chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE details/ No PQC; HCP called to report a TE. 3 Administered doses. Dose was administered on 9/11/2023, excursion occurred on 9/7/2023.; This spontaneous report has been received from a health care professional and refers to a. patient of unknown age and gender  The patient's pertinent medical history , other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 11-SEP-2023, the patient was vaccinated with 3 doses of a varicella virus vaccine live (oka/merck) (VARIVAX) injection that had suffered a temperature excursion (product storage error), (lot number W039293 has been determined to be valid for varicella virus vaccine live (oka/merck) (VARIVAX), with an expiration date established as 11-DEC-2024), administered for prophylaxis (strength, and anatomical site of administration were not provided). The temperature excursion had a timeframe of 30 minutes at a temperature of -14 degrees Celsius (C) and -10 C up to 8 C). No adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: No further AE details. No PQC.; Personnel called to request information on if MMR II can be given with Normal Saline instead of the Sterile Diluent that is supplied with the vaccine. Caller is not a licensed HCP, and further research for MIR was not able to be conducted. C; This spontaneous report was received from Other and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, , administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided); sterile diluent (STERILE DILUENT) solution for injection/infusion, , administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided); and  sodium chloride (NORMAL SALINE),  (strength, formulation, dose description, lot #, expiry date, route of administration, and indication were not provided).  On an unknown date, military personnel called to request information on if MMR II can be given with Normal Saline instead of the Sterile Diluent that is supplied with the vaccine. Caller is not a licensed HCP, and further research for RA was not able to be conducted. Caller states all other staff has left for the day and that they will reach out to the RA tomorrow for RA. Caller reports that the Lot and Exp date are unknown by the reporter. The dose was given on 8/10/2023. Permission to contact the lead military equivalent to medical assistant given. No further AE details. No PQC.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/PQQQC reported.; HCP calling to report an AE regarding the PROQUAD vaccine. HCP reported that the PROQUAD vaccine was administered to a unknown adult patient. HCP provided limited demographic data. Permission was not provided to contact the HCP. Request case 02480129; This spontaneous report was received from Pharmacist and refers to an adult patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 27-SEP-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5ml/ 1st dose, lot #X007358, expiration date: 09-AUG-2024, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, HCP called to report an AE regarding the PROQUAD vaccine. HCP reported that the PROQUAD vaccine was administered to a unknown adult patient. HCP provided limited demographic data. Permission was not provided to contact the HCP. Request case 02480129 filed. No additional AE/PQQQC reported.  Lot Number X007358 is valid.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pharmacist called stating that at "28 or 29 year old" female patient stated that she only received one dose of GARDASIL 9 "at least a year ago." Caller stated the patient left before providing their name or any additional information. No additional A; No additional AE; This spontaneous report was received from a pharmacist and refers to a female patient 28- or 29-year-old. No information on patient's medical history, current conditions and concomitant medications was provided.   On an unknown date the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided) (inappropriate schedule of product administration and no adverse event).
