chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Neuralgia
Clinical narrative: Patient is reporting that she started to experience nerve pain from elbow down starting two days after receiving Adacel vaccine.
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient at clinic with parents for Pfizer Bivalent booster vaccine.  Pfizer Bivalent Covid-19 vaccine was administered without being diluted.  Event also reported to Pfizer Manufacturer Safety Team and recommended not to give covid-19 vaccines for now. If patient reacting well may receive more doses within recommended schedule at discretion of pcp.  Recommended provider and parents to monitor patient and intervene accordingly.
Age: 1.58
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: No adverse event. Moderna monovalent vaccine given after 4/18/2023.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: I21.4 ACUTE NON ST ELEVATION MI 4/13/2023 NON-ST ELEVATION MYOCARDIAL INFARCTION
Age: 7.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient at clinic with parents for Covid-19 Bivalent booster. Pfizer Bivalent Covid-19 vaccine was administered without being diluted.  Event also reported to Pfizer Manufacturer Safety Team and recommended not to give covid-19 vaccines for now. If patient reacting well may receive more doses within recommended schedule at discretion of pcp.  Recommended provider and parents to monitor patient and intervene accordingly.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Interstitial lung disease, Respiratory failure
Clinical narrative: J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/3/2023 INTERSTITIAL LUNG DISEASE
Age: 0.67
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered, No adverse event
Clinical narrative: No adverse event. Moderna monovalent vaccine given after 4/18/2023.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Small intestinal obstruction
Clinical narrative: R09.02 HYPOXIA 3/27/2023 SMALL BOWEL OBSTRUCTION
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalized with covid; fully vaccinated with 3 boosters
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Congenital ureteropelvic junction obstruction, Hypoxia
Clinical narrative: HYPOXIA 4/12/2023 CONGENITAL URETEROPELVIC JUNCTION OBSTRUCTION
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalized with covid; fully vaccinated
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Epilepsy, Seizure
Clinical narrative: EPILEPSY, UNSPECIFIED 5/2/2023 SEIZURES, GENERALIZED, UNSPECIFIED TYPE
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Colonic abscess, Diverticulitis, Diverticulitis intestinal perforated, Neuropathy peripheral, Sepsis
Clinical narrative: G62.9 PERIPHERAL NEUROPATHY 4/17/2023 DIVERTICULITIS OF SIGMOID W PERFORATION G62.9 PERIPHERAL NEUROPATHY 4/17/2023 SEPSIS WO ACUTE ORGAN DYSFUNCTION G62.9 PERIPHERAL NEUROPATHY 4/17/2023 DIVERTICULAR ABSCESS
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fibula fracture, Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, MODERATE 5/3/2023 LEFT FIBULA UNSPECIFIED TYPE DISTAL PHYSEAL FX, INIT
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient received the Moderna Pink cap when they should have received the Moderna blue cap.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema
Clinical narrative: red circular rash at injection site, treatment is warm compress and massage
Age: 52.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Body temperature increased, Fatigue, Headache, Pain
Clinical narrative: The first shot I had no reaction to but the second gave me bad reactions including 99-102 temperatures, fatigue, body aches, headache, and joint pain.
