chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's were reported; A vaccine coordinator reported that improperly stored doses of PEDVAX HIB and ROTATEQ were administered to two patients.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On an unknown date, vaccines included haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot #U034522, expiration date: 22-JUN-2024) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #W011278, expiration date: 01-NOV-2023) underwent a temperature excursion at 34.3 Fahrenheit (F) for 1 hour 18 minutes. There was no previous temperature excursion.  On 04-OCT-2022, the patient was vaccinated with improperly stored doses of haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (quantity: 1, lot #U034522, expiration date: 22-JUN-2024; strength, dose and route of administration were not provided) used as directed to prevent haemophilis influenza B infection; and rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 milliliter oral liquid, quantity: 1, lot #W011278, expiration date: 01-NOV-2023, administered orally as directed to prevent rotavirus infection (Product storage error). No additional AE's and no PQC's were reported (No adverse event).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA001275:
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improperly stored doses of PEDVAX HIB and ROTATEQ were administered to two patients; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.   On 03-OCT-2022, the patient was vaccinated with improperly stored haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) quantity 1, lot #U034522, expiration date: 22-JUN-2024, used as directed to prevent haemophilis influenza B infection (strength, route of administration, vaccination scheme frequency, anatomical location, and dose were not reported); and  rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 milliliter oral liquid, quantity 1, lot #W011278, expiration date: 01-NOV-2023, administered orally, used as directed to prevent roatvirus infection (vaccination scheme frequency, and dose were not reported) (Product storage error). Temperature excursion as following: 34.3 Fahrenheit (F); time frame: 1 hour 18 minutes. There was no previous temperature excursion. No additional adverse event was reported (no adverse event).  This is one of two reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE; Nurse reporting MMRII was administered one day after expiration. No additional AE. No PQC.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medial history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 06-OCT-2022, the patient was vaccinated with one day after expiration measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (recombinant human albumin (rHA)) 0.5 mL,  lot # T033814 with expiration date 05-OCT-2022, for prophylaxis (strength, route of administration and anatomical location were not reported). No additional adverse event (AE) was reported.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shingles vaccine and got shingles/Suspected vaccination failure; Got 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.   Co-suspect products included COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and the 1st dose of COVID 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: 30-Sept-2022 Reporter's comment: The case was received from the patient via (Facebook) interactive digital media. The patient had covid vaccine knocked out the shingles vaccine. The patient knew cause got shingles after first covid vaccine and had shingles shingles vaccine. Additional supportive information: It was unknown if the reporter considered the shingles to be related to COVID vaccine. 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. As it was not clear that shingles was occurred after or before the shingles vaccine, therefore in worst approach, the case was kept valid with Suspected vaccination failure and shingles considering shingles occurred after shingles vaccine.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Blister, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Shingles (terrible case/ hospitalized)/ Shingles on the right lower side of my abdomen/back; Pain (worst pain); Blisters; Had Shingrex vaccine, got shingles/Suspected vaccination failure; 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 (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID-19 BOOSTER) for prophylaxis.   On an unknown date, the patient received Shingrix and COVID-19 BOOSTER. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles (serious criteria hospitalization), pain (serious criteria hospitalization) and blister. The patient was treated with gabapentin. On an unknown date, the outcome of the vaccination failure, shingles, pain and blister were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and blister to be related to Shingrix.     Additional Information: GSK receipt date: 01-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the Shingrix vaccine and three weeks after his/her Covid booster, got a terrible case of shingles on the right lower side of my abdomen/back.  Outbreak was slow to appear on his/her skin so was hospitalized overnight trying to find the source of the pain. Blisters finally appeared after a week, then started Gabapentin mega doses for several months.  The patient had  worst pain, he/she ever endured. The patient still wonder whether the booster diminished the effectiveness of Shingrix vaccine. Additional supportive information: It was unknown if the reporter considered the shingles, pain and blister to be related to COVID-19 Booster. 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 the two shot vaccine, still got shingles/Suspected vaccination failure; Still got 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.   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: 2-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the most recent two shot vaccine and still got shingles. The reporter denied to follow-up. 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.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Was vaccinated and still got shingles/Suspected vaccination failure; Still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 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: 2-Oct 2022 Reporter's comment: The case was received from the patient's wife via interactive digital media. The vaccine did not prevent them.  