chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: what would happen if a patient mistakenly received only the liquid component of the Shingrix vaccine; what would happen if a patient mistakenly received only the liquid component of the Shingrix vaccine; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media 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 details were provided as follows: The case was reported by the consumer for herself or himself. The age at vaccination was not reported. The reporter stated that, he or she was wondering what would happen if a patient mistakenly received only the liquid component of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: take the shingles vaccine and he got shingles/ suspected vaccination failure; he got shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a elderly 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.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The patient was reporter's uncle. The age at vaccination was not reported but the patient was in his 80's. The patient never had Shingles and then taken the Shingles vaccine and he got shingles from it. The reporter stated that we better be careful what we allow them to inject us with. 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.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: received the adult dose instead of a pediatric dose; received the adult dose instead of a pediatric dose; received his fourth dose of engerix-B; This case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 17-year-old male patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 4th dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced adult product administered to child, overdose and extra dose administered. On an unknown date, the outcome of the adult product administered to child, overdose and extra dose administered were unknown.  Additional details were provided as follows:  The patient received 4th dose of adult Engerix-B, instead of a pediatric dose, which led to adult product administered to child, overdose and extra dose administered. The reporter consent to follow up. This case has been linked with US2021122656, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021122656:Same Reporter
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Scab, Vaccination failure
Clinical narrative: first dose/October 2020/ second dose December 2020/last week/HCP diagnosed her with shingles/ Suspected Vaccination failure; HCP diagnosed her with shingles; developed wet blisters on her right face/ have started to crust over and heal/not resolved completely.; crust over; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 2nd dose of Shingrix. In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, between 5 and 6 months after receiving Shingrix and between 7 and 8 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister and crust. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the blister and crust were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, blister and crust to be related to Shingrix and Shingrix.  Additional details were reported as follows: This case was reported by patient herself. Last week before reporting date, the patient developed wet blisters on her right face. The healthcare professional diagnosed her with shingles and started her on Valtrex. The patient stated that the blisters had started to crust over and heal but had not resolved completely. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming herpes zoster was unknown at the time of reporting.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Skin ulcer, Vaccination failure
Clinical narrative: received the two doses of Shingrix a couple of years ago/ she got shingles last year/ suspected Vaccination failure; she got shingles last year; starting to get sores; experience itchiness; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (as a kid). Previously administered products included Shingles vaccine (received the one-dose shingles vaccine 7 to 8 years ago from the reporting date).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix (intramuscular). On an unknown date, several years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, skin ulcer and pruritus. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the skin ulcer and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, skin ulcer and pruritus to be related to Shingrix and Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported. A couple of years ago, the patient received the two doses of Shingrix. In 2020, last year the patient got shingles. In 2021, this year at the time of reporting, she was starting to get sores and experienced itchiness. The patient recently received the Pfizer covid vaccine, which she reported had made her feel crappy, she further described this crappy feeling by saying that she was tired and it felt like it was dragging like she was pushing herself. The patient did mention that her medications were causing other problems (unspecified). The patient declined to give her address or email address. The reporter consented to follow-up. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming herpes zoster was unknown at the time of reporting. No further information was reported.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 29 month old patient received a dose of Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 29-month-old female patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 22nd August 2022) 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 (intramuscular) and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Nurse practitioner reported a 29 month old patient received a dose of Kinrix., which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: M
Vaccine: MENB
