of vaccination and/or at the time of the adverse event.  It was reported that patient was inadvertently administered doses of the monovalent vaccines for which expiration date was 13-Jul-2022.  No treatment medicine were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2023: Follow-up received wherein reporter details, dosage information, expiration date, batch number and I narrative information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:master case
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Reported that they inadvertently administered 51 doses of the monovalent vaccines expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Reported that they inadvertently administered 51 doses of the monovalent vaccines expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022) and NO ADVERSE EVENT (No adverse event) in a 99-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 025L20A, 030L20A and 069H21A) for COVID-19 prophylaxis.     Acute illness at the time of vaccination, chronic illness or if patient has ever been diagnosed with COVID-19 was unknown.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Reported that they inadvertently administered 51 doses of the monovalent vaccines expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Reported that they inadvertently administered 51 doses of the monovalent vaccines expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Reported that they inadvertently administered 51 doses of the monovalent vaccines expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022).    No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2023: Significant follow up received. Route of administration and dose details for 4th dose and narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:(Master case)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date; No adverse event; 9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date), PRODUCT STORAGE ERROR (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date), PRODUCT STORAGE ERROR (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date) and PRODUCT STORAGE ERROR (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date).    No concomitant medication was reported.  It was unknown if any other vaccines in the 4 weeks prior to COVID-19 vaccine was received.  9 patients received doses of the Moderna COVID-19 vaccine bivalent after its beyond use date lot AS7168B.  On 14-Dec-2022, the vial was initially stored in the fridge.  Pharmacist would like to be advised about the stability information, validity of the doses and if the patients should be revaccinated.  Vials was of size 2.5ml which did not undergo any temperature excursions.  This case contains information for the 7th of 9 patients described by the reporter.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704964 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704964:Master case - 1st adult patient (vaccine start date: 13-Jan-2023)