chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site pain, Oropharyngeal pain, Pain
Clinical narrative: Lots of muscle pain at the injection site; Feeling tired; Achy; Flu-lik; Bad sore throat/pharyngitis; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site muscle pain, tiredness, pain, influenza-like symptoms and sore throat. On an unknown date, the outcome of the injection site muscle pain, tiredness, pain, influenza-like symptoms and sore throat were not recovered/not resolved.   It was unknown if the reporter considered the injection site muscle pain, tiredness, pain, influenza-like symptoms and sore throat to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's comments:  The reporter stated that she had received the second vaccine on Monday and she was still feeling tired, achy, flu-like and lots of muscle pan at the injection site.  She also had a bad sore throat. The reporter had asked if all these symptoms were related to the shingles vaccine and how long would do the last. The patient was provided information as per the package insert/prescribing information. The reporter had also asked if her sore throat was due to the vaccine. The reporter had consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Very sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 31st October 2022, the patient received Shingles vaccine. On 1st November 2022, 1 days after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK receipt date :01-NOV-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient received shingle vaccine the day before reporting and the patient was sick on the day reporting. The patient asked how long did side effects last after shot .
Sex: U
Vaccine: VARZOS
Symptoms: Product availability issue
Clinical narrative: The patient did not receive the second dose, as it was unavailable; This case was reported by a consumer via call center representative and described the occurrence of product availability issue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (4 or 5 years ago, the patient got the first dose of the Shingrix vaccine).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product availability issue. On an unknown date, the outcome of the product availability issue was unknown.   Additional Information: GSK Receipt Date: 02-Nov-2022 Reporter's comment: The patient did not receive the second dose, as it was unavailable.  The patient asked do he/she need to get the 2nd dose or start over with the 1st dose. The reporter advised that the patients consulted with their healthcare provider about this guidance and their individual situation.The permission for consent to follow-up was denied. Additional supportive information: The patient did not receive the second dose, as it was unavailable, which led to product supply issue.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pain, Skin discolouration, Swelling
Clinical narrative: Red; Silver dollar size bump; Silver dollar size bump; Painful; This case was reported by a nurse via sales rep and described the occurrence of erythema in a 64-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 9XL7N, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st October 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, less than a week after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced erythema, skin discoloration, local swelling and pain. On an unknown date, the outcome of the erythema, skin discoloration, local swelling and pain were unknown.   It was unknown if the reporter considered the erythema, skin discoloration, local swelling and pain to be related to Fluarix Quadrivalent 2022-2023 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 Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient was a retired nurse. The reporter stated that the patient received Fluarix vaccine and after that she experienced red, painful and silver dollar size bump. The reporter agrees to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a nurse via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, 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.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-Nov-2022 Reporter's comment: The patient contracted shingles, the day after received Shingrix vaccine. The reporter agrees to follow up from GlaxoSmithKline. Additional supportive information: This case has been linked to the case US2022AMR160156 reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR160156:Same reporter
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Pain
Clinical narrative: achenes; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 1st November 2022, the patient received Shingles vaccine and Flu vaccine. In November 2022, less than a week after receiving Shingles vaccine and Flu 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 and Flu vaccine.     Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that had shingles shot and flu vaccine the day prior to the reporting. The patient asked can patient take Advil for ache.