Age: 50.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE/PQC reported; Medical Assistant calling to report adverse event regarding patient being administered an expired dose of MMR II.  Medical Assistant reported that adult patient was inadvertently administered an expired dose of MMR II on 9/19/2023, in which the MMR I; This spontaneous report was received from a medical assistant, referring to a 50-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 19-SEP-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), at a dose of 0.5 milliliter (ml) of a two dose series (strength, anatomical site of vaccination and route of administration were not reported; lot number W011885, expiration date was reported and validated as 04-SEP-2023) as prophylaxis (expired product administered). Medical Assistant stated that this was the patient's first dose in the series and that the patient had not reported any medical concerns or symptoms related to the administration of the expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pneumothorax
Clinical narrative: ended up in the hospital with a collapsed lung; This serious case was reported by a consumer via interactive digital media and described the occurrence of collapse of lung in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   The patient's past medical history included shingles (The patient experienced the excruciating pain of shingles in 2019), pain (The pain was so debilitating) and blistery rash (blistering rash on her abdomen was incredibly painful It felt like thousands of tiny needles constantly burning and pricking her).   On an unknown date, the patient received Shingrix and INFLUENZA VACCINE. On an unknown date, an unknown time after receiving Shingrix and an unknown time after receiving INFLUENZA VACCINE, the patient experienced collapse of lung (Verbatim: ended up in the hospital with a collapsed lung) (serious criteria hospitalization and GSK medically significant).  The outcome of the collapse of lung was not reported.   The reporter considered the collapse of lung to be possibly related to Shingrix.     The company considered the collapse of lung to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 23-SEP-2023 The reporter's sister took Shingrix vaccine along with the Flu shot and landed in the hospital with a collapsed lung. Emergency room doctor said stop taking multiple vaccines at a time. The patient should not receive Shingrix if they were allergic to any of its ingredients or had an allergic reaction to a previous dose of Shingrix. The reporter think that the event might have been related to the Product/Device. Follow-up was not possible as no contact details were available. The company considered the collapse of lung to be possibly related to Influenza vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza
Clinical narrative: felt like I had the 24 hour flu; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 13-SEP-2023, an unknown time after receiving Shingrix, the patient experienced influenza (Verbatim: felt like I had the 24 hour flu).  On 14-SEP-2023, the outcome of the influenza was resolved (duration 1 day).   It was unknown if the reporter considered the influenza to be related to Shingrix.     It was unknown if the company considered the influenza to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-SEP-2023 On Wednesday, The patient felt like having the 24 hour flu and rested all day.  The patient was much better on Thursday.  No response was necessary. The reporter was requested for follow up.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, DTPPVHBHPB
Symptoms: Incorrect dose administered
Clinical narrative: infant given 2 month dose of Pediarix and a dose of Vaxelis; This non-serious case was reported by a nurse via sales rep and described the occurrence of accidental overdose in a 9-week-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included VAXELIS for prophylaxis.   On an unknown date, the patient received Pediarix and VAXELIS. On an unknown date, an unknown time after receiving Pediarix, the patient experienced accidental overdose (Verbatim: infant given 2 month dose of Pediarix and a dose of Vaxelis).  The outcome of the accidental overdose 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: 20-SEP-2023 The reporter reported that the 9 week old infant patient received 2 month dose of Pediarix and a dose of Vaxelis.  The reporter stated the error happened because the clinic was carying both DTap combo vaccines and the infant needed a HIB dose.  The medical assistant mistakenly gave Vaxelis instead of a single antigen HIB vaccine. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: COVID19, FLUX, RVX
Symptoms: Pain in extremity
Clinical narrative: little sore on my arms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis and COVID-19 VACCINE (COVID19 VACCINE) for prophylaxis.   On 20-SEP-2023, the patient received RSV vaccine, INFLUENZA VACCINE and COVID19 VACCINE. On 20-SEP-2023, less than a day after receiving RSV vaccine and an unknown time after receiving INFLUENZA VACCINE, the patient experienced pain in arm (Verbatim: little sore on my arms).  The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK receipt date: 20-SEP-2023 This case was reported the patient via interactive digital media. The patient got 3 shots today (on the day of reporting) RSV, Infuenza flu and Covid-19 and had little sore on arm. Follow-up not possible as no contact details provided.
Sex: U
Vaccine: RVX
Symptoms: Fatigue, Pain
Clinical narrative: Fatigue; lot of aches; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Previously administered products included Prednisone (the patient had too dealt with yearly bronchitis. Prednisone helped). Concurrent medical conditions included bronchitis. Concomitant products included prednisone.   On 16-SEP-2023, the patient received RSV vaccine. On 17-SEP-2023, 1 days after receiving RSV vaccine, the patient experienced fatigue (Verbatim: Fatigue) and pain (Verbatim: lot of aches).  The outcome of the fatigue and pain were resolved.   It was unknown if the reporter considered the fatigue and pain to be related to RSV vaccine.     It was unknown if the company considered the fatigue and pain to be related to RSV vaccine.   Additional Information: GSK receipt date 20 Sep 2023: This case was reported by a consumer via interactive digital media. The patient reported that he/she had too dealt with yearly bronchitis. Prednisone helped. Got the new Moderna just this past Saturday along with RSV. Fatigue and lot of aches the next day, but ok now.  The patient stated anti vaccers could go their route, but he/she had no sympathy if they did not make it.
