chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19-2, FLU4, VARZOS
Symptoms: Arthralgia, Injected limb mobility decreased, Pain in extremity, Periarthritis
Clinical narrative: PT RECEIVED 3 VACCINES ON 11/29/2022 FLUARIX ,PFIZER AND SHINGRIX . Patient came to the pharmacy on 01/11/2023 and complained about left arm/shoulder pain that started after getting the vaccines (she received Fluarix and Shingrix on left arm) and limited mobility of her arm. Pt reported using a medrol dose pack that helped her with pain. The patient also stated that she submitted VAERS on her own. 08102023 patients again came to the pharmacy and reported continuing side effects of shoulder and arm pain. She has been to different providers and  received cortisone shots that helped her for a bit but the pain is back. Her MRI was denied by insurance. Her doctor also suspects frozen shoulders.  Patient might pay out
Age: 74.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Redness, swelling, pain, feverish arm,  hot
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Interchange of vaccine products, Wrong product administered
Clinical narrative: No other AE and no PQC; Physician calling for herself to report she received 2 doses of GARDASIL QUADRIVALENT and completed the series with a third dose of GARDASIL 9 in 2016.; Physician calling for herself to report she received 2 doses of GARDASIL QUADRIVALENT and completed the series with a third dose of GARDASIL 9 in 2016.; This spontaneous report has been received from a physician referring to herself as a female patient of unknown age.  The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On unknown dates, the patient was vaccinated with the first and second doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, anatomical location, route of administration, lot#, and expiration date were not reported). On an unspecified date in 2016, the patient completed the series with a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, anatomical location, route of administration, lot#, and expiration date were not reported). Both vaccines were given for prophylaxis (interchange of vaccine products) (wrong product administered). No adverse event was reported.
Age: 0.17
Sex: U
Vaccine: VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional AEs were reported; 8 week old infant received VARIVAX; This spontaneous report was received from other health professional and refers to an 8-week-old patient of unknown gender. The patient's medical history and concomitant therapies were not reported.  On 09-AUG-2023, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number X007373 has been verified to be a valid lot number with expiration date not provided but wstablished as12-MAR-2025, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). No additional AEs were reported.   .
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 64 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Mar2021 as dose 1, single (Lot number: 037A21B), on 25Apr2021 as dose 2, single (Lot number: 04b21A), on 01Apr2022 as dose 4 (booster), single (Lot number: 048L21A), on 30Sep2022 as dose 5 (booster), single (Lot number: AS7163B) and on 19May2023 as dose 6 (booster), single (Lot number: AS7164B) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "hypertension" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: have had COVID 4 times and I have had 5 Pfizer shots; have had COVID 4 times and I have had 5 Pfizer shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, 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), outcome "unknown" and all described as "have had COVID 4 times and I have had 5 Pfizer shots". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I have had COVID 4 times; Positive, notes: I have had COVID 4 times; Positive, notes: I have had COVID 4 times; Positive, notes: I have had COVID 4 times. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 12:30 as dose 4 (booster), single (Lot number: GJ2524) at the age of 35 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "class 1 obesity" (unspecified if ongoing); "right thyroidectomy" (unspecified if ongoing), notes: hx of right thyroidectomy; "high platelet count" (unspecified if ongoing), notes: high platelet count. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information:There is none known allergies.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Sex: F
Vaccine: COVID19
Symptoms: Near death experience
