chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Initial insomnia, Insomnia, Loss of personal independence in daily activities, Magnetic resonance imaging head, Muscle twitching
Clinical narrative: In 2 weeks after the second shot I felt muscle twitching (mostly in my calves), vibration in different parts of my body, painful pins and needles, severe insomnia, jerk movements while falling asleep, internal tremor, burning in legs and arms. I visited 8 neurologists, 2 immunologists, took Lyrica, Gabapentin, Medrol, Miaser, Magnesium, VitB complex and many other supplements. All my symptoms did not change, I am straggling every day, can not work and live normal live. Desperately need help.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Tremor, Vibratory sense increased
Clinical narrative: In 2 weeks after the second shot I felt muscle twitching (mostly in my calves), vibration in different parts of my body, painful pins and needles, severe insomnia, jerk movements while falling asleep, internal tremor, burning in legs and arms. I visited 8 neurologists, 2 immunologists, took Lyrica, Gabapentin, Medrol, Miaser, Magnesium, VitB complex and many other supplements. All my symptoms did not change, I am straggling every day, can not work and live normal live. Desperately need help.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: product was stored in the fridge for 42 days; No adverse event; Dose administered after being stored in the fridge for 42 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after being stored in the fridge for 42 days), PRODUCT STORAGE ERROR (product was stored in the fridge for 42 days) 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. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Oct-2022 at 2:16 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after being stored in the fridge for 42 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (product was stored in the fridge for 42 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after being stored in the fridge for 42 days), PRODUCT STORAGE ERROR (product was stored in the fridge for 42 days) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after being stored in the fridge for 42 days) and PRODUCT STORAGE ERROR (product was stored in the fridge for 42 days).    No concomitant medicine were reported. It was reported that the vaccine was stored in the fridge for 42 days. Vaccine did not experience temperature excursions. Lot 083B22A was delivered on 8/29/22 and placed in the freezer. Vaccine was moved from the freezer to the fridge on 8/30/22 and administered on 10/10/22. Vial was first punctured on 10/10/22 at 2:15 PM and administered on 10/10/22 at 2:16PM.      No treatment medicine were reported.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received PROQUAD that had undergone temperature excursion; No additional AE reported; This spontaneous report was received from a healthcare worker and refers to a male patient of unknown age.  The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, lot #W006584, with expiration date reported as 11-DEC-2022 but upon internal validation confirmed as 23-AUG-2023, as prophylaxis (strength, dose, frequency, route of administration and anatomical location were not provided).   The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored at a temperature of 76.1 degrees Fahrenheit (F) for a time frame of 322 hours and 15 minutes. There was another previous temperature excursion, however no information was provided.  There was no additional adverse events.  This is one of three cases from the same reporter.; Sender's Comments:  US-009507513-2209USA009404: US-009507513-2209USA009412:02253610
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE; Caller is a state vaccine coordinator who reports a vaccines were administered following a temperature excursion. Nine patients were reported to have received this product following the temperature excursion; other AEs are reported in cases 02256465,; This spontaneous report was received from state vaccine coordinator, concerning to 4-month-old patient of unknown gender. The patient's medical history, previous allergies reaction, concomitant medications and concurrent conditions were not reported.   On 27-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral, (lot # W004501, has been verified to be a valid lot to ROTATEQ, expiration date: 20-APR-2023) for prophylaxis (strength and dose regimen were not provided). The administered vaccine, live, oral, pentavalent (ROTATEQ) underwent to temperature excursion of  8.6 degree Celsius for 18 minutes (product storage error). Additionally, it was informed that there were a previous temperature excursion on unknown dates of 11.5 degree Celsius for 1 hours 6 minutes, 8.8 degree Celsius for 21 minutes and 9.6 degree Celsius for 6 hours 41 minutes. No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010908: US-009507513-2209USA010872: US-009507513-2209USA010921: US-009507513-2209USA010983: US-009507513-2209USA010940: US-009507513-2209USA010884: US-009507513-2209USA010833: US-009507513-2209USA010910:
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The physician reported that a patient received improperly stored vaccine.; This spontaneous report was received from a physician and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 14-SEP-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U024221, expiration date: 04-AUG-2023, administered for prophylaxis (strength, dose and route of administration were not provided) (product storage error). Administered dose of vaccine underwent temperature excursion: -12.5 Celsius degrees for 1 hour. None previous temperature excursion was noted. No additional adverse event was reported (no adverse event).