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: patient / date of birth was 29-Aug-2020, received a dose of Bexsero on 12-Nov-2020; received a dose of Bexsero on 12-Nov-2020 in the hospital anticipating an splenectomy (indication); 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 10-week-old male patient 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.   On 12th November 2020, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 12th November 2020, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and off label use. On an unknown date, the outcome of the inappropriate age at vaccine administration and off label use were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter reported that a patient received a dose of Bexsero at 10 weeks of age in the hospital anticipating an splenectomy (indication), which led to inappropriate age at vaccine administration and off label use. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Myelofibrosis, Platelet count decreased, Post herpetic neuralgia
Clinical narrative: reports a diagnosis of myelofibrosis; reports a diagnosis of  / low platelets; postherpetic neuralgia; shingles; This case was reported by a consumer via call center representative and described the occurrence of myelofibrosis in a 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, unknown after receiving Shingrix, the patient experienced myelofibrosis (serious criteria GSK medically significant), platelets decreased, post herpetic neuralgia and shingles. Shingrix was discontinued. On an unknown date, the outcome of the myelofibrosis, platelets decreased, post herpetic neuralgia and shingles were unknown.   It was unknown if the reporter considered the myelofibrosis, platelets decreased, post herpetic neuralgia and shingles to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported. Approximately two and a half years ago, the patient received 1st dose of Shingrix vaccine and approximately one and a half months after receiving the 1st dose, she experienced shingles and post herpetic neuralgia. The patient chose not to obtain the 2nd dose and she had consulted with her healthcare professional regarding whether or not she should proceed with receiving the 2nd dose.  The patient reported a diagnosis of myelofibrosis and low platelets and it was unclear whether this was diagnosed prior to or following the Shingrix vaccine. The patient reported she called GlaxoSmithKline and the CDC (Center for disease control) and reported her experience with Shingrix. While there were many details provided about her experience with the vaccine, the patient elected to remain anonymous and not share information for follow-up. The reporter did not consent to follow-up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Found an extra / vial alone / Guessing / a patient / received Menveo vial 1 liquid portion / alone; Found an extra / vial alone / Guessing / a patient / received Menveo vial 1 liquid portion / alone; 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 Men ACWY-CRM NVS (Menveo) (batch number AMVA439A, expiry date 31st August 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, 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 details were provided as follows: The age at vaccination was not reported. The patient was administered only the liquid containing antigens C, W-135 and Y of Menveo without mixing the solution with the powder (antigen A), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The details regarding the patient was not reported. The reporter consented to follow up by email.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: expired dose of Infanrix on June 9th, 2021/ dose expired on May 21st, 2021; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Infanrix) (batch number unknown, expiry date 21st May 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th June 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix 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: The age at vaccination was not reported. The patient received dose of Infanrix that was already got expired on 21st May 2021, which led to expired vaccine used. The health care professional had no information available about the patient and she offered to provide more information during the follow-up. The reporter consented to follow up.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered the diluent component / without lyophilized powder; Administered the diluent component / without lyophilized powder; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number 2EC54, expiry date 11th November 2022) for prophylaxis.   On 8th June 2021, the patient received Shingrix. On 8th June 2021, 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 details were provided as follows: The patient received only the diluent component of Shingrix without lyophilized powder which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Sex: U
Vaccine: HEPAB, HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: had not received dose three.; received the first dose of Twinrix in September 2019, the second dose on 08-Oct-2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long 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, HAB (Twinrix) for prophylaxis and 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 1st dose in September 2019).   On 8th October 2020, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 8th October 2020, an unknown time after receiving Twinrix, Twinrix and Twinrix Pre-Filled Syringe Device and unknown after starting Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a pharmacist intern. The age at vaccination was not reported for 2nd dose and it was not applicable for 3rd dose. The patient was vaccinated with 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: her first dose of Shingrix December 7, 2019; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 7th December 2019).   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 information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The patient could not recall the route of administration. The reporter consented to follow up.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypokinesia
Clinical narrative: "put him to bed for 4 days"; This case was reported by a consumer via call center representative and described the occurrence of movements reduced in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced movements reduced. On an unknown date, the outcome of the movements reduced was recovered/resolved.   It was unknown if the reporter considered the movements reduced to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient's ex-wife. The patient received his 2nd dose of Shingrix and was in bed for 4 days. The lot and expiry date was not provided. The report did not consented to follow up. This case has been linked with case US2021AMR124573, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR124573:Same reporter, different patient (invalid case)
