chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.58
Sex: F
Vaccine: UNK
Symptoms: Incorrect dose administered
Clinical narrative: Our infant was seen at this clinic for their 18 month checkup and scheduled vaccinations. She was given a Hepatitis B vaccine. After the appointment, we were informed that she was given an excessive does of the vaccine. She should have received an infant's dose, however an adult's dose was administered.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administration error
Clinical narrative: Accidently gave Boostrix from wrong stock. No adverse effect noted. Patient contacted.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Antiviral treatment, Computerised tomogram, Herpes zoster, Pain, Pruritus
Clinical narrative: I received it in December of 2021, in September of 2022 itching and pain off and on. In October I had sharp pain that I could not bear. I went to the emergency room and they did CT scan, Xray, then they said it looked like shingles. They gave me antiviral medication and i had no pain after that.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: I received it in December of 2021, in September of 2022 itching and pain off and on. In October I had sharp pain that I could not bear. I went to the emergency room and they did CT scan, Xray, then they said it looked like shingles. They gave me antiviral medication and i had no pain after that.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antibody test, Antiphospholipid antibodies, Antithrombin III, Beta-2 glycoprotein antibody, Blood thyroid stimulating hormone
Clinical narrative: I've experienced blood clot in my left leg, dizziness and vertigo when I stand up, numbness in my arms, legs, hands, and feet,  I feel out of breath after doing anything more extraneous than a walk,  sometimes, out of nowhere, i'll just suddenly feel out of breath and will need to sit down/try to calm down in order to return to normal (I'm assuming this is A-fib), i've experienced head and chest pressure, sometimes out of nowhere I will feel like I'm going to pass out including one time recently where I started shaking and teeth chattering (this was in 80 degree weather in state and i've come to realize I feel so much worse now in humid weather than I ever did before  as I seem to get the worst body aches during that time. And above all, I feel body fatigue nearly every day
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiolipin antibody, Chest X-ray, Chest discomfort, Chills, Coagulation factor V level
Clinical narrative: I've experienced blood clot in my left leg, dizziness and vertigo when I stand up, numbness in my arms, legs, hands, and feet,  I feel out of breath after doing anything more extraneous than a walk,  sometimes, out of nowhere, i'll just suddenly feel out of breath and will need to sit down/try to calm down in order to return to normal (I'm assuming this is A-fib), i've experienced head and chest pressure, sometimes out of nowhere I will feel like I'm going to pass out including one time recently where I started shaking and teeth chattering (this was in 80 degree weather in state and i've come to realize I feel so much worse now in humid weather than I ever did before  as I seem to get the worst body aches during that time. And above all, I feel body fatigue nearly every day
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram thorax, Dizziness, Dizziness postural
Clinical narrative: I've experienced blood clot in my left leg, dizziness and vertigo when I stand up, numbness in my arms, legs, hands, and feet,  I feel out of breath after doing anything more extraneous than a walk,  sometimes, out of nowhere, i'll just suddenly feel out of breath and will need to sit down/try to calm down in order to return to normal (I'm assuming this is A-fib), i've experienced head and chest pressure, sometimes out of nowhere I will feel like I'm going to pass out including one time recently where I started shaking and teeth chattering (this was in 80 degree weather in state and i've come to realize I feel so much worse now in humid weather than I ever did before  as I seem to get the worst body aches during that time. And above all, I feel body fatigue nearly every day
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Dyspnoea exertional, Fatigue, Feeling abnormal, Full blood count
Clinical narrative: I've experienced blood clot in my left leg, dizziness and vertigo when I stand up, numbness in my arms, legs, hands, and feet,  I feel out of breath after doing anything more extraneous than a walk,  sometimes, out of nowhere, i'll just suddenly feel out of breath and will need to sit down/try to calm down in order to return to normal (I'm assuming this is A-fib), i've experienced head and chest pressure, sometimes out of nowhere I will feel like I'm going to pass out including one time recently where I started shaking and teeth chattering (this was in 80 degree weather in state and i've come to realize I feel so much worse now in humid weather than I ever did before  as I seem to get the worst body aches during that time. And above all, I feel body fatigue nearly every day
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gene mutation identification test, Head discomfort, Humidity intolerance, Hypoaesthesia, Influenza virus test