The patient was vaccinated and still got shingles. The reporter denied to follow-up. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: pain/although the worst pain only lasted 2-3 days; got the shots 2 years ago, got Shingles last month/suspected vaccination failure; shingles/Still got shingles last month; 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. In September 2022, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 02-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the Shingles shots 2 years ago and still got shingles last month.  The recovery had taken 3 weeks. Less than 2 years after vaccination, the patient had experienced pain. Although the worst pain only lasted 2 to 3 days. The reporter denied to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The suspect was coded as per narrative information.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Urticaria
Clinical narrative: Large swelling from elbow to breast; Welts; This case was reported by a nurse via sales rep and described the occurrence of swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 29th July 2020).   On 30th November 2020, the patient received the 2nd dose of Shingrix. In December 2020, 24 hrs after receiving Shingrix, the patient experienced swelling and welts. On an unknown date, the outcome of the swelling and welts were unknown.   The reporter considered the swelling and welts to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comments: The patient received second dose of Shingrix and 24 hours after vaccination patient experienced large swelling occurred from elbow all the way across breast and welts too. The reporter believed it was related to Shingrix. The reporter agrees to follow up from GlaxoSmithKline.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2021, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 27-Sep-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received the booster vaccine. The next day patient developed the shingles. Additional Supportive Information: The follow up would not possible, as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Headache, Migraine, Pain
Clinical narrative: Migraine attack; Pain; Headache; Was in bed for two days; This case was reported by a consumer via interactive digital media and described the occurrence of migraine in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles twice in 40s).   In September 2022, the patient received the 1st dose of Shingrix. In September 2022, less than 2 weeks after receiving Shingrix, the patient experienced migraine, pain, headache and bedridden. On an unknown date, the outcome of the migraine, pain and headache were unknown and the outcome of the bedridden was recovered/resolved.   The reporter considered the migraine, pain, headache and bedridden to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 27-Sep-2022 Reporter's comment: This case was reported by the patient via interactive digital media. Some folks had poor reaction to the shot.  The patient age was now 57 years and got 1st shot last week.  The patient was in bed for two days with pain and headache etc. and then it triggered a bad migraine attack.  The patient did not had one in a decade that was bad.  The patient guesses that she would go back for shot 2 but she was scared of losing another week like this would like to be seen more studies about the link between migraine attaches and shingrix. Additional supportive information: The follow-up would not be possible, as no contact details were available. This case was linked with US2022AMR139468 reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR139468:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: got the shot, hurt like hell; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: This case was reported by patient via interactive digital media. The patient stated that he got the Shingles shot and it hurt like hell but worth it. The reporter stated that his brother had shingles for a year, suffered daily. Additional supportive information: The follow-up would not possible, as no contact, details were available. This case had been linked with case US2022AMR140129, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR140129:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: got the shot, hurt like hell; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: The patient's husband reported this case via interactive digital media. The reporter stated that he and his wife got the Shingles shot and it hurt like hell but worth it. The reporter stated that his brother had shingles for a year, suffered daily. Additional supportive information: The follow-up would not possible, as no contact, details were available. This case had been linked with case US2022AMR140127, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR140127:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient did not complete the series. It has been 25 months since her initial dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   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: 29-Sep-2022 Reporter's Comments: The pharmacist reported that the patient did not complete the series and it has been 25 months since her initial dose.  The reporter asked did the patient need to start the series over or just complete the original series. The reporter consent to follow-up was granted. The case was linked with case US2022140216, reported by same reporter for different patient. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2022140216:Same reporter
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: expired vaccines inadvertently administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number T93SR, expiry date 30th June 2022) 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 an unknown date, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra 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: 27-SEP-2022 Reporter's Comments: The medical assistant reported there were 2 boxes of Fluarix that left over from last year which was expired on June 2022. The three vaccines from it was inadvertently administered to 3 patients. The vaccine administration facility was the same as Primary Reporter No other details were available.  Please note that hcp mentioned that the Fluarix was from last year, the drop down list for suspected vaccine name Fluarix does not show any option for last year hence Fluarix Quadrivalent 2020-2021 season was picked. The reporter did not consent to follow up. Additional Supportive Information: The patient received an expired dose of Fluarix Quadrivalent 2020-2021, which led to expired vaccine used. This is 1 of the 3 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR139387:Same reporter US-GSK-US2022AMR139388:Same reporter