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of shingrix on  6 march 2020, never got 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 Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 6th March 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: Age at vaccination was not applicable to this report. No other details of patient available. Pharmacist reported that patient got first dose of shingrix on 6th March 2020. The patient never got the 2nd dose, which led to incomplete course of vaccination. The reporter asked about 2nd dose or to revaccinate. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient was given only the adjuvant portion; Patient was given only the adjuvant portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 3N3GH, expiry date 28th January 2023) for prophylaxis.   On 9th June 2021, the patient received Shingrix (unknown). On 9th June 2021, 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 details were provided as follows: Age at vaccination was not reported. The patient was given only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  The reporter had no patient information at hand at time of the call. The reporter consented to follow up but agreed to follow-up via postal mail. The reported batch number pertains to Shingrix adjuvant.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Restless legs syndrome
Clinical narrative: having restless leg syndrome from her mid thighs down through her toes; This case was reported by a consumer via call center representative and described the occurrence of restless legs syndrome in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included peripheral neuropathy and pernicious anemia.   On 8th June 2021 15:00, the patient received the 1st dose of Shingrix. In June 2021, 9 hrs after receiving Shingrix, the patient experienced restless legs syndrome. On an unknown date, the outcome of the restless legs syndrome was not recovered/not resolved.   It was unknown if the reporter considered the restless legs syndrome to be related to Shingrix.  Additional details were provided are as follows: The case was reported for patient herself. The patient received dose of Shingrix and on same day in midnight, she experienced restless leg syndrome from her mid thighs down through her toes. She had notified her doctor. She was still experiencing restless leg syndrome.  No additional information were provided. The consumer consented to follow up. The case was linked with case US2021125154 reported by same reporter. The event onset date was  kept partial to reflect precise TTO value.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021125154:Same Reporter
Sex: F
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: all up in bed sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a female 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 sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient's sister. The age at vaccination was not reported. The patient got the Shingrix shot and was all up in bed sick.   The reporter did not provide any patient information and did not state whether it was her sister's 1st or 2nd injection. The reporter did not consent to follow up. This case has been linked with case US2021125155, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021125155:Same Reporter
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1: OCTOBER: 2019 Dose 2:06/9/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 3PD3E, expiry date 8th October 2022) for prophylaxis.   Previously administered products included shingrix (In October 2019, 1st dose received with batch number 4797C and expiry date 26th January 2022).   On 9th June 2021, the patient received the 2nd dose of Shingrix. On 9th June 2021, 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 details were provided as follows: The reporter was a registered pharmacist manager.. The patient received 2nd dose delayed than the recommended schedule, which led to lengthening of vaccination schedule. The reporter would like to know if a 3rd dose was needed. The reporter consented to follow up. This case had been linked to the case US2021125159, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021125159:same reporter
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1:11/29/2019: Dose 2:06/9/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 3PD3E, expiry date 8th October 2022) for prophylaxis.   Previously administered products included Shingrix (On 29th November 2019, 1st dose received with batch number M57C5 and expiry date 9th April 2022).   On 9th June 2021, the patient received the 2nd dose of Shingrix. On 9th June 2021, 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 details were provided as follows: The reporter was a registered pharmacist manager. The patient received 2nd dose delayed than the recommended schedule, which led to lengthening of vaccination schedule. The reporter would like to know if a 3rd dose was needed. The reporter consented to follow up. This case had been linked to the case US2021125158, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021125158:same reporter
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received an early third dose of Twinrix (before 6 months).; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short 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 1st dose on an unknown date) and Twinrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd 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 drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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 age at vaccination was not reported. The patient received an early third dose of Twinrix (Before 6 months), which led to shortening of vaccination schedule. The further information was not provided. The reporter did not consented to follow up.
