chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Lung disorder, Treatment noncompliance
Clinical narrative: Narrative: Patient with a relevant PMH of COPD, tobacco use, obesity, and sleep apnea. Patient administered Moderna COVID vaccine on 02/11/21 and 03/11/21. On 08/31/2021 patient reported to PCP that he was "having lung issues" after his second vaccine and reported having several tests done at a Pulmonary clinic outside of the Facility. At that time he reported that "his Pulmonologist was concerned hat he might have an autoimmune disease". Upon review of his CPAP history on 09/21/21 patient reported to not using his CPAP due to "the COVID 19 vaccine triggering an autoimmune response and the bottom half of both lungs are black". Outside medical records report patient is a poor historian
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Immunisation reaction, Myocarditis
Clinical narrative: Pt received first COVID vaccine 1/27/21 and the second vaccine on 2/22/2021. Patient was admitted to hospital on 2/17/21 (discharged on 2/21/21) for NSTEMI and myocarditis. Patient has had numerous follow up with cardiology as outpatient. Deemed that myocarditis was temporally related to COVID vaccine.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: GUILLAIN-BARRE SYNDROME; This spontaneous report received from a patient concerned a 54 year old male with unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user and non smoker and other pre-existing medical conditions included: The patient does not have any allergies and no known drug allergies, no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 12-MAY-2021 into right arm for covid-19 prophylaxis. Age at time of vaccination 54 years old. No concomitant medications were reported.  It was reported on an around on 26-MAY-2021 or 27-MAY-2021, the patient ended up waking up paralyzed and was not able to walk or talk and could not use hands (no hands). The patient was able to press the emergency contact button on his phone, and they came and picked him up and took him to the hospital. On 01-JUN-2021, the patient underwent a spinal tap and he was diagnosed with Guillain-Barre syndrome. He just got out of rehab and cannot write. The patient was in rehab for 8 and half months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from guillain-barre syndrome. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20230111409- Guillain-barre syndrome. The event has a compatible/suggestive temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Balance disorder, Discomfort, Feeling abnormal
Clinical narrative: 15 MONTHS INTO THIS, SLEEP ON AVERAGE 16 HOURS A DAY; CONSTANT DISCOMFORT; FEEL LIKE BALANCE OR EQUILIBRIUM IS OFF/FEEL OFF (PUT A CANE IN VEHICLE AS TEMPORARY SUPPORT); CAN'T WORK; JOINT PAIN; FEEL LIKE RAN THE MARATHON, ZERO STAMINA; SEVERE GOLF BALL SIZE LUMP AT THE INJECTION SITE; WITHIN 2 WEEKS OF GETTING THE COVID SHOT, HAD BRAIN FOG; WITHIN 2 WEEKS OF GETTING THE COVID SHOT HAD FEELING OF AUNTS TINGLING AROUND ON THE BACK OF HEAD; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: back surgery (years ago), and concurrent conditions included: myocarditis (Years ago patient had myocarditis.), and prediabetic (The patient was prediabetic 2 years pre-vaccine.), and other pre-existing medical conditions included: Patient had been working since 16 and was living normal lifestyle with 6 hours of sleep before the vaccination. Patient had all kinds of shots in his lifetime before vaccination. Patient never had any same issues before the vaccination. The patient experienced little lump when treated with influenza vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A expiry: UNKNOWN) dose was not reported, administered on 25-OCT-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 2021, the patient experienced within 2 weeks of getting the covid shot, had brain fog, and within 2 weeks of getting the covid shot had feeling of aunts tingling around on the back of head. On 26-OCT-2021, the patient experienced severe golf ball size lump at the injection site. On an unspecified date, the patient experienced 15 months into this, sleep on average 16 hours a day, constant discomfort, feel like balance or equilibrium is off/feel off (put a cane in vehicle as temporary support), can't work, joint pain, and feel like ran the marathon, zero stamina. Laboratory data (dates unspecified) included: Laboratory test ruled out arthritis, and lupus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe golf ball size lump at the injection site, within 2 weeks of getting the covid shot, had brain fog, within 2 weeks of getting the covid shot had feeling of aunts tingling around on the back of head, 15 months into this, sleep on average 16 hours a day, feel like ran the marathon, zero stamina, joint pain, feel like balance or equilibrium is off/feel off (put a cane in vehicle as temporary support), can't work, and constant discomfort. This report was non-serious. This case, from the same reporter is linked to 20230116969.