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: redness at the site of application; swelling at the site of application; itching at the site of application; nausea; fatigue after administration.; fever; joint pain; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number YR7AA, expiry date 14th April 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st September 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 21st September 2022, less than a day after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced injection site erythema, injection site swelling, injection site itching, nausea, fatigue, fever and joint pain. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site itching, nausea, fatigue, fever and joint pain were recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site itching, nausea, fatigue, fever and joint pain to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comments:  The reporter stated adverse reaction that the patient suffered after administration of Boostrix.  The reporter mentioned that since the day of administration the patient showed redness, swelling, and itching at the site of application. Moreover, patient suffered from nausea, fatigue, fever and joint pain after receiving Boostrix dose. Finally, the reporter mentioned that the patient was getting better but had not fully recovered. The Vaccine Administration Facility is the same as Primary Reporter. The reporter gave consent to follow up.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pyrexia
Clinical narrative: redness at the site of application; swelling at the site of application; itching at the site of application; nausea; fatigue after administration.; fever; joint pain; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number YR7AA, expiry date 14th April 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st September 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 21st September 2022, less than a day after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced injection site erythema, injection site swelling, injection site itching, nausea, fatigue, fever and joint pain. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site itching, nausea, fatigue, fever and joint pain were recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site itching, nausea, fatigue, fever and joint pain to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comments:  The reporter stated adverse reaction that the patient suffered after administration of Boostrix.  The reporter mentioned that since the day of administration the patient showed redness, swelling, and itching at the site of application. Moreover, patient suffered from nausea, fatigue, fever and joint pain after receiving Boostrix dose. Finally, the reporter mentioned that the patient was getting better but had not fully recovered. The Vaccine Administration Facility is the same as Primary Reporter. The reporter gave consent to follow up.
Age: 9.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: kinrix was administered to a 8 year old patient; administered on 6/2/2022, IPV:1 DOSE :6/18/2013, IPV:2 DOSE : 8/22/2013; 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 9-year-old male patient who received DTPa-IPV (Kinrix) (batch number 24P2N, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included IPV (On 18th June 2013 1st dose received) and IPV (On 22 nd Aug 2013 2nd dose received).   On 2nd June 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 2nd June 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered 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: 27-SEP-2022 Reporters comment: The medical assistant reported 2 doses of IPV in 2013 and that the 8 year patient received Kinrix vaccine. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up Additional Supportive information: The 8 year patient received kinrix vaccine and already 2 doses of IPV in 2013, which led inappropriate age at vaccine administered and inappropriate schedule of vaccine administered. Date of birth and age provided by Health Care Professional did not match. Unable to reach Health Care Professional clarify.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Pain near the injection site; Swelling near the injection site; Warmth near the injection site; Hardness near the injection site; Redness near the injection site; Headache; Fatigue; Nausea; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th May 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm, swelling arm, skin warm, induration, erythema of extremities, headache, fatigue and nausea. The patient was treated with paracetamol (Tylenol) and antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the pain in arm, swelling arm, skin warm, induration, erythema of extremities, headache, fatigue and nausea were unknown.   It was unknown if the reporter considered the pain in arm, swelling arm, skin warm, induration, erythema of extremities, headache, fatigue and nausea to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comments:  The reporter was the patient.   The patient received her first dose of SHINGRIX and she experienced pain, swelling, warmth, hardness, and redness   near the injection site.   This area was the size of her palm.   She also experienced headache, fatigue , and nausea.   The patient took Tylenol to alleviate symptoms, and also was prescribed antibiotics (undefined). The reporter give consent to follow up. Additional supportive information: This case has been linked with the case US2022138685 reported by same reporter; Sender's Comments:  US-GSK-US2022138685:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Pain near the injection site; Swelling near the injection site; Warmth near the injection site; Hardness near the injection site; Redness near the injection site; Headache; Fatigue; Nausea; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th May 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm, swelling arm, skin warm, induration, erythema of extremities, headache, fatigue and nausea. The patient was treated with paracetamol (Tylenol) and antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the pain in arm, swelling arm, skin warm, induration, erythema of extremities, headache, fatigue and nausea were unknown.   It was unknown if the reporter considered the pain in arm, swelling arm, skin warm, induration, erythema of extremities, headache, fatigue and nausea to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comments:  The reporter was the patient.   The patient received her first dose of SHINGRIX and she experienced pain, swelling, warmth, hardness, and redness   near the injection site.   This area was the size of her palm.   She also experienced headache, fatigue , and nausea.   The patient took Tylenol to alleviate symptoms, and also was prescribed antibiotics (undefined). The reporter give consent to follow up. Additional supportive information: This case has been linked with the case US2022138685 reported by same reporter; Sender's Comments:  US-GSK-US2022138685:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Malaise
Clinical narrative: Malaise; Flu like symptoms; Shivering; This case was reported by a consumer via call center representative and described the occurrence of malaise in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced malaise, influenza-like symptoms and shivering. On an unknown date, the outcome of the malaise, influenza-like symptoms and shivering were recovered/resolved.   It was unknown if the reporter considered the malaise, influenza-like symptoms and shivering to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comment: The reporter was a patient's wife. The patient experienced malaise, flu like symptoms and shivering which lasted for approximately 48 hours. The reporter did not consent to follow up. Additional supportive information: This case had been linked with US2022138683 reported by same reporter.; Sender's Comments:  US-GSK-US2022138683:Same reporter
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Extra dose administered
Clinical narrative: Two doses administered on the same day; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 18-month-old male patient who received DTPa (Infanrix) (batch number 3M9Y7, expiry date 3rd March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th September 2022, the patient received Infanrix. On an unknown date, the dose was an unknown dose. On 27th September 2022, the patient started Infanrix Pre-Filled Syringe Device. On 27th September 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose 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: 27-SEP-2022 Reporter's Comment: The reporter reported that the patient of 1 year and 6 months old received 2 doses of Infanrix vaccine on the same day. The reporter did not consent to follow up. Additional supportive information: The patient received a two dose of Infanrix on the same day, which led to overdose.
Age: 47.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 47YO was admiistered Pediarix; Pediarix administered instead of Boostrix; 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 47-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number T4Y35, expiry date 28th November 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th September 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 26th September 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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: 27-September-2022 Reporter's comment: Reporter stated that patient was inadvertently administered a dose of Pediarix instead of Boostrix. At the time of reporting, patient had not been redosed. The vaccine administration facility is the same as primary reporter. Reporter consent to follow up. Additional supportive information: A 47 year old patient was inadvertently administered a dose of Pediarix instead of Boostrix, which led to inappropriate age at vaccination administered and wrong vaccine administered.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Engerix-B pediatric dose given to adult; Adult received Engerix B pediatric; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 49-year-old male patient who received HBV (Engerix B pediatric) (batch number DA224, expiry date unknown) for prophylaxis.   On 15th February 2017, the patient received the 1st dose of Engerix B pediatric. On 15th February 2017, unknown after receiving Engerix B pediatric, 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.   Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comments:  The pharmacist reported that pediatric dose was given to an adult patient. The Vaccine Administration Facility is the same as Primary Reporter. Agent was unable to pull up the lot number provided by the pharmacist but the pharmacist believed that it could potentially be a pediatric Engerix-B so adverse event was reported. The reporter gave consent to follow up. Additional Supportive Information: pediatric dose was given to an adult patient, which led to underdose and adult use of child product
Age: 1.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Menveo administered instead of MMR.; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-month-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA677A, expiry date 30th April 2023) for prophylaxis.   On 27th September 2022, the patient received Menveo. On 27th September 2022, unknown after receiving Menveo, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comment: The reporter was medical assistant. The reporter reported that, 12 months old patient was administered a dose of Menveo instead of MMR. The vaccine administration facility was the same as primary reporter. She was in a hurry to be transferred to second line agent and did not provide mailing address information. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, 12 months old patient was administered a dose of Menveo instead of MMR, which led to wrong vaccine administered .