Clinical narrative: Your COVID vaccine almost killed my wife; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: NEAR DEATH EXPERIENCE (life threatening), outcome "unknown", described as "Your COVID vaccine almost killed my wife".  Additional information: I will never take another MRNA vaccine. Your COVID vaccine almost killed my wife so you can make all of the MRNA vaccine with MRNA but my family nor I will ever take another MRNA vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: headache; chills; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Aug2023 as dose number unknown, 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: HEADACHE (non-serious) with onset 10Aug2023, outcome "not recovered"; CHILLS (non-serious) with onset Aug2023, outcome "recovered" (Aug2023); PYREXIA (non-serious) with onset Aug2023, outcome "recovered" (Aug2023), described as "fever". Additional information: The caller mentioned that she took the vaccine last sunday and had a general side effects like chills and fever. She added that it went away and everything was fine but yesterday and today she have been having a really bad headache and wanted to know if that is normal with the vaccine because she's having a bad headache.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension, Metastases to bone, Neoplasm malignant, Renal cancer
Clinical narrative: I95.9 HYPOTENSION 3/31/2023 CANCER METASTATIC TO BONE LOCALIZED KIDNEY CANCER, UNSPECIFIED SITE
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19
Clinical narrative: Background: Patient is a 91 Y female with HTN, subclinical hyperthyroidism, history of TIA, memory loss admitted for acute hypoxemic respiratory failure due to COVID 19 infection
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Gait disturbance, Walking aid user
Clinical narrative: RN Message Notes: Key Symptoms and Assessment: no new/worsening sx, x3-4 days ago difficulty walking/staggering, able to stand up, has to use assistance to walk, baseline ambulates independently, denies SOB, O2 92%  Pertinent History: ER 7/29/23 covid, DM2, HF, HTN, Chronic Respiratory failure  Other: none    Additional Information:
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Injection site erythema, Injection site rash, Injection site reaction, Injection site warmth
Clinical narrative: Site of injection at her left arm began to feel warm, ws reddish in the area, had a patch of fine bumps, and felt of pins and needles.  Also experienced severe fatigue the next day.  Patient contacted her PCP who prescribed her oral abx.    Based on my telephone assessment of the patient, this is standard, immunologic reaction to COVID-19 vaccine.  Localized erythema, urticaria, and warmth at site of injection as with vaccinations in general.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Paraesthesia
Clinical narrative: Site of injection at her left arm began to feel warm, ws reddish in the area, had a patch of fine bumps, and felt of pins and needles.  Also experienced severe fatigue the next day.  Patient contacted her PCP who prescribed her oral abx.    Based on my telephone assessment of the patient, this is standard, immunologic reaction to COVID-19 vaccine.  Localized erythema, urticaria, and warmth at site of injection as with vaccinations in general.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Inappropriate schedule of product administration, Wrong patient received product
Clinical narrative: Not time for vaccine, given in error to incorrect sibling. No side effects reported.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Nausea
Clinical narrative: Pain at injection site, fatigue, nausea, headache
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Palpitations, Pyrexia
Clinical narrative: Chest pain and tightness. Racing heart and palpitations. Fever and lightheaded. All started within 24 hours of vaccine and lasted for week. The chest pain, tightness, and lightheadedness still occurs at times.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain
Clinical narrative: injection site pain, injection site starting the day after the vaccination
Age: 77.0
Sex: M
Vaccine: FLUA4, TDAP
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: nausea, vomiting, dizziness, started evening of vaccination and persisted through morning, patient seeking medical attention at hospital
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Infant irritability
Clinical narrative: Infant developed inconsolable crying and fussiness for several hours after receiving shots. Continued for 3 days
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: No report of symptoms from patient; Nurse calling to report adverse event for improperly stored and administered PEDVAXHIB.  Nurse stated that the PEDVAXHIB had been stored in their freezer since 7/11/2023, and that the last time a PEDVAXHIB vaccine was administered was on that date of; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On 11-JUL-2023, the patient was vaccinated with a haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 mL (lot # W015927, expiration date: 15-FEB-2025) 2 dose series (unknown which dose received) as prophylaxis, which was improperly stored in the freezer since this date. No reported symptoms from patient.