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Impaired work ability, Injection site mass, Laboratory test, Paraesthesia
Clinical narrative: 15 MONTHS INTO THIS, SLEEP ON AVERAGE 16 HOURS A DAY; CONSTANT DISCOMFORT; FEEL LIKE BALANCE OR EQUILIBRIUM IS OFF/FEEL OFF (PUT A CANE IN VEHICLE AS TEMPORARY SUPPORT); CAN'T WORK; JOINT PAIN; FEEL LIKE RAN THE MARATHON, ZERO STAMINA; SEVERE GOLF BALL SIZE LUMP AT THE INJECTION SITE; WITHIN 2 WEEKS OF GETTING THE COVID SHOT, HAD BRAIN FOG; WITHIN 2 WEEKS OF GETTING THE COVID SHOT HAD FEELING OF AUNTS TINGLING AROUND ON THE BACK OF HEAD; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: back surgery (years ago), and concurrent conditions included: myocarditis (Years ago patient had myocarditis.), and prediabetic (The patient was prediabetic 2 years pre-vaccine.), and other pre-existing medical conditions included: Patient had been working since 16 and was living normal lifestyle with 6 hours of sleep before the vaccination. Patient had all kinds of shots in his lifetime before vaccination. Patient never had any same issues before the vaccination. The patient experienced little lump when treated with influenza vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A expiry: UNKNOWN) dose was not reported, administered on 25-OCT-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 2021, the patient experienced within 2 weeks of getting the covid shot, had brain fog, and within 2 weeks of getting the covid shot had feeling of aunts tingling around on the back of head. On 26-OCT-2021, the patient experienced severe golf ball size lump at the injection site. On an unspecified date, the patient experienced 15 months into this, sleep on average 16 hours a day, constant discomfort, feel like balance or equilibrium is off/feel off (put a cane in vehicle as temporary support), can't work, joint pain, and feel like ran the marathon, zero stamina. Laboratory data (dates unspecified) included: Laboratory test ruled out arthritis, and lupus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe golf ball size lump at the injection site, within 2 weeks of getting the covid shot, had brain fog, within 2 weeks of getting the covid shot had feeling of aunts tingling around on the back of head, 15 months into this, sleep on average 16 hours a day, feel like ran the marathon, zero stamina, joint pain, feel like balance or equilibrium is off/feel off (put a cane in vehicle as temporary support), can't work, and constant discomfort. This report was non-serious. This case, from the same reporter is linked to 20230116969.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site nerve damage, Joint range of motion decreased, Oedema peripheral, Pain in extremity
Clinical narrative: I was given two shots on this vaccination.  The bivalent moderna shot.  I got the covid part in the left arm and the flue shot in the right arm.  The person who administered the shots hit a nerve in the right arm.  I have had significant pain and inflammation and decreased range of motion in my arm since.  I don?t have insurance so I wasn?t able to get treatment until this past week.  I went to the clinic at a pharmacy and got steroid, ibuprofen, and they also prescribe an antibiotic but the pharmacist wouldn?t give it to me.  They got mad and said I didn?t need it.   Im a certified process technician and on the day this I vaccine injury occurred my husband was also vaccinated.  He got his two shots first and then I got mine.  The fourth shot was the one that caused the injury.  You shouldn?t be allowing them to give shots like that because the person got careless and went fast.  We should have gotten our shots by different people not in a row like that.  The  more repetitive you are with the shots, the more likelihood of an injury.  I know the lady didn?t mean to do it, but my arms jacked up and the pharmacy ain?t going to help me pay for the physical therapy I?m going to need.  I?m going to need another round of steroids and anti inflammatory medications and well as physical therapy because my arm is hinged and I am having trouble dressing and doing my hair.  I?m right handed.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Pt had hives. Vitals: 115/74, 82,16 Pt given benadryl PO @8:30pm.  Pt stable and released from the vaccination site.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Blood pressure measurement, Hypertension, Rash, Urticaria
Clinical narrative: on 9/22/22 my BP was normal at Dr. After the vaccine on 10/6/22, I had rash/hives at end of October. I dont know when the elevated BP started, but I hadnt felt right for some time and took my BP Dec 8, 2022. It was 182/121. Called my PCP and they checked me and doubled my dose of Valsartan and went back in 2 weeks. (12/22/2022) They doubled my dose again as it was still elevated and uncontrolled. Here we are another 2 weeks later and its still uncontrolled and elevated. Ended in ER 12/21/22 because my BP was 179/110 which is level 3 hypertension and apparently an emergency. Whats it gonna take for someone to take this serious as I am taking it???