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: received diluent without the powder; received diluent without the powder. Was revaccinated; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 2459T, expiry date 8th October 2023) for prophylaxis.   On 27th September 2022, the patient received the 2nd dose of Shingrix. On 27th September 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.    Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comment: The reporter called to report that, at the time of reporting, a patient received Shingrix diluent portion without the powder.  After this shot, the patient was revaccinated with a Shingrix full dose.  This was patient´s Shingrix second dose on Shingrix´s schedule. The reporter consented to follow up by email. Additional Supportive Information: The reporter called to report that, at the time of reporting, a patient received Shingrix diluent portion without the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: Diarrhea for two weeks; This case was reported by a pharmacist via call center representative and described the occurrence of diarrhea in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comment: The reporter reported via chat that a patient received Shingrix vaccine and three days later got diarrhea, which had continued for two weeks.  The reporter did not provide any additional information before leaving chat.  The reporter was asked for permission to follow-up but did not respond.
Sex: U
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: pediatric patient received adult Engerix-b; pediatric patient received adult Engerix-b; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a patient who received HBV (Engerix B adult) (batch number 5DL22, expiry date 22nd March 2020) for prophylaxis.   On an unknown date, the patient received Engerix B adult. On an unknown date, unknown after receiving Engerix B adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comment: The reporter believed that, a pediatric patient received a pediatric dose of Engerix-B but might have got recorded as adult Engerix-B. The Engerix-B was administered in 2018. The reporter believed that, a pediatric patient received a pediatric dose of Engerix-B but might have got recorded as adult Engerix-B, filed as there was a potential for adverse event.  The reporter was unable to pull up the lot number provided by the healthcare professional. The reporter did not consent to follow-up. Additional Supportive Information: The reporter believed that, a pediatric patient received a pediatric dose of Engerix-B but might have got recorded as adult Engerix-B, which led to overdose and adult product administered to child.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: GOT SHOT LONGER THAN 10 MONTHS AGO; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 19th November 2021).   On an unknown date, the patient did not  receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 28-September-2022 Reporter's comment:  The pharmacist stated that patient did not received the 2nd dose. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Infanrix to 62 year-old patient; This case was reported by a physician via call center representative and described the occurrence of adult use of a child product in a 62-year-old male patient who received DTPa (Infanrix) (batch number LS444, expiry date 16th September 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th September 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 17th September 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced adult use of a child product. On an unknown date, the outcome of the adult use of a child product 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: 28-SEP-2022 Reporter's Comment: The reporter reported for information about the administration of Infanrix to a 62 years old patient. The reporter asked how to proceed with this patient. The reporter consented to follow up. Additional supportive information: A 62 years old patient received infanrix vaccine, which led to adult use of a child product.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Hep A pediatric dose a week after expiration; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received 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 expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.      Additional Information: GSK receipt date: 28-SEP-2022 Reporters comment:  The reporter reported that as per chat information on vaccines and their administration after expiration, the Hep A pediatric dose a week after expiration was unknown, manufacturer unknown, no reporter details, product details, patient details were provided as chat dropped, Unknown if this occurred or even if this was a GSK vaccine The reporter did not consent to follow-up. Additional Supportive information: No confirmation of the brand or if the expired vaccine was administered were provided. As no consent for Follow up was given, the event Expired vaccine used was conservatively coded and Hepatitis A vaccine was coded as the suspect product. .
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 2nd dose on 28th December 2021) and Shingrix (received 1st dose on 22nd September 2021).   On 29th September 2022, the patient received the 3rd dose of Shingrix. On 29th September 2022, 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: 29-SEP-2022 Reporter's comment:  This case was reported by pharmacist. Pharmacist reported a patient accidently got a 3rd dose of shingrix today on SEP 29th, 2022.  The patient was not immunocompromised. The reporter consented to follow up. Additional supportive information: As patient accidently got a 3rd dose of Shingrix which led extra dose administered.