Sex: U
Vaccine: VARZOS
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This case was reported by a consumer via interactive digital media and described the occurrence of sore throat 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 sore throat. On an unknown date, the outcome of the sore throat was unknown.   It was unknown if the reporter considered the sore throat to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter had asked that could the Shingrix shot caused a sore throat. Additional supportive information: Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site pain, Oropharyngeal pain, Pain
Clinical narrative: Lots of muscle pain at the injection site; Feeling tired; Achy; Flu-like; Bad sore throat; This case was reported by a consumer via interactive digital media and described the occurrence of injection site muscle pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 31st October 2022, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced injection site muscle pain, tiredness, pain, influenza-like symptoms and sore throat. On an unknown date, the outcome of the injection site muscle pain, tiredness, pain, influenza-like symptoms and sore throat were not recovered/not resolved.   It was unknown if the reporter considered the injection site muscle pain, tiredness, pain, influenza-like symptoms and sore throat to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received second dose of Shingles vaccine on Monday (the day before reporting) and still felt tired, achy, flu-like and lots of muscle pain at the injection site.  The patient also had a bad sore throat. The patient asked were all these symptoms related to the Shingles vaccine and how long did they last. Additional Supportive Information: Vaccination date captured as 31st October 2022 conservatively. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Lymph node swelling; Stomach pain; Fever of 99-100 for 2-3 days; Headache; Nausea; Swelling 1 inch below the injection site/ increased to the size of a soft ball.; Tenderness 1 inch below the injection site; Redness 1 inch below the injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (Had chickenpox as a child). Concurrent medical conditions included arthritis. Concomitant products included adalimumab (Humira).   In September 2022, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site swelling, injection site tenderness, injection site erythema, swollen lymph nodes, stomach pain, fever, headache and nausea. On an unknown date, the outcome of the injection site swelling, injection site tenderness, injection site erythema and fever were recovered/resolved and the outcome of the swollen lymph nodes, stomach pain, headache and nausea were unknown.   It was unknown if the reporter considered the injection site swelling, injection site tenderness, injection site erythema, swollen lymph nodes, stomach pain, fever, headache and nausea to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-NOV-2022 Reporter's comments: The reporter was the patient who had received the Shingrix one and half months ago from the time of reporting and had experienced swelling, tenderness, and redness 1 inch below the injection site, which had increased to the size of a soft ball.  This had occurred for 5 days. The fever was of 99-100 degree Fahrenheit for 2-3 days, but she usually runs a low temperature of 97.6 Fahrenheit. She did not took any Tylenol or Ibuprofen, because she did not wanted to get it impacted on her immune response. She also had experienced lymph node swelling, stomach pain, headache, and nausea.  Shingrix was administered during her off week of Humira. She did test herself of COVID since this reaction with Shingrix made her think she had COVID. Her COVID test came back negative.  She did not receive any other vaccines at the time that Shingrix was administered. The reporter had consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Nausea, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Lymph node swelling; Stomach pain; Fever of 99-100 for 2-3 days; Headache; Nausea; Swelling 1 inch below the injection site/ increased to the size of a soft ball.; Tenderness 1 inch below the injection site; Redness 1 inch below the injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (Had chickenpox as a child). Concurrent medical conditions included arthritis. Concomitant products included adalimumab (Humira).   In September 2022, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site swelling, injection site tenderness, injection site erythema, swollen lymph nodes, stomach pain, fever, headache and nausea. On an unknown date, the outcome of the injection site swelling, injection site tenderness, injection site erythema and fever were recovered/resolved and the outcome of the swollen lymph nodes, stomach pain, headache and nausea were unknown.   It was unknown if the reporter considered the injection site swelling, injection site tenderness, injection site erythema, swollen lymph nodes, stomach pain, fever, headache and nausea to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-NOV-2022 Reporter's comments: The reporter was the patient who had received the Shingrix one and half months ago from the time of reporting and had experienced swelling, tenderness, and redness 1 inch below the injection site, which had increased to the size of a soft ball.  This had occurred for 5 days. The fever was of 99-100 degree Fahrenheit for 2-3 days, but she usually runs a low temperature of 97.6 Fahrenheit. She did not took any Tylenol or Ibuprofen, because she did not wanted to get it impacted on her immune response. She also had experienced lymph node swelling, stomach pain, headache, and nausea.  Shingrix was administered during her off week of Humira. She did test herself of COVID since this reaction with Shingrix made her think she had COVID. Her COVID test came back negative.  She did not receive any other vaccines at the time that Shingrix was administered. The reporter had consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes virus infection
Clinical narrative: outbreak of herpes; This case was reported by a nurse via sales rep and described the occurrence of herpes virus infection in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Acyclovir (PRN as needed for outbreaks, refer case US2022AMR161275).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced herpes virus infection. The patient was treated with acyclovir. On an unknown date, the outcome of the herpes virus infection was not recovered/not resolved.   It was unknown if the reporter considered the herpes virus infection to be related to Shingrix.   Linked case(s) involving the same patient:US2022AMR161275   Additional Information: GSK Receipt Date: 03-NOV-2022 Reporter's Comment: The patient was over 50 years of age, contracted herpes virus.  The patient received Shingrix shot and had an outbreak of herpes and now was taking daily acyclovir for continuous outbreak.  The patient reported to doctor that if she stopped taking daily Acyclovir that the outbreak re-started since, she received the vaccine.  The doctor advised her not to take the second shot of Shingrix. The reporter did not agree to follow up from GlaxoSmithKline.; Sender's Comments:  US-GSK-US2022AMR161275:same reporter, same patient