Sex: M
Vaccine: RVX
Symptoms: Pain in extremity
Clinical narrative: no side effects other than a sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm (Verbatim: no side effects other than a sore arm.).  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 RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK Receipt date: 21-SEP-2023 This case was reported by patient's wife via interactive digital media. The reporter reported that the patient got the RSV vaccine as soon as it was available, no side effects other than a sore arm. Follow up was not possible as no contact details were available. This case was linked with case US2023AMR132088, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR132088:same reporter, different patient
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Stress
Clinical narrative: developed shingles outbreak the following day; stress; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced shingles (Verbatim: developed shingles outbreak the following day) and stress (Verbatim: stress).  The outcome of the shingles was not reported and the outcome of the stress was not resolved.   It was unknown if the reporter considered the shingles and stress to be related to Shingrix.     It was unknown if the company considered the shingles and stress to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-SEP-2023 The patient got her first shingles vaccine and developed shingles outbreak the following day. Doctor thought it was weird because it was not a live vaccine. She thought the outbreak could also be related to stress the patient was currently experiencing. The reporter agrees to follow up from GSK.
Sex: U
Vaccine: RSV
Symptoms: Injection site rash
Clinical narrative: rash at the injection site; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of injection site rash in a 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 injection site rash (Verbatim: rash at the injection site).  The outcome of the injection site rash was not reported.   It was unknown if the reporter considered the injection site rash to be related to Arexvy.     It was unknown if the company considered the injection site rash to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-SEP-2023 The follow up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Not feeling well; This non-serious case was reported by a physician and described the occurrence of feeling unwell in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: Not feeling well).  The outcome of the feeling unwell was resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.     It was unknown if the company considered the feeling unwell to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR132349   Additional Information: GSK Receipt Date: 22-SEP-2023 The reporter reported that the patient received Shingrix vaccine and experienced not feeling well. The reporter did not specify the nature of his not feeling well but stated that it was lasted for a couple of days. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR132349:Same patient/ Shingrix dose second
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Vaccine positive rechallenge
Clinical narrative: Not feeling well; This non-serious case was reported by a physician and described the occurrence of feeling unwell in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (1st dose received on an unknown date, refer linked case US2023AMR132345).   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 feeling unwell (Verbatim: Not feeling well).  Rechallenge with Shingrix was positive. The outcome of the feeling unwell was resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.     It was unknown if the company considered the feeling unwell to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR132345   Additional Information: GSK Receipt Date: 22-SEP-2023 The reporter reported that the patient received Shingrix vaccine and experienced not feeling well. The reporter did not specify the nature of his not feeling well but stated that it was lasted for a couple of days. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR132345:Same patient/ Shingrix dose first
Sex: U
Vaccine: RVX
Symptoms: Malaise
Clinical narrative: still feel deathly ill; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 21-SEP-2023, the patient received RSV vaccine. In SEP-2023, an unknown time after receiving RSV vaccine, the patient experienced feeling unwell (Verbatim: still feel deathly ill).  The outcome of the feeling unwell was not resolved.   It was unknown if the reporter considered the feeling unwell to be related to RSV vaccine.     It was unknown if the company considered the feeling unwell to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 22-SEP-2023 The patient self-reported this case via interactive digital media. The patient got his/her RSV vaccine yesterday (from reporting date) and still feel deathly ill. The patient asked how long it would last.
Sex: U
Vaccine: MMR
Symptoms: Product preparation error
Clinical narrative: priorix vaccine may have been reconstituted with a Merck sterile water diluent; This non-serious case was reported by a physician via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced wrong solution used in drug reconstitution (Verbatim: priorix vaccine may have been reconstituted with a Merck sterile water diluent).  The outcome of the wrong solution used in drug reconstitution 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 19 Sep 2023 The physician had a vial of priorix vaccine that might have been reconstituted with a Merck sterile water diluent (he had a pfs of priorix diluent left and no more vaccine)  The reporter asked would he need do a patient recall? The reporter consented to follow up. The patient received priorix vaccine might have been reconstituted with a Merck sterile water diluent which led to wrong solution used in drug reconstitution.
