chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: U
Vaccine: MMRV, MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No  additional AEs were reported; Medical assistant reported that a 38 years old patient received PROQUAD due to human error; This spontaneous report was received from a medical assistant concerning a 38-year-old patient of unknown gender. Patient's concurrent conditions, pertinent medical history and concomitant therapy details were not provided.  On 27-JUN-2024, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection, lot #x022920, with expiration date: 12-MAR-2025, administered for prophylaxis (strength, frequency, route of administration and anatomical location were not provided) (Inappropriate age at vaccine administration).  No additional adverse events were reported.
Age: 38.0
Sex: U
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No  additional AEs were reported; Medical assistant reported that a 38 years old patient received PROQUAD due to human error; This spontaneous report was received from a medical assistant concerning a 38-year-old patient of unknown gender. Patient's concurrent conditions, pertinent medical history and concomitant therapy details were not provided.  On 27-JUN-2024, the patient was vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection, lot #x022920, with expiration date: 12-MAR-2025, administered for prophylaxis (strength, frequency, route of administration and anatomical location were not provided) (Inappropriate age at vaccine administration).  No additional adverse events were reported.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Atrial fibrillation
Clinical narrative: patient's husband stated went to the hospital 3 days after vaccination with afib
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac disorder
Clinical narrative: Just diagnosed with covid; Just diagnosed with covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jul2024, outcome "unknown" and all described as "Just diagnosed with covid". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid. Clinical course: Patient stated: Just diagnosed with Covid, 01Jul2024, was sick over weekend. Doctor told patient Paxlovid would help.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400204457 same patient/product, different dose/events;
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial flutter
Clinical narrative: Just diagnosed with covid; Just diagnosed with covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jul2024, outcome "unknown" and all described as "Just diagnosed with covid". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid. Clinical course: Patient stated: Just diagnosed with Covid, 01Jul2024, was sick over weekend. Doctor told patient Paxlovid would help.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400204457 same patient/product, different dose/events;
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Just diagnosed with covid; Just diagnosed with covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jul2024, outcome "unknown" and all described as "Just diagnosed with covid". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid. Clinical course: Patient stated: Just diagnosed with Covid, 01Jul2024, was sick over weekend. Doctor told patient Paxlovid would help.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400204457 same patient/product, different dose/events;
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported. No additional AE/PQC reported.; HCP called to report VARIVAX was administered to a patient after experiencing a T/E.; This spontaneous report was received from a health care professional (nurse), referring a 15-months-old child of unknown gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On 08-MAR-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, at the dose of 0.5 milliliter (mL) as prophylaxis after a temperature excursion (strength, dose number, frequency, route of administration, and anatomical locations of application were not reported; lot number X021930 has been verified to be a valid lot number for varicella virus vaccine live (Oka/Merck), with expiration date reported and established as 29-AUG-2025)(product storage error). No additional adverse event (AE) was reported (no adverse event).
Age: 74.0
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP calling to report PEDVAX HIB was inadvertently administered today, 6/28/2024, after its labeled expiry date of 6/23/2024. HCP reports the vaccine had not experienced any previous temperature excursions. No side effects reported. No additional inf; 74 years; This spontaneous report was received from a nurse and refers to a 74-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-JUN-2024 (when the pt was 74 days old), the patient was vaccinated with an expired dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (lot # U031543 is valid for haemophilus b conjugate vaccine (meningococcal protein conjugate), expiration date: 23-NOV-2024; strength,  vaccination scheme, dose, route of administration and anatomical location of administration were not provided) administered as prophylaxis (expired product administered and product administered to patient of inappropriate age). No additional adverse event were reported.
