chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, VARZOS
Symptoms: Vaccination site nerve damage
Clinical narrative: Sciatic nerve problems; Nerve damage in the injection arm; Mono; Herpes zoster reactivation; Herpes simplex reactivation; Immediately after receiving the vaccine I noticed a difference (IQ)/ As soon as I got the ZOSTAVAX vaccine my IQ shot back up to 159; This spontaneous report has been received from a consumer referring to herself as an adult female patient of unknown age. The patient's pertinent medical history included history of mono, chicken pox multiple times, and family history of Alzheimer. Patient's concomitant medication included levothyroxine, topiramate, and allergy pills. Patient's drug reactions or allergies included baby aspirin.  On an unknown date in 2018 (also reported as 4 years ago), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneous injection, (dose, strength, frequency, site of vaccination, route of administration, expiration date, and lot number were not provided) administered for prophylaxis. On an unknown date, the patient was vaccinated with a COVID-19 vaccine (reported as Johnson and Johnson COVID 19 vaccine), and on December 10th of an unknown year, the patient vas vaccinated with elasomeran (MODERNA COVID-19 VACCINE).  The reporter stated that the zoster vaccine live (ZOSTAVAX), had a benefit she did not expect "I did not know at the time, but the zoster vaccine live (ZOSTAVAX) cured herpes type 1 and type 2". She stated that her intelligent quotient (IQ) was 159 and it tanked at 75 (before vaccine) and no one could figure out the reason; immediately after she received the vaccine, she noticed a difference. It was also reported that as soon as she got the zoster vaccine live (ZOSTAVAX), her IQ shot back up to 159 (unexpected therapeutic benefit). The reporter informed that at the time she received the zoster vaccine live (ZOSTAVAX), she did not realize she had herpes type 1. She also stated that, after she received the Johnson and Johnson COVID-19 vaccine, it reactivated all the viruses she previously suffered from (herpes zoster reactivation and herpes simplex reactivation). Additionally, she reported that after she received one of the COVID 19 vaccines, she experienced nerve damage in the injection arm (vaccination site nerve damage), mono (mononucleosis infectious), and sciatic nerve problems (sciatic nerve neuropathy). The causal relationship between pembrolizumab (KEYTRUDA) and the events were not provided.  The outcome of the events was not provided. The action taking regarding the suspect therapy and the events was not provided.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional AEs reported; Caller reported 30 year old female received 1st GARDASIL 9 in 2007 and received 2nd GARDASIL 9 vaccine on 10/15/2022.  Lot number and expiration date documented for 2nd dose.  Information for 1st dose is unknown.   No other information provided.  No; This spontaneous report was received from a pharmacist and refers to a 30-year-old female patient. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On an unknown date in 2007, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, anatomical location, lot #, and expiration date were not reported) and on 15-OCT-2022, the patient received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 ml, administered intramuscularly, lot # U019412 confirmed to be valid for formulation syringe, expiration date 30-OCT-2023 (anatomical location was not reported), both for prophylaxis (inappropriate schedule of product administration). No additional adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event reported; Expired dose of ROTATEQ  was administered to a patient; This spontaneous report was received from a medical assistant and and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported    On 21-OCT-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally,  lot # 1742415, expiration date 12-OCT-2022, for prophylaxis (dose not reported) (expired product administered).        Medical assistant confirmed the vaccine was stored according to the recommended storage range until administration and was not involved in a prior excursion. No additional adverse event and no product quality complain were reported.
Age: 20.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A 20 year old patient received PROQUAD.; no additional advers event; This spontaneous report was received from a medical assistant and refers to a 20-year-old patient.  The patient's medical history, concurrent conditions, and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, lot #, expiry date, and route of administration were not provided) as prophylaxis (Product administered to patient of inappropriate age). No adverse event was reported.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/; A vaccine coordinator called to report an AE where improperly stored dose of  were administered to a patient; This spontaneous report has been received from a vaccine coordinator regarding 18-month-old patient of unknown gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 21-OCT-2022, the patient was vaccinated with an improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) injection, lot # W023937 confirmed to be valid with expiration date 06-DEC-2023 (exact dose, route of administration, and anatomical location were not reported), for prophylaxis.  On an unknown date, before administration, the vaccine underwent a temperature excursion of 33.6 degrees Fahrenheit (F) for 3 hours and 46.9 degrees Fahrenheit (F) for 1 hour and 48 minutes (product storage error). On an unspecified dates, there were previous temperature excursions reported as follows: 34.3 degrees Fahrenheit for 48 minutes, 34.3 degrees Fahrenheit for 1 hour and 42 minutes, 34.9 degrees Fahrenheit for 1 hour 18 minutes, and 34.3 degrees Fahrenheit for 1 hour and 18 minutes. No adverse effects were reported. No additional information was provided to further clarify these details.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no additional adverse event; patient was supposed to have been administered a dose of TDap, but was accidentally administered a dose of GARDASIL 9; This spontaneous report was received from medical assistance and refers to 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 accidentally administered a dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) (strength, lot #, expiry date, anatomical location, and route of administration were not provided) as  prophylaxis; instead of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) (strength, formulation, dose description, lot #, expiry date, route of administration, and indication were not provided). No adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; HCP states that ROTATEQ was administered to a patient after temperature excursions; This spontaneous report was received from a pharmacist regarding to a patient of unspecified age and gender. The patient's pertinent medical history, drug reactions and allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #W002561, expiration date: 07-OCT-2023 (dosage regimen was not provided) administered orally as prophylaxis (product storage error).   The improperly stored vaccine dose underwent a temperature excursion for 1 hour at 9.13 degrees Celsius (C), and 37 hours and 15 minutes at minimum of -8.45 C without previous excursions. No adverse events were reported.
Age: 0.08
Sex: F
Vaccine: RV5
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: the patient did not experience any side effects.; patient who is 5 weeks and 1 day old was administered a few drops of ROTATEQ on 10/27/2022.; patient who is 5 weeks and 1 day old was administered a few drops of ROTATEQ on 10/27/2022.; This spontaneous report was received from a medical assistant regarding a 5-week-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 27-OCT-2022, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) taken orally (strength, dosage regimen, lot #, and expiry date were not provided) for prophylaxis (Product administered to patient of inappropriate age). It was reported that the patient received a few drops of the vaccine (Incorrect dose administered). She did not experience any side effects. The patient did not received treatment and did not sought medical attention.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information.; a dose of PROQUAD was administered on 10/18/2022 after a temperature excursion.; This spontaneous report was received from an office manager regarding a 12-month-old patient of an unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 18-OCT-2022, the patient was vaccinated with an improper stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot #W017571, expiration date: 29-NOV-2023, (strength, dosage regimen, and route of administration were not provided) administered as prophylaxis (Product storage error).  The improperly stored vaccine underwent a temperature excursion of 6 degrees Fahrenheit (F) up to 14 degrees Fahrenheit (F) (10.91 F) for 1 hour without previous excursions. No adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse reporting a temperature excursion for VARIVAX that occurred on 10/10/2022 states a dose has been administered. No additional information provided. No additional AE/PQC  Names of vaccines involved: VARIVAX: U032852 10/20/2023        ?    Tempe; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 10-OCT-2022, the varicella virus vaccine live (oka/merck)(VARIVAX) lot # U032852, expiration date 20-OCT-2023 had a temperature excursion of 6.8 degrees Fahrenheit for 30 minutes, and on 22-OCT-2022 0.5 milliliters were administrated to a patient (product storage error). No adverse event was reported.  There were no previous excursions detected.
Sex: F
Vaccine: HEP
Symptoms: Iridocyclitis, Iris adhesions
Clinical narrative: asymptomatic bilateral anterior uveitis; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to 58-year-old female, with no history of autoimmune disease. Concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown) (dose, route, site of administration, lot # and expiration date not reported) for prophylaxis. Three weeks after vaccination, the patient experienced asymptomatic bilateral anterior uveitis. It was also reported, that uveitis following vaccination was with development of posterior synechiae in her right eye only. Then, due to the event, as she received her first "Moderna COVID-19 vaccine" on 25-FEB-2021, she also received an eye examinations by an ophthalmologist just after her vaccination and then weekly to evaluate for any ocular changes.   The outcome of the event asymptomatic bilateral anterior uveitis was unknown. The causality assessment between the suspect vaccine and the event was assessed as related.  After internal review, the event asymptomatic bilateral anterior uveitis was considered to be medically significant.   Literature report:   A copy of the published article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; vaccine administered after temperature excursion; This spontaneous report was received from a Medical Assistant concerning a patient of unknown age and gender. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 07-NOV-2022, the patient was vaccinated with an improperly storage dose varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 ml administered subcutaneously (SQ) as prophylaxis, lot number W017551 with expiration date 01-JUN-2024. The vaccine underwent a temperature excursion of -11.7 C for 6 hours and 17 minutes with no previous temperature excursions (Product storage error). No additional adverse events were reported (No adverse event).; Sender's Comments:  US-009507513-2211USA002369: US-009507513-2211USA002303:
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Only waited 30 minutes before eating after taking the doses; A spontaneous report was received from a physician assistant on 05OCT2022. It described a female patient (unknown age) who "only waited 30 minutes before eating after taking the doses" (PT: Product administration error). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient took all four doses of Vivotif but only waited 30 minutes before eating after taking her doses. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer only waited 30 minutes before eating after taking the Vivotif doses (product administration error). Vivotif dose should be taken at least one hour before a meal. Considering the nature of the event, the causality of product administration error is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer only waited 30 minutes before eating after taking the Vivotif doses (product administration error). Vivotif dose should be taken at least one hour before a meal. Considering the nature of the event, the causality of product administration error is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.
Age: 75.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: she had a fever of 102; bad headache; This case was reported by a consumer via patient support programs and described the occurrence of fever in a 76-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (Trelegy Ellipta) inhalation powder (batch number RN8B, expiry date December 2023) for emphysema, chronic obstructive pulmonary disease and asthma, fluticasone fur+umeclidinium+vilanterol ellipta dry powder inhaler device (Trelegy Ellipta Dry Powder Inhaler Device) inhaler (batch number RN8B, expiry date December 2023) for emphysema, chronic obstructive pulmonary disease and asthma and COVID-19 VACCINE (COVID 19 VACCINE BOOSTER) for prophylaxis.   Concurrent medical conditions included gout and arthritis. Concomitant products included prednisone.   On 27th October 2022, the patient received the 1st dose of Flu vaccine. In October 2021, the patient started Trelegy Ellipta at an unknown dose and frequency and Trelegy Ellipta Dry Powder Inhaler Device. On 27th October 2022, the patient received COVID 19 VACCINE BOOSTER. On 27th October 2022, less than a day after receiving Flu vaccine and unknown after starting Trelegy Ellipta and Trelegy Ellipta Dry Powder Inhaler Device, the patient experienced fever and headache. Trelegy Ellipta was continued with no change. On an unknown date, the outcome of the fever and headache were not recovered/not resolved.   It was unknown if the reporter considered the fever and headache to be related to Flu vaccine. The reporter considered the fever and headache to be unrelated to Trelegy Ellipta and Trelegy Ellipta Dry Powder Inhaler Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-OCT-2022  Reporter's comments: This case was reported by a consumer via patient support programs. The reporter stated that the patient had received the first dose of the flu shot and the covid fourth booster vaccine and had experienced a fever of 102 degree Fahrenheit. The reporter stated that she has a bad headache and was currently taking Trelegy Ellipta. Less than a day after Covid booster vaccination, the patient had fever and headache. The reporter had consent to follow-up. It was unknown if the reporter had considered the chickenpox to be related to COVID 19 VACCINE BOOSTER.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: didn't get my 2nd dose when suppose to; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received almost 2 years ago from the date of reporting).   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: 31-OCT-2022 Reporter's Comment: The patient self-reported this case. The patient asked he/she did not get his/her 2nd dose of Shingrix when he/she was supposed to. Should he/she start all over or just get 2nd. The reporter asked what a patient should do if their second dose of Shingrix was later than six months after receiving the first dose. The patient read suggestion, but it had been almost two years since first dose. So, he/she thought he/she should asked. The patient also stated that his/her healthcare provider did not know because it had been so long and asked him/her to contact GlaxoSmithKline. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to Incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash all over their body; This case was reported by a nurse via sales rep and described the occurrence of generalized rash in a 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 generalized rash. On an unknown date, the outcome of the generalized rash was unknown.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's comment: The nurse reported that the patient received a dose of Shingrix and got a rash all over body. The reporter was unsure if either was reported so reporting since it was unknown. The reporter stated that he gave a lot of Shingrix and these were the only two times he had this reaction. The reporter did not agrees to follow up from GlaxoSmithKline. Additional Supportive Information: This case had been linked with US2022AMR159095, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR159095:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash all over their body; This case was reported by a nurse via sales rep and described the occurrence of generalized rash in a 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 generalized rash. On an unknown date, the outcome of the generalized rash was unknown.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's comment: The nurse reported that the patient received a dose of Shingrix and got a rash all over body. The reporter was unsure if either was reported so reporting since it was unknown. The reporter stated that he gave a lot of Shingrix and these were the only two times he had this reaction. The reporter did not agrees to follow up from GlaxoSmithKline. Additional Supportive Information: This case had been linked with US2022AMR159094, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR159094:Same reporter
Age: 6.0
Sex: U
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: My six year-old received Bexsero vaccine today.; This case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a 6-year-old patient who received Men B NVS (Bexsero) 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 2nd November 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd November 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 02-NOV-2022 Reporter's comments: This case was reported by the reporter via interactive digital media. The reporter stated that her six year-old accidentally received the Bexsero vaccine on the day of reporting. The reporter had also asked about the risk. Additional supportive information: The patient who had received Bexsero vaccine was of six years old age, which had led to inappropriate age at vaccine administration. Follow-up would not possible as no contact details were available.
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 month-old administered Fluarix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number ZC776, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st October 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 31st October 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 31-Oct-2022 Reporter's comment: The medical assistant called to inquire regarding any adverse reactions to look for or any studies which were available. The medical assistant reported that the 4 month old patient was inadvertently administered Fluarix today on 31st October 2022 in their facility. The consent to follow up was granted. Additional supportive information: The patient received vaccine at the age of 4 month, hence inappropriate age at vaccine administration was captured. This case was linked with case US2022126175, reported by the same reporter.; Sender's Comments:  US-GSK-US2022126175:Same reporter
Sex: M
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: vaccines were warm to touch with ice packs melted; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a male patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 31-OCT-2022 Reporter's comment: The pharmacist had called to inquire on how to proceed with the vaccine. The pharmacist had stated that they had received a Flulaval delivery and vaccines were warm to touch with ice packs melted. Another Pharmacist had placed the vaccines into quarantine. Afterwards, three patients were administered the vaccines by another Healthcare Professional (HCP) in their facility. One patient was administered on 21 October 2022, one patient on 22 October 2022 and last patient on 27 October 2022. The pharmacist was unable to provide any additional details. The reporter did not consent to follow-up. Additional supportive information: At the time of reporting, the Flulaval Quadrivalent vaccine was not stored as per the recommended storage condition, which had led to incorrect storage of drug. This was one of the case reported amongst the three patients.; Sender's Comments:  US-GSK-US2022157187:same reporter US-GSK-US2022157186:same reporter
Sex: F
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Vaccines was warm to touch with ice packs melted; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd October 2022, the patient received FluLaval Quadrivalent 2022-2023 season. On 22nd October 2202, the patient started Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 31-OCT-2022 Reporter's comment: The pharmacist had called to inquire on how to proceed with the vaccine. The pharmacist had stated that they had received a Flulaval delivery and vaccines were warm to touch with ice packs melted. Another Pharmacist had placed the vaccines into quarantine. Afterwards, three patients were administered the vaccines by another Healthcare Professional (HCP) in their facility. One patient was administered on 21 October 2022, one patient on 22 October 2022 and last patient on 27 October 2022. The pharmacist was unable to provide any additional details. The reporter did not consent to follow-up. Additional supportive information: At the time of reporting, the Flulaval Quadrivalent vaccine was not stored as per the recommended storage condition, which had led to incorrect storage of drug. This was one of the case reported amongst the three patients.; Sender's Comments:  US-GSK-US2022157185:same reporter US-GSK-US2022157187:same reporter
Sex: F
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: vaccines were warm to touch, and were administered; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 31-OCT-2022 Reporter's comment:  The pharmacist had called to inquire on how to proceed with the vaccine. The pharmacist had stated that the patient received a Flulaval delivery and vaccines were warm to touch with ice packs melted. Another Pharmacist had placed the vaccines into quarantine. Afterwards, three patients were administered the vaccines by another healthcare professional in their facility.  The patient was administered on 27 October 2022.  The pharmacist was unable to provide any additional details. The reporter did not consent to follow-up. This case had been linked with US2022157186 and US2022157185 , same reporter.; Sender's Comments:  US-GSK-US2022157186:same reporter US-GSK-US2022157185:same reporter
Sex: F
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 month patient received a Flulaval dose; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number pc53y, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st October 2022, the patient received the 1st dose of FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 21st October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 31-Oct-2022 Reporter's Comment:  The nurse reported that 2 month patient received a Fulaval dose by mistake. The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The 2 months patient received Flulaval dose, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: HEP, TDAP
Symptoms: Product storage error
Clinical narrative: Boostrix went out of range, could have been used; Engerix-B box is still sealed, it was not used after the prior excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Boostrix and Engerix B. On an unknown date, unknown after receiving Boostrix and not applicable after receiving Engerix B, the patient experienced incorrect storage of drug and intercepted product storage error. On an unknown date, the outcome of the incorrect storage of drug and intercepted product storage error were unknown.   Additional Information: GSK receipt date: 31 Oct 2022 Reporter comment: The reporter was medical assistant. Reporter requested stability information for Boostrix and Engerix-B vaccines that went out of range for 269 minutes to a maximum temperature of 52.9 degree F. Reporter reported the vaccines also had a prior excursion on 28th September 2022 to 3rd October 2022 lasting for 114 hours. The maximum temperature was 96.4 degree F.  The reporter stated that vaccines were cleared to use when they called in that excursion on 3rd October 2022.  The reporter states the Engerix-B box was still sealed; it was not used after the prior excursion. The reporter did not believe the Boostrix vaccines had been used either, but it was possible since the box was open, so she would have to go back through records to check. Vaccines should had been discarded after the prior excursion was called in on 3rd October 2022. Reporter consented to follow up. Additional supportive information: As Boostrix vaccine that went out of range for 269 minutes to a maximum temperature of 52.9 degree F, which led to incorrect storage of drug. As Engerix-B vaccine that went out of range for 269 minutes to a maximum temperature of 52.9 degree F and it was not used, which led to intercepted product storage error.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient was accidentally given 3rd dose of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 31-OCT-2022 Reporters comment: The health care professional reported that patient was accidentally given 3rd dose of Shingrix. The reporter disconnected from the chat. No additional information was available. The reporter did not consent to follow-up. Additional Supportive information: The patient received 3rd dose of Shingrix, which led to extra dose administered.
Age: 74.0
Sex: F
Vaccine: COVID19, FLUX, PPV, VARZOS
Symptoms: Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: pain in left arm; Muscle weakness; muscle pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis, PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis and COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   On 6th October 2022, the patient received Shingrix, Flu vaccine, the 1st dose of PNEUMONIA VACCINE (intramuscular) and COVID VACCINE. On 6th October 2022, 1 hr after receiving Shingrix and Flu vaccine, the patient experienced pain in arm, muscle weakness and muscle pain. On an unknown date, the outcome of the pain in arm, muscle weakness and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, muscle weakness and muscle pain to be related to Shingrix and Flu vaccine.     Additional Information: GSK Receipt Date: 01-NOV-2022 Reporter's comment: The patient self-reported this case. The patient received doses of a Covid vaccine and Flu vaccine in her right arm and she received a Pneumonia vaccine and Shingrix vaccine in her left arm.  One hour after the vaccines were administered she reported pain in her left arm along with muscle weakness of that arm.  The muscle pain and weakness had continued on and off since the injection and was still not completely resolved. The lot number and expiration dates of vaccine were not available. The reporter consented to follow-up. Consent to contact HCP given. Additional supportive information: It was unknown if the reporter considered the pain in arm, muscle weakness and muscle pain to be related to Pneumonia vaccine and Covid vaccine.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult patient received a pediatric dose.; adult patient received a pediatric dose.; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 53-year-old female patient who received HBV (Engerix B pediatric) (batch number FB9RH, expiry date 21st January 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st October 2022, the patient received the 3rd dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 31st October 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the 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.   Additional Information: GSK receipt date: 1-Nov-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email. Additional supportive information: The patient received a pediatric Engerix B dose, which led to underdose and adult use of child product.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired dose given to a patient; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) for prophylaxis.   In October 2022, the patient received Havrix. In October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 1-Nov-2022 Reporter's comment: The nurse reported that an expired dose of Havrix was given to the patient a week ago (no exct date). The vaccine was expired in end of September (not exactly sure). The reporter did not had any further information and did not gave consent to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used. Expiry date was not coded as only month was reported day and year was unknown.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Injection site pain
Clinical narrative: burning at the injection site; received most of the dose, not all; This case was reported by a other health professional via call center representative and described the occurrence of injection site burning in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number GS57B, expiry date 29th September 2023) for prophylaxis.   On 1st November 2022, the patient received the 1st dose of Shingrix. On 1st November 2022, less than a day after receiving Shingrix, the patient experienced injection site burning and incomplete dose administered. On an unknown date, the outcome of the injection site burning and incomplete dose administered were unknown.   It was unknown if the reporter considered the injection site burning to be related to Shingrix.     Additional Information: GSK receipt date: 1-Nov-2022 Reporter's comment: The medical assistant reported that the patient received her first dose of Shingrix in unknown arm and jerked her arm toward the end of the administration when it started burning at the injection site.   The reporter believed that the patient had received most of the dose, but not all.  At the time of reporting, the dose has not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received most of dose, but not all, which led to incomplete dose administered.
Age: 73.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Prescribed 2-mL dose, received 1-mL dose/requested to receive Hepatitis B vaccine (Engerix B) double adult dose, however the patient received a single adult dose.; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 73-year-old male patient who received HBV (Engerix B adult) (batch number 25K3M, expiry date 2nd June 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th October 2022, the patient received the 1st dose of Engerix B adult 1 ml and Engerix B Pre-Filled Syringe Device. On 18th October 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced underdose. On an unknown date, the outcome of the underdose 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: 1-Nov-2022 Reporter's comment: The pharmacist reported that the patient was preparing for hemodialysis and was requested to receive Hepatitis B vaccine (Engerix B) double adult dose, however the patient received a single adult dose. The vaccine administration facility was the same as primary reporter.  The case was under escalation to determine if patients should receive 1ml or 2ml dose of Engerix B adult before hemodialysis. The reporter did not consented to follow-up. Additional supportive information: The patient received a single adult dose, which led to underdose.
Age: 14.0
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 14 years old received an infanrix dose; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-year-old patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 1-Nov-2022 Reporter's comment: The reporter consented to follow-up. The case was linked with case US2022158126 reported by same reporter. Additional supportive information: The patient received an Infanrix dose at inappropriate age, which led inappropriate age at vaccine administration.; Sender's Comments:  US-GSK-US2022158126:same reporter
Age: 6.0
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 6 years old received a boostrix vaccine; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 1-Nov-2022 Reporter' comment: The reporter consented to follow-up. The case was linked with case US2022158125 reported by same reporter. Additional supportive information: The patient received Boostrix vaccine at inappropriate age, which led to inappropriate age at vaccine administration.; Sender's Comments:  US-GSK-US2022158125:same reporter
Age: 42.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pediatric  dose administered to Adult; Pediatric  dose administered to Adult; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 42-year-old male patient who received HAV (Havrix pediatric) (batch number 95EG7, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd November 2022, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 2nd November 2022, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the 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.   Additional Information: GSK receipt date: 2-Nov-2022 Reporter's comment: The reporter consented to follow-up by email. Additional supportive information: A pediatric dose of Havrix was administered by mistake to an adult patient, which led to underdose and adult use of a child product.