chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Vaccination failure
Clinical narrative: blisters broke out; Getting over them and had the shot/suspected vaccination failure; getting over them; painful / Felt like an ice pick stabbing; This case was reported by a consumer via interactive digital media and described the occurrence of Suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included knee operation (First a fall, then knee surgery for msnicusi and ligament) and sepsis (then in hospital again with sepsis, sick for a year). Additional patient notes included Tansfusion- iron.   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, pain and blister.On an unknown date, the outcome of the vaccination failure and blister were unknown and the outcome of the shingles was recovering/resolving and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and blister to be related to Shingles vaccine.   Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient mentioned that this year was bad year and a half, first fall then knee surgery for meniscus and ligament, then in hospital again with sepsis, sick for a year, then iron transfusions, then shingles. The patient stated he/she just now getting over them (shingles) and had the shingles vaccine. The patient stated they were extremely painful. The worst pain was before the blisters broke out. The patient felt like an ice pick stabbing for 3 solid days. The patient stated he/she wanted to be healthy even though he/she on a heating pad right now at the time of reporting, he/she thankful, it could be worse. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as contact details was not available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: uncomfortable with PHN.; received two doses of Shingrix/ Last episode/ suspected Vaccination failure; Last episode; This case was reported by a pharmacist and described the occurrence of suspected vaccination failure in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included immunoglobulin therapy, shingles (had 7 breakthrough, refer linked case US2021AMR216523) and pneumonia bacterial. Previously administered products included Pneumovax with an associated reaction of pneumonia viral (received as late as July 2015 yet has had viral pneumonia twice and bacterial pneumonia once), Hizentra and valacyclovir (a maintenance dose of 500 mg valacyclovir qd, increasing to bid and tid if improvement not seen in shingles). Concurrent medical conditions included immunodeficiency.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In October 2021, more than 2 years after receiving Shingrix and Shingrix and an unknown time after starting Valacyclovir, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced post herpetic neuralgia. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and prednisone. On an unknown date, the outcome of the vaccination failure, shingles and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported. The patient was having immunodeficiency. The patient received 2 doses of Shingrix in the fall of 2018. Since the vaccination, she had 7 breakthrough Shingles infections.  The patient's physician had her on a maintenance dose of 500mg Valacyclovir QD, increasing to BID and TID if improvement not seen. Last episode of shingles was about two weeks before the date of reporting, she had to use Valacyclovir 1g TID x1 week, then 500mg TID along with Prednisone. Given that these were happening so often, she wondered if a third dose of Shingrix would be advisable. She was quite uncomfortable with post-herpetic neuralgia. Her physician said the usual 2 shots was the maximum. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles was unknown at the time of reporting. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR216523:same reporter
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: given 1 month after 7th birthday; This case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The patient received Kinrix approximately 1 month after 7th birthday, which led to inappropriate age at vaccine administration. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: the second knocked me off my butt; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid 19 vaccine (1st dose received on an unknown date), Covid 19 vaccine (2nd dose received on an unknown date) and Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and felt knocked off his/her butt, like his/her second Covid 19 shot did. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got both shots, 6 months later had shingles/ suspected vaccination failure; terrible case of shingles on my face, neck and shoulder; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, 6 months after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient stated that vaccine does not work for everyone. The patient received the series of both shots and 6 months later had a terrible case of shingles on face, neck and shoulder. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: feel tired; slightly feverish; This case was reported by a consumer and described the occurrence of tiredness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness and fever. On an unknown date, the outcome of the tiredness and fever were unknown.   It was unknown if the reporter considered the tiredness and fever to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at the vaccination was not reported. The patient received dose of Shingrix vaccine and felt tired and slightly feverish. The reporter asked GlaxoSmithKline could anyone felt tired and slightly feverish after getting the Shingrix vaccine. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Fainting after getting Shingrix shot; This case was reported by a consumer via (Shingrix GSK) interactive digital media and described the occurrence of faint in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, several hours after receiving Shingrix, the patient experienced faint (serious criteria GSK medically significant). On an unknown date, the outcome of the faint was unknown.   It was unknown if the reporter considered the faint to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported. The reporter asked that fainting could happen several hours after getting the Shingrix shot. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot and is now  having shingles outbreaks/ suspected vaccination failure; shingles outbreaks; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 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 details were provided as follows: The patient was the reporter's mother. The age at vaccination was not reported. The patient got the shot and was now constantly having shingles outbreaks all the time. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Can I break out in shingles from the vaccine/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, 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.   The reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingrix shot and still got shingles from the vaccine. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Hypoaesthesia, Paraesthesia, Polymyalgia rheumatica
