chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Diarrhoea, Feeling abnormal
Clinical narrative: feeling very badly; including diarrhea; This non-serious case was reported by a nurse via sales rep and described the occurrence of feeling bad in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Shingrix and Flu vaccine. On an unknown date, an unknown time after receiving Shingrix and Flu vaccine, the patient experienced feeling bad (Verbatim: feeling very badly) and diarrhea (Verbatim: including diarrhea).  The outcome of the feeling bad and diarrhea were resolved.   It was unknown if the reporter considered the feeling bad and diarrhea to be related to Shingrix and Flu vaccine.     It was unknown if the company considered the feeling bad and diarrhea to be related to Shingrix and Flu vaccine.   Additional Information: GSK Receipt Date: 25-AUG-2023 It was reported that the male patient took his Shingrix and his flu shot on the same day. Brand of flu shot was unknown. Patient reported feeling very badly, including diarrhea. Patient was now over his side effects.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I should have gotten by second shringrix shot in March of 2023. Unfortunately I forgot.; This non-serious case was reported by a consumer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: I should have gotten by second shringrix shot in March of 2023. Unfortunately I forgot.).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-AUG-2023 The patient self-reported this case. The patient asked should he/she start the series over. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: UNK
Symptoms: Illness
Clinical narrative: RSV vaccine made my husband very sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: RSV vaccine made my husband very sick).  The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to RSV vaccine.     It was unknown if the company considered the sickness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 27-AUG-2023 This case was reported by a consumer via interactive digital media. RSV vaccine made my husband very sick. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received second dose of Shingrix three years after my first dose; This non-serious case was reported by a consumer and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years ago prior to the reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Received second dose of Shingrix three years after my first dose).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 25-AUG-2023 The patient reported that he or she received Second dose of Shingrix vaccine after 3 years of receiving first dose of Shingrix vaccine. The reporter wanted to know if he or she need to receive third dose. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: one week later developed shingles; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced shingles (Verbatim: one week later developed shingles).  The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 29-Aug-2023 The patient received the dose of Shingrix and one week later developed Shingles. The physician did not remember who the patient was. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Arm pain).  The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt date: 29-AUG-2023 The reporter stated that she had grade 3 arm pain after dose of Shingrix, so much so that she did not complete 2nd dose. The reporter consented to follow up.
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Fluarix administration of expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 7-month-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 953Y2, expiry date 30-JUN-2023) for prophylaxis.   On 22-AUG-2023, the patient received Fluarix Quadrivalent 2022-2023 season. On 22-AUG-2023, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: Fluarix administration of expired dose).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 23-AUG-2023 A reporter reported that a patient received on August 22nd 2023 a dose of expired Fluarix which led to expired vaccine used.  The reporter wanted to know the patient should be re vaccinated. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Possible late 2nd dose of Shingrix; This non-serious case was reported by a physician via sales rep and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Possible late 2nd dose of Shingrix).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 23-Aug-2023 The reporter reported on behalf of sales representative regarding possible late 2nd dose of Shingrix on an unknown date which led to drug dose administration interval too long. The vaccine administration facility was the same as primary reporter. No other adverse event information made available Safety team emailed contact information. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Therapeutic response decreased
Clinical narrative: titers were low; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a patient who received HBV (Engerix B adult) for prophylaxis.   On an unknown date, the patient received Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced therapeutic response decreased (Verbatim: titers were low).  The outcome of the therapeutic response decreased was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-AUG-2023 The reporter mentioned the Adult patient received their Engerix dose last year (2022) but the patient's titers were low, this was why the physician recommended a higher dose Engerix. The reporter stated that the physician would like to administer a Engerix high dose of 40 mcg but the HCP has 20 mcg of Engerix on hand and how to proceed. It was Engerix vaccine dose has not been administered yet to the patient. The reporter declined to provide patient details. The reporter did not consent to follow up.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product preparation issue
