chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: has the shingles and he got the shot / 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 male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient had the shingles and he got the shot. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vaccine, shingles/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 (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 was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the vaccine years ago but the patient was recovering from shingles of 4 weeks right now from the day of reporting. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles months AFTER 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 (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had chicken pox and all of the usual childhood maladies).   On an unknown date, the patient received Shingles vaccine. On an unknown date, several months 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 case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient developed a light case of Shingles several years ago a few months after having had the vaccine. So much for the prevention. However the patient guess, it could have been worse the patient not gotten the shot. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation was unknown at the time of reporting. The follow up was not required
Sex: F
Vaccine: MEN
Symptoms: Death, Pain
Clinical narrative: die of Men B; die of Men B, hurt her; This case was reported by a consumer via interactive digital media and described the occurrence of death in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced death (serious criteria death and GSK medically significant) and pain. On an unknown date, the outcome of the death was fatal and the outcome of the pain was unknown. The reported cause of death was unknown cause of death.   The reporter considered the death to be related to Meningococcal B vaccine. It was unknown if the reporter considered the pain to be related to Meningococcal B vaccine.  Additional details provided were as follows: The case was reported by the patient's parent. The age at vaccination was not reported. The reporter reported that he/she hate what the vaccine did to his/her daughter. The reporter reported that the patient was more likely to get hit by lighting more than once than die of Men B, but they hurt her and they did not care. The reporter stated that they trick people into thinking that all meningitis was the same, but it was not, but they would not benefit if they knew that. Follow-up would not be possible as no contact details provided. Note: The event death was conservatively captured as the information received was not clear as the patient was died from receiving Men B vaccine.; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got the shot now suffering shingles/ suspected vaccination failure; shingles; painful; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain 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 shingles shot few years ago and now suffering from shingles. The patient stated that shingles shot did not work for him/her. The patient also stated that shingles are very painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot for shingles/ got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via 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 reported as follows: The age at vaccination was not reported. The reporter knew a lady who got the shot for shingles and got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had the shingles shot / have the shingles now/suspected vaccination failure; shingles; Muach pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 80-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the shingles shot a few years ago from the date of reporting but had the shingles now.  The patient had never had this much pain in my life.  The patient praying that it would soon go away. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Vaccination failure
Clinical narrative: Have them now. Had the vaccine both injections/ suspected vaccination failure; Have them now/It has migrated from my right side to my left. On my left hand especially.; blisters; 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and blister. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and blister were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and blister to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient had shingles at the time of reporting. Shingles has migrated from my right side to left. On left hand especially. The patient stated it was so strange and straight-line blisters. The patient stated that the shingles case could have been worse if the patient would have had I not gotten the vaccine. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: she got the vax, then got shingles/ suspected vaccination failure; bad case of shingles around her eye; bad case of shingles on her scalp.; 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), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient was told by her physician how bad shingles could be and he advised her to get the shingles shot. The patient never had shingles before, so she decided to get the vaccination. Then, she got a bad case of shingles around her eye and on her scalp. 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: have it after vaccines/ shingles/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 (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox.   On an unknown date, the patient received Shingles vaccine. In September 2021, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with silver colloidal and gabapentin. 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 self-reported this case. The age at vaccination was not reported. The patient got shingles two weeks ago from reporting date, even after Shingles vaccines, it was only a small area and it almost more that he/she could handle. The patient mentioned that anyone could get shingles multiple times vaccine or not. The patient reported that the vaccine helps the severity. The patient had ordered some colloidal silver off and dab it one several times a day as silver was a bactericide that used both orally and topically. The patient advised that could get information about it. The patient reported that Gabapentin which was for shingles relief was only thing that helped him/her. 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 vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: died; got GBS; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a 70-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's cousin had a shingles but never receive the Shingle shot because it could cause Guillain Barre syndrome).   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the guillain barre syndrome was unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death and guillain barre syndrome to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the cousin of the patient. The age at vaccination was not reported. The reporter stated that, my cousin (patient) who got Guillain Barre syndrome and died in a month after the Shingle shot. It took over her whole system and she had no health problems.  The reporter said, they would tell you it was very rare but reporter have known 3 people. This is 1 of the 4 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR208072:same reporter US-GLAXOSMITHKLINE-US2021AMR208071:same reporter US-GLAXOSMITHKLINE-US2021AMR208073:same reporter; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not receive their second dose, it has been over 2 years; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago from the date of reporting).   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 reporter asked, if the patient did not receive their second dose of Shingrix withing 2-6 months and it has been over 2 years, did they need to repeat the series. Till the time of reporting, the patient, did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Needle issue, Underdose