Sex: U
Vaccine: RSV
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact, Needle issue, Underdose
Clinical narrative: patient received under dose of medication; needle broke off; Arexvy leaked out onto the patient skin; Arexvy leaked out onto the patient skin; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 19-SEP-2023, the patient received Arexvy (intramuscular). On 19-SEP-2023, an unknown time after receiving Arexvy, the patient experienced accidental underdose (Verbatim: patient received under dose of medication), needle broken (Verbatim: needle broke off), exposure via skin contact (Verbatim: Arexvy leaked out onto the patient skin) and inadvertent exposure to vaccine (Verbatim: Arexvy leaked out onto the patient skin).  The outcome of the accidental underdose, needle broken, exposure via skin contact and inadvertent exposure to vaccine were unknown.   Additional Information: GSK Receipt Date: 19-Sep-2023 The pharmacist stated that the needle broke off while administering the Arexvy causing the patient to receive an under dose of the medication and also, the medication Arexvy leaked out onto the patient skin when the needle broke off which led to accidental underdose, needle broken, exposure via skin contact and inadvertent exposure to vaccine. The reporter questioned whether or not the remaining part of the dose should be given later or just give the initial dose once more. The reporter was transferred to Medical Information for these questions and was given medical disclaimer and was referred to Healthcare professional. The reporter consented to follow up.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Infanrix vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-year-old male patient who received DTPa (Infanrix) (batch number LS444, expiry date 16-SEP-2023) for prophylaxis.   On 19-SEP-2023, the patient received the 4th dose of Infanrix. On 19-SEP-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: received an expired dose of Infanrix vaccine).  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: 19-Sep-2023 It was reported that a patient received an expired dose of Infanrix vaccine administered inadvertently which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: use of three 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 59-year-old female patient who received Herpes zoster (Shingrix) (batch number CR5XF, expiry date 23-AUG-2025) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On 01-MAY-2023, the patient received the 3rd dose of Shingrix. On 01-MAY-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: use of three dose of shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 19-SEP-2023 A pharmacist called in to request information about the safety information available for the use of three doses of Shingrix. partial information was given, which led to extra dose administered. The Vaccine Administration Facility is the same as Primary Reporter. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix :late for2nd dose; This non-serious case was reported by a physician 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 (more than 1 year ago received 1st 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: Shingrix :late for2nd dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-SEP-2023 The physician reported that a patient who had 1 of 2 doses more than 1 year ago.  The reporter asked did she only need to had the 2nd dose of Shingrix or needed to start the vaccine sequence all over again. Till the time of reporting the patient did not receive the 2nd dose, which led to incomplete course of vaccination. Follow-up not possible as no contact details provided.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: patient received a dose of Infanrix that had expired on September 16th 2023; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 18-month-old female patient who received DTPa (Infanrix) (batch number AK443, expiry date 16-SEP-2023) for prophylaxis.   On 18-SEP-2023, the patient received Infanrix. On 18-SEP-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: patient received a dose of Infanrix that had expired on September 16th 2023).  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: 19-SEP-2023 The vaccine administration facility was the same as primary reporter The physician reported that a patient received a dose of Infanrix on 18th September 2023 that had expired on September 16th 2023, which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: A patient has received first dose but it's now past 6 months; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 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: A patient has received first dose but it's now past 6 months).The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date:19-Sep-2023 The reporter was curious the maximum amount of time between doses of Shingrix.  A patient had received first dose but it was now past 6 months, what was the recommendation for patient. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The case had been linked to US2023128908, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023128908:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of shingrix on August 25th 2023 and got the 2nd dose too early; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 20-SEP-2023, the patient received the 2nd dose of Shingrix. On 20-SEP-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: first dose of shingrix on August 25th 2023 and got the 2nd dose too early).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 20-Sept-2023 The pharmacist asked that need to repeat dose. The reporter did not consent to follow-up. The patient received second dose of Shingrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received first dose of Shingrix and never received the second; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 19 January 2023).   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: received first dose of Shingrix and never received the second).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-Sep-2023 The reporter stated that patient received first dose of Shingrix and never received the second dose to complete the series which led to incomplete course of vaccination. According to the reporter the treating physician was not aware. No other information provided by the reporter. The reporter did not consent to follow up.