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1 dose in 2020, another dose today; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received first dose in 2020).   On 3rd November 2022, the patient received the 2nd dose of Shingles vaccine. On 3rd November 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 3-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had 1 dose of Shingrix in 2020 according to his/her records.  The patient did not remember getting a second shot and forgot about the first and had another first dose on day of reporting.  The patient asked that was it ok or he/she still need another shot. Additional supportive information: The patient received the second shot later than the recommended interval, which led to lengthening of vaccine schedule. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in 2020, another dose today (03Nov2022); This case was reported by a consumer and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2020).   On 3rd November 2022, the patient received the 2nd dose of Shingrix. On 3rd November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 3-Nov-2022 Reporter's comment: The patient had forgotten about dose that until he/she checked online records through the vaccination website. The patient went on the day of reporting and had a first dose again. The patient asked that he/she should still get the second dose in December especially since it's been so long after the first one in 2020. Additional supportive information: The patient received the second shot later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling; Numbness; This case was reported by a consumer via call center representative and described the occurrence of tingling in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced tingling and numbness. On an unknown date, the outcome of the tingling and numbness were recovered/resolved.   It was unknown if the reporter considered the tingling and numbness to be related to Shingrix.     Linked case(s) involving the same patient:  US2022160202   Additional Information: GSK Receipt Date: 03-NOV-2022 Reporter's Comment: The reporter was a patient. The patient reported that she received pair of Shingrix vaccine in 2020. The patient stated that the numbness and tingling was not present before receive the Shingrix vaccine. The patient stated that before 10 months the tingling and numbness had been present for some time. The reporter did consent to follow up. Additional supportive information: for the tolerance of the 2nd dose, refer linked case US2022160202,  reported by same reporter.; Sender's Comments:  US-GSK-US2022160202:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles (terrible case); 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 (Shingles vaccine) for prophylaxis.   On 26th October 2022, the patient received Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, 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 Shingles vaccine.     Additional Information: GSK Receipt Date: 03-Nov-2022 Reporter's Comments: This case was reported by a patient's wife via interactive digital media. The reporter stated that the patient got the vaccination last Wednesday from reporting and he now had a terrible case of Shingles. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: one dose 2-3 years ago, did not follow up with second; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received first dose 2 to 3 years ago).   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: 1-Nov-2022 Reporter's comment: The reporter asked that if the patients had one dose of 2 to 3 years ago, but did not follow-up with the second one, should they start all over or just receive one more dose. This was a chat question, asked for demographics and the chatter declined and then abandoned the chat. Additional supportive information: Till the time of reporting, the patients did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Engerix-B pediatric administered to adult; Engerix-B pediatric administered to adult; This case was reported by a nurse via call center representative and described the occurrence of underdose in a adult male patient who received HBV (Engerix B pediatric) (batch number FB9RH, expiry date 24th January 2024) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 µg. On an unknown date, 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: 01-NOV-2022 Reporter's Comment: The nurse reported that during an audit they found that the Engerix-B pediatric doses were administered to the 5 or 6 adult patients. The vaccine administration facility was the same as the primary reporter. The reporter consented to follow up.  Additional Supportive Information: The adult patient was administered a pediatric dose of Engerix-B, which led to underdose and adult use of a child product. This case had been linked with US2022158095 by same reporter for different patient.; Sender's Comments:  US-GSK-US2022158095:Same reporter US-GSK-US2022158096:Same reporter - Deleted US-GSK-US2022158133:Same reporter - Deleted
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Engerix-B pediatric administered to adult; Engerix-B pediatric administered to adult; This case was reported by a nurse via call center representative and described the occurrence of underdose in a patient who received HBV (Engerix B 10 mcg) for prophylaxis.   On an unknown date, the patient received Engerix B 10 mcg 10 ug. On an unknown date, unknown after receiving Engerix B 10 mcg, 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: 01-NOV-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that during an audit they found that the Engerix-B pediatric doses were administered to the 5 or 6 adult patients. The vaccine administration facility was the same as the primary reporter. The reporter consented to follow up.  Additional Supportive Information: The adult patients was administered a pediatric dose of Engerix-B, which led to underdose and adult use of a child product. This case had been linked with US2022158132 by same reporter for different patient. Note: The reporter did not know the exact number of patients was 5 or 6 so conservatively this case was processed as master case.; Sender's Comments:  US-GSK-US2022158132:Same reporter
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: never received the third dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received HBV (Engerix B) for prophylaxis.  Previously administered products included Engerix B (1st and 2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, 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: 01-Nov-2022 Reporter's comment: The nurse practitioner called to inquire for Engerix that could they complete it. Was there a maximum time to get the third dose or should they restart series. Nurse PR actioner reported 6 to 8 patients never received the third dose at 6 months for Engerix. The reporter wanted to know how to proceed. NP was unable to provide any patient or vaccine details. Did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 3rd dose, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2022AMR159868:same reporter
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: potentially late for the 2nd dose; 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 HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix  (received first dose on an unknown date ).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course 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 Information: GSK receipt date: 2-Nov-2022 Reporter's comment: The pharmacist stated a patient was potentially late for the second dose of the Twinrix series. The reporter did not consent to follow up and stated she was unsure whether she could provide additional information, so she did not provide further details. Did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Twinrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: HCP combined two adjuvant vials, product was not administered; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 2-Nov-2022 Reporter's comment: The pharmacist reported that the product was not administered. Nothing else was reported. The reporter did not consent to follow-up. Additional supportive information: The pharmacist  mistakenly combined two Shingrix adjuvant vials rather than an adjuvant and antigen vial, which led to wrong solution used in drug reconstitution.
Age: 6.0
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 6 YO was administered Bexsero; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-year-old male patient who received Men B NVS (Bexsero) (batch number A2X3Y, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd November 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd November 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 2-Nov-2022 Reporter's comment: The medical physician called to inquired any precautions, any advice on what to do on their end. The reporter confirmed that the vaccine was administered in their facility just a couple of hours ago. The reporter did not consent to follow-up. Additional supportive information: The patient was accidentally administered Bexsero in left deltoid at inappropriate age, which led to inappropriate age at vaccine administration.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Extra dose administered
Clinical narrative: Got a dose 19OCT2022 and another 2NOV2022; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 68-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 9XL7N, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT).   On 2nd November 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 2nd November 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered 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: 2-Nov-2022 Reporter's comment: The caller provided an email after transfer to second-line agent. The caller did not ask if email follow-up  was okay because the health care professional wanted to remain anonymous in their system. In accordance with their ways of working, the caller will email the health care professional's contact details. The caller consented to follow-up with a phone call, but the caller wished to stay anonymous in their system. Additional supportive information: The patient inadvertently received another dose of Fluarix (same lot) on the day of reporting, which led to extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on Feb2019, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st shot in February 2019).   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: 1-Nov-2022 Reporter's comment: The pharmacist reported that the patient was yet to receive Shingrix 2nd shot. The reporter did not had the lot number or expiration date of the shot given. The reporter had limited information. The caller center representative stated that it was his/her understanding that even if the reporter knew who the patient's primary care physician was he would not had been permitted to share that information with him/her without the patient's consent. Thus since he/she did not get the impression that the patient was present in the at the time of the report, he/she did not asked. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd shot of Shingrix, which led to incomplete course of vaccination.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Laboratory test normal, Off label use
Clinical narrative: 1st dose Oct2018, 2nd May2019; Shingrix to prevent Chickenpox; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 2nd dose of Shingrix. In October 2018, the patient received the 1st dose of Shingrix. In October 2018, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced off label use. In May 2019, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long and off label use were unknown.   Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's comment: The patient self-reported this case. The patient received her first dose of Shingrix in October 2018 and her second dose in May of 2019. The patient stated that she had never had chickenpox and her doctor confirmed this with lab work.  The patient also stated that her doctor gave her the first dose of Shingrix to prevent chickenpox and she received the second dose at a pharmacy. The reporter did not consent to follow-up. Additional Supportive Information: The patient also stated that her doctor gave her the first dose of Shingrix to prevent chickenpox, which led to off label use. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: without it being reconstituted with the powder component; received only the liquid adjuvant portion of Shingrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication 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 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: 02-NOV-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient might had received only the liquid adjuvant portion of the Shingrix vaccine without it being reconstituted with the powder component. The reporter stated that this could had been 1 or 2 doses of adjuvant only for these patients, the reporter was unsure at this time, the review of the medical records to confirm was pending. The reporter did not had the dates of administration, lot number, expiration date and any patient information at the time of the reporting. The vaccine administration facility was the same as the primary reporter. The reporter did consent to follow up. Additional supportive information:  The reporter gave by error Shingrix adjuvant diluent portion only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered This case was 1 of 3 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR159619:same report, other patient US-GSK-US2022AMR159620:same report, other patient
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Extra dose administered, Incomplete course of vaccination
Clinical narrative: Hep-B dose 1 in 2020, dose 2 not received; Received third dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st and 2nd dose received on an unknown date) and Hepatitis B vaccine (1st dose received on 2020).   On an unknown date, the patient did not receive the 2nd dose of Hepatitis B vaccine and received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Hepatitis B vaccine and not applicable after receiving Shingrix, the patient experienced incomplete course of vaccination and extra dose administered. On an unknown date, the outcome of the incomplete course of vaccination and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the patient received 1st dose of Hepatitis B series of unknown brand in 2020 and then never received 2nd dose. The reporter stated that the patient also inadvertently received 3rd dose of Shingrix vaccine. No further details were provided on the call. The reporter did consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Hepatitis B vaccine, which led to incomplete course of vaccination. The patient received extra dose of Shingrix vaccine inadvertently, which led to extra dose administered.