Clinical narrative: did not receive the complete dose; needle leaked; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 38-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th September 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 28th September 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incomplete dose administered and needle leak. On an unknown date, the outcome of the incomplete dose administered and needle leak were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The reporter stated that during administration of Boostrix, the needle leaked and the patient did not receive the complete dose, which led to incomplete dose administered. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 11/15/2020, wondering if needed to repeat; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15th 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 as follows: The patient self-reported the case. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient wondered if he needed to repeat Shingrix. The patient refused to provide any additional demographic details. The patient consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: second dose on 09/29/2021, developed shingles; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included diabetes.   On 29th September 2021, the patient received Shingrix. On 29th September 2021, less than a day after receiving Shingrix, the patient experienced shingles. On 29th September 2021, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient received shingrix vaccine and developed shingles in exact same dermatone as previous shingles. The patient was diabetic. The reporter consented to follow-up.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dysphonia, Injection site pain, Lower respiratory tract congestion, Pain in extremity
Clinical narrative: Soreness at injection site; Sinus problems; Chest congestion; persistent Cough; Increased phlegm production; Raspy voice; Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 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.   On 27th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 28th September 2021, 1 days after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced injection site pain, sinus disorder, lower respiratory tract congestion, persistent cough, phlegm, hoarse voice and pain in arm. On an unknown date, the outcome of the injection site pain, sinus disorder, lower respiratory tract congestion, persistent cough, phlegm, hoarse voice and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, sinus disorder, lower respiratory tract congestion, persistent cough, phlegm, hoarse voice and pain in arm to be related to Fluarix Quadrivalent 2021-2022 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 were provided as follows: This case was reported by the patient herself. The reporter was unsure if vaccine received was manufactured by GlaxoSmithKline, but believed it might had been Fluarix. The patient was experiencing soreness in the left arm/at injection site, sinus problems, chest congestion, a persistent cough, increased phlegm production, and a raspy voice. All symptoms began on the nest day and all symptoms were ongoing. The reporter did not consent to follow-up.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Productive cough, Sinus disorder
Clinical narrative: Soreness at injection site; Sinus problems; Chest congestion; persistent Cough; Increased phlegm production; Raspy voice; Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 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.   On 27th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 28th September 2021, 1 days after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced injection site pain, sinus disorder, lower respiratory tract congestion, persistent cough, phlegm, hoarse voice and pain in arm. On an unknown date, the outcome of the injection site pain, sinus disorder, lower respiratory tract congestion, persistent cough, phlegm, hoarse voice and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, sinus disorder, lower respiratory tract congestion, persistent cough, phlegm, hoarse voice and pain in arm to be related to Fluarix Quadrivalent 2021-2022 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 were provided as follows: This case was reported by the patient herself. The reporter was unsure if vaccine received was manufactured by GlaxoSmithKline, but believed it might had been Fluarix. The patient was experiencing soreness in the left arm/at injection site, sinus problems, chest congestion, a persistent cough, increased phlegm production, and a raspy voice. All symptoms began on the nest day and all symptoms were ongoing. The reporter did not consent to follow-up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Lymphadenopathy, Pain in extremity, Paraesthesia
Clinical narrative: malaise; left clavicular lymph node enlargement; tingling; left arm soreness; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included ophthalmic herpes zoster (2017).   On 2nd August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 2nd August 2021, less than a day after receiving Shingrix, the patient experienced pain in arm, enlargement of lymph nodes and tingling of extremity. On an unknown date, the patient experienced malaise. On an unknown date, the outcome of the pain in arm, malaise and enlargement of lymph nodes were recovered/resolved and the outcome of the tingling of extremity was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, malaise, enlargement of lymph nodes and tingling of extremity to be related to Shingrix.  Additional details were provided as follows: The physician reported that patient received Shingrix in left deltoid. The patient experienced left arm soreness, malaise, left clavicular lymph node enlargement, and left sided tingling down the body radiating to left upper extremity.  Adverse event was filed.  Number and website for GlaxoSmithKline medical information given for future reference and warm transfer provided. The reporter consented to follow up.