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Reporter is a retired pharmacist stating that his sister (the patient) received the PNEUMOVAX 23 vaccine approximately 2 weeks ago and is still having arm soreness today. Reporter states the patient had the PNEUMOVAX 23 vaccine administered in her ri; This spontaneous report was received from a retired Pharmacist and refers to a 79-year-old female.  The patient's medical history included  unspecified cholesterol issues, unspecified blood pressure issues, and not known surgeries. The patient's concurrent conditions were not reported. Concomitant medications included influenza vaccine (INFLUENZA VACCINE, reported as FLU SHOT). The patient has taken (unspecified) cholesterol medication in the past; however, the patient may not be on the medication any longer. The patient may also be on an (unspecified) blood pressure medication.  The reporter stated that his sister (the patient) received the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered intramuscularly for prophylaxis (reported as pneumococcal disease) (strength, dose, lot #, and expiry date were not provided) in her right arm on 19-SEP-2022 (reported as approximately 2 weeks ago) and was still having arm soreness on 03-OCT-2022 (reported as today). On the same day, she had the influenza vaccine (INFLUENZA VACCINE, reported as FLU SHOT) administered in her left arm (strength, dose, route of administration, indication, lot #, and expiry date were not provided) .   The reporter advised his sister (the patient) to take ibuprofen for the soreness and advised her to report the soreness to her treating HCP. She started taking ibuprofen on 01-OCT-2022 (reported as 2 days ago) and was afraid to take more than 400 mg of ibuprofen per day.     The causal relationship between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2210USA006645:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse event; Caller reports that an expired dose of MMR II was administered to a patient today. Caller confirmed that dose was properly stored up through time of administration. No additional adverse events reported. No product quality complaints. No further info; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 06-OCT-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, 1 dose, lot #T031437, expiration date: 15-SEP-2022, administered as prophylaxis (strength, and route of administration were not provided) (expired product administered). It was reported that the dose was properly stored up through time of administration. No additional adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; Nurse calling for information on expired MMR II administered to a patient.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. The patient's concomitant therapies included sterile diluent that was used for vaccine reconstitution.  On 11-OCT-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin (rHA) (M-M-R II) subcutaneous injection, lot # T033814, expiration date 05-OCT-2022 (dose, dose number, strength, route and site of administration were not provided) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pharmacist called to request for information regarding administration of GARDASIL 9 after interruption in 3-dose schedule for 21 year old patient who received first dose in 2020 and is now requesting to complete series.; No additional AEs; This spontaneous report was received from a pharmacist and refers to a 21-year-old female patient. The patient's medical history, concomitant therapies, and concurrent conditions were not provided.  On an unknown date in 2020, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, dose of 0.5 milliliter, once (strength, route and site of administration, lot # and expiration date were not provided) for prophylaxis. The patient was now requesting to complete vaccination series (inappropriate schedule of product administration). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Caller reported expired dose of MMR II  was administered.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies, and concurrent conditions were not provided.  On 12-OCT-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin (rHA) (M-M-R II) subcutaneous injection, dose of 0.5 ml, administered subcutaneously, lot # T034389, expiration date 08-OCT-2022 (dose number, strength, and site of vaccination were not provided) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Healthcare business professional states unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients.; This spontaneous report was received from a health care professional referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 27-SEP-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally, lot number: W020106, expiration date was internally confirmed as 16-MAY-2023 (dose and dose number were not reported) and an improperly stored dose of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) pre-filled syringe, lot number: U7205AA, expiration date was internally confirmed as 23-OCT-2024 (dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse event (AE) details were provided (no adverse event).  On 26-SEP-2022, the administered doses of the suspect vaccines experienced a temperature excursion of the highest temperature of 9 degrees Celsius (C) for a total time of 15 minutes. It was unknown, whether the administered suspect vaccines experienced a previous temperature excursion. It was unknown, whether a digital data logger was involved.; Sender's Comments:  US-009507513-2210USA006289:2210USA006289 US-009507513-2210USA006287:2210USA006287 US-009507513-2210USA006288:2210USA006288
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE's were reported; Patient that received a dose of ROTATEQ after it expired. / The patient received their dose on 11-OCT-2022 and the dose expired on 5-OCT-2022.; This spontaneous report has been received from a medical assistant referring a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 11-OCT-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliter, lot number 1742084 with expiration date 05-OCT-2022, administered orally for prophylaxis (strength and vaccination scheme were not provided) (expired product administered) No additional adverse events were reported.