Clinical narrative: Polymyalgia Rheumatica; Fatigue; joint pain; tingling in feet/tingling 6 inches about ankle; Numbness in feet/Numbness 6 inches about ankle; This case was reported by a consumer via call center representative and described the occurrence of polymyalgia rheumatica in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included knee operation (occurred 2 years ago from the date of reporting). Previously administered products included Shingrix (1st dose received 3/4 months before receiving 2nd dose on an date unknown).   On 20th December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant), fatigue, joint pain, tingling and numbness. The patient was treated with prednisone. On an unknown date, the outcome of the polymyalgia rheumatica was not recovered/not resolved and the outcome of the fatigue, joint pain and tingling were recovered/resolved and the outcome of the numbness was unknown.   It was unknown if the reporter considered the polymyalgia rheumatica, fatigue, joint pain, tingling and numbness to be related to Shingrix.  Additional details provided were as follows: The case was reported by the patient. Within 2 weeks of receiving the 2nd dose, the patient felt numbness and tingling in his feet and 6 inches above his ankle. The patient had knee surgery which occurred 2 years before the date of reporting and that the adverse events that he experienced were not due to the surgery. The patient had joint pain and fatigue that got worse and was referred to his rheumatologist. The patient was prescribed Prednisone for polymyalgia rheumatica and was now weaning off from this medication. The reporter declined to give further information and demographic information for his sister. The reporter consented to follow up. The case had been linked with US2021216680, reported by same reporter for patient's sister.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021216680:same reporter
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: suspected vaccination failure/received second Shingrix, has possibly shingles; has possibly shingles; non-itchy rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 1st December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 19th October 2021, more than a year after receiving Shingrix and 322 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.  Additional details provided were as follows: The case was reported by the patient herself. The age at vaccination was not reported for 1st dose of Shingrix. The patient received her 2nd dose in her right arm and at the time of reporting she had a non itchy rash on her left neck around to the mid point of her left back. The patient thought it might possibly be a case of shingles but she had not been to the health care professional to confirm yet. The reporter did not give permission to contact health care professional. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting. The reporter did not consented to follow-up.
Sex: U
Vaccine: HEPA
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: not received dose two due to pandemic; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in an unspecified number of patients who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (1st dose received, 2 years ago of reporting date).   On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, approximately twenty patients received dose one of Havrix about two years ago and had not received dose two, till the reporting date due to pandemic and the shut down. The reporter did not provide patient demographics, lot number or expiration date.  No additional details were provided.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: exposed to freezing temperatures; This case was reported by a nurse via call center representative and described the occurrence of incorrect product storage in a 23-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th October 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage 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 details were provided as follows: The patient received the vaccines after being exposed to freezing temperatures (minus 1 degree C for total amount of time of 25 min) on 18th October 2021 and 19th October 2021. The reporter consented to follow up. This case is one of the five, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021218244:same reporter US-GLAXOSMITHKLINE-US2021218242:same reporter US-GLAXOSMITHKLINE-US2021218245:same reporter US-GLAXOSMITHKLINE-US2021218239:same reporter
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: exposed to freezing temperatures; This case was reported by a nurse via call center representative and described the occurrence of incorrect product storage in a 26-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th October 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage 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 details were provided as follows: The patient received the vaccines after being exposed to freezing temperatures (minus 1 degree C for total amount of time of 25 min) on 18th October 2021 and 19th October 2021, which led to incorrect product storage. The reporter consented to follow up. This is one of five cases, reported by the same reporter.  ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021218244:same reporter US-GLAXOSMITHKLINE-US2021218242:same reporter US-GLAXOSMITHKLINE-US2021218245:same reporter US-GLAXOSMITHKLINE-US2021218238:same reporter
Age: 7.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Interchange of vaccine products, Product administered to patient of inappropriate age
Clinical narrative: Infanrix to 7 year old pt as 4th dose; and this is the 2nd Tdap; 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 7-year-old male patient who received DTPa (Infanrix) (batch number 4L9E4, expiry date 7th February 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis and DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Previously administered products included Pentacel (received first two doses on an unknown date).   On 20th October 2021, the patient received the 4th dose of Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Tdap Vaccine. On 20th October 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device and not applicable after receiving Tdap Vaccine, the patient experienced inappropriate age at vaccine administration and interchange of vaccine products. On an unknown date, the outcome of the inappropriate age at vaccine administration and interchange of vaccine products 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 details were provided as follows: The patient received the third dose of Tdap and fourth dose of Infanrix which led to interchange of vaccine products. The patient had received fourth dose of Infanrix at 7 years of age which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: M
Vaccine: FLUX
Symptoms: Hypersensitivity, Incorrect dose administered
Clinical narrative: incomplete doses; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 7-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received two incomplete doses of Influenza Vaccine Quadrivalent Unspecified Season when he was a new born, which led to incomplete dose administered. There was the reason why it were not full doses. The incomplete doses did not gave the patient an allergic reaction.  Then the patient received other Flu shot and had an allergic reaction and for the last 4 years the patient was vaccinated with Flulaval and had a reaction too, refer linked cases. This case is one of the 7 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR220135: US-GLAXOSMITHKLINE-US2021AMR220134: US-GLAXOSMITHKLINE-US2021AMR220133: US-GLAXOSMITHKLINE-US2021218250: US-GLAXOSMITHKLINE-US2021AMR220136: US-GLAXOSMITHKLINE-US2021AMR220131:
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Accidental underdose, Syringe issue
Clinical narrative: needle leaked during administration; did not receive the full dose; This case was reported by a nurse via call center representative and described the occurrence of syringe issue in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMZA584A, expiry date 31st August 2022) for prophylaxis.   On 11th October 2021, the patient received Menveo. On 11th October 2021, unknown after receiving Menveo, the patient experienced syringe issue and accidental underdose. On an unknown date, the outcome of the syringe issue and accidental underdose were unknown.  Additional details were reported as follows: This case was reported by the nurse. The nurse stated that the needle leaked during administration of Menveo and the patient did not receive the full dose, which led to syringe issue and accidental underdose. The reporter consented to follow-up.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Given a vaccine expired on 06/30/2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 26-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number XT4Z7, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st October 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 21st October 2021, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval 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 details were provided as follows: The patient received an expired Flulaval shot. The reporter consented to follow up.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: 2nd dose of Fluarix; given Fluarix, supposed to get Vaqta; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 2-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number HZ2JR, 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.   Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUARIX TETRA PFS).   On 21st October 2021, the patient received the 2nd dose of Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 21st October 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the outcome of the extra dose administered 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 details were provided as follows: The patient was inadvertently given a 2nd dose of Fluarix on the day of reporting, after receipt of her first dose on 8th October 2021, which led to extra dose administered. The patient was supposed to get Vaqta but received Fluarix, which led to wrong vaccine administered. The reporter consented to follow up via phone.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: receive Rotarix via intramuscular instead of oral; This case was reported by a nurse via call center representative and described the occurrence of inappropriate route of vaccination in a 10-week-old male patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 6th October 2021, the patient received Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 6th October 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On 6th October 2021, the outcome of the inappropriate route of vaccination 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 details were provided as follows: The patient received Rotarix via intramuscular instead of oral, which led to inappropriate route of vaccination. The patient was evaluated in the hospital.  No further details provided. The reporter consented to follow up.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Sensory loss, Swelling, Urticaria
Clinical narrative: swelling; hives; lost feeling on her arm; This case was reported by a nurse via call center representative and described the occurrence of swelling in a 16-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 724K2, expiry date unknown) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included stevens johnson syndrome.   In August 2020, the patient received Fluarix Tetra 2020-2021 season. In August 2021, the patient started Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, between 1 and 3 months after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced swelling, hives and loss of sensation. On an unknown date, the outcome of the swelling, hives and loss of sensation were unknown.   It was unknown if the reporter considered the swelling, hives and loss of sensation to be related to Fluarix Tetra 2020-2021 season and Fluarix Tetra 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 details provided were as follows: The case was reported by patient's mother. The nurse reported that the patient received Fluarix dose last year from the date of reporting and she started with hives, swelling and she lost feeling in her arm.  They were working with the patient´s doctor to see which component affected and cause this bad reaction to the patient. The reporter consented to follow up by email.
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number unknown, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st October 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 21st October 2021, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval 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 details were provided as follows: The reporter was office manager. The patient received an expired Flulaval shot inadvertently. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in November of 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November 2020).   On an unknown date, the patient received 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 details were provided are as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. Pharmacist inquired that when the patient should receive the 2nd dose or if they should restart the series. The caller provided 2nd dose response from Shingrix frequently asked questions content. The caller was not at work, therefore he did not had information regarding the patient. No additional details were provided by the caller. The reporter did not consented to follow-up.
Age: 16.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Administration of powder portion with sterile solution.; Administration of powder portion with sterile solution.; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMZA521A, expiry date 30th April 2022) for prophylaxis.   On 4th August 2021, the patient received Menveo. On 4th August 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional details were reported as follows: The nurse reported that the patient received just the powder portion of Menveo reconstituted with sterile solution, adjuvanted portion was not administered, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Dec2020, no 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 28th December 2020).   On an unknown date, the patient received 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 details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that the patient was late for their second dose of Shingrix and till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up (email).