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 33 year old received Pediarix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 33-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number ZK4XF, expiry date 01-APR-2025) for prophylaxis.   The patient's past medical history included stem cell transplant.   On 01-SEP-2023, the patient received the 1st dose of Pediarix. On 01-SEP-2023, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: 33 year old received Pediarix).  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: 20-Sep-2023 The medical assistant reported that clinic had a 33 year old female patient who had been ordered to be re immunized following stem cell transplant.  She had been ordered to receive DTaP vaccination, but Healthcare professional noted she was older than the approved age for DTaP vaccinations. The patient had already been given a dose of Pediarix. At the time of reporting, no further doses had been given. 33 year old received Pediarix which led to inappropriate age at vaccine administration The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Sex: U
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO).   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: Inappropriate schedule of vaccine).  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: 20-SEP-2023 The reporter unable to provide any vaccine or patient details. The patient received the 2nd dose of Bexsero early at 25 days instead of at a month, which lead to shortening of vaccine schedule. Health care professional (HCP) did not consent to follow-up from safety.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: patient was administered a dose of Infanrix which expired on September 16; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 19-month-old female patient who received DTPa (Infanrix) (batch number Ls444, expiry date 16-SEP-2023) for prophylaxis.   On 20-SEP-2023, the patient received Infanrix. On 20-SEP-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: patient was administered a dose of Infanrix which expired on September 16).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: 20-Sep-2023 The reporter stated that a patient was administered a dose of Infanrix which expired, which led to expired vaccine used.  The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: hot at injection site; red spot at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (got the other vaccine for shingles years ago). Concomitant products included INFLUENZA VACCINE (FLU VACCINE (NAME UNKNOWN)).   On 18-SEP-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). In SEP-2023, an unknown time after receiving Shingrix, the patient experienced injection site warmth (Verbatim: hot at injection site) and injection site erythema (Verbatim: red spot at the injection site).  The outcome of the injection site warmth and injection site erythema were unknown.   It was unknown if the reporter considered the injection site warmth to be related to Shingrix. The reporter considered the injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site warmth to be related to Shingrix. The company considered the injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-SEP-2023 The patient reported she got the Flu vaccine the same day when she administered Shingrix vaccine but on the right arm. The brand name of the flu vaccine was unknown.   The patient stated she had a big red spot at the injection site from the Shingrix thank you so much for this life a life line really she did not had to bug the doctor to see if everything was normal or ok. The size of spot that occurred was half a dollar, but bigger than a quarter. The patient stated that spot was hot, it was warm on the reporting day but yesterday (19th September 2023) it was hotter. Lot and expiration date of either vaccines were unknown.  No additional information was provided. The reporter did not provide consent to follow up with healthcare professional.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Early 3rd dose.; Late 2nd dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 73-year-old female patient who received HAB (Twinrix) (batch number 2PG39) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 02-SEP-2023, the patient received the 3rd dose of Twinrix. On 19-AUG-2023, the patient received the 2nd dose of Twinrix. On 19-AUG-2023, not applicable after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose.). On 02-SEP-2023, the patient experienced drug dose administration interval too short (Verbatim: Early 3rd dose.). The outcome of the drug dose administration interval too short and drug dose administration interval too long 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: 20-SEP-2023 The reporter did not consent to follow-up. The patient received 3rd dose of Twinrix earlier than recommended interval, which led to shortening of vaccination schedule.  The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient who received the first dose of shingrix 1 year ago and today (Sep 20th 2023) the patient received the second dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose of Shingrix 1 year ago).   On 20-SEP-2023, the patient received the 2nd dose of Shingrix. On 20-SEP-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: a patient who received the first dose of Shingrix 1 year ago and today (Sep 20th 2023) the patient received the second dose).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 20-SEP-2023 The nurse called to ask for information a patient who received the 1st dose of Shingrix 1 year ago and today (on the day of reporting) the patient received the 2nd dose.  The health care professional (HCP) asked if the patient needed a third dose.  The reporter did not provide information about first dose given. The patient received 2nd dose after 1 year which led to lengthening of the vaccination schedule The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: She accidently got another dose of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient received 2 doses of Shingrix 3 years ago) and Shingrix.   On 20-SEP-2023, the patient received the 3rd dose of Shingrix. On 20-SEP-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: She accidently got another dose of Shingrix).  The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 20-SEP-2023 The patient self-reported this case. The patient received 2 doses of Shingrix 3 years ago. The patient accidently got another dose of Shingrix from the pharmacy today, which led to extra dose administered. The reporter did not consent to follow-up.