Age: 0.5
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered at inappropriate site, Product administered to patient of inappropriate age
Clinical narrative: Kinrix given 6 month female; Kinrix vaccine given on right thigh; This non-serious case was reported by a physician via sales rep and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received DTPa-IPV (Kinrix) (batch number 34mf9) for prophylaxis.   On 10-JUN-2024, the patient received Kinrix (right thigh). On 10-JUN-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix given 6 month female) and vaccine administered at inappropriate site (Verbatim: Kinrix vaccine given on right thigh). The outcome of the inappropriate age at vaccine administration and vaccine administered at inappropriate site 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: 26-JUN-2024 The physician reported that the 6-month-old patient received the Kinrix vaccine on right thigh, which led to an inappropriate age at vaccine administration and vaccine administered at inappropriate site.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: I didn't feel well; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP. Other Case identifier(s): MOD-2024-770340, US-OCCC-CINT0014464, US-MODERNATX-MOC20240626000045.  An elderly patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I didn't feel well".  Additional information: Patient first vaccines were Pfizer and did not feel well.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Blepharospasm, Hypoaesthesia, Muscle twitching, Paraesthesia, Product administered at inappropriate site
Clinical narrative: Vaccine was not administered in the right deltoid of the upper arm. It was administered diagonally below the side of the right deltoid, more towards the lower part of the left upper arm.  Patient first experienced slight numbness in the left hand, progressing to pins and needles, then to twitching. From the left hand, twitching and numbness also included the right hand and right arm. Twitching progressed further to the right eye and to the right neck area.  These symptoms were spontaneous and sporadic. Patient stops whatever she was doing whenever these occur and continue after the symptoms subside.
Sex: U
Vaccine: TDAP
Symptoms: Hypersensitivity, Impaired work ability, Injection site discomfort, Injection site pain
Clinical narrative: to this day the pain in the arm where they gave me the vaccine has not stopped; feel as if I had something inside where they gave me the vaccine; it caused a slight allergic reaction; seeing my work affected, in the kitchen because i am chef; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concurrent medical conditions included allergy (since the patient was 8 years old he/she had been allergic to many things).   On an unknown date, the patient received Boostrix (unknown arm). On an unknown date, an unknown time after receiving Boostrix, the patient experienced injection site pain (Verbatim: to this day the pain in the arm where they gave me the vaccine has not stopped), injection site discomfort (Verbatim: feel as if I had something inside where they gave me the vaccine), allergic reaction (Verbatim: it caused a slight allergic reaction) and activities of daily living impaired (Verbatim: seeing my work affected, in the kitchen because i am chef). The outcome of the injection site pain was not resolved and the outcome of the injection site discomfort, allergic reaction and activities of daily living impaired were not reported.   It was unknown if the reporter considered the injection site pain, injection site discomfort and activities of daily living impaired to be related to Boostrix. The reporter considered the allergic reaction to be related to Boostrix.   It was unknown if the company considered the injection site pain, injection site discomfort and activities of daily living impaired to be related to Boostrix. The company considered the allergic reaction to be related to Boostrix.   Additional Information: GSK Receipt Date: 19-JUN-2024 This case was reported by a patient via interactive digital media. The patient reported that almost 2 months ago the patient received this vaccine that was requested to be able to reside in the country. The patient had always been a very healthy person and all his/her annual exams confirm it, but when he/she received this vaccine, it caused a slight allergic reaction. To this day the pain in the arm where they gave him/her the vaccine has not stopped, when they asked him/her on the pain scale he/she had in arm from 1 to 10, with 10 being the maximum pain, the pain was 20, apart from that felt as if he/she had something inside where they gave the vaccine, seeing his/her work affected, in the kitchen because he/she was a chef. At this point the patient was already desperate, and the patient would like someone to give him/her an answer about this effect that was not removed. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Incorrect route of product administration
Clinical narrative: Shorter interval; patient received the second dose of Shingrix subcutaneously instead of intramuscularly; 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 female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 21-JUN-2024, the patient received the 2nd dose of Shingrix (subcutaneous). On 21-JUN-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Shorter interval) and intramuscular formulation administered by other route (Verbatim: patient received the second dose of Shingrix subcutaneously instead of intramuscularly). The outcome of the drug dose administration interval too short and intramuscular formulation administered by other route were unknown.   Additional Information: GSK Receipt Date: 25-JUN-2024 A pharmacist reported that a patient received the second dose of Shingrix subcutaneously instead of intramuscularly which led to Intramuscular formulation administered by other route.  The reporter wanted to know was the second dose valid. The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Shingrix earlier than the recommended interval, which led to shortening of the vaccine schedule.
Sex: M
Vaccine: RVX
Symptoms: Herpes zoster
Clinical narrative: Outbreak of shingles; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles 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 shingles (Verbatim: Outbreak of shingles). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to RSV vaccine.     It was unknown if the company considered the shingles to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 25-JUN-2024 An HCP reported that she recently had a patient who had active shingles after receiving the RSV vaccine but it was not known whether it was the GSK arexvy or the Pfizer vaccine.