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not yet received second dose; This case was reported by a consumer 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 approximately 5 years ago from reporting date).   On an unknown date, the patient received 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 details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter declined to provide demographics. The reporter did not consent to follow up.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Death, Drug interaction
Clinical narrative: possible drug interaction between Shingrix and Humira; This case was reported by a consumer via call center representative and described the occurrence of drug interaction in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included adalimumab (Humira) for product used for unknown indication.   In November 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient started Humira at an unknown dose and frequency. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced drug interaction (serious criteria death and hospitalization). The action taken with Humira was unknown. On 2nd December 2020, the outcome of the drug interaction was fatal. The patient died on 2nd December 2020. The reported cause of death was drug interaction.   It was unknown if the reporter considered the drug interaction to be related to Shingrix.  Additional details were provided as follows: The reporter was the wife of patient. In November 2020, the patient received Shingrix vaccine on same day (does not have exact date). The reporter asked, were there any contraindications or drug interactions between Shingrix and Humira. She stated that before they received first dose, healthcare professional (HCP) did not ask if the patient was on Humira and she and her husband (who was only one on Humira) received the first dose of Shingrix. Emergency room (ER) Visit Required. The reporter stated that 2 weeks later the patient was hospitalized and died on 2nd December 2020. The reporter stated when she went to get Shingrix dose 2 for herself in January 2021, HCP asked if she was taking Humira and she was not. She then realized that there might have been a connection with those two products (Humira and Shingrix) which encouraged her to provide this information to other pharma company. The reporter consented to follow up.; Reported Cause(s) of Death: Possible drug interaction
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a physician via sales rep and described the occurrence of shingles in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 2P9XB, expiry date 31st January 2023) for prophylaxis.   The patient's past medical history included covid-19 (the patient was tested positive for Covid on 22nd September 2021, prior of receiving Shingrix vaccine).   On 15th October 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 20th October 2021, 5 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The physician reported that patient received Shingrix on her left deltoid and developed shingles and the shingles symptoms started on 20th October 2021.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination site reaction
Clinical narrative: Had a bad reaction to the first dose; Did not get second dose in recommended window; This spontaneous case was reported by an occupational therapist and describes the occurrence of VACCINATION SITE REACTION (Had a bad reaction to the first dose) and PRODUCT DOSE OMISSION ISSUE (Did not get second dose in recommended window) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Had a bad reaction to the first dose) and PRODUCT DOSE OMISSION ISSUE (Did not get second dose in recommended window). At the time of the report, VACCINATION SITE REACTION (Had a bad reaction to the first dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not get second dose in recommended window) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was temporarily withheld on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   NO Concomitant medication was reported NO treatment Drug was reported
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: MIGRAINE; Protocol: 21-0012: A Phase 1 2 Study of Delayed Heterologous SARS CoV 2 Vaccine Dosing Boost After Receipt of EUA Vaccines.  Manufacturer Receipt Date: 07-OCT-2021  A clinical investigator reported that subject of unspecified age and sex (subject number and site number were not reported) experienced non-serious grade 1 migraine. The event occurred unknown days after COVID-19 vaccine Ad26.COV2.S was administered intramuscularly for prophylactic vaccination. The action taken with study vaccine was not applicable. The outcome was recovered.  The subject's height, and weight were not reported. No past medical history or concurrent conditions were reported. No concomitant medications were reported.  On an unknown date, the subject was treated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported.   On 19-JUL-2021, the subject experienced migraine.  The subject recovered from migraine on 19-JUL-2021.  Investigator's causality assessment:  The event of migraine was related to the study vaccine.  Company causality assessment: The event of migraine was related to the study vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure
Clinical narrative: ACUTE KIDNEY INJURY; ACUTE HYPOXIC RESPIRATORY FAILURE; This spontaneous report was received from literature: Characteristics and outcomes of adverse events after COVID-19 vaccination. 2021 Oct 13; 2/5. This report concerned a 92 year old male. The objective of this study was to describe fatal and non-fatal possible Adverse Events after COVID-19 vaccine administration. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypertension, congestive heart failure, chronic kidney disease, and renal cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced acute kidney injury and acute hypoxic respiratory failure. On an unspecified date, the patient died of acute kidney injury and acute hypoxic respiratory failure. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The authors concluded that although reported adverse events (AEs) were not necessarily caused by the vaccination, this study provided further information about possible AEs after COVID-19 immunization, especially those requiring hospital admission. This study also supported prior data that serious AEs post vaccination were much lower than primary COVID-19 infections. Also, need for further studies to investigate causalities between vaccines and reported AEs across all age groups was highlighted. This report was serious (Death).; Sender's Comments: V0: 20211045466-covid-19 vaccine ad26.cov2.s-acute kidney injury. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20211045466-covid-19 vaccine ad26.cov2.s-acute hypoxic respiratory failure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: ACUTE HYPOXIC RESPIRATORY FAILURE; ACUTE KIDNEY INJURY