Sex: U
Vaccine: MMR
Symptoms: Product use in unapproved indication, Pyrexia
Clinical narrative: Inbound call from Merck FBE who reports potential MMR-II adverse event. While speaking with a pharmacist she states he mentioned they had a 12 month old patient with immunodeficiency who received an MMR vaccine who was not supposed to receive a live; Infant had fever for a week and they were considering measles infection; This spontaneous report was received from a pharmacist and refers to a 12 month old patient of unknown gender. The patient's concurrent conditions included immunodeficiency. The patient's medical history, concomitant medications , drug reactions or allergies were not reported.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #, expiration date, dose, route of administration, anatomical location not provided) as prophylaxis; which was not supposed to receive it due to the patient's immunodeficiency (product use in unapproved indication).  On an unknown date in July 2023 (between 9th and 15th), the patient experienced fever for a week; therefore, they were considering measles infection due to vaccination, but in the end it was determined as a diagnosis of fever. At the reporting time, the outcome of the fever was unknown.   Causality assessment between fever and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse events; HCP called to report that a patient was administered a dose of VARIVAX that suffered a TE. Supported TE case number is 02435007. No symptomatic AE reported. No Additional AE/PQC reported.  Names of vaccines involved (including lot/expiration) VARIVAX; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-JUL-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #w034707, expiration date: 01-NOV-2024, administered as prophylaxis (strength, and route of administration were not provided), that suffered a temperature excursion (TE) at a temperature of 35.2 Fahrenheit degrees (14 F up to 46 F) (-10 Celsius degrees up to 8 C) during 4 hours and 40 minutes (Product storage error). No additional symptomatic adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Injury
Clinical narrative: herpes zoster; ophtalmologic complications; other zoster related injuries; This initial spontaneous report has been received from a lawyer regarding a case in litigation, concerning a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions, or allergies were not reported. On 02-NOV-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneous injection (dose, strength, vaccination scheme, route of administration, anatomical location lot number and expiration date were not provided), administered for long-term prevention of shingles and zoster-related conditions. It was reported that on an unknown date, resulting from pt's zoster vaccine live (ZOSTAVAX) use including herpes zoster, ophthalmologic complications, and other zoster related injuries, resulting in injuries to themselves. The pt had sustained and would continue to sustain severe physical injuries, emotional distress, mental anguish, economic losses, and other damages. At the time of reporting, the pt had not recovered from the events. The reporter considered all the aforementioned events to be related to zoster vaccine live (ZOSTAVAX).  All the events were considered as disabling by reporter.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Blister, Scar
Clinical narrative: scars from the blisters; The patient received PNEUMOVAX 23 on 8/17/2018 and developed blisters on his skin later that evening or the next day. The blisters were large in size and filled with liquid.; This spontaneous report was received from patient's mother and refers to a 51-year-old male patient. The patient's medical history was not reported. His concurrent conditions included cerebral palsy and intellectual disability. Concomitant medications included buspirone hydrochloride (BUSPAR), atorvastatin (ATORVASTATIN), gabapentin (GABAPENTIN), and water pill.   On 17-AUG-2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, valid lot #R006466, expiration date: 24-OCT-2019, administered for prophylaxis (dose, frequency, strength, anatomical location, and route of administration were not provided).  On the same date (also reported as later that evening or the next day), the patient developed blisters on his skin. The blisters were large in size and filled with liquid. He went to the emergency room where the blisters were cleaned with betadine, and he was given a prescription medication. The caller reported that it took the patient around 6 months to heal from this and that he still had scars from the blisters.  The causal relationship between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported.; Medical assistant reported that an expired MMR II vaccine was given to a patient today 8/10/2023.; This spontaneous report has been received from a health care professional, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 10-AUG-2023, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) subcutaneous injection, as prophylaxis (lot number: U022316, which was determined to be valid, with an expiration date on 15-JUL-2023, therapy type: rHA), with sterile diluent (MERCK STERILE DILUENT) diluent (lot number: W000452, which was determined to be valid, with an expiration date on 23-JUL-2024) (expired product administered) (strengths, doses, schemes, routes and anatomical locations of administration were not reported).  No additional event was reported.   No further information was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE/no PQC.; Physican reported an adult patient received PROQUAD instead of MMRII.; Adult paitent received PROQUAD; This spontaneous report has been received from a physician, regarding an adult patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On an unspecified date in August 2023 (reported as "believes it was today"), the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, as prophylaxis (strength, dose, scheme, route and anatomical location of administration were not reported) instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (wrong vaccine administered, Product administered to patient of inappropriate age).  No additional event was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: ROTATEQ that experienced a temperature excursion and was administered.; No side effects reported; This spontaneous report was received from a healthcare professional referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) which experienced a temperature excursion and was administered orally for prophylaxis (lot# W0291190 with an expiration date on 28-JAN-2024) (strength, dose, and anatomical location were not provided).  The dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was exposed to a temperature excursion of 9.3 Celsius degrees (C°) during a time frame of 11 minutes (poduct storage error). There was prior temperature excursion of 18.8°C for 2 hours 55 minutes and 0 seconds.  No side effects reported.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: patient received a dose of Menveo reconstituted with sterile water; patient received a dose of Menveo reconstituted with sterile water; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 14-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA721A) for prophylaxis.   On 08-AUG-2023, the patient received Menveo. On 08-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: patient received a dose of Menveo reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: patient received a dose of Menveo reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 09-AUG-2023 A nurse reported that a patient received a dose of Menveo reconstituted with sterile water and wanted to know how to proceed. The patient received Menveo reconstituted with sterile water which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; Inbound call from nurse calling to report temperature excursion.  HCP states that MMR-II may have been administered to patient.  Confirmed that no symptomatic adverse events were reported.  Caller states that product may have been administered during; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-JUL-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, 0.5 milliliter, lot #W022640, expiration date: 15-APR-2024, administered as prophylaxis (strength, and route of administration were not provided). It was reported that the vaccine experienced a temperature excursion at a temperature of 49.26 Fahrenheit degrees during 3 hours and 45 minutes (Product storage error). No previous temperature excursions nor additional adverse events were reported.
Age: 25.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; after an expired dose of VARIVAX (expiration 24JUN2023) was administered to a patient on 02AUG2023. Pharmacist only provided patient initials. No PQC or additional AE reported.; This spontaneous report has been received from a medical assistant, concerning a 25-year-old male patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported. The patient received covid-19 vaccine.  On 02-AUG-2023, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, (lot number U019903 was verified to be valid, expiration date reported and confirmed as 24-JUN-2023), subcutaneous in left arm, administered as prophylaxis (exact dose, was not provided) (Expired product administered). No additional adverse event (AE) nor product quality complaint (PQC) were reported.
Age: 58.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: persistent rashes; This spontaneous report was received from a lawyer regarding a case in litigation and referred to an adult patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 20-SEP-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dose, route, lot number and expiration date were not provided). On an unspecified date (reported as subsequently), the patient experienced persistent rashes. On unspecified dates, the patient was treated by healthcare providers for the event. The outcome of the event was not reported. The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Pharmacist reported that a patient received a 3rd dose of shingrix on Aug10th 2023.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-AUG-2023, the patient received the 3rd dose of Shingrix. On 10-AUG-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Pharmacist reported that a patient received a 3rd dose of shingrix on Aug10th 2023.). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 10-AUG-2023 The patient received 3rd dose, which led to extra dose administered. The reporter consented to follow up.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Administration of an expired Twinrix dose to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number P9LT9, expiry date 01-JAN-2023) for prophylaxis.   On 09-AUG-2023, the patient received Twinrix. On 09-AUG-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Administration of an expired Twinrix dose to a patient). The outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt Date: 09-AUG-2023 The reporter wanted to know the guidance on this situation. The reporter did not provided patient information. The patient received a Twinrix which was already expired, which led to expired vaccine used. The reporter did consent to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: currently has shingles / Suspected vaccination failure; shingles; first Shingrix dose was 4 to 6 weeks prior to second dose; This serious case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (prior to receiving Shingrix).   