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative, Product administered to patient of inappropriate age
Clinical narrative: 9-month-old, fully-vaccinated female had inadequate (2/23 = 9%) protective Streptococcus pneumoniae titers and inadequate response (5/23 = 22%) following pneumococcal polysaccharide vaccination; 9-month-old, fully-vaccinated female had inadequate (2/23 = 9%) protective Streptococcus pneumoniae titers and inadequate response (5/23 = 22%) following pneumococcal polysaccharide vaccination;   This literature marketed report has been received from the authors of a published article, titled as stated above, and refers to a 9-month-old female patient.  On an unknown date, the patient was fully vaccinated with pneumococcal 23v polysaccharide vaccine (dose, units, route of administration, anatomical location, lot#, and expiration date were not reported) for prophylaxis (Product administered to patient of inappropriate age).  On an unknown date, she had inadequate (2/23 = 9%) protective Streptococcus pneumoniae titers and inadequate response (5/23 = 22%) following pneumococcal polysaccharide vaccination (Antibody test negative). The outcome of the event was not reported.  The authors considered the event of antibody test negative to be related to pneumococcal 23v polysaccharide vaccine.  A copy of the published article is attached as further documentation of the patient's experience.  Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: no side effects reported; MRII was inadvertently administered on 6/13/2024 after its labeled expiry date of 6/3/2024; This spontaneous report was received from a nurse and refers to a 49-year-old. patient  The patient's medical history, concurrent conditions were not reported.  On 13-JUN-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) injection, lot #X012185, expiration date: 03-JUN-2024 (expired vaccine used) (strength, and route of administration were not provided). Concomitant medications included sterile diluent (MERCK STERILE DILUENT) (manufacturer unknown).
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Anxiety, Inappropriate schedule of product administration, Vomiting
Clinical narrative: Gardasil 1st dose on 16-JUN-2023 and could not received 2n dose on 17-JUN-2024; was unable to receive the 3rd vaccine which was Gardasil; Anxious; he started vomiting; This spontaneous report was received from a nurse refers to a male patient of unknown age. The patient's concurrent conditions included depression and anxiety. The patient's historical medications, medical history, and concomitant medications were not reported.     On 16-JUN-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot number and expiration date not reported) for prophylaxis. On 17-JUN-2024, the patient was vaccinated with meningococcal vaccine a/c/y/w conj (crm197)(MENVEO) and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid(TDAP) (doses, routes of administration, lot numbers and expiration dates not reported) both for prophylaxis. On the same date, after the administration of those 2 vaccines, the patient became anxious and started vomiting (anxiety and vomiting), therefore, the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (inappropriate schedule of product administration) lot number 2014634, expiration date 20-SEP-2025 could not be administered (product dose omission issue).     The outcome of anxiety and vomiting and their causal relationship with the vaccine were not reported.
Age: 0.67
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no AE; patient was administered their third dose of ROTATEQ one week after 8 months of age; inappropriate schedule of vaccine administered; This spontaneous report was received from physician and refers to an 8-month and 6 day-old (also reported as 8 months and week) patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 23-FEB-2024, the patient was vaccinated with third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, (lot #1933923 was valid, expiration date: 28-APR-2024, administered orally, exact dose was not provided) for prophylaxis (Product administered to patient of inappropriate age, Inappropriate schedule of product administration). No symptoms reported. No adverse event (AE)/product quality complaint (PQC) (No adverse event).