Clinical narrative: I've experienced blood clot in my left leg, dizziness and vertigo when I stand up, numbness in my arms, legs, hands, and feet,  I feel out of breath after doing anything more extraneous than a walk,  sometimes, out of nowhere, i'll just suddenly feel out of breath and will need to sit down/try to calm down in order to return to normal (I'm assuming this is A-fib), i've experienced head and chest pressure, sometimes out of nowhere I will feel like I'm going to pass out including one time recently where I started shaking and teeth chattering (this was in 80 degree weather in state and i've come to realize I feel so much worse now in humid weather than I ever did before  as I seem to get the worst body aches during that time. And above all, I feel body fatigue nearly every day
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging abdominal, Metabolic function test, Pain, Protein C, Protein S
Clinical narrative: I've experienced blood clot in my left leg, dizziness and vertigo when I stand up, numbness in my arms, legs, hands, and feet,  I feel out of breath after doing anything more extraneous than a walk,  sometimes, out of nowhere, i'll just suddenly feel out of breath and will need to sit down/try to calm down in order to return to normal (I'm assuming this is A-fib), i've experienced head and chest pressure, sometimes out of nowhere I will feel like I'm going to pass out including one time recently where I started shaking and teeth chattering (this was in 80 degree weather in state and i've come to realize I feel so much worse now in humid weather than I ever did before  as I seem to get the worst body aches during that time. And above all, I feel body fatigue nearly every day
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Prothrombin level, Respiratory syncytial virus test, SARS-CoV-2 test, Scan with contrast, Thrombosis
Clinical narrative: I've experienced blood clot in my left leg, dizziness and vertigo when I stand up, numbness in my arms, legs, hands, and feet,  I feel out of breath after doing anything more extraneous than a walk,  sometimes, out of nowhere, i'll just suddenly feel out of breath and will need to sit down/try to calm down in order to return to normal (I'm assuming this is A-fib), i've experienced head and chest pressure, sometimes out of nowhere I will feel like I'm going to pass out including one time recently where I started shaking and teeth chattering (this was in 80 degree weather in state and i've come to realize I feel so much worse now in humid weather than I ever did before  as I seem to get the worst body aches during that time. And above all, I feel body fatigue nearly every day
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tremor, Ultrasound Doppler, Vertigo, X-ray limb
Clinical narrative: I've experienced blood clot in my left leg, dizziness and vertigo when I stand up, numbness in my arms, legs, hands, and feet,  I feel out of breath after doing anything more extraneous than a walk,  sometimes, out of nowhere, i'll just suddenly feel out of breath and will need to sit down/try to calm down in order to return to normal (I'm assuming this is A-fib), i've experienced head and chest pressure, sometimes out of nowhere I will feel like I'm going to pass out including one time recently where I started shaking and teeth chattering (this was in 80 degree weather in state and i've come to realize I feel so much worse now in humid weather than I ever did before  as I seem to get the worst body aches during that time. And above all, I feel body fatigue nearly every day
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Cough, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness and swelling at the location of vaccination.
Age: 66.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administration error
Clinical narrative: Patient was administered vaccine in error.  Patient had already received the vaccine last year  04/2023 and did not need to receive the vaccine this year.  Patient did not have any adverse reactions or problems and is aware was given a vaccine that is not due to be given.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Decreased appetite, Pyrexia, Rash, Rash macular
Clinical narrative: Approx. 8hr after vaccination patient developed deeply erythematous macular rash over most of the upper arm, swelling of the upper arm, and fever. The following day they had loss of appetite. Today (3 days after vaccination) swelling and fever have resolved. The erythematous rash has decreased in surface area though still present.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Decreased appetite, Peripheral swelling, Pyrexia, Rash, Rash macular
Clinical narrative: Approx. 8hr after vaccination patient developed deeply erythematous macular rash over most of the upper arm (right worse than left), swelling of the upper arm, and fever. The following day they had loss of appetite. Today (3 days after vaccination) swelling and fever have resolved. The erythematous rash has decreased in surface area though still present.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Arthralgia, Blood creatine phosphokinase, Histone antibody positive, Red blood cell sedimentation rate
Clinical narrative: Autoimmune markers in lab and chronic joint pain
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Smooth muscle antibody
Clinical narrative: Autoimmune markers in lab and chronic joint pain
Age: 9.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No symptoms or Adverse outcomes at this time. Patient was given the TDap dose roughly 8 months early.