On 09-AUG-2019, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid). On an unknown date, the patient received the 1st dose of Shingrix. On 09-AUG-2019, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: first Shingrix dose was 4 to 6 weeks prior to second dose). On an unknown date, the patient experienced vaccination failure (Verbatim: currently has shingles / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The patient was treated with famciclovir (Famvir). The outcome of the vaccination failure and drug dose administration interval too short were unknown and the outcome of the shingles was resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt date: 09-AUG-2023 The reporter was a patient and reported that he received 2 doses of Shingrix and currently had shingles and this was the first episode since vaccination. The reporter reported that his second dose was 4 to 6 weeks prior to that 1st dose but it was certain as he did not have his paperwork with him. The reporter reported that he was took an 8-day course of Famvir and shingles outbreak was improving. The reporter did not consent to follow up. This case was considered as suspected vaccination failure as detail regarding laboratory test was unknown at a time of reporting. The patient received the 2nd dose earlier than recommended interval, which led to lengthening of vaccination schedule.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only the liquid portion of Menveo was administered to a patient; only the liquid portion of Menveo was administered to a patient; 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 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA792A, expiry date 31-JAN-2024) for prophylaxis.   On 08-AUG-2023, the patient received Menveo. On 08-AUG-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: only the liquid portion of Menveo was administered to a patient) and inappropriate dose of vaccine administered (Verbatim: only the liquid portion of Menveo was administered to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-AUG-2023 The reporter was a medical assistant. The reporter called to report only the liquid portion of Menveo was administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: did not receive the full 0.5mL.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a female patient who received Herpes zoster (Shingrix) (batch number 259GZ, expiry date 15-MAY-2025) for prophylaxis.   On 08-AUG-2023, the patient received the 2nd dose of Shingrix. On 08-AUG-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: did not receive the full 0.5mL.). The outcome of the inappropriate dose of vaccine administered was unknown.   Additional Information: Receipt Date: 09-AUG-2023 The pharmacist reported that a patient moved away during administration of their second dose of Shingrix and did not receive the full 0.5mL, which led to inappropriate dose of vaccine administered. The reporter was unable to say how much of the product the patient received. The reporter did not wish to share the patient's initials and date of birth without speaking to her first. No additional information provided. The reporter consented to follow up.
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: 11 year old received 2 doses of Menveo.; 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 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA761A, expiry date 30-NOV-2023) for prophylaxis.   Previously administered products included Menveo (1st dose received on 02nd March 2023).   On 09-AUG-2023, the patient received the 2nd dose of Menveo. On 09-AUG-2023, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: 11 year old received 2 doses of Menveo.). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 09-AUG-2023 The medical assistant informed that earlier on the day of reporting  an 11 year old patient received a dose of Menveo, but such patient had already received one dose of Menveo back on 2nd March 2023 which led to extra dose administered. The reporter consented to follow up.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: patient was inadvertently administered a Bexsero dose instead of the intended Menveo dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received Men B NVS (Bexsero) (batch number 5P2P7, expiry date 31-JAN-2026) for prophylaxis.   On 09-AUG-2023, the patient received Bexsero (right arm). On 09-AUG-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: patient was inadvertently administered a Bexsero dose instead of the intended Menveo dose). The outcome of the wrong vaccine administered was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt date: 10-Aug-2023 The clinic infection assistant called to inquired that how to proceed. The reporter did not consent to follow-up. The patient was inadvertently administered a Bexsero dose instead of the intended Menveo dose, which led to wrong vaccine administered.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reported they have the diluent component of Menveo left and think that the Lyophilized component has been reconstituted with normal saline and administered to patient; reported they have the diluent component of Menveo left and think that the Lyophilized component has been reconstituted with normal saline and administered to patient; 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 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA955A, expiry date 31-JUL-2024) for prophylaxis.   On 04-AUG-2023, the patient received Menveo (right deltoid). On 04-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: reported they have the diluent component of Menveo left and think that the Lyophilized component has been reconstituted with normal saline and administered to patient) and inappropriate dose of vaccine administered (Verbatim: reported they have the diluent component of Menveo left and think that the Lyophilized component has been reconstituted with normal saline and administered to patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-AUG-2023 The reporter was medical assistant. The reporter called to inquire any guidance. No additional details were reported. The reporter did not consent to follow-up. The reporter reported that they had the diluent component of Menveo left and thought that the lyophilized component had been reconstituted with normal saline and administered to patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was 1 of 2 cases, reported by the same reporter.