Sex: U
Vaccine: RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Healthcare business professional states unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients/ were administered to multiple patients since they were invloved in a temperature excursion; This spontaneous report was received from a health care professional referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 03-OCT-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, route of administration defaulted to oral, lot number: W020106, expiration date was internally confirmed as 16-MAY-2023 (exact dose and dose number were not reported) and an improperly stored dose of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) pre-filled syringe, lot number: U7205AA, expiration date was internally confirmed as 23-OCT-2024 (exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse event (AE) details were provided (no adverse event).  On 26-SEP-2022, the administered doses of the suspect vaccines experienced a temperature excursion of the highest temperature of 9 degrees Celsius (C) for a total time of 15 minutes. It was unknown, whether the administered suspect vaccines experienced a previous temperature excursion. It was unknown, whether a digital data logger was involved.
Sex: U
Vaccine: RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Healthcare business professional states unspecified vaccines involved in an unspecified temperature excursion may have been administered to unknown patients/ were administered to multiple patients since they were invloved in a temperature excursion; This spontaneous report was received from a health care professional referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 04-OCT-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, route of administration defaulted to oral, lot number: W020106, expiration date was internally confirmed as 16-MAY-2023 (exact dose and dose number were not reported) and an improperly stored dose of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) pre-filled syringe, lot number: U7205AA, expiration date was internally confirmed as 23-OCT-2024 (exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse event (AE) details were provided (no adverse event).  On 26-SEP-2022, the administered doses of the suspect vaccines experienced a temperature excursion of the highest temperature of 9 degrees Celsius (C) for a total time of 15 minutes. It was unknown, whether the administered suspect vaccines experienced a previous temperature excursion. It was unknown, whether a digital data logger was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral, Vaccination failure
Clinical narrative: getting injection, suffered horrible outbreak/Suspected vaccination failure; neuropathy still trouble her; suffered horrible outbreak early this year; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), neuropathy (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the neuropathy was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, neuropathy and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 14-Oct-2022 Reporter's comment: The case was received from the patient's children via interactive digital. The reporter was sure, learn about shingles, but thought very hard before getting an injection.  The patient did a couple years ago, and suffered a horrible outbreak early this year.  The neuropathy still troubles the patient.  The reporter stated that personally, he/she would look to a healthy lifestyle, not pharmaceutical promises. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: the patient was only given the liquid CYW portion; the patient was only given the liquid CYW portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA723Z, expiry date 31st August 2023) for prophylaxis.   On 10th October 2022, the patient received Menveo. On 10th October 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: 10-Oct-2022 Reporter's comment: The clinic supervisor reported the patient was administered with a dose of Menveo on 10th October 2022. The reporter stated that the provider was not aware there were two vials to reconstitute before administration, and the patient was only given the liquid CYW portion. At the time of reporting, the dose had not been repeated. The reporter gave permission for follow-up. Additional Supportive Information: The patient was only given the liquid CYW portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. There was discrepancy in the vaccination date reported in source document which was future date, hence it was captured as per narrative.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: red rash at injection area; red rash at injection area; This case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site rash and injection site erythema. On an unknown date, the outcome of the injection site rash and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash and injection site erythema to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-OCT-2022 Reporter's Comment: This case was reported by a patient via (Shingrix GSK) interactive digital media. The patient received dose of Shingles vaccine and asked how long would he/she had red rash at injection area. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain
Clinical narrative: injection site pain; injection site hard; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced injection site pain and injection site induration. On an unknown date, the outcome of the injection site pain and injection site induration were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injection site induration to be related to Shingles vaccine.     Additional Information: GSK receipt date:13-OCT-2022 Reporters comment: This case was reported by a consumer via interactive digital media  The patient received the shingle vaccine and experienced the injection site is painful and hard.  The patient asked was this normal.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fever; Aches and pains; Fatigue; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2022, the patient received the 1st dose of Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced fever, pain and fatigue. On an unknown date, the outcome of the fever, pain and fatigue were unknown.   It was unknown if the reporter considered the fever, pain and fatigue to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient just got Shingles vaccine 3 days ago from the date of reporting and had reaction fever aches and pains and fatigue. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix) (batch number 7ya99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 7th October 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 10-OCT-2022 Reporter's Comment: The reporter reported that the patient received expired dose of Havrix vaccine. No adverse event was reported. The reporter did not provide patient's identifiers. The reporter did consent to follow up. Additional supportive information: The patient received a Havrix which was already expired, which led to expired vaccine used.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received first dose of Havrix and the vaccine had expired on September 30th 2022; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 40-year-old female patient who received HAV (Havrix 1440 adult) (batch number 7ya99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2022, the patient received the 1st dose of Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 7th October 2022, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 10-Oct-2022 Reporter's comment: The pharmacist reported that the patient received the first dose of Havrix vaccine which had been expired on 30th September 2022.  The consent to follow up was granted.  The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: expired Bexsero was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 4th October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: Reporter's comment: Medical assistant reported that the expired Bexsero was administered to patient. The reporter consented to follow-up. Additional Supportive Information: The patient received a dose of Bexsero which was already expired, which led to expired vaccine used. This case had been linked with case US2022144896, reported by the same reporter.; Sender's Comments:  US-GSK-US2022144896:same reporter
Sex: F
Vaccine: MENB
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: Expired Bexsero administered; 60YO was administered Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 60-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 6th October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were 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: 10-OCT-2022 Reporter's Comment:  Reporter stated that 60 year old patient administered expired dose. Reporter asked how to proceed with patient vaccination.  Additional supportive information: As patient received expired dose and taken vaccine at inappropriate age which led to expired vaccine used and inappropriate age at vaccination. Reporter consented to follow up.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient was administrated with an expired dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 30-year-old female patient who received HAV (Havrix) (batch number 7ya99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 7th October 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 10-Oct-2022 Reporter's comment: The medical assistance reported on 10th October 2022 that the patient was administrated with an expired dose of Havrix on 7th October 2022. The vaccine expired on 30th September 2022.  No adverse event was reported. The consent to follow up was granted.  Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 7th October 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 10-OCT-2022 Reporter's comment: The Health care provider (HCP) had asked via chat if there was an expired Hep A (Havrix) vaccine given to the patient, was it invalid. It had expired on 30th September 2022 and it was given to the patient on 07th October 2022. The chat had got disconnected. No patient or HCPs identifiers were reported. The report was completed with the only information that was gathered during the chat. Follow-up would not possible as no contact details were available. Additional supportive information: The patient had received an expired dose of Havrix, which led to expired vaccine used.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 7th October 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 10-Oct-2022 Reporter's comment: The registered nurse manager reported that the patient was administered with expired dose of Havrix vaccine. The reporter consented to follow up. Additional Supportive Information: The patient was administered an expired dose of Havrix, which led to expired vaccine used.