Clinical narrative: Inappropriate Reconstitution Technique/had been tilting the vaccines but not shaking them; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 4-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number EJ577, expiry date 13-JUN-2025) for prophylaxis.   On 23-AUG-2023, the patient received the 2nd dose of Pediarix. On 23-AUG-2023, an unknown time after receiving Pediarix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique/had been tilting the vaccines but not shaking them) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 24-Aug-2023 CMA stated that they noticed a solid mass in the Pediarix PFS and asked if this was normal  She stated that she checked some of the other syringes and some had them and some did not. She stated that she was speaking with a colleague who informed her that they are supposed to shake the PFS before administering.  She said that when she shook a syringe, she noticed that the mass did go away and that they had been tilting the vaccines but not shaking them. The vaccine administration facility was the same as primary reporter. The patient received vaccine which was not shook properly, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: received a dose of expired Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received Herpes zoster (Shingrix) (expiry date 30-JUL-2023) for prophylaxis.   On 23-AUG-2023, the patient received Shingrix. On 23-AUG-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: received a dose of expired Shingrix).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-AUG-2023 The pharmacist reported that a patient received a dose of Shingrix on August 23th 2023 expired in July 2023 which led to expired vaccine used. The vaccine administration facility is the same as primary reporter. The healthcare professional mentioned that patient was on her 60s, did not have the exact age or date of birth. No lot number provided. The reporter consented to follow up.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, MENB, MNQ, RV1
Symptoms: Product storage error
Clinical narrative: had a temperature excursion for 160 hours during which they could have reached temperatures beyond the maximum permitted; This non-serious case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, HBV (Engerix B) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, DTPa (Infanrix) for prophylaxis and DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation, Bexsero, Menveo, Engerix B, Havrix, Kinrix, Infanrix and Pediarix. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, Bexsero, Menveo, Engerix B, Havrix, Kinrix, Infanrix and Pediarix, the patient experienced incorrect storage of drug (Verbatim: had a temperature excursion for 160 hours during which they could have reached temperatures beyond the maximum permitted).The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-AUG-2023 The reporter called to inform that Bexsero, Engerix-B, Havrix, Infanrix, Kinrix, Menveo (2-vial), Pediarix, Rotarix (Liquid presentation) had a temperature excursion for 160 hours during which they could have reached temperatures beyond the maximum permitted and administered to the patients, which led to incorrect storage of drug. Due to technical limitations in the system, they could not ensure the vaccines were viable so they had to be discarded.  Prior to this decision, some vaccines were administered to patients.  At the moment of the call healthcare professional did not have a number of patients or the vaccines they were given.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up. The case had been linked to US2023115613, reported by the same reporter.
Age: 20.0
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error, Wrong product administered
Clinical narrative: was in the fridge for a couple of days before administration; received Shingrix instead of the intended Flu Shot; patient was 20 years old and not immunocompromised but inadvertently received Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 20-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-AUG-2023, the patient received Shingrix (left deltoid). On 24-AUG-2023, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: received Shingrix instead of the intended Flu Shot) and inappropriate age at vaccine administration (Verbatim: patient was 20 years old and not immunocompromised but inadvertently received Shingrix). On an unknown date, the patient experienced incorrect storage of drug (Verbatim: was in the fridge for a couple of days before administration).  The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and incorrect storage of drug were unknown.   Additional Information: GSK Receipt date: 25-AUG-2023 A pharmacist reported that a patient was administered the reconstituted Shingrix after it was in the fridge for a couple of days before administration which led to incorrect storage of drug.  After gathering age for safety report, pharmacist reported the patient was 20 years old and not immunocompromised but inadvertently received Shingrix instead of the intended Flu Shot which led to wrong vaccine administered and inappropriate age at vaccine administered. The reporter wanted to know what happens after the 6 hours of the reconstituted Shingrix and did it break down or something.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: hadn't received the 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th August 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: hadn't received the 2nd dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 25-Aug-2023 A pharmacist called to inform that a patient had not received the 2nd dose yet. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted with a sterile diluent instead of the supplied AS01b diluent; reconstituted with a sterile diluent instead of the supplied AS01b diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number ZM749, expiry date 22-AUG-2025) for prophylaxis.   In AUG-2023, the patient received Shingrix. In AUG-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with a sterile diluent instead of the supplied AS01b diluent) and inappropriate dose of vaccine administered (Verbatim: reconstituted with a sterile diluent instead of the supplied AS01b diluent).The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 25-AUG-2023 The reporter was clinical operations manager reported that a nurse administered a dose of Shingrix that was reconstituted with a sterile diluent instead of the supplied AS01b diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. They were not sure which patient it was that received this dose, they had it narrowed down to 4 patients.  The dose was given sometime between 5th August 2023 to 22nd August 2023. At the time of reporting, no repeat doses had been administered. The reporter consented to follow up. This was 1 of 4 case, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR116986:same reporter US-GSK-US2023116324:same reporter US-GSK-US2023AMR116985:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received early second dose of Shingrix was administered to patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 3ZX3E, expiry date 02-JUL-2025) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 25-AUG-2023, the patient received the 2nd dose of Shingrix. On 25-AUG-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Received early second dose of Shingrix was administered to patient).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 25-AUG-2023 The reporter reported that the patient received an early second dose of Shingrix vaccine. The patient received 2nd dose of Shingrix, early than the recommended interval, which led to shortening of vaccination schedule. The reporter did not consent to follow up.
Age: 23.0
Sex: F
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 2nd dose of Bexsero early; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 23-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO).   On 25-JUL-2023, the patient received the 2nd dose of Bexsero. On 25-JUL-2023, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: Received 2nd dose of Bexsero early).  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 Information: GSK Receipt Date: 25-AUG-2023 The patient received 2nd dose of Bexsero, early than the recommended interval, which led to shortening of vaccination schedule. The reporter did not consent to follow up.
Age: 18.0
Sex: U
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 18 year old patient received an adult (1ml) dose of Engerix in July 2023; 18 year old patient received an adult (1ml) dose of Engerix in July 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 18-year-old patient who received HBV (Engerix B adult) for prophylaxis.   In JUL-2023, the patient received the 1st dose of Engerix B adult 1 ml. In JUL-2023, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: 18 year old patient received an adult (1ml) dose of Engerix in July 2023) and adult product administered to child (Verbatim: 18 year old patient received an adult (1ml) dose of Engerix in July 2023).  The outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK receipt date: 25-Aug-2023 A pharmacist did not had patient or vaccination details, other than the 1st dose was given sometime in July. No symptoms were reported. The vaccine administration facility was the same as primary reporter. Did not consent to follow-up. An 18 year old patient received an adult dose of Engerix-B, which led to overdose and adult product administered to child.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: mistakenly received a third dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2021) and Shingrix (2nd dose was given in early 2022). Concomitant products included amoxicillin + clavulanic acid (Augmentin).   On 25-AUG-2023, the patient received the 3rd dose of Shingrix (intramuscular, unknown deltoid) .5 ml. On 25-AUG-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: mistakenly received a third dose of Shingrix).The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 25-AUG-2023 The reporter mistakenly received a third dose of Shingrix at the time of reporting (extra dose), which led to extra dose administered. The third dose was given because the patient did not know if she would already receive her second Shingrix dose and when the pharmacist checked the Vaccine Registry he only noticed one previous dose. When the immunization record was printed, after the third dose had been given, it was noted that two doses were previously given.  