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Inappropriate Reconstitution Technique; Inappropriate Reconstitution Technique; 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 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA955A, expiry date 31-JUL-2024) for prophylaxis.   On 04-AUG-2023, the patient received Menveo (right deltoid). On 04-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Inappropriate Reconstitution Technique) and inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-AUG-2023 The reporter was medical assistant. The reporter called to inquire any guidance. No additional details were reported. The reporter did not consent to follow-up. The reporter reported that they had the diluent component of Menveo left and thought that the lyophilized component had been reconstituted with normal saline and administered to patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023109475:2nd patient
Age: 58.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Maladministration Engerix-B after expiration date; 4th hep b on patient' s schedule; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 58-year-old male patient who received HBV (Engerix B adult) (batch number AC397, expiry date 08-AUG-2023) for prophylaxis.   On 11-AUG-2023, the patient received the 4th dose of Engerix B adult. On 11-AUG-2023, an unknown time after receiving Engerix B adult, the patient experienced expired vaccine used (Verbatim: Maladministration Engerix-B after expiration date) and extra dose administered (Verbatim: 4th hep b on patient' s schedule). The outcome of the expired vaccine used and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 11-AUG-2023 The pharmacist reported that a patient received a dose of Engerix-B adult on 11th August 2023 which was expired on 8th August 2023, which led to expired vaccine used. The patient received Engerix B adult as 4th hepatitis b dose on patient' s schedule, which led to extra dose administered. The reporter consented to follow up.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect dose administered
Clinical narrative: the patient grabbed the syringe and caused an incomplete dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 11-AUG-2023, the patient received Kinrix. On 11-AUG-2023, an unknown time after receiving Kinrix, the patient experienced incomplete dose administered (Verbatim: the patient grabbed the syringe and caused an incomplete dose). The outcome of the incomplete dose administered was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt date: 11-Aug-2023 The pharmacist stated that when a patient was administering Kinrix, the patient grabbed the syringe, which led to incomplete dose administered.  The reporter did not consent to follow-up, and had no additional information.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: she received her first Shingrix vaccination a little more than a year ago and states she did get her second vaccination, as she was unaware she needed another vaccination to complete the series; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received her first Shingrix vaccination a little more than a year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: she received her first Shingrix vaccination a little more than a year ago and states she did get her second vaccination, as she was unaware she needed another vaccination to complete the series). The outcome of the incomplete course of vaccination was unknown.   Additional Information: Receipt Date: 11-AUG-2023 The reporter stated that she did get her second Shingrix vaccination, as she was unaware and she needed another vaccination to complete the series. The minimal information obtained to file adverse event. The consent was not asked. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose was not administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose was not administered). The outcome of the incomplete course of vaccination was unknown.   Additional Information: Receipt Date: 11-AUG-2023 The 2nd dose of Shingrix was not administered yet. The Vaccine Administration Facility was the same as primary reporter. The reporter did not consent to follow-up. Till the time of reporting , the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: Menveo and Boostrix administered not on the deltoid muscle and SC instead of IM.; This non-serious case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Menveo (subcutaneous, unknown deltoid) and Boostrix (subcutaneous, unknown deltoid). On an unknown date, an unknown time after receiving Menveo and Boostrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Menveo and Boostrix administered not on the deltoid muscle and SC instead of IM.). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK receipt date: 11-AUG-2023 Regular Nurse (RN) was looking information to share with the physician about Menveo and Boostrix administered not on the deltoid muscle and subcutaneously instead of Intramuscular. Health care professional (HCP) mentioned that there was a patient involved but there was no data available that she could provided to GSK and Manager of Quality Department of Health was doing a report and a follow up on this case. The patient received Boostrix and Menveo via subcutaneously instead of intramuscularly, which led to Intramuscular formulation administered by other route. The reporter did not consent to follow up.
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: This vaccine was used after BUD.  Parent did not report any adverse reaction after receiving this vaccine.
Age: 18.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 21.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: This vaccine was given after BUD. Parent did not report any adverse  reaction after receiving this vaccine.