Age: 35.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dizziness, Immediate post-injection reaction, Tinnitus
Clinical narrative: Patient immediately experienced light headedness and then afterwards ringing in the ears for 3-4 minutes
Age: 0.5
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous report has been received from a lawyer and physician, via a memo and medical records from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (2303USA000365), concerning a 6-month-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 26-APR-2008 and 31-OCT-2008, the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) (reported as HBV) (dose, route of vaccination, vaccination site, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration).On the same day (31-OCT-2008), the subject was also vaccinated with diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL).  The pt's vaccines also included diphtheria, tetanus, acellular pertussis, hepatitis b, polio (dTAP-HBV-POL) administered on 20-JUN-2008 and 29-AUG-2008; haemophilus influenzae b (HIB) vaccine administered 20-JUN-2008, 30-JAN-2009 and 06-AUG-2009; diphtheria, tetanus, pertussis (DTaP) vaccine administered on 29-APR-2009; measles, mumps, rubella (MMR) vaccine administered on 29-APR-2009 and 09-AUG-2012; hepatitis A vaccine (HAV) administered on 29-APR-2009 and 06-NOV-2009; pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) administered on 30-APR-2010; influenza (INF) vaccine administered on 17-OCT-2011, 22-SEP-2012, 21-DEC-2013 and 15-NOV-2014; diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX) administered on 09-AUG-2012; influenza vaccine inact split 4v (FLUARIX QUADRIVALENT) administered on 11-OCT-2015; influenza vaccine inact sag 3v (FLUVIRIN) administered on 11-NOV-2016; HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administered on 25-JUL-2017 and 25-JAN-2018; meningococcal vaccine a/c/y/w conj (crm197) (MENVEO) administered on 28-NOV-2017 and influenza vaccine inact split 4v (FLULAVAL QUADRIVALENT) administered on 27-OCT-2017 and 26-OCT-2018.  This is one of the three reports concerning the same patient.; Sender's Comments:  US-009507513-2303USA000365: US-009507513-2307USA001584:
Sex: F
Vaccine: HPV9
Symptoms: Injection site reaction, Seroma
Clinical narrative: called on behalf of a HCP who reported her daughter received her first GARDASIL 9 injection approximately 2 years ago and developed a seroma at the injection site.; This spontaneous report has been received from a registered nurse and refers to her daughter, a female patient of approximately 11 or 12 years. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On an unknown date in 2021 (reported as approximately 2 years ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, for prophylaxis (dose, strength, lot number, expiration date, vaccination scheme, route of administration was not provided).   On an unknown date, the patient developed a seroma at the injection site. The operator of the device was unknown by the reporter. The patient had not received the second dose due to wanting to know what the commonality and risk of reoccurrence was with side effects/adverse reactions. It was unknown by the reporter if the patient sought medical attention, if she received any treatment or if any laboratory diagnostics or studies were performed. The patient recovered from the event.   The causal relationship between the event with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: has healed herself 99% from  GARDASIL; This spontaneous report was received from unspecified reporter and refers to a female of an unknown age..  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection,  (strength, dose description, lot #, expiry date, route of administration, and indication were not provided).  On an unknown date, the patient has healed herself 99% from  GARDASIL. At the time of reporting, the patient was recovering from the event  The causal relationship between has healed herself 99% from  GARDASIL and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dementia, Hormone level abnormal, Insomnia, Sleep deficit
Clinical narrative: death; dementia; potentially years of sleep deprivation (Chronic Insomnia); activation of stress hormones; This spontaneous report was received from medical consultant and refers to a 27-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, , administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced dementia, the patient experienced potentially years of sleep deprivation (Chronic Insomnia), the patient experienced activation of stress hormones. At the time of reporting, the outcome of the events was not reported.  The reporter considered activation of stress hormones to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  The reporter considered potentially years of sleep deprivation (Chronic Insomnia) to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).   The causal relationship between other events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown.    Upon internal review, the event of dementia was determined to be medically significant.
Sex: F
Vaccine: HPV4
Symptoms: Allergy to vaccine, Blood pressure abnormal, Hypersensitivity, Loss of consciousness, Syncope
Clinical narrative: BP 50/32; lost conciousness; "fainting" was due to an acute allergy-related response to the yeast and/or other component(s)in the vaccine,; This spontaneous report was received from medical consultant and refers to a female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date in 2006, the patientwas vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in approximately 2006, the patient experienced life threatening blood pressure(BP) of 50/32 (unit not provided), lost conciousness- "fainting" was due to an acute allergy-related response to the yeast and/or other component(s)in the vaccine,. At the time of reporting, the outcome of the events was not known.  The reporter considered lost conciousness to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The reporter considered "fainting" was due to an acute allergy-related response to the yeast and/or other component(s)in the vaccine, to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  The causal relationship between BP 50/32 and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown.   Upon internal review, the event lost conciousness was determined to be medically significant. The reporter considered the event BP 50/32 to be Life Threatening.
Sex: F
Vaccine: HPV4
Symptoms: Coagulopathy, Thrombectomy, Thrombosis
Clinical narrative: Clotting, similar to Covid-19 Amyloid clots, have been found by a Surgeon, and surgically removed; This spontaneous report was received from  an unspecified reporter and refers to a female patient of unknown age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, , administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided). It was reported that on an unknown date the patient  experienced clotting, similar to Covid-19 Amyloid clots,it was found by a Surgeon, and surgically removed. At the time of reporting, the outcome of the event  was not known.   The causal relationship between blood clot and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown.   Upon internal review, the event of blood clot was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the vaccine but now have shingles/ SuspectedVaccination failure; Shingles; 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: Had the vaccine but now have shingles/ SuspectedVaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 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.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 06-JUL-2023 This case was reported by a consumer via interactive digital media.  The patient had the vaccine but now had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Pain in extremity, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; nerve feeling/pain; 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.   The patient's past medical history included shingles (had it in April).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and nerve pain (Verbatim: nerve feeling/pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and nerve pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and nerve pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and nerve pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-JUL-2023 The case was received from the patient interactive digital media. The patient was vaccinated and 3 months later he/she had on left leg on the back of it where he/she had the shingles. The patient stated that he/she still had not recovered all the nerve feeling on half of his/her foot and the pain was unbelievable. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 19 diseases that affected him just after turning 44 years old; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a adult 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 inappropriate age at vaccine administration (Verbatim: 19 diseases that affected him just after turning 44 years old). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 03-JUL-2023 The case was received from the patient's wife via interactive digital media. The reporter would say that you were right if she had not seen it happened herself, but she had faith in god of the infinite universe, and from his love he inspired her to treat herself with plants and meditation.  The reporter got out of a strong depression which had me dead whilst alive for years when neither medicine, nor churches, nor psychologists could get rid of it.  The reporter stated now look at the reaction my husband had to the vaccine for the virus? 19 diseases that affected him just after turning 44 years old, what a coincidence after being vaccinated, right?  The reporter stated that the physician only told him that he was predisposed to had them all later, let's say when he would turn 70 or later on, but they occurred earlier, thank God, reporter was an anti-vaxer? And with diabetes and asthma that she kept under control with the understanding that god gave her to be patient and investigate which plants can help me overcome the virus?  Without medication and another key was to exercise enough? And investigate the placebo effect when treating with plants, please? The follow-up could not be possible as no contact details were available. The patient received Shingrix at inappropriate age (under 44 years), which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: her arm was sore; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: her arm was sore). The outcome of the pain in arm was resolved (duration 3 days).   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-JUL-2023 The reporter did not consent to follow up.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient accidentally received the Dtap instead of the Tdap vaccine; 11 years old received infanrix; 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 DTPa (Infanrix) (batch number 9R2D7, expiry date 23-MAY-2025) for prophylaxis.   On 19-JUN-2023, the patient received Infanrix. On 19-JUN-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: patient accidentally received the Dtap instead of the Tdap vaccine) and inappropriate age at vaccine administration (Verbatim: 11 years old received infanrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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: 05-JUL-2023 A registered medical assistant called and reported that a patient accidentally received the Dtap instead of the Tdap vaccine which led to wrong vaccine administered. The reporter wished to know if any information was available. The provided information about vaccine, event and patient agreed to receive follow up. The vaccine administration facility is the same as primary reporter. 11 years old received Infanrix which led to inappropriate age at vaccine administered. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Incorrect route of product administration
Clinical narrative: Engerix-B: administered via wrong site/Engerix-B via dialysis site -portal vein instead of IM; Engerix-B via dialysis site -portal vein instead of IM; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate route of vaccination in a patient who received HBV (Engerix B) for prophylaxis.   On 06-JUL-2023, the patient received Engerix B. On 06-JUL-2023, an unknown time after receiving Engerix B, the patient experienced inappropriate route of vaccination (Verbatim: Engerix-B: administered via wrong site/Engerix-B via dialysis site -portal vein instead of IM) and intramuscular formulation administered by other route (Verbatim: Engerix-B via dialysis site -portal vein instead of IM). The outcome of the inappropriate route of vaccination and intramuscular formulation administered by other route were unknown.   Additional Information: GSK Receipt Date: 06-JUL-2023 The reporter consented to follow up. The reporter reported that a nurse administered Engerix-B via dialysis site -portal vein instead of IM, which led to inappropriate route of vaccination and intramuscular formulation administered by other route.
Age: 94.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Social problem
Clinical narrative: not receive her second dose of Shingrix due to fear of being exposed to COVID; shingles; post herpetic neuralgia (PHN); This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 94-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, unknown arm). On 06-JUL-2023, the patient received the 2nd dose of Shingrix. In JAN-2023, 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: shingles) and post herpetic neuralgia (Verbatim: post herpetic neuralgia (PHN)). On an unknown date, the patient experienced social problem (Verbatim: not receive her second dose of Shingrix due to fear of being exposed to COVID). The outcome of the shingles and post herpetic neuralgia were not resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the shingles and post herpetic neuralgia to be related to Shingrix.     It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingrix.   Additional Information: GSK receipt date: 07-JUL-2023 The reporter was the patient.  She received her first Shingrix dose in early 2020, about one month before the COVID pandemic started.  She did not receive her second dose of Shingrix within the recommended 2 to 6 months due to fear of being exposed to COVID in the pharmacy or physician's office. About 2 years after her first Shingrix dose, in January 2023, she developed shingles with post herpetic neuralgia. The PHN continued.  One day before reporting, patient received her second Shingrix dose.  Nothing else was reported. The reporter did not consent to follow-up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Rash, Symptom recurrence, Urticaria
Clinical narrative: she experienced heat, rash, and hives on the left arm at that time; she experienced heat, rash, and hives on the left arm at that time; she experienced heat, rash, and hives on the left arm at that time; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 95R52, expiry date 08-NOV-2020) for prophylaxis.   Concomitant products included clobetasol propionate (Clobetasol Propionate Cream).   On 09-NOV-2019, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced hives (Verbatim: she experienced heat, rash, and hives on the left arm at that time), rash (Verbatim: she experienced heat, rash, and hives on the left arm at that time) and feeling hot (Verbatim: she experienced heat, rash, and hives on the left arm at that time). Shingrix was discontinued. The outcome of the hives, rash and feeling hot were not resolved.   It was unknown if the reporter considered the hives, rash and feeling hot to be related to Shingrix.     It was unknown if the company considered the hives, rash and feeling hot to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-JUL-2023 The reporter stated that she experienced heat, rash, and hives on the left arm at that time, and then on 3rd July 2023, the symptoms reoccurred.  The reporter stated that during the call that she never received her second dose and did not intend on getting the second dose.  The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received 2 adjuvants components in her left arm without active component; received 2 adjuvants components in her left arm without active component; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-JUL-2023, the patient received Shingrix (left arm). On 07-JUL-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: received 2 adjuvants components in her left arm without active component) and inappropriate dose of vaccine administered (Verbatim: received 2 adjuvants components in her left arm without active component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 10-Jul-2023 According to the pharmacist, the patient was doing fine. No lot was provided. Transferred to medical information for further assistance. The reporter consented to follow-up. The patient received 2 adjuvants components in her left arm without active component, due to a inappropriate reconstitution technique, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first Shingrix dose on 10/29/2019 and a second dose on 2/6/2023.; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 29th October 2019).   On 06-FEB-2023, the patient received the 2nd dose of Shingrix. On 06-FEB-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first Shingrix dose on 10/29/2019 and a second dose on 2/6/2023.). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 10-JUL-2023 The reporter asked if the patient needed a third dose or if the patient had to restart the series of Shingrix.  The reporter did not provide lot number and expiry date of the 2 doses of Shingrix The reporter consented to follow up. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of shingrix in May 2022 and has not received a second shingrix dose since then; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in May 2022 in left arm).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first dose of shingrix in May 2022 and has not received a second shingrix dose since then). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-JUL-2023 The reporter had not received a second Shingrix dose yet. The reporter was unable to provide lot number or expiration date of the Shingrix dose she received. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: patient received a third dose 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 19-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA938A, expiry date 31-JUL-2024) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: patient received a third dose of Menveo). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 10-JUL-2023 The reporter consented to follow up.  The reporter reported that a patient received a third dose of Menveo, which led to extra dose administered.