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 1ml dose was given to a 19-year-old patient by mistake instead of a 0.5ml.; Inappropriate ageat vaccine administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 19-year-old male patient who received HBV (Engerix B) (batch number SX27B) for prophylaxis.   On 19-AUG-2023, the patient received Engerix B. On 19-AUG-2023, an unknown time after receiving Engerix B, the patient experienced accidental overdose (Verbatim: 1ml dose was given to a 19-year-old patient by mistake instead of a 0.5ml.) and inappropriate age at vaccine administration (Verbatim: Inappropriate ageat vaccine administration).  The outcome of the accidental overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 20-SEP-2023 The pharmacy technician called to report a 1ml dose was given to a 19 year old patient by mistake instead of a 0.5ml, which lead to accidental overdose and inappropriate age at vaccine administration. The reporter consented to follow up only by phone, no email provided.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site oedema, Pain, Pain in extremity, Vomiting
Clinical narrative: there was slight edema at the site of injection and the patient was only able to raise his arm slightly due to the pain; complaining of arm pain; the patient was vomiting; The patient was seen and there was slight edema at the site of injection and the patient was only able to raise his arm slightly due to the pain; This non-serious case was reported by a physician via call center representative and described the occurrence of injection site edema in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number 4m24z, expiry date 31-JUL-2026) for prophylaxis.   On 18-SEP-2023, the patient received Bexsero (left deltoid). In SEP-2023, an unknown time after receiving Bexsero, the patient experienced injection site edema (Verbatim: there was slight edema at the site of injection and the patient was only able to raise his arm slightly due to the pain), pain in arm (Verbatim: complaining of arm pain), vomiting (Verbatim: the patient was vomiting) and mobility decreased (Verbatim: The patient was seen and there was slight edema at the site of injection and the patient was only able to raise his arm slightly due to the pain). The patient was treated with paracetamol (Tylenol) and methyl salicylate (Icy Hot). The outcome of the injection site edema, pain in arm, vomiting and mobility decreased were unknown.   It was unknown if the reporter considered the injection site edema, pain in arm, vomiting and mobility decreased to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site edema, pain in arm, vomiting and mobility decreased to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-SEP-2023 The reporter who stated that patient received Bexsero on Monday.  On Tuesday, the patient's mother called the office and stated that the patient was complaining of arm pain (left arm).  The patient was seen and there was slight edema at the site of injection and the patient was only able to raise his arm slightly due to the pain.  The patient was instructed to take Tylenol and Icy Hot.  This morning, the mother called again to state that the patient was vomiting. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Shingrix - Expired dose administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number 4XA55, expiry date 13-JUL-2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Shingrix - Expired dose administration).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 20-SEP-2023 A pharmacist reported that a 51 year old patient received an expired dose of Shingrix, which led to expired vaccine used. The HCP asked for guidance on this situation. The reporter consented to follow up.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Blood glucose normal
Clinical narrative: patient is getting a morning glucose level of 137 and before it used to be 120; This non-serious case was reported by a consumer via call center representative and described the occurrence of glucose increased in a 75-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 15-SEP-2023, the patient received the 1st dose of Arexvy (right arm). In SEP-2023, an unknown time after receiving Arexvy, the patient experienced glucose increased (Verbatim: patient is getting a morning glucose level of 137 and before it used to be 120).  The outcome of the glucose increased was not reported.   It was unknown if the reporter considered the glucose increased to be related to Arexvy.     It was unknown if the company considered the glucose increased to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-SEP-2023 The patient self-reported this case. The patient received Arexvy vaccine last Friday, after receiving the vaccine the patient was getting a morning glucose level of 137 and before it used to be 120. The reporter did not consent to follow-up.