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Colposcopy abnormal, Human papilloma virus test positive, Loop electrosurgical excision procedure, Smear cervix abnormal
Clinical narrative: the patient was tested in Nov 2023 and tested positive for LowGrade Squamous Intraepithelial Lesion(LGSIL); had multiple medical procedures; FBE reported that the patient tested positive for HPV after completing the vaccination series with GARDASIL./the patient was tested for ASCU which was positive for HPV; LowGrade Squamous Intraepithelial Lesion (LGSIL) was revealed after a pap smear.; colposcopy revealed High-grade Squamous Intraepithelial Lesion (HSIL) for Cervical Intraepithelial Neoplasia Grade 1 (CIN 1) and CIN 2; This spontaneous report was received from a health care professional (Nurse Practitioner) via a company representative, referring an adult female patient. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were unknown by the reporter.  On unspecified dates in 2013 (when the patient was 15-years-old), the patient was vaccinated with the first, second and third dose of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) injection, for prophylaxis (strengths, exact doses, routes of administration, vaccination scheme frequencies, anatomical locations, lot numbers and expiration dates were not reported).  On an unknown date in 2022 (when the patient was approximately 24-years- old, after completing the vaccination series with quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL)), the patient tested positive for Human Papillomavirus (HPV) and had multiple medical procedures (Human papilloma virus test positive and Medical procedure). Also, on an unknown date in 2022, Low Grade Squamous Intraepithelial Lesion (LGSIL) was revealed after a pap smear; a colposcopy revealed High-grade Squamous Intraepithelial Lesion (HSIL) for Cervical Intraepithelial Neoplasia Grade 1 (CIN 1) and CIN 2 and the patient had a Loop Electrosurgical Excision Procedure (LEEP) procedure (Low grade squamous intraepithelial lesion and High grade squamous intraepithelial lesion).   On an unknown date in 2023, the patient was tested for Atypical Squamous Cells of Undetermined Significance (ASCUS) which was positive for HPV and negative for serotypes 16, 18 and 45. The patient was tested (unspecified test) in November 2023 and tested positive for LGSIL and had another colposcopy but was inconclusive for HPV (Low grade squamous intraepithelial lesion). It was unknown by reporter, if the patient sought medical attention, if any treatment was given for the event, or if any other laboratory diagnostics or studies were performed. At the moment of the report the outcome of the adverse events was unknown.  The causal relationship between the adverse events and the suspect vaccine was not provided.   Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: Soreness; Itching; Soreness at the injection site for a little over a month.; This spontaneous report was received from a medical assistant via company representative 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, the patient was vaccinated with the first, second, and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strengths, doses, lot numbers, expiry dates, routes and sites of administration were not provided) administered for prophylaxis by a health professional.  On unknown day in 2024 (reported as for a little over a month), the patient has had soreness at the injection site (vaccination site pain). On an unspecified date, after first and second dose of the suspect vaccine, the patient had some soreness (pain) and itching (pruritus), but the third dose of the suspect vaccine was significantly more bothersome. At the time of reporting the outcome of the events was not reported. No additional information was provided.  The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding all the events was considered as not applicable.   The causal relationship between the events of vaccination site pain, pain, pruritus and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AES were reported; Physician reported that on 6/27/2024 a patient received MMR II and PROQUAD on the same day due to human error.  No additional AEs were reported. No further information provided.  No PQC.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 27-JUN-2024 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (exact dose, dose number, route and site of administration, lot number and expiration date were not provided) and was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (exact dose, dose number, route and site of administration, lot number and expiration date were not provided) on the same day due to human error (accidental overdose and  no adverse event).
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms reported.No additional AE/PQC; Nurse calling to inquire about the validity of an administered dose of an expired ROTATEQ vaccine.  Caller stated that the ROTATEQ  dose had a labeled expiration date of  05/21/2024 and was administered on 05/30/2024.; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 30-MAY-2024 (confliction information also reported as 01-JUN-2024), the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1968382, expiration date was reported and confirmed as 21-MAY-2024, (strength and exact dose were not provided) administered orally for prophylaxis (Expired product administered). Operator of device was reported as health professional. The nurse inquired about the validity of an administered dose of the expired vaccine. The nurse stated that the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) dose had a labeled expiration date of 21-MAY-2024. No symptoms reported. No further information was available. No additional adverse event or product quality complaint.
Age: 0.5
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No side effects reported. No additional AE/PQC.; MMRII was administered inadvertently to a 6 month old on 28JUN2024.; This spontaneous report was received from a medical assistant and refers to a 6-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 28-JUN-2024, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) injection, lot #X019102, expiration date was reported and confirmed as 16-JUL-2025 (strength, exact dose and route of administration were not provided) administered for prophylaxis (Product administered to patient of inappropriate age). No side effects reported. Operator of Device was a Healthcare Professional. No other medical information known. No additional adverse event or product quality complaint.
Sex: U
Vaccine: MMRV, UNK, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: no adverse event; accidently received an extra dose of VARIVAX, last week; administering PROQUAD to the patien instead of MMR II; This spontaneous report was received from a Medical Asistance (MA) and refers to 4-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  The reporter stated that the patient came in for their 4-year check up, and she assumed the patient needed the "routine" 4-year vaccines which included measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and was unaware that the patient had already received two prior doses of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis: on 15-MAR-2024 the patient was vaccinated with the first dose, 0.5ml , lot #X001000, expiration date: 09-JAN-2025; and on 09-AUG-2023 with the second dose, 0.5ml, lot#: U027326, expiration date was not provided, however upon internal validation was established as: 02-SEP-2023 (strength, route of administration, and anatomical site of vaccination were not provided).   On 26-JUN-2024, the medical assistance received an email from her vaccine coordinator notifying her that the patient should have only received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (strength, dose, lot# and expiration date was not provided) for prophylaxis, but the MA had inadvertently administered  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), injection, 0.5 ml, lot #X027624, expiration date: 28-MAY-2025 (strength, route of administration, and anatomical site of vaccination were not provided)  to the patient instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (strength, dose, lot# and expiration date was not provided) (Wrong product administered). No additional adverse event (AE) (no adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test normal, Myalgia, Neuropathy peripheral
Clinical narrative: neuropathy-like symptoms in her feet; Generalized myalgia; This serious case was reported by a nurse via sales rep and described the occurrence of peripheral neuropathy in a adult 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, several days after receiving Shingrix, the patient experienced peripheral neuropathy (Verbatim: neuropathy-like symptoms in her feet) (serious criteria GSK medically significant) and generalized muscle aches (Verbatim: Generalized myalgia). The outcome of the peripheral neuropathy and generalized muscle aches were not resolved.   It was unknown if the reporter considered the peripheral neuropathy and generalized muscle aches to be related to Shingrix.     The company considered the peripheral neuropathy to be unrelated to Shingrix. It was unknown if the company considered the generalized muscle aches to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-JUN-2024 Patient had generalized myalgia, muscle pain and neuropathy-like symptoms in her feet after received first dose. The reporter stated that the symptoms started within a few days after vaccination and to reporters knowledge were unresolved was reported as worsened. The patient was tested for lupus and it was negative. The reporter was not the patients healthcare provider and was unsure if this adverse event was previously reported. and feels it was likely not related.; Sender's Comments: Neuropathy peripheral is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got vaccinated and have it again right now; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got vaccinated and have it again right now). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-JUN-2024  This case was self-reported by patient via interactive digital media. The patient got vaccinated with Shingrix vaccine and had it again right now. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Shingles vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/ my husband had the shot and sitting here now with them; had the shot and sitting here now with them/ Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/ my husband had the shot and sitting here now with them) (serious criteria GSK medically significant) and shingles (Verbatim: had the shot and sitting here now with them/ Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   The company considered the vaccination failure to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 29-JUN-2024 This case was reported by a patient's wife via interactive digital media. The patient's wife reported the patient had the shot and sitting here now (at the time of reporting) with them. She google the shot and said it stayed strong in your body for 7 years. Their doctor got the shot did not always help. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: patient received only the liquid portion of Hiberix without the lyophilized component; patient received only the liquid portion of Hiberix without the lyophilized 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 Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: patient received only the liquid portion of Hiberix without the lyophilized component) and inappropriate dose of vaccine administered (Verbatim: patient received only the liquid portion of Hiberix without the lyophilized component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-JUN-2024 A vaccines sales representative mentioned that she received a report from an Healthcare professional regarding the administration of the diluent of Hiberix without the lyophilized portion which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The sales representative did not provide details such as patient information and dose lot number and expiration date. The sales representative mentioned she would call us back once she gets this information.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included eczema (pre existing Shingrix) and bug bite (large reactions from bug bites that take time to go away).   On 12-JUN-2024, the patient received the 1st dose of Shingrix (right arm). On 14-JUN-2024, 2 days after receiving Shingrix, the patient experienced injection site erythema (Verbatim: redness at the injection site). The outcome of the injection site erythema was not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-JUN-2024 This case was reported by patient itself. The patient experienced redness at the injection site. The patient reports that she was still having this redness at the injection site as of today, 21-JUN-2024. The reporter did not consent to follow-up.
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: We gave an Engerix-B pediatric dose to an adult; We gave an Engerix-B pediatric dose to an adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 56-year-old male patient who received HBV (Engerix B) (batch number CM294, expiry date 19-APR-2024) for prophylaxis.   Previously administered products included Heplisav-b (on 6th June 2023 received 1st dose).   On 20-DEC-2023, the patient received Engerix B. On 20-DEC-2023, an unknown time after receiving Engerix B, the patient experienced adult use of a child product (Verbatim: We gave an Engerix-B pediatric dose to an adult) and underdose (Verbatim: We gave an Engerix-B pediatric dose to an adult). The outcome of the adult use of a child product and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-JUN-2024 A nurse reported that he/she gave an Engerix-B pediatric dose to an adult which led to adult use of a child product and underdose. The reporter mentioned that on 06 June 2023 the patient received the 1st dose of the Hepatitis B series, from the brand Heplisav-b.  The vaccine administration facility was the same as primary reporter.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Accidentally given expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received MMR (Priorix) (batch number EP99Z, expiry date 13-MAY-2024) for prophylaxis.   On 14-MAY-2024, the patient received Priorix. On 14-MAY-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Accidentally given expired dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-JUN-2024 The practice nurse was wondering about when Priorix actually expired if accidentally given after the expiration date which led to expired vaccine used. If it was given 1 day after expiration did the patient need to had another dose or was it still good. Yes, a few patients received expired doses ranging from being expired for 1 day to 1 week. The vaccine administration facility was the same as primary reporter. The case is linked with US2024078697, same reporter, different patient.; Sender's Comments:  US-GSK-US2024078697:Same reporter/Different patient
Age: 1.25
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: inadvertently administered Kinrix instead of Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7745R, expiry date 22-AUG-2025) for prophylaxis.   On 25-JUN-2024, the patient received Kinrix. On 25-JUN-2024, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: inadvertently administered Kinrix instead of Infanrix). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 25-JUN-2024 Nurse reported a 15 month old male patient was inadvertently administered Kinrix instead of Infanrix which led to wrong vaccine administered. This was the patient's fourth dose of DTaP and IPV. The dose was administered from lot number 7745R (expiration date 22 August 2025).
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Medical Assistant stated that on June 26th 2024 they accidentally administered first dose of Shingrix for a patient using only the diluent portion without reconstituting; Medical Assistant stated that on June 26th 2024 they accidentally administered first dose of Shingrix for a patient using only the diluent portion without reconstituting; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number N425G, expiry date 07-DEC-2025) for prophylaxis.   On 26-JUN-2024, the patient received the 1st dose of Shingrix. On 26-JUN-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: Medical Assistant stated that on June 26th 2024 they accidentally administered first dose of Shingrix for a patient using only the diluent portion without reconstituting) and inappropriate preparation of medication (Verbatim: Medical Assistant stated that on June 26th 2024 they accidentally administered first dose of Shingrix for a patient using only the diluent portion without reconstituting). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 26-JUN-2024 A medical assistant stated that on 26 June 2024 they accidentally administered first dose of Shingrix for a patient using only the diluent portion without reconstituting which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter.
Age: 0.92
Sex: M
Vaccine: MNQ
Symptoms: Underdose
Clinical narrative: patient received only half of the dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 2R7L7, expiry date 31-DEC-2024) for prophylaxis.   On 24-JUN-2024, the patient received Menveo. On 24-JUN-2024, an unknown time after receiving Menveo, the patient experienced underdose (Verbatim: patient received only half of the dose). The outcome of the underdose was unknown.   Additional Information: GSK Receipt Date: 26-JUN-2024 A nurse called to inform about a Menveo dosing error, where an 11 year old patient received only half of the dose. According to the reporter, the nurse who administered it was not able to put the whole dose through the arm of the patient which led to underdose.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: product was exposed to a temperature of 54 degree Fahrenheit for 2 hours; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number F5492, expiry date 27-OCT-2024) for prophylaxis.   On 26-JUN-2024, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced incorrect storage of drug (Verbatim: product was exposed to a temperature of 54 degree Fahrenheit for 2 hours). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-JUN-2024 A medical assistant called to report a temperature excursion for Kinrix, in which this product was exposed to a temperature of 54 degree Fahrenheit for 2 hours. According to caller, before making the report of the excursion a dose of Kinrix had been administered earlier that day to a 4 year old patient which led to incorrect storage of drug.