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Blood pressure increased, Computerised tomogram head, Culture urine, Electrocardiogram, Hypertension
Clinical narrative: on 9/22/22 my BP was normal at Dr. After the vaccine on 10/6/22, I had rash/hives at end of October. I dont know when the elevated BP started, but I hadnt felt right for some time and took my BP Dec 8, 2022. It was 182/121. Called my PCP and they checked me and doubled my dose of Valsartan and went back in 2 weeks. (12/22/2022) They doubled my dose again as it was still elevated and uncontrolled. Here we are another 2 weeks later and its still uncontrolled and elevated. Ended in ER 12/21/22 because my BP was 179/110 which is level 3 hypertension and apparently an emergency. Whats it gonna take for someone to take this serious as I am taking it???
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Hypertensive emergency, Metabolic function test, Microscopy, Rash, Troponin
Clinical narrative: on 9/22/22 my BP was normal at Dr. After the vaccine on 10/6/22, I had rash/hives at end of October. I dont know when the elevated BP started, but I hadnt felt right for some time and took my BP Dec 8, 2022. It was 182/121. Called my PCP and they checked me and doubled my dose of Valsartan and went back in 2 weeks. (12/22/2022) They doubled my dose again as it was still elevated and uncontrolled. Here we are another 2 weeks later and its still uncontrolled and elevated. Ended in ER 12/21/22 because my BP was 179/110 which is level 3 hypertension and apparently an emergency. Whats it gonna take for someone to take this serious as I am taking it???
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Urine analysis, Urticaria
Clinical narrative: on 9/22/22 my BP was normal at Dr. After the vaccine on 10/6/22, I had rash/hives at end of October. I dont know when the elevated BP started, but I hadnt felt right for some time and took my BP Dec 8, 2022. It was 182/121. Called my PCP and they checked me and doubled my dose of Valsartan and went back in 2 weeks. (12/22/2022) They doubled my dose again as it was still elevated and uncontrolled. Here we are another 2 weeks later and its still uncontrolled and elevated. Ended in ER 12/21/22 because my BP was 179/110 which is level 3 hypertension and apparently an emergency. Whats it gonna take for someone to take this serious as I am taking it???
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 57-year-old male patient received BNT162b2 (PFIZER COVID-19 VACCINE), on 27Mar2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 17Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 13Jul2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Currently treating kidney stone" (ongoing), notes: Currently treating kidney stone and also enlarged prostate; "enlarged prostate" (ongoing), notes: Currently treating kidney stone and also enlarged prostate; "known allergies Sea food" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (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 vaccination failure, covid-19 and included treatment with PF-07321332, ritonavir (PAXLOVID).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 0.75
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; 9 Month Old Patient was administered GARDASIL 9 by Unknown Healthcare Professional on 12/30/2022; This spontaneous report has been received from a Healthcare Business Professional who was in charge of vaccine storage/stability, concerning a 9-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 30-DEC-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, lot number, expiration date, route of administration, and anatomical location were not provided) as prophylaxis (Product administered to patient of inappropriate age).  No additional adverse events (AEs) were reported. No further information was provided.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE details; 1 dose of VAQTA was inadvertently administered to a patient less than the recommended age; This spontaneous report was received from a nurse referring to an infant (could have been 6 weeks old, 7 months old, or 9 months old, but the reporter was not sure exactly which patient received the vaccine) patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On an unspecified date between 26-DEC-2022 and 30-DEC-2022, the patient was inadvertently vaccinated with 1 dose of hepatitis A vaