chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient did not have any adverse effects or symptoms after receiving this dose; Caller is a medical assistant who reports an 18-month-old patient received a dose of GARDASIL 9.; This spontaneous report has been received from a medical assistant concerning an 18-month-old patient with unknown gender.   The patient's concurrent conditions, medical history and concomitant therapies, drug reactions or allergies were not reported.  On 27-SEP-2022, the patient was vaccine with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter administered as prophylaxis, (lot number 1780878 which has been verified to be valid, expiration date reported and validated as 02-DEC-2023) (strength and vaccination scheme were not reported) (inappropriate age at vaccine administration). No additional adverse events were reported in the patient.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: Onset date: 9/8/2022; No additional AE reported; Caller reported VARIVAX that had undergone temperature excursion was administered to a patient.; This spontaneous report was received from a nurse regarding a 1-day-old patient of unknown gender. There was no information about the patient's drug reactions or allergies, medical history, concurrent conditions, nor concomitant medications.   On 08-SEP-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # U016065, expiration date 20-MAY-2022, (formulation, strength, dose, dose number, route of administration and anatomical site of vaccination were not reported) for prophylaxis (improper storage of product in use) (inappropriate age at vaccine administration). The vaccine administered was stored with an unknown temperature for a time frame of 1 hour and 45 minutes. It was not reported if a data logger was used. There was a previous temperature excursion. No additional adverse event (AE)were reported (no adverse event).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2210USA000872: US-009507513-2210USA000877: US-009507513-2210USA000999: US-009507513-2210USA001062: US-009507513-2210USA001209: US-009507513-2210USA001524: US-009507513-2210USA001533: US-009507513-2210USA001538: US-009507513-2210USA001904: US-009507513-2210USA000872:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; improperly stored vaccine was administered to a patient.; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. Information regarding the patients' medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies was not provided.  On an unknown date, there was a temperature excursion registered for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) of -11.8 Celsius degrees for 1 hour 45 minutes and 0 seconds. There was no previous temperature excursion reported.  On 27-SEP-2022, the patient was vaccinated with the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, lot # W017567, expiration date reported as 29-DEC-2023, but upon internal validation established as 29-NOV-2023 (dose, route of administration, and anatomical location were not provided) administered for prophylaxis (product storage error).   No additional adverse event was reported.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; vaccine administered after temperature excursion; This spontaneous report was received from a nurse, concerning a 3-year-old patient of unknown gender. Information regarding the patients' medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies was not provided.  On an unknown date, there was a temperature excursion registered for varicella virus vaccine live (oka/merck) (VARIVAX) of -11.8 Celsius degrees for 1 hour 45 minutes and 0 seconds. It was reported that there was no previous temperature excursion reported (conflicting information, also reported previous temperature excursion as "yes").  On 30-SEP-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # U039726, expiration date 15-DEC-2023, (dose, route of administration, and anatomical location were not provided) administered for prophylaxis (product storage error).   No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; improperly stored vaccine was administered to a patient; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. Information regarding the patients' medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies was not provided.  On an unknown date, there was a temperature excursion registered for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) of -11.8 Celsius degrees for 1 hour 45 minutes and 0 seconds. There was no previous temperature excursion reported.  On 23-SEP-2022, the patient was vaccinated with the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, lot # W019623, expiration date 19-DEC-2023, (dose, route of administration, and anatomical location were not provided) administered for prophylaxis (product storage error).   No additional adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Allergy to metals, Allergy to surgical sutures, Dermatitis contact, Gluten sensitivity, Hypersensitivity
Clinical narrative: allergic reactions; Caller does not think that she will be able to complete the series/ Caller has also had to cancel her second dose; Consumer reporting AE for GARDASIL 9. Consumer states she is 51 years old and received her first dose of GARDASIL 9 on 05JUL2022. Consumer states GARDASIL 9 was recommended to her from her OBGYN after she had HPV cancer removed when she was 48 years; Caller stated that she experienced a rash for a few weeks after she received the first dose of her vaccine.; Information has been received from a 51-year-old female patient, referring on herself. The patient's medical history included human papillomavirus infection (HPV) and had precancerous polyps in 2021. She had them removed in 2021 and in June 2022, she discovered that they came back, during check ups (she received a puncture and they showed up as "Cervical intraepithelial neoplasia III (CIN 3)". Additional medical history were reported that she has had a hard time with anesthetics in previous years. The patient stated that she had to have them removed a second time. The concurrent conditions and concomitant therapies were not reported.   On 05-JUL-2022, the patient received the first dose of started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection in the left bicep (strength, lot #, expiry date, and route of administration were not provided), administered for prophylaxis. The patient stated that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was recommended to her from her obstetrics and gynaecology (OBGYN) professional after she had HPV cancer removed when she was 48 years old.   On an unspecified date in 2022 (reported as "few weeks after she received the first dose of the vaccine"), she experienced a rash for a few weeks after she received the first dose of her vaccine. She received the vaccine in her left bicep. The patient stated that the rash did not spread, and it stayed in one area. She used Lanolin cream to keep the rash moist, and the rash was gone on an unspecified date in 2022 (reported "by the 29th"). The patient was scheduled to receive her second vaccine on 12-SEP-2022, but had to cancel the appointment (Inappropriate schedule of product administration). On an unknown date, she stated that she experienced allergic reactions to nylon sutures, metal, gluten, adhesives and nickel.  The outcome of the allergic reactions was not reported.  The causal relationship between the rash and the allergic reactions with the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Rash
Clinical narrative: allergic reactions; Caller does not think that she will be able to complete the series/ Caller has also had to cancel her second dose; Consumer reporting AE for GARDASIL 9. Consumer states she is 51 years old and received her first dose of GARDASIL 9 on 05JUL2022. Consumer states GARDASIL 9 was recommended to her from her OBGYN after she had HPV cancer removed when she was 48 years; Caller stated that she experienced a rash for a few weeks after she received the first dose of her vaccine.; Information has been received from a 51-year-old female patient, referring on herself. The patient's medical history included human papillomavirus infection (HPV) and had precancerous polyps in 2021. She had them removed in 2021 and in June 2022, she discovered that they came back, during check ups (she received a puncture and they showed up as "Cervical intraepithelial neoplasia III (CIN 3)". Additional medical history were reported that she has had a hard time with anesthetics in previous years. The patient stated that she had to have them removed a second time. The concurrent conditions and concomitant therapies were not reported.   On 05-JUL-2022, the patient received the first dose of started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection in the left bicep (strength, lot #, expiry date, and route of administration were not provided), administered for prophylaxis. The patient stated that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was recommended to her from her obstetrics and gynaecology (OBGYN) professional after she had HPV cancer removed when she was 48 years old.   On an unspecified date in 2022 (reported as "few weeks after she received the first dose of the vaccine"), she experienced a rash for a few weeks after she received the first dose of her vaccine. She received the vaccine in her left bicep. The patient stated that the rash did not spread, and it stayed in one area. She used Lanolin cream to keep the rash moist, and the rash was gone on an unspecified date in 2022 (reported "by the 29th"). The patient was scheduled to receive her second vaccine on 12-SEP-2022, but had to cancel the appointment (Inappropriate schedule of product administration). On an unknown date, she stated that she experienced allergic reactions to nylon sutures, metal, gluten, adhesives and nickel.  The outcome of the allergic reactions was not reported.  The causal relationship between the rash and the allergic reactions with the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Age: 56.0
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder
Clinical narrative: balance problems; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 64 years old  female patient (pt). No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 21-DEC-2014, the pt was inoculated with the zoster vaccine live (ZOSTAVAX) vaccine at pharmacy as recommended for long-term prevention of shingles and zoster-related conditions (dose, route, and lot # not provided). Subsequently, the pt, was treated by a health care for balance problems(date unspecified date). The outcome of the event was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Polymyalgia rheumatica
Clinical narrative: polymyalgia rheumatica; Information has been received on 11-OCT-2022 from a lawyer, regarding a case in litigation, concerning a patient (pt) of an unknown age and gender. It was reported that on an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, units, route and anatomical location of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered polymyalgia rheumatica. As a result of those symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the reporting time, the pt has not recovered from the event.  The event of polymyalgia rheumatica was considered to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of polymyalgia rheumatica was considered to be medically significant and disabling by the investigator.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE; an improperly stored vaccine was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender. Information regarding the patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 08-AUG-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliters (mL) once, as prophylaxis (route of administration, vaccine scheme and anatomical site were not reported; lot number 1879870 has been verified to be valid, expiration date reported and established as 16-OCT-2023). The vaccine was exposed to a temperature excursion of 34.5 degrees Fahrenheit (F) during a time frame of 1 hour and 7 minutes (product storage error). In addition, the vaccine was exposed to a previous temperature excursion of 66.7 F for 13 hours 52 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA005936: US-009507513-2210USA005917:MSD US-009507513-2210USA005937: US-009507513-2210USA005929: US-009507513-2210USA005979: US-009507513-2210USA005624: US-009507513-2210USA005942: US-009507513-2210USA005994: US-009507513-2210USA005996: US-009507513-2210USA006007:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reporting an improperly stored vaccine was administered to a patient. No additional clarifying statements or details provided. See related AE case numbers in notes. No additional AE. No PQC.  ?    Names of vaccines involved: ROTATEQ (Lot: 18798; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 22-JUL-2022, the patient was vaccinated with an improperly storage dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, 2 milliliters once orally as prophylaxis (lot number: 1879870, which was determined to be valid, with an expiration date on 16-OCT-2023) (product storage error) (strength and scheme was not reported). The administered dose underwent a temperature excursion of 34.4 degrees Fahrenheit (F) for 1 hour and 7 minutes. It was reported that a previous temperature excursion of 66.7 degrees F for 13 hours and 52 minutes occurred. No additional adverse event was reported.   This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2210USA005624: US-009507513-2210USA005916: US-009507513-2210USA005917: US-009507513-2210USA005929: US-009507513-2210USA005937: US-009507513-2210USA005994:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional adverse event (AE); A 6-month old child that received a dose of VARIVAX instead of VAXELIS.; This spontaneous report was received from medical assistant referring to a 6-month-old patient of unknown gender.No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 14-OCT-2022, the patient was vaccinated with a wrong dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milligram (mg), lot number W011624, expiration date: 06-APR-2024 who had been verified to be a valid number, instead 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) (wrong product administered).  It was reported, that the patient additionally received their scheduled doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and pneumococcal vaccine conj 7v (crm197) (PREVNAR) (strength, doses, frequencies, anatomical sites of injection, lot numbers and expiration dates were not provided). No additional adverse event was provided. The outcome of wrong product administered as well as the causality assessment were not provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE..; HCP reporting an improperly stored vaccine was administered to a patient.; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported   On 07-JUL-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, administered orally, for prophylaxis (vaccination scheme, frequency, and anatomical site of injection were not reported) (lot number 1879870 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 16-OCT-2023). The administered dose of the vaccine was stored at a temperature of 34.5 degrees Fahrenheit (F), during a time frame of 1 hour and 7 minutes, as recorded by a digital data logger. There was a previous temperature excursion reported as: 66.7 degrees Fahrenheit (F), during a time frame of 13 hours and 52 minutes. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA005917:MSD
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; improperly stored vaccine was administered; This spontaneous report was received from medical assistant and refers to an unknown age and gender patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-SEP-2022, the patient was vaccinated with an improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, at a dose of 0.5 ml/once, lot #w007371, expiration date: 13-JUL-2023, administered intramuscularly for prophylaxis (strength, anatomical site injection were not provided) (product storage error). The suspect vaccine exposed to a temperature of 34.5 Degree Fahrenheit for a timeframe of 1 Hour 7 Minutes 0 Seconds with a previous temperature excursion of 66.7 Degree Fahrenheit for 13 Hours 52 Minutes 0 Seconds.  No additional adverse event information was provided.  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2210USA005917:MSD
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/I had the shots and got it on shoulder, arm and down back; Got it on shoulder, arm and down back; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 15-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shots and got them anyway on his/her left shoulder and arm and down his/her back.  The patient agreed that it was the worst. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset 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.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Vaccinated friend developed shingles; Shingles; Was miserable; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (serious criteria GSK medically significant), shingles and feeling miserable. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the feeling miserable was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.     Additional Information: GSK receipt date: 15-Oct-2022 Reporter's comment: The case was received from the patient's friend via interactive digital media. The reporter stated good for you. The reporter have had two friends develop shingles recently one of whom was vaccinated. The vaccinate one was miserable but recovered fairly quickly. The other was in misery for weeks. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset 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.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had both shots and still ended up getting it/suspected vaccination failure; getting it on the right side of my face; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 17-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had both shots and still ended up getting them on the right side of his/her face.  The patient want his/her money back. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Friend got shot, then shingles/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 16-Oct-2022 Reporter's comment: The case was received from the patient's friend via interactive digital media. The patient got the shingles shot and got shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset 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.
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Too many Hep A vaccines (4 or 5)/HCP thought she needed to get additional doses everytime; Kept missing recommended dose intervals; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a female patient who received Hepatitis A vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis A vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine, the patient experienced extra dose administered and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the extra dose administered and inappropriate schedule of vaccine administered were unknown.   Linked case(s) involving the same patient:  US2022AMR148351, US2022AMR148935   Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's comments: The nurse stated that she had Havrix and Engerix-B prefilled syringes that she placed needles on, but the patient had changed her mind. Reporter had asked that for how long they were stable. The reporter had probed and stated that the patient had changed her mind because she had too many Hepatitis A vaccines (4 or 5) because she kept missing the recommended intervals for the doses and her Healthcare Professional (HCP) thought that she needed to get additional doses every time.  Healthcare professional (HCP) had mentioned that the patient was from out of the country and could not provide any information on if the vaccines were Havrix or another Hepatitis A series.  The reporter did not consent to follow-up and stated that the doses were not administered at their facility. Additional supportive information: The patient had too many Hepatitis A vaccines (4 or 5) because she kept missing the recommended intervals for the doses, which had led to extra dose administered and inappropriate schedule of vaccine administered. For tolerance of Havrix and Engerix B vaccines refer case US2022AMR148351 and US2022AMR148935, reported by same reporter. As the number of doses received was not clear hence only single suspect and event were captured.; Sender's Comments:  US-GSK-US2022AMR148351:Same reporter US-GSK-US2022AMR148935:Same reporter
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: expiration 9/30/22, administered 10/6/expired vaccine, no more than basic 1st aid needed; This case was reported by a physician via sales rep and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, 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 .5 ml 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. 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 Reporters comment: The reporter reported that the patient received the Bexsero vaccine on 06th Oct 2022 and expired on 30th Sep 2022 No harm - reached to patient no more than basic 1st aid needed. The reporter did not consent to follow-up. Additional Supportive information: The patient received the Bexsero vaccine which was already expired, which led to expired vaccine used.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: few days, 4 patient received Boostrix expired dose by error; 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.   On an unknown date, the patient received Boostrix. On an unknown date, 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 had reported that a dose of Boostrix was given by error on the past few days to the patient which was already expired on 30th September 2022. Lot number data was not available. No other information was available at the moment. The reporter did not consent to follow up.  Additional supportive information: The patient had received an expired dose of Boostrix, which led to expired vaccine used. This case was one of four cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022146819:same reporter US-GSK-US2022AMR147249:same reporter US-GSK-US2022AMR147251:same reporter
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.   On an unknown date, the patient received Boostrix. On an unknown date, 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 had reported that a dose of Boostrix was given by error on the past few days to the patient which was already expired on 30th September 2022. Lot number data was not available. No other information was available at the moment. The reporter did not consent to follow up.  Additional supportive information: The patient had received an expired dose of Boostrix, 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-US2022146819:same reporter US-GSK-US2022AMR147250:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Migraine
Clinical narrative: migraine; This case was reported by a consumer via interactive digital media and described the occurrence of migraine in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2022, the patient received Shingrix. In October 2022, less than a day after receiving Shingrix, the patient experienced migraine. The patient was treated with zolmitriptan. On an unknown date, the outcome of the migraine was not recovered/not resolved.   The reporter considered the migraine to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 13-OCT-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. Patient reported that last night got my first Shingrix vaccine. Patient received vaccine at 7 pm last night and at the time of reporting it was 11:30 am. Patient had migraine which he/she believed was related to a weather front rather than the shot. Patient was able to take a Zolmitriptan pill for his/her migraine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Social problem
Clinical narrative: Little bit of shingles; 1st dose 2020, pandemic came and never could get 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, not applicable after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced shingles and social problem. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the shingles 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 interactive digital media. The patient received first dose of Shingles vaccine in 2020 and then pandemic came and he/she never could get the second one and now the patient had a little bit of shingles. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Left my arm so sore; I can barely lift it; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm and mobility decreased 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 his/her Shingles vaccine and left his/her arm so sore, he/she could barely lift it, but he/she stated bet this was mild compared to getting the shingles. The patient also stated he/she have to get the booster in 6 months. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Pain
Clinical narrative: chills; body aches; upset stomach; tired for two days; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced tiredness, chills, general body pain and upset stomach. On an unknown date, the outcome of the tiredness, chills, general body pain and upset stomach were recovered/resolved.   It was unknown if the reporter considered the tiredness, chills, general body pain and upset stomach 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 received the dose of Shingles vaccine other day and was tired for two days, with chills, body aches and an upset stomach.  The patient stated that so glad that was gone. The patient was not looking forward to the next shot, but so grateful that he/she had gotten at least one. The patient reported hope they felt better soon. The pharmacist told him/her people typically felt bad for just two days. Additional supportive information: The follow-up would not possible, as no contact, details were available. This case had been linked with case US2022AMR148248, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR148248:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: feel bad for just two days; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in an unspecified number of patients 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 feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's Comment: The pharmacist reported this case via interactive digital media. The pharmacist told him/her that the people typically felt bad for just two days. Additional supportive information: The follow-up would not possible, as no contact, details were available. This case had been linked with case US2022AMR148244, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR148244:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Little soreness in arm where I got the shot; 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 an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.    Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that, aside from a little soreness in his/her arm where he/she got the shingles shot, the patient had no negative reaction at all. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First shot 2018. Can I still get second; 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 (received 1st dose on 20th June 2018).   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: 18-OCT-2022 Reporter's Comment:  The patient asked, if he/she could still get second shot or did he/she had to start over. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 66.0
Sex: M
Vaccine: HEPA
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: adult given pediatric dose; adult given pediatric dose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 66-year-old male patient who received HAV (Havrix pediatric) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   On 4th September 2022, the patient received the 1st dose of Havrix pediatric. On 4th September 2022, unknown after receiving Havrix pediatric, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: Pharmacist stated an adult patient was inadvertently given a pediatric dose of Havrix. No further details provided. Pharmacist provided consent for safety follow up. Reporter consented to follow up. Additional supportive information: As adult patient received pediatric dose which led to adult use of a child product and accidental under dose.
Sex: U
Vaccine: TDAP, UNK, VARZOS
Symptoms: Product storage error
Clinical narrative: Fluarix QIV, Boostrix, and Shingrix vaccines that went below range for 11 hours to a low of -4.1 degrees Celsius, had been administered to patients; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number patients who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.  Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2022-2023 season, Fluarix Tetra Pre-Filled Syringe Device, Boostrix and Shingrix. On an unknown date, unknown after receiving Fluarix Quadrivalent 2022-2023 season, Fluarix Tetra Pre-Filled Syringe Device, Boostrix and Shingrix, 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: 11-Oct-2022 Reporter's comment: The pharmacist reported via chat that Fluarix Quadrivalent, Boostrix, and Shingrix vaccines that went below range for 11 hours to a low of minus 4.1 degrees Celsius, had been administered to patients after the freezing excursion.   The chat session was ended by the reporter without providing any additional information and answering follow-up permission inquiry. The consent to follow-up was granted. Additional supportive information: The pharmacist reported via chat that Fluarix Quadrivalent, Boostrix, and Shingrix vaccines that went below range for 11 hours to a low of minus 4.1 degrees Celsius, had been administered to patients after the freezing excursion, which led to incorrect storage of drug.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Engerix-B pediatric dose administered to adult; Engerix-B pediatric dose administered to adult; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 33-year-old female patient who received HBV (Engerix B pediatric) (batch number YM444, expiry date 22nd May 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 9th October 2022, the patient received Engerix B pediatric 10 ug and Engerix B Pre-Filled Syringe Device. On 9th 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: 11-OCT-2022 Reporter's Comment: The reporter stated that, an Engerix-B pediatric dose was administered to an adult patient.  The reporter consented to follow up via mail. Additional Supportive Information: The reporter stated that, an Engerix-B pediatric dose was administered to an adult patient, which led to underdose and adult use of a child product. The case had been linked to US2022146235, reported by the same reporter for a different patient.; Sender's Comments:  US-GSK-US2022146235:Same reporter
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Engerix-B pediatric dose administered to adult; Engerix-B pediatric dose administered to adult; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 35-year-old male patient who received HBV (Engerix B pediatric) (batch number YM444, expiry date 22nd May 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 9th October 2022, the patient received Engerix B pediatric 10 ug and Engerix B Pre-Filled Syringe Device. On 9th 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: 11-OCT-2022 Reporter's Comment: The reporter stated that, an Engerix-B pediatric dose was administered to an adult patient.  The reporter consented to follow up via mail. Additional Supportive Information: The reporter stated that, an Engerix-B pediatric dose was administered to an adult patient, which led to underdose and adult use of a child product. The case had been linked to US2022146203, reported by the same reporter for a different patient.; Sender's Comments:  US-GSK-US2022146203:Same reporter