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Given only the liquid portion; Given only the liquid portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 19th August 2022, the patient received the 2nd dose of Menveo. On 19th August 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: 11-OCT-2022 Reporter's Comment: The reporter was an assistant manager. The reporter reported that the patient received only the liquid portion of the Menveo vaccine. The reporter stated that this was the patient second dose of the Menveo series. No lot number available and no further details provided during the call. The reporter did consent to follow up. Additional supportive information: The liquid portion of the Menveo vaccine was administered, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Administrated an expired dose of Bexsero; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number abxb58aa, expiry date 20th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 7th October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 11-OCT-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient received an expired dose of Bexsero vaccine. No adverse event was reported Patient identifiers was not provided. The reporter did consent to follow up. Additional supportive information: The patient received a Bexsero which was already expired, which led to expired vaccine used.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: inadvertently administered an expired Bexsero dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB59AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 11th October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 11-Oct-2022 Reporter's comment: The pharmacist called to inquire and asked was there any harm to the patient, should they revaccinate.  The registered pharmacist reported they inadvertently administered an expired Bexsero dose (expiry date was September 2022) to a patient.  The reporter did not consent to follow-up. Additional Supportive Information: The patient received expired dose of Bexsero, which led to expired vaccine used.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: received expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number unknown, expiry date 30th September 2022) for prophylaxis.   In October 2022, the patient received Boostrix. In October 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's Comment: The pharmacist reported that a dose of Boostrix given by error on the past few days to the patient and it was already expired.  No other information was available at the moment. The reporter did not consent to follow up.  Additional Supportive Information: The use of Boostrix dose, which was already expired on 30th September 2022, which led to expired vaccine used. This case was one of four cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR147249:same reporter US-GSK-US2022AMR147250:same reporter US-GSK-US2022AMR147251:same reporter
Age: 31.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Received a Menveo dose that had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 31-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA576A, expiry date 31st July 2022) for prophylaxis.   On 12th October 2022, the patient received Menveo. On 12th October 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's Comment: The reporter reported that the patient received expired Menveo vaccine. The reporter did consent to follow up. Additional supportive information: The patient received a Menveo which was already expired, which led to expired vaccine used.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Administered a dose reconstituted with sterile water; Administered a dose reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA724Z, expiry date unknown) for prophylaxis.   On 28th September 2022, the patient received Menveo. On 28th September 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's Comment: The reporter reported that the medical assistant administered a Menveo vaccine to a patient that was reconstituted with sterile water instead of the supplied CYW-135 liquid conjugate. The expiry date was not recorded. At the time of the reporting, the repeat dose was not administered. The vaccine administration facility was same as the primary reporter. The reporter did consent to follow up. Additional supportive information: Menveo reconstituted with sterile water instead of the supplied CYW-135 liquid conjugate, which led to Wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 64.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: was given an expired dose; 2nd dose beyond the 6-12 month; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 64-year-old female patient who received HAV (Havrix adult) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Previously administered products included Havrix adult (1st dose received on 20th March 2020).   On 12th October 2022, the patient received the 2nd dose of Havrix adult 1 ml. On 12th October 2022, unknown after receiving Havrix adult, the patient experienced expired vaccine used and drug dose administration interval too long. On an unknown date, the outcome of the expired vaccine used and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's Comments: The caller was a nurse reporting that a patient was given an expired dose of Havrix today.  The reporter also states that the patient got their first dose of Havrix March 2020 and so the second dose they got today was beyond the 6-12 month recommended second dosing schedule. The reporter did not consent to follow up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used. The patient received 2nd dose of  Havrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 2021, never received the 2nd; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose received on 15 Jul 2021).   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: 13-Oct-2022 Reporter's comment: The pharmacy technician reported that the patient received first dose of Shingrix series. The patient never received the second dose.  The reporter did not have the lot number and expiration date information for the first dose. At the time of reporting, the second dose was not administered.  The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.