Sex: M
Vaccine: DTAPHEPBIP, IPV
Symptoms: Accidental overdose
Clinical narrative: patient received 2 doses of IPV at the same time; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number NL35L, expiry date 04-APR-2025) for prophylaxis.   Co-suspect products included POLIO VACCINE (IPOL) for prophylaxis.   Previously administered products included IPOL (1st dose received on an unknown date) and IPOL (2nd dose received on an unknown date). Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (INFANRIX), HAEMOPHILUS B CONJUGATE VACCINE (MENINGOCOCCAL) (PEDVAXHIB) and HEPATITIS B VACCINE.   On 10-JUL-2023, the patient received Pediarix and IPOL. On 10-JUL-2023, an unknown time after receiving Pediarix and an unknown time after receiving INFANRIX, the patient experienced accidental overdose (Verbatim: patient received 2 doses of IPV at the same time). The outcome of the accidental overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-JUL-2023 The health care professional (HCP) called in to report the administration by mistake of Pediarix to a patient who received the same day Ipol, Infanrix, and PedvaxHib. The reporter mentioned that with Pediarix the patient received the 4th dose of HepB.  The patient received the 5th Dtap (Infanrix) and because of the maladministration of Pediarix, the patient received 2 doses of IPV at the same time. The HCP asked for potential adverse reaction following vaccination. During the call, permission to follow up was not requested. The patient received by mistake Pediarix and Ipol on the same day, which led to accidental overdose.
Sex: F
Vaccine: MENB
Symptoms: Interchange of vaccine products
Clinical narrative: Interchange of vaccine/it was noted the patient had actually started the MenB series with Trumenba; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 05-JUL-2023, the patient received Bexsero. On 07-JUN-2023, the patient received TRUMENBA. On 05-JUL-2023, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: Interchange of vaccine/it was noted the patient had actually started the MenB series with Trumenba). The outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-JUL-2023 The patient had requested Bexsero be given and it was not until after dose was administered that it was noted the patient had actually started the MenB series with Trumenba, given. The lot number requested on call but not available at time of call.  The reporter consented to follow up. The reporter reported that a patient was given a dose of Bexsero.  The patient received Trumenba after Bexsero , which led to interchange of vaccine products.
Age: 0.5
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Drug Used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old female patient who received HBV (Engerix B pediatric) (batch number lp724, expiry date 18-MAY-2023) for prophylaxis.   On 30-JUN-2023, the patient received Engerix B pediatric (intramuscular, rt. vastus lateralis) .5 ml. On 30-JUN-2023, an unknown time after receiving Engerix B pediatric, the patient experienced expired vaccine used (Verbatim: Expired Drug Used). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-JUL-2023 The reporter gave permission for GSK to contact her. The reporter consented to follow up. The patient received an expired Engerix-B, which led to expired vaccine used.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Lethargy, Malaise, Myalgia, Pain in extremity
Clinical narrative: Inappropriate schedule of vaccine; Lethargy; Sore arm (L); General feeling of unwellness; Muscle Aches; This non-serious case was reported by a consumer via call center representative and described the occurrence of lethargy in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2020).   On 07-JUL-2023, the patient received the 2nd dose of Shingrix (left arm). On 07-JUL-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine). In JUL-2023, the patient experienced lethargy (Verbatim: Lethargy), pain in arm (Verbatim: Sore arm (L)), feeling unwell (Verbatim: General feeling of unwellness) and muscle pain (Verbatim: Muscle Aches). The outcome of the lethargy, feeling unwell, muscle pain and drug dose administration interval too long were unknown and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the lethargy, pain in arm, feeling unwell and muscle pain to be related to Shingrix.  It was unknown if the company considered the lethargy, pain in arm, feeling unwell and muscle pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-JUL-2023 The reporter was the patient. The reporter gave consent to follow up with healthcare professional (pharmacy). The reporter did not consent to follow up. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Cannot find proof that she had her second Shingrix vaccination; 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 (1st dose received on 12th January 2019).   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: Cannot find proof that she had her second Shingrix vaccination). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-JUL-2023 The patient was self-reported this case. The patient reported that she can not find the proof that she had received second dose of Shingrix vaccine. The reporter stated that there was possible late dose for second vaccination. No further information was known. The reporter requested to consent the follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: inadvertently administered an expired Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 10-JUL-2023, the patient received Kinrix (right deltoid). On 10-JUL-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: inadvertently administered an expired Kinrix). 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: 11-JUL-2023 The reporter inquired if any information available and how to proceed. The reporter reported that they inadvertently administered an expired Kinrix in the right deltoid. The reporter did not consent to follow-up from safety. The patient received expired Kinrix, which led to expired vaccine used.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: was his 3rd Shingrix vaccination (extra dose); 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 70-year-old male patient who received Herpes zoster (Shingrix) (batch number y77xy, expiry date 21-AUG-2024) for prophylaxis.   On 11-JUL-2023, the patient received the 3rd dose of Shingrix (left deltoid). On 11-JUL-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: was his 3rd Shingrix vaccination (extra dose)). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 11-JUL-2023 The reporter stated that she administered a Shingrix vaccination to a patient, in his left deltoid. She noted that this was his 3rd Shingrix vaccination (extra dose) when documenting vaccination in patient's chart. The reporter consented to follow up. The patient received 3rd Shingrix vaccination (extra dose), which led to extra dose administered.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Patient complained of a sore injection site arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Patient complained of a sore injection site arm) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 022B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Patient complained of a sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Patient complained of a sore injection site arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-732147 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732147:same patient and different product
Age: 0.5
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose, Wrong product administered
Clinical narrative: No side effects; he received his initial Moderna bivalent dose today 7Jul2023 and his pediatrician gave him .2 ml from a the maroon cap vial; he received his initial Moderna bivalent dose today 7Jul2023 and his pediatrician gave him .2 ml from a the maroon cap vial; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (he received his initial Moderna bivalent dose today 7Jul2023 and his pediatrician gave him .2 ml from a the maroon cap vial), UNDERDOSE (he received his initial Moderna bivalent dose today 7Jul2023 and his pediatrician gave him .2 ml from a the maroon cap vial) and NO ADVERSE EVENT (No side effects) in a 6-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: PCV13 and DTap-HepB-IPV. Past adverse reactions to the above products included No adverse event with DTap-HepB-IPV and PCV13.    On 07-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .2 milliliter. On 07-Jul-2023, the patient experienced WRONG PRODUCT ADMINISTERED (he received his initial Moderna bivalent dose today 7Jul2023 and his pediatrician gave him .2 ml from a the maroon cap vial) and UNDERDOSE (he received his initial Moderna bivalent dose today 7Jul2023 and his pediatrician gave him .2 ml from a the maroon cap vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No side effects). At the time of the report, WRONG PRODUCT ADMINISTERED (he received his initial Moderna bivalent dose today 7Jul2023 and his pediatrician gave him .2 ml from a the maroon cap vial), UNDERDOSE (he received his initial Moderna bivalent dose today 7Jul2023 and his pediatrician gave him .2 ml from a the maroon cap vial) and NO ADVERSE EVENT (No side effects) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No side effects) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (he received his initial Moderna bivalent dose today 7Jul2023 and his pediatrician gave him .2 ml from a the maroon cap vial) and UNDERDOSE (he received his initial Moderna bivalent dose today 7Jul2023 and his pediatrician gave him .2 ml from a the maroon cap vial).    No concomitant medication was reported. No side effect was reported. No treatment medication was reported.
Age: 52.0
Sex: F
Vaccine: PNC20
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 52-year-old female patient (not pregnant) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 20Jun2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 20Jun2023, outcome "unknown".  Additional information: It was unknown if the patient received  any other vaccine within 4 weeks prior to the vaccine. It was unknown if the patient received  other medications in two weeks.    The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid-19 treatment; covid-19 treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (batch/lot number: unknown) for covid-19 immunization. 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 "covid-19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient stated, "I have a question if I reacted to your booster, is it safe to take this drug (Paxlovid) for COVID?" When paraphrased the concern, the patient stated, "That is right, and I am reacted a lot. That was to the booster not to the first two shot." The consumer stated, "No, I was calling Paxlovid already, I picked up Paxlovid, I am not calling Pfizer, I am calling for the Paxlovid. I did not call for the vaccine, I called for Paxlovid nothing about the vaccine. Is there is a safety issue?".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.