Age: 44.0
Sex: F
Vaccine: CHOL, HEPAB, IPV, MMR, TDAP, TYP, YF
Symptoms: Angioedema, Urticaria
Clinical narrative: Returned pts call regarding angioedema and hives following vaccines on 4/30. Pt reports hives developed 1 day after vaccines and she went to urgent care on 5/4 with angioedema where she was given oral steroid. Pt finished oral steroid on 5/10. Reports on 5/11 angioedema came back and she went to Urgent care today and received a steroid injection 5/13. Also was given hydroxyzine q10 hours. Patient was calm and cooperative during phone call. Denies wheezing and difficulty breathing. Denies fever, chills, N&V. Advised to involve PCP as well and return to Urgent care or ER if difficulty breathing and/or wheezing, or new symptoms develop.
Sex: F
Vaccine: HPV9
Symptoms: Injection site discharge, Syringe issue, Underdose
Clinical narrative: after the needle was inserted into the patient's arm and the plunger, portion of the liquid leaked out/ Caller stated it was unable to be determined if the leakage was coming from the patient's arm or  from the syringe; device leakage; poor quality device used; Caller stated it is unable to be determined how much of the liquid leaked out and how much of it was actually administered.; No additional AE; This spontaneous report was received from a nurse via company representative and refers to a 39-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  It was reported that, upon administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot# 019863 [Lot Number 019863 is not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)], expiration date 14-FEB-2025, after the needle was inserted into the patient's arm and the plunger was pushed, a portion of the liquid of rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), leaked out (product leakage). It was stated i that it was unable to be determined if the leakage was coming from the patient's arm or from the syringe (device leakage) (poor quality device used). Moreover, it was unable to be determined how much of the liquid leaked out and how much of it was actually administered (accidental underdose). The syringe or the needle did not appear to have any defects. The patient is asymptomatic. The syringe is unable to be retrieved and photos are unable to be submitted due to the product already being disposed of. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; a dose of VARIVAX was administered after experiencing a temperature excursion; This spontaneous report has been received from a nurse, referring to a patient of unknown age and gender. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not provided.  On 13-MAY-2024, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, lot# X025846, expiry date 31-OCT-2025, for prophylaxis (dose, route of administration and anatomical location were not reported). The vaccine was administered after a temperature excursion (-11.1 degrees Celsius for 1 hour 54 minutes 0 seconds) (product storage error). There were no previous temperature excursions. No additional adverse event was reported.  This is one of 3 reports received from the same reporter.; Sender's Comments:  US-009507513-2405USA004809:2405USA004809 US-009507513-2405USA004837:2405USA004837
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Papilloma viral infection, Product administered to patient of inappropriate age
Clinical narrative: The caller stated that she had HPV in college but then was clear for decades/ has another infection of HPV; found out that she has another infection of HPV; The caller was concerned because this was 3 months in between instead of 2 months like is recommended.; unapproved indication; inappropriate age of vaccine administration; The caller is also over the age of 45.; This spontaneous report was received from consumer and refers to a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2007, the patient was vaccinated with all 3 doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). On an unknown date in January 2024, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On an unknown date in April 2024, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration, Product administered to patient of inappropriate age and Product use in unapproved indication).  On an unknown date (also reported as after vaccination in college), the patient experienced infection of HPV. On unknown date (also reported as receantly), the patient developed HPF infection. At the time of reporting, the outcome of the events was not known.    