Nothing else was reported. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received their first 2 doses of Engerix-B 5 months apart; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 38-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix-B (received first dose 5 months apart on 14th March 2023 of batch number C44K4).   On 25-AUG-2023, the patient received the 2nd dose of Engerix B. On 25-AUG-2023, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: received their first 2 doses of Engerix-B 5 months apart).  The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-Aug-2023 A pharmacist wished to know how to proceed.  Partial information about event, vaccine and patient was given.  The Vaccine Administration Facility was the same as Primary Reporter. Did not consent to follow-up. The patient received second dose of Engerix-B later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not taken the second dose; This non-serious case was reported by a physician via sales rep 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 first dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has not taken the second dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 25-Aug-2023 The physician reported that the patient had not taken the second dose and now it was been over a year. The reporter asked that the patient start over with the vaccine or could just take the second dose on the day of reporting. The medical information did not speak with the health care provider, so please follow-up with the sales representative for more information. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: her arm was a little bit sore; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-JUN-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: her arm was a little bit sore).The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  It was unknown if the company considered the pain in arm to be related to Shingrix.   Linked case(s) involving the same patient: US2023116339   Additional Information: GSK Receipt Date: 25-AUG-2023 The reporter was the patient who stated that she received Shingrix.  According to reporter her arm was a little bit sore but no other problem.  The reporter consented to follow up. For tolerance of 2nd dose of Shingrix, refer case US2023116339.; Sender's Comments:  US-GSK-US2023116339:2nd dose case, same patient, same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient wished to received their second dose of Shingrix 3 years after the initial dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 01-FEB-2020 with batch number 4ME42 and expiry date 23-JAN-2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient wished to received their second dose of Shingrix 3 years after the initial dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-AUG-2023 The pharmacist wanted to know how to proceed. The vaccine administration facility for 1st dose was the same as primary reporter. VAERS details were reported for 1st dose. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 1.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix was administered to a 1 year old patient; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 1 year old patient).  The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-AUG-2023 The reporter was a consumer who works for vaccines for children. The reporter reported that she thought she was in a chart that the Kinrix vaccine was administered to the 1 year child patient. Reporter was going to follow up with the clinic and look at the chart to ensure that she was correct. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter did not consent to follow up.
Age: 1.5
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Underdose, Wrong product administered
Clinical narrative: administered boostrix instead of Infanrix; 18 month patient received boostrix; 18 month patient received boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 18-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number KP547, expiry date 29-NOV-2024) for prophylaxis.   On 04-AUG-2023, the patient received Boostrix. On 04-AUG-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: administered boostrix instead of Infanrix), inappropriate age at vaccine administration (Verbatim: 18 month patient received boostrix) and underdose (Verbatim: 18 month patient received boostrix).  The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and underdose were unknown.   Additional Information: GSK Receipt date: 25-AUG-2023 A medical assistant reported that an 18 month old baby was administered boostrix instead of Infanrix which led to wrong vaccine administered. The 18 month patient received boostrix which led to Inappropriate age at vaccine administration and underdose. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: fever; headache; fatigue; This non-serious case was reported by a physician via sales rep and described the occurrence of fever in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fever (Verbatim: fever), headache (Verbatim: headache) and fatigue (Verbatim: fatigue).  The outcome of the fever, headache and fatigue were unknown.   It was unknown if the reporter considered the fever, headache and fatigue to be related to Arexvy.     It was unknown if the company considered the fever, headache and fatigue to be related to Arexvy.   Additional Information: GSK receipt date: 25-Aug-2023 A physician stated that a patient in her 70s (date of birth and exact age were not reported) received Arexvy vaccination recently (date unknown) at a local (unknown) pharmacy and developed fatigue, headache and fever.  Onset, duration and outcome were not reported.  Nothing else was reported. May follow up with health care professional/reporter for details that were not provided to GlaxoSmithKline field representative. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PATIENT DID RECEIVE BOTH DOSES, BUT THEY WERE 2 YEARS APART; This non-serious 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 Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: PATIENT DID RECEIVE BOTH DOSES, BUT THEY WERE 2 YEARS APART).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 26-AUG-2023 and 27-AUG-2023 The patient did receive both doses, but they were 2 years apart which led to lengthening of vaccination schedule. Asked does he need to get a 3rd dose. The reporter consented to follow up. No further details provided on form. Specialist submitting all available details.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: same area and is quite painful; 5th case of Shingles; Suspected vaccination failure; first episode of Shingles occurred in October 2021; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 13-FEB-2020, the patient received the 2nd dose of Shingrix. On 15-DEC-2019, the patient received the 1st dose of Shingrix. In OCT-2021, between 1 and 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: first episode of Shingles occurred in October 2021). On 27-AUG-2023, the patient experienced shingles (Verbatim: 5th case of Shingles). On an unknown date, the patient experienced pain (Verbatim: same area and is quite painful).  The outcome of the vaccination failure, shingles, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, shingles and pain to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, shingles and pain to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 28-Aug-2023 The patient stated she had her 1st and 2nd Shingrix vaccination and had 5 cases of Shingles beginning in 2021. The patient had first episode of Shingles occurred in October 2021.   She stated that her 5th case of Shingles started 27 August 2023.  The location of the Shingles rash with each outbreak had been on her lower back in the same area and was quite painful. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of SHINGRIX on 01/20/2023 should they get the second dose; This non-serious case was reported by a consumer 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 (On 20th January 2023, received first dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first dose of SHINGRIX on 01/20/2023 should they get the second dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 28-AUG-2023 Reporter wanted to remain anonymous. The reporter was an employee that works at the physician office and asked a question for a patient. Reporter also would not give any information about the patient for whom she asked the Shingrix question. Reporter asked if patient received the first dose of Shingrix should they get the second dose if it was past the recommended schedule. Response was provided as Individual medical guidance for patients should be provided by medical professionals and was not something GSK provides to patients. The FDA approved dosing schedule for Shingrix was the first dose at month 0, followed by a second dose 2-6 months after the first dose. The CDC had provided guidance that if it had been more than 6 months since a patient received the first dose, they should get the second dose as soon as possible; patients did not need to restart the vaccine series however, the efficacy of alternative dosing regimens had not been evaluated. Data regarding the safety of alternative regimens where limited individuals might remain at risk for herpes zoster during a longer than recommended interval between doses 1 and 2, they advised that patients consult with their healthcare provider about this guidance and their individual situation. VAERS details were reported for 1st dose of Shingrix. The follow-up could not be possible as the as no contact details were available. Till the time of reporting, the patient had not received the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This serious case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced bell's palsy (Verbatim: Bell's Palsy) (serious criteria GSK medically significant).  The outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.     It was unknown if the company considered the bell's palsy to be related to Shingrix.   Additional Information: GSK receipt date: 28-Aug-2023 The Field representative called in to report that a healthcare professional reported that a patient suffered from Bell's Palsy after receiving a dose of Shingrix.  They provided limited information and gave the e-mail of the aforementioned healthcare professional. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site necrosis
Clinical narrative: patient developed a reaction with the formation of necrotic tissue at the injection site; This serious case was reported by a other health professional via sales rep and described the occurrence of injection site necrosis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site necrosis (Verbatim: patient developed a reaction with the formation of necrotic tissue at the injection site) (serious criteria GSK medically significant).  The outcome of the injection site necrosis was unknown.   It was unknown if the reporter considered the injection site necrosis to be related to Shingrix.     It was unknown if the company considered the injection site necrosis to be related to Shingrix.   Additional Information: GSK Receipt date: 28-AUG-2023 A reporter reported that a patient developed a reaction with the formation of necrotic tissue at the injection site after receiving a dose of Shingrix.  They provided limited information and gave the e-mail of the aforementioned healthcare professional. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Flatulence, Headache
Clinical narrative: Nausea with Flatulence; Flatulence; woke up Saturday morning with diarrhea.; she felt fatigue/explains this as feeling tired; groggy; Loss of appetite; Headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus.   On 25-AUG-2023, the patient received the 1st dose of Shingrix (left deltoid). On 25-AUG-2023, less than a day after receiving Shingrix, the patient experienced fatigue (Verbatim: she felt fatigue/explains this as feeling tired) and groggy (Verbatim: groggy). On 26-AUG-2023, the patient experienced diarrhea (Verbatim: woke up Saturday morning with diarrhea), appetite lost (Verbatim: Loss of appetite) and headache (Verbatim: Headache). On 28-AUG-2023, the patient experienced nausea (Verbatim: Nausea with Flatulence) and flatulence (Verbatim: Flatulence).  The patient was treated with loperamide hydrochloride (Imodium). The outcome of the fatigue was not resolved and the outcome of the groggy was not reported and the outcome of the diarrhea, nausea and flatulence were resolved and the outcome of the appetite lost and headache were resolved (duration 24 hrs).   It was unknown if the reporter considered the fatigue, groggy, diarrhea, appetite lost, headache, nausea and flatulence to be related to Shingrix.     It was unknown if the company considered the fatigue, groggy, diarrhea, appetite lost, headache, nausea and flatulence to be related to Shingrix.   Additional Information: GSK receipt date: 29-Aug-2023 The patient called to report symptoms after receiving her 1st dose of Shingrix on Friday and states that the night of Shingrix vaccine administration she felt fatigue and explains this as feeling tiered and groggy.   Friday night she went to bed and woke up Saturday morning with diarrhea.   The patient stated that she took 3 doses of Imodium for 2 days and then diarrhea resolved.   Saturday, 3 days after the vaccine, she had a loss of appetite and headache that lasted for 24 hours.   The patient also experienced nausea with excessive flatulence during the night.  In August 2023, all symptoms were recovered except fatigue. Reviewed the package inset adverse event section with reporter.   The reporter stated that she had a call out to her physician right now. The reporter consented to follow-up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Nausea with Flatulence; Flatulence; woke up Saturday morning with diarrhea.; she felt fatigue/explains this as feeling tired; groggy; Loss of appetite; Headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus.   On 25-AUG-2023, the patient received the 1st dose of Shingrix (left deltoid). On 25-AUG-2023, less than a day after receiving Shingrix, the patient experienced fatigue (Verbatim: she felt fatigue/explains this as feeling tired) and groggy (Verbatim: groggy). On 26-AUG-2023, the patient experienced diarrhea (Verbatim: woke up Saturday morning with diarrhea), appetite lost (Verbatim: Loss of appetite) and headache (Verbatim: Headache). On 28-AUG-2023, the patient experienced nausea (Verbatim: Nausea with Flatulence) and flatulence (Verbatim: Flatulence).  The patient was treated with loperamide hydrochloride (Imodium). The outcome of the fatigue was not resolved and the outcome of the groggy was not reported and the outcome of the diarrhea, nausea and flatulence were resolved and the outcome of the appetite lost and headache were resolved (duration 24 hrs).   It was unknown if the reporter considered the fatigue, groggy, diarrhea, appetite lost, headache, nausea and flatulence to be related to Shingrix.     It was unknown if the company considered the fatigue, groggy, diarrhea, appetite lost, headache, nausea and flatulence to be related to Shingrix.   Additional Information: GSK receipt date: 29-Aug-2023 The patient called to report symptoms after receiving her 1st dose of Shingrix on Friday and states that the night of Shingrix vaccine administration she felt fatigue and explains this as feeling tiered and groggy.   Friday night she went to bed and woke up Saturday morning with diarrhea.   The patient stated that she took 3 doses of Imodium for 2 days and then diarrhea resolved.   Saturday, 3 days after the vaccine, she had a loss of appetite and headache that lasted for 24 hours.   The patient also experienced nausea with excessive flatulence during the night.  In August 2023, all symptoms were recovered except fatigue. Reviewed the package inset adverse event section with reporter.   The reporter stated that she had a call out to her physician right now. The reporter consented to follow-up.