Sex: U
Vaccine: FLU4, HEPA
Symptoms: Product storage error
Clinical narrative: freezing excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis and flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th September 2021, the patient received Havrix, FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix, FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient received a Havrix and Flulaval that had been exposed to freezing temperatures, which led to incorrect storage of drug. The reporter consented to follow-up.
Age: 0.42
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received 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 5-month-old male patient who received HBV (Engerix B) (batch number 77BS9, expiry date 22nd September 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th September 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 30th September 2021, unknown after receiving Engerix B and Engerix B 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 reported as follows: This case was reported by the medical assistant. The age at vaccination was not reported. On 30th September 2021, the patient received a dose Engerix B pre-filled syringe which was already expired on 22nd September 2021. The reporter did not consent to follow-up.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: both were given and were already received a year ago; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 13-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 33ac7, expiry date 7th November 2022) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number amva568a, expiry date 31st May 2022) for prophylaxis.   Previously administered products included Boostrix (received 1st dose a year before the date of reporting) and Menveo (received 1st dose a year before the date of reporting).   On 30th September 2021, the patient received the 2nd dose of Boostrix and the 2nd dose of Menveo. On 30th September 2021, unknown after receiving Boostrix and Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: The Patient had already received Boostrix and Menveo a year before the date of reporting and on 30th September 2021 patient received Boostrix and Menveo again, which led to extra dose administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Rash pruritic, Vaccination failure
Clinical narrative: received the Shingrix vaccine/wonders if this is shingles/ suspected vaccination failure; wonders if this is shingles/ suspected Shingles; Itchy rash; This case was reported by a consumer via call center representative and described the occurrence of 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 2nd dose of Shingrix (intramuscular) and the 1st dose of Shingrix. On 10th September 2021, between 1 and 2 years after receiving Shingrix and more than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and itchy rash. The patient was treated with hydrocortisone (Hydrocortisone Cream). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and itchy rash to be related to Shingrix and Shingrix.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received last dose of Shingrix 1 and 1/2 years before the date of reporting (no further details remembered). After receiving Shingrix, the patient experienced an itchy rash on her body. The itchy rash covers from above her knees, both thighs across her stomach and around to her back.  The rash started about 3 weeks before the date of reporting, then pretty much cleared up after 1 week and now as of day of reporting it was back again, in the same locations on her body. The pharmacy told her to put hydrocortisone cream to help with the itching. The hydrocortisone cream does help stop the itching.  The reporter wonders if this itchy rash was shingles. The patient was referred to healthcare professional (HCP). The reporter did not consent to follow-up. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received Menveo reconstituted with sterile water; received Menveo reconstituted with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate reconstitution technique in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA571A, expiry date 30th June 2022) for prophylaxis.   On 1st October 2021, the patient received Menveo. On 1st October 2021, unknown after receiving Menveo, the patient experienced inappropriate reconstitution technique and incorrect dose administered. On an unknown date, the outcome of the inappropriate reconstitution technique and incorrect dose administered were unknown.   It was unknown if the reporter considered the inappropriate reconstitution technique and incorrect dose administered to be related to Menveo.  Additional information was provided as follows: The patient received a Menveo vaccination on the day of reporting but they reconstituted with sterile water instead of the approved diluent of Menveo, which led to inappropriate reconstitution technique and incorrect dose administered.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: administration twice to a 12 y/o patient; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA581A, expiry date 31st August 2022) and (batch number AMAVA581A, expiry date 31st August 2022) for prophylaxis.   On 21st September 2021, the patient received Menveo. On 21st September 2021, the dose was an unknown dose. On 21st September 2021, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional information was provided as follows: The nurse reported that administration of Menveo on dates of administration of 10th Sep 2021 and 21st Sep 2021 to a  patient. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration
Clinical narrative: administered an IV push of fluarix; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 61-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra) (batch number fd723, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd October 2021, the patient received Fluarix Tetra (intrvenous push) and Fluarix Tetra Pre-Filled Syringe Device. On 2nd October 2021, unknown after receiving Fluarix Tetra and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route 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 intravenous push of Fluarix quadrivalent, which led to intramuscular formulation administered by other route. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain
Clinical narrative: Achiness; Malaise; This case was reported by a consumer via call center representative and described the occurrence of pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and malaise. On an unknown date, the outcome of the pain and malaise were recovered/resolved.   It was unknown if the reporter considered the pain and malaise to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's wife. The reporter stated that the patient experienced malaise and achiness from his first dose of Shingrix. The reporter had called to also inquire about receiving Twinrix and Covid-19 vaccine booster. The reporter consented to follow-up.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Product Used; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA57AA, expiry date 30th September 2021) 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 3rd October 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd October 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. Pharmacist reported that over the weekend a different pharmacist administered a dose of Bexsero to patient on 3rd October 2021 that was expired on 30th September 2021, which led to expired vaccine used. Health care professional gave permission to follow up The reporter consented to follow up.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling, Urticaria
Clinical narrative: bumps on her skin; itchy rash; hives on her body; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 91-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2021, the patient received the 1st dose of Shingrix (intramuscular). On 17th September 2021, 16 days after receiving Shingrix, the patient experienced itchy rash and hives. On 4th October 2021, the patient experienced local swelling. On an unknown date, the outcome of the itchy rash was not recovered/not resolved and the outcome of the hives and local swelling were unknown.   It was unknown if the reporter considered the itchy rash, hives and local swelling to be related to Shingrix.  Additional details provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine in right arm and experienced itchy rash that looks like hives on her body. The reporter stated that the rash comes and goes, 33 days after receiving Shingrix, the rash was itchier and there were more bumps on her skin. The patient reported that she had an appointment with the dermatologist today (on day of reporting). The patient did not give permission to contact healthcare professional. The reporter did not consent to follow-up.
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient younger than indicated received dose; 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 female patient who received DTPa-IPV (Kinrix) (batch number pk27b, expiry date 17th January 2023) 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 information was provided as follows: The patient younger than indicated received a dose of Kinrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received Hib (Hiberix) (batch number TF4EB, expiry date 26th September 2021) for prophylaxis.   On 1st October 2021, the patient received the 4th dose of Hiberix. On 1st October 2021, unknown after receiving Hiberix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional information was provided as follows: The patient received an expired dose of Hiberix vaccine. The reporter consented to follow up. The case was linked with US2021207017, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021207017:Same reporter
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix B was administered from a expired vial; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number unknown, expiry date 30th September 2021) for prophylaxis.   On 4th October 2021, the patient received Engerix B. On 4th October 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that a dose of Engerix-B was administered to a patient from a vial that expired on 30th September 2021. The pharmacist did not have patient information or vaccine lot number. The pharmacist did not provide contact information. The reporter did not consent to follow-up.
Age: 0.25
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 3 month old male patient was administrated a dose; 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 3-month-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number e9r44, expiry date 30th June 2022) 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 1st October 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 1st October 2021, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: It was reported that 3 months old patient was administrated a dose of the FluLaval Quadrivalent by mistake, which led to inappropriate age at vaccine administration.  The HCP did not clarify from what season the vaccine administrated belonged to.  No further events were reported. The reporter agreed to be contacted for follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Psychotic disorder, Pyrexia
Clinical narrative: PSYCHOSIS, PARANOID OR DELUSIONAL; FEVER STATE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced psychosis, paranoid or delusional, and fever state. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from psychosis, paranoid or delusional, and the outcome of fever state was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. Initial information was processed along with the additional information received on 05-OCT-2021 The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. 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 suspected immunological vaccine failure. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000196118.; Sender's Comments: V0: 20211007061-covid-19 vaccine ad26.cov2. s-suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has an unknown/unclear 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: SPECIAL SITUATIONS