The causal relationship between both HPV infection events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown. The reporter considered both of HPV infection events to be not related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Just an extremely painful arm; hot 8 cm below my injection site; red 8 cm below my injection site; swelling 8 cm below my injection site; Itchy feeling 8 cm below my injection site; This non-serious case was reported by a consumer and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-MAY-2024, the patient received the 1st dose of Shingrix. In MAY-2024, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Just an extremely painful arm), localized feeling of warmth (Verbatim: hot 8 cm below my injection site), localized erythema (Verbatim: red 8 cm below my injection site), local swelling (Verbatim: swelling 8 cm below my injection site) and localized itching (Verbatim: Itchy feeling 8 cm below my injection site). The outcome of the pain in arm was not reported and the outcome of the localized feeling of warmth, localized erythema, local swelling and localized itching were not resolved.   It was unknown if the reporter considered the pain in arm, localized feeling of warmth, localized erythema, local swelling and localized itching to be related to Shingrix.     It was unknown if the company considered the pain in arm, localized feeling of warmth, localized erythema, local swelling and localized itching to be related to Shingrix.   Additional Information: GSK receipt date: 08-MAY-2024 The reporter reported that the patient had received first dose of Shingrix vaccine and experienced extremely painful arm, hot, red, swelling and itchy feeling 8 cm below her injection site. The reporter reported that they did not look during insertion, so she imagined this was literally due to technique as long as it will still be effective.
Age: 80.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: they administered to a patient outside of the age range; This non-serious case was reported by a pharmacist via patient support programs and described the occurrence of inappropriate age at vaccine administration in a 80-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number E4A39) for prophylaxis.   Concomitant products included neomycin sulfate, polymyxin b sulfate (Antibiotic).   On 11-MAY-2024, the patient received Menveo (left arm). On 11-MAY-2024, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: they administered to a patient outside of the age range). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 05-MAY-2024 The pharmacist called to inquire if there were any side effects for Menveo they administered to a patient outside of the age range, which led to inappropriate age at vaccine administration. The patient was on antibiotic for an unknown indication.
Sex: U
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: Diluent not added to active ingredient; diluent only was given to the patient; This non-serious case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy (unknown arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: Diluent not added to active ingredient) and inappropriate dose of vaccine administered (Verbatim: diluent only was given to the patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-MAY-2024 The clinic support staff supervisor reported that the Arexvy diluent was not mixed with the antigen and diluent only was given to the patient which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. They were seeking elastitags to connect the two Arexvy vials to prevent this incident from happening in the future.  The reporter did not consent to follow up.
Sex: U
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: giving Arexvy to lung transplant patients ages 50-59; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included lung transplant.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: giving Arexvy to lung transplant patients ages 50-59). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 13 May 2024 The reporter was giving Arexvy to lung transplant patients ages 50 to 59 years which led to inappropriate age at vaccine administration. The reporter did not agree to follow up.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered
Clinical narrative: Pediarix and Engerix-B were administered today to a 6-month-old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9PG49, expiry date 28-DEC-2024) and (batch number 9P329, expiry date 06-MAR-2026) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included IPV (received IPV vaccine on an unknown date) and Dtap (received Dtap vaccine on an unknown date).   On 06-MAY-2024, the patient received Pediarix. On 06-MAY-2024, the patient received Engerix B. On 06-MAY-2024, an unknown time after receiving Pediarix and Engerix B, the patient experienced overdose (Verbatim: Pediarix and Engerix-B were administered today to a 6-month-old patient). The outcome of the 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: 06-MAY-2024 The registered nurse reported that the both Pediarix and Engerix-B were administered today a 6th month old patient, which led to overdose. Therefore, administering two doses of Hepatitis B. The patient had a total of Hepatitis B doses including two that were given today, three doses of IPV and Dtap total including's Pedairix.
Sex: U
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: extra dose of Arexvy; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of extra dose administered in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: extra dose of Arexvy). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 08-MAY-2024  A pharmacist reported that a patient accidentally received an extra dose of Arexvy which led to extra dose administered. The reporter wanted to ask please provide guidance and any safety data available.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Administration of expired Kinrix dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number C472T, expiry date 15-MAR-2024) for prophylaxis.   On 04-APR-2024, the patient received Kinrix. On 04-APR-2024, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Administration of expired Kinrix 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: 10-MAY-2024 The nurse reported that they gave an expired Kinrix vaccine to the patient, which led to an expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product storage error
Clinical narrative: Shingrix accidentally placed in the freezer and frozen exposed to minus 9 Fahrenheit for hours; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intercepted product storage error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced intercepted product storage error (Verbatim: Shingrix accidentally placed in the freezer and frozen exposed to minus 9 Fahrenheit for hours). The outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 10-MAY-2024 The office manager called to check stability of Shingrix vaccine accidentally placed in the freezer and frozen exposed to minus 9 Fahrenheit for hour, which led to an intercepted product storage error. The office manager reported that they were looking for the vaccines and found in the freezer. The health care professional confirmed there were 2 full boxes, and they were not administered to any patient. The manager inquired was there a return or refund for the vaccines. The reporter did not consent to follow up.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: gave an expired dose of Engerix-B; 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 16-year-old female patient who received HBV (Engerix B pediatric) (batch number 97KT7, expiry date 15-MAR-2024) for prophylaxis.   On 10-MAY-2024, the patient received the 1st dose of Engerix B pediatric. On 10-MAY-2024, an unknown time after receiving Engerix B pediatric, the patient experienced expired vaccine used (Verbatim: gave an expired dose of Engerix-B). 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: 10-MAY-2024 The reporter reported that she gave an expired dose of Engerix-B to a patient which led to, expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: swelling at the injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 66-year-old female 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 swelling (Verbatim: swelling at the injection site). On 10-MAY-2024, the outcome of the injection site swelling was resolved.   It was unknown if the reporter considered the injection site swelling to be related to Shingrix.     It was unknown if the company considered the injection site swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-MAY-2024 The healthcare professional reported a patient developed swelling at the injection site after the patient received the Shingrix vaccine. The reporter stated that they monitored the patient for about 2 hours on the day of reporting night put ice on it and the swelling was resolved.
Age: 80.0
Sex: U
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: pharmacist called to inform that 80 year old patient had received a dose of Menveo one vial presentation; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 80-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number E4A39, expiry date 30-JUN-2025) for prophylaxis.   On 11-MAY-2024, the patient received Menveo. On 11-MAY-2024, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: pharmacist called to inform that 80 year old patient had received a dose of Menveo one vial presentation). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 13-MAY-2024 The pharmacist called and informed that 80 year old patient had received a dose of Menveo one vial presentation which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 19.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Product dispensing error, Wrong product administered
Clinical narrative: The pharmacy dispensed the SHINGRIX vaccine instead of the VZV vaccine; received the SHINGRIX vaccine instead of receiving the VZV Vaccine; 19 year old patient received the Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 19-year-old female patient who received Herpes zoster (Shingrix) (batch number F4LD5, expiry date 27-SEP-2025) for prophylaxis.   On 15-APR-2024, the patient received Shingrix. On 15-APR-2024, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: received the SHINGRIX vaccine instead of receiving the VZV Vaccine) and inappropriate age at vaccine administration (Verbatim: 19 year old patient received the Shingrix). On an unknown date, the patient experienced drug dispensing error (Verbatim: The pharmacy dispensed the SHINGRIX vaccine instead of the VZV vaccine). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and drug dispensing error were unknown.   Additional Information: GSK receipt date: 13-MAY-2024 The nurse reported that a patient received Shingrix vaccine instead of receiving the varicella zoster vaccine(Chicken Pox Vaccine), which led to wrong vaccine administered. The patient received a dose of Shingrix at an inappropriate age, which led to inappropriate age at vaccine administration. The pharmacy dispensed the Shingrix vaccine instead of varicella zoster vaccine, which led to drug dispensing error. The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Expired product administered, Incorrect dose administered
Clinical narrative: Expired dose administered (Priorix)/that it expired in 5/11/2024, which is just a few days ago; Overdose (Havrix); it was just not the pediatric dose, it was the adult 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 12-month-old female patient who received MMR (Priorix) (batch number 447N4, expiry date 11-MAY-2024) for prophylaxis.   Co-suspect products included HAV (Havrix 1440 adult) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis.   On 13-MAY-2024, the patient received Priorix (subcutaneous) and Havrix 1440 adult. On 13-MAY-2024, an unknown time after receiving Priorix and not applicable after receiving Havrix 1440 adult, the patient experienced expired vaccine used (Verbatim: Expired dose administered (Priorix)/that it expired in 5/11/2024, which is just a few days ago), overdose (Verbatim: Overdose (Havrix)) and adult product administered to child (Verbatim: it was just not the pediatric dose, it was the adult dose). The outcome of the expired vaccine used, overdose and adult product administered to child 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: 13-MAY-2024 The certified medical assistant called to report the 2 situations.  The first one, the reporter was dealing with was a 12 months old, they were given the 12 months vaccines and they gave an MMR Priorix which was normally fine but when they went to put in the system it showed that it was expired on 11th May 2024 , which was just a few days ago but it was shown in the system that it expired which led to expired vaccine used. The reporter just waned to know if the patient would be ok. The reporter had one more question. So, for the same patient, they gave a hepatitis A too it was not expired it was just not the pediatric dose, it was the adult dose which led to adult product administered to child and overdose. The health care professional did not count with an email address so she was not able to provide one, instead, she provided a Fax number and mailing address. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: Swollen Arm; Inflammation on her arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number C5M4M, expiry date 30-SEP-2025) for prophylaxis.   The patient's past medical history included shoulder operation (The patient had surgery on both shoulders over 5 to 10 years pre existing Shingrix).   On 02-APR-2024, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: Swollen Arm) and injection site inflammation (Verbatim: Inflammation on her arm). The outcome of the injection site swelling was resolved and the outcome of the injection site inflammation was unknown.   It was unknown if the reporter considered the injection site swelling and injection site inflammation to be related to Shingrix.     It was unknown if the company considered the injection site swelling and injection site inflammation to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-MAY-2024 The reporter is a pharmacist reported that female patient received her first dose of Shingrix in her left deltoid. The pharmacist reported that after the vaccination she developed a severe injection site reaction. The pharmacist reported that the patient had surgery on both shoulders over 5 to 10 years (pre existing Shingrix). After received the Shingrix, patient arm was swollen for more than a few weeks (unknown time frame or dates). The patient had to got a Steroid Injection (unknown product information) for the swelling and inflammation on her arm experienced after receiving Shingrix. No further information was provided about this adverse event. The reporter consented to follow up.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Patient received an expired vaccine MMR Priorix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received MMR (Priorix) (batch number 2AR75) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Patient received an expired vaccine MMR Priorix). 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: 13-MAY-2024 The registered nurse reported that the patient received an expired vaccine MMR Priorix, which led to expired vaccine used. The reporter consented to follow up.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: inadvertent administration of an extra Bexsero dose; inadvertent administration of an extra Bexsero dose instead of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number 2y393, expiry date 30-APR-2027) for prophylaxis.   On 13-MAY-2024, the patient received the 3rd dose of Bexsero. On 13-MAY-2024, an unknown time after receiving Bexsero, the patient experienced extra dose administered (Verbatim: inadvertent administration of an extra Bexsero dose) and wrong vaccine administered (Verbatim: inadvertent administration of an extra Bexsero dose instead of Engerix-B). The outcome of the extra dose administered and wrong 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: 13-MAY-2024  A reporter reported that a nurse gave an incorrect vaccine today which resulted in the inadvertent administration of an extra Bexsero dose, the patient was to receive an Engerix-B vaccine which led to Extra dose administered and Wrong vaccine administered.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received first dose of Shingrix 3 years ago and he came on March 2nd 2024 to get a late second dose; 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 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 4N9PF, expiry date 12-DEC-2025) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose 3 years ago on an unknown date).   On 03-MAR-2024, the patient received the 2nd dose of Shingrix. On 03-MAR-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received first dose of Shingrix 3 years ago and he came on March 2nd 2024 to get a late second dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 13-MAY-2024 The reporter had a patient here in the pharmacy that wanted to get one of vaccines, Shingrix.  They had a small problem though, he was given one dose of Shingrix about 3 years ago, he never completed the 2nd dose and he came in here in our pharmacy back in March and received the 2nd dose, however his doctor recommended to get 2 doses cause he was not able to complete the previous 2 doses within 12 or 6 month.  The patient was back to receive a third dose because his doctor recommended it.  He was a little hesitant to get a 3rd dose since the first dose was done 3 years ago and the 2nd dose in march. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue, Single component of a two-component product administered
Clinical narrative: patient received only the conjugate component (gray cap) containing the MenCYW-135 liquid, the vaccine was not reconstituted with the MenA lyophilized conjugate component; patient received only the conjugate component (gray cap) containing the MenCYW-135 liquid, the vaccine was not reconstituted with the MenA lyophilized conjugate component; 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 patient who received Men ACWY-CRM NVS (Menveo) (batch number amva984a, expiry date 30-SEP-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient received only the conjugate component (gray cap) containing the MenCYW-135 liquid, the vaccine was not reconstituted with the MenA lyophilized conjugate component) and inappropriate dose of vaccine administered (Verbatim: patient received only the conjugate component (gray cap) containing the MenCYW-135 liquid, the vaccine was not reconstituted with the MenA lyophilized conjugate component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-MAY-2024 The healthcare professional called and reported that the patient received only the conjugate component (gray cap) containing the MenCYW-135 liquid and the vaccine was not reconstituted with the MenA lyophilized conjugate component (orange cap) of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administered an expired Bexero dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a male patient who received Men B NVS (Bexsero) (batch number J52PN, expiry date 21-MAR-2024) for prophylaxis.   On 10-MAY-2024, the patient received the 1st dose of Bexsero. On 10-MAY-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: administered an expired Bexero 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: 14-MAY-2024 The pharmacist mentioned they accidentally administered an expired Bexsero dose which led to expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 2.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Drug Used; 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 2-year-old male patient who received HBV (Engerix B pediatric) (batch number 333M4, expiry date 07-APR-2024) for prophylaxis.   On 14-MAY-2024, the patient received Engerix B pediatric. On 14-MAY-2024, an unknown time after receiving Engerix B pediatric, the patient experienced expired vaccine used (Verbatim: Expired Drug Used). 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: 14-MAY-2024 The reporter stated that a patient received Hepatitis B vaccine, Engerix-B, pediatric version and it was expired, which led to expired vaccine used. The reporter wants to know if everything was fine. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: patient received a dose of Arexvy but it had been reconstituted with the wrong diluent; patient received a dose of Arexvy but it had been reconstituted with the wrong diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number FK5AC, expiry date 23-MAR-2025) for prophylaxis.   On an unknown date, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced wrong solution used in drug reconstitution (Verbatim: patient received a dose of Arexvy but it had been reconstituted with the wrong diluent) and inappropriate dose of vaccine administered (Verbatim: patient received a dose of Arexvy but it had been reconstituted with the wrong diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-MAY-2024 The director of operations (other healthcare professional) called and requested on how to proceed after the patient received a dose of Arexvy but it had been reconstituted with the wrong diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter asked if the previous question was true what risks were present if a second dose was given and asked what would be the time frame that would be recommended in this scenario. They did clarify that there was a possibility that 1 patient out of 4 had been affected but were unsure as to whom and were also unsure about the vaccination date, stating it could have taken place between November 2023 and March 2024.  They provided data for the 4 patients and vaccine. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up. This was 1 of the 4 cases, reported by the same reporter; Sender's Comments:  US-GSK-US2024060819:same reporter/ Different patient US-GSK-US2024060818:Same reporter / different patient US-GSK-US2024060821:Same reporter / different patient