Age: 12.0
Sex: M
Vaccine: DTAP, MENB
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Bexsero / were administrated instead of Boostrix and Menveo on June 9 2021; Infanrix were administrated instead of Boostrix and Menveo on June 9 2021; 12 years old male patient  / Infanrix / administrated instead of Boostrix and Menveo on June 9 2021; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB26AB, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) (batch number 5RM39, expiry date 25th November 2022) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th June 2021, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On 9th June 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device and not applicable after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered, wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered, wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a medical assistant. The patient was administered Bexsero and Infanrix instead of Boostrix and Menveo, which led to wrong vaccine administered. The patient received Infanrix at 12 years of age which led to inappropriate age at vaccine administration. No adverse event was reported. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: first dose / on September 13th 2018 / second dose on December 13th 2018 / remains / with shingles./ suspected vaccination failure; remains until today with shingles; This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included acyclovir.   On 13th December 2018, the patient received the 2nd dose of Shingrix. On 13th September 2018, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, 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 not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The reporter was a pharmacist intern.  The age at vaccination was not reported. The reporter stated that the patient remained with shingles till the time of reporting. No lot number or expiration date were provided. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and exact time to onset were unknown. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Didn´t received his second dose of shingrix after he received his first dose during 2018; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2018).   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. Till the time of reporting, the patient did not receive his second dose of Shingrix which led to incomplete course of vaccination.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinus pain, Sneezing, Suspected COVID-19, Toothache
Clinical narrative: SUSPECTED COVID-19 INFECTION; SNEEZING; HURTING OF TEETH; SINUS PAIN; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 67 year old white, not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker and no alcohol use. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 205A21A, expiry: Unknown) frequency one total, dose was not reported, administered on 10-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 22-MAY-2021, the patient started to have symptoms of coughing, fever, body aches, shortness of breath (subsumed under suspected covid-19 infection), sneezing, teeth hurt and sinus pain. She decided to take a covid-19 test and it came back positive (coded as suspected clinical vaccination failure and suspected covid-19 infection). She also stated that she lived healthy clean life. On an unspecified date, laboratory data included: Covid-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sneezing, hurting of teeth, sinus pain, suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality compliant: 90000181578. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information was received from Central Complaint Vigilance on 03-JUN-2021. The following information was updated and incorporated into the case narrative: Product quality complaint number, additional reporter as contact, and narrative was updated accordingly.; Sender's Comments: V0:20210604940-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SNEEZING; HURTING OF TEETH; SINUS PAIN; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 67 year old white, not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker and no alcohol use. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 205A21A, expiry: Unknown) frequency one total, dose was not reported, administered on 10-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 22-MAY-2021, the patient started to have symptoms of coughing, fever, body aches, shortness of breath (subsumed under suspected covid-19 infection), sneezing, teeth hurt and sinus pain. She decided to take a covid-19 test and it came back positive (coded as suspected clinical vaccination failure and suspected covid-19 infection). She also stated that she lived healthy clean life. On an unspecified date, laboratory data included: Covid-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sneezing, hurting of teeth, sinus pain, suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality compliant: 90000181578. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information was received from Central Complaint Vigilance on 03-JUN-2021. The following information was updated and incorporated into the case narrative: Product quality complaint number, additional reporter as contact, and narrative was updated accordingly.; Sender's Comments: V0:20210604940-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cold sweat, Cough, Nasal congestion, Pyrexia