Sex: U
Vaccine: DTAPHEPBIP, DTAPIPV, HEP, MENB, TDAP
Symptoms: Product storage error
Clinical narrative: Temperature excursion of 28.9°C; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Engerix B, Engerix B Pre-Filled Syringe Device, Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Engerix B, Engerix B Pre-Filled Syringe Device, Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-Nov-2022 Reporter's comment: The nurse reported that Bexsero, Pediarix, Kinrix, Engerix-B and Boostrix was administered to several patients (number was not provided) after temperature excursion of 28.9 degree Celsius.  This excursion took place on 14th October 2022. No information was provided about the patients as the person whom reported the incident stated she did not had that information on hand but that she would try to reach out or that she would respond to inquiries from the safety department to her registered email. The information was solicited multiple times, yes the reporter stated on multiple occasions that she did not had it. The reporter consented to follow-up. Additional supportive information: The patients received Bexsero, Pediarix, Kinrix, Engerix-B and Boostrix after temperature excursion, which led to incorrect storage of drug.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: pain at the injection site; swelling at the injection site; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 9XL7N, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st October 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, less than a week after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Fluarix Quadrivalent 2022-2023 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 Information: GSK Receipt Date: 02-Nov-2022 Reporter's comment: The patient received dose of Fluarix vaccine and experienced pain and swelling at the injection site. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up.
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Diarrhoea, Headache, Injection site pain, Nasal congestion
Clinical narrative: injection site sore, left arm; and hours later she experienced wheezing; congestion getting better/Nasal congestion; Headache is better now but still remains.; Feels achy; Feels weak; now has diarrhea; Fever 101-104.5; threw up; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of adverse reaction (had a reaction to the Flu shot when patient was 11). Concurrent medical conditions included multiple allergies.   On 31st October 2022, the patient received the 1st dose of Fluarix Quadrivalent 2022-2023 season (intramuscular) and Fluarix Tetra Pre-Filled Syringe Device. On 31st October 2022, less than a day after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vomiting and fever. On 2nd November 2022, the patient experienced diarrhea. On an unknown date, the patient experienced injection site pain, wheezing, nasal congestion, headache, pain and feelings of weakness. The patient was treated with benadryl allergy (nos) (Benadryl Allergy), epinephrine (Epi Pen) and paracetamol (Tylenol). On an unknown date, the outcome of the injection site pain was unknown and the outcome of the wheezing and nasal congestion were recovering/resolving and the outcome of the headache, diarrhea, pain and feelings of weakness were not recovered/not resolved and the outcome of the vomiting and fever were recovered/resolved.   It was unknown if the reporter considered the injection site pain, wheezing, nasal congestion, headache, vomiting, diarrhea, pain, feelings of weakness and fever to be related to Fluarix Quadrivalent 2022-2023 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 Information: GSK receipt date: 02-NOV-2022 Reporters comment:  The reporter reported left arm a little sore at injection site and hours later she experienced wheezing. She took Benadryl ( allergies)  and carried an EPI Pen. The patient was still wheezing and congestion getting better. Headache was better now but still remained. She reported she threw up the night of vaccine and now had diarrhea. She felt achy and weak. On the date of reporting, she reported fever was 101 degree F which had been higher, with the highest temperature recorded hours after vaccine and fever was 104.5 degree F. She had been taking Tylenol for the fever and aches. No other information provided.  Consented to follow up.