Clinical narrative: COUGHING WHEN LYING DOWN; COLD SWEATS AT NIGHT, WITH BLANKETS BEING WET; WEIGHT LOSS/LOST 20 POUNDS; CONGESTION; FEVER; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included shellfish allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-APR-2021, the subject experienced coughing when lying down. On 19-APR-2021, the subject experienced cold sweats at night, with blankets being wet. On 19-APR-2021, the subject experienced weight loss/lost 20 pounds. On 19-APR-2021, the subject experienced congestion. On 19-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F, and Weight (NR: not provided) Lost 20 pounds. Treatment medications (dates unspecified) included: amoxicillin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from coughing when lying down, fever, cold sweats at night, with blankets being wet, weight loss/lost 20 pounds, and congestion. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: COUGHING WHEN LYING DOWN; COLD SWEATS AT NIGHT, WITH BLANKETS BEING WET; WEIGHT LOSS/LOST 20 POUNDS; CONGESTION; FEVER; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included shellfish allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-APR-2021, the subject experienced coughing when lying down. On 19-APR-2021, the subject experienced cold sweats at night, with blankets being wet. On 19-APR-2021, the subject experienced weight loss/lost 20 pounds. On 19-APR-2021, the subject experienced congestion. On 19-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F, and Weight (NR: not provided) Lost 20 pounds. Treatment medications (dates unspecified) included: amoxicillin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from coughing when lying down, fever, cold sweats at night, with blankets being wet, weight loss/lost 20 pounds, and congestion. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: EXPIRED VACCINE ADMINISTERED; INCORRECT STORAGE OF DRUG; This spontaneous report received from a physician concerned a patient of unspecified age and sex. 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 not reported, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced incorrect storage of drug. On 28-MAY-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administered and incorrect storage of drug was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: LOST SEVERE AMOUNT BLOOD PLATELETS; This spontaneous report received from a patient concerned a 61 year old male. 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced lost severe amount blood platelets. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lost severe amount blood platelets was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE ADMINISTERED 6 HOURS POST PUNCTURING; This spontaneous report received from a pharmacist concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 04-JUL-2021) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced vaccine administered 6 hours post puncturing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered 6 hours post puncturing was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vertigo
Clinical narrative: COULD NOT SWALLOW HER FOOD DUE TO NAUSEA; COULD NOT BREATHE VERY WELL; NIGHT SWEATS; RIGHT ARM AND LEG BEGAN TO HURT; CHILLS; HEADACHE; TIREDNESS OR FATIGUE WAS UNGODLY; NAUSEA; VERTIGO-LIKE FEELING; PASSED OUT ON FLOOR; CHEST PAINS HERE-AND-THERE NOT CONSTANT; This spontaneous report received from a patient concerned a 64 year old white and non Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included colitis, non alcohol user, smoker (2 cigarettes per day), allergy to penicillin cause chest pains and swelling, allergy to sulfa cause chest pains and swelling, and medication sensitive. The patient had no drug abuse or illicit drug use. The patient experienced sick when treated with influenza vaccine (flu shot), chest pains and swelling when treated with codeine, and naproxen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 23-JUL-2021) dose was not reported, 1 in total, administered at right arm on 13-MAY-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient could not swallow food due to nausea and could not breathe very well (difficulty in breathing) and fatigue was ungodly. On 13-MAY-2021, the patient had tiredness, headache, nausea, night sweats and chills after took the vaccine. The right arm and right leg began to hurt. Tiredness was not gone away and Lightheadedness here-and-there. The patient had chest pains here-and-there, that was not constant. The patient felt like she had vertigo and passed out on her floor twice last week in MAY-2021 and on 04-JUN-2021. The Lightheadedness and dizziness presented again on 04-JUN-2021. A chill was come-and-go. The right arm and leg pain have resolved on 04-JUN-2021. She was not reached out to her primary care provider for medical advice. Patient mentions that she was medication sensitive. The patient had tendency for low blood pressure, but her low blood pressure was fine at 120/80 mmHg. The patient took Norco for pain and occasionally took Zofran for nausea. The patient had history of colitis and these medications help her. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from night sweats, and right arm and leg began to hurt on 04-JUN-2021, had not recovered from tiredness or fatigue was ungodly, chills, vertigo-like feeling, headache, chest pains here-and-there not constant, passed out on floor, and nausea, and the outcome of could not breathe very well and could not swallow her food due to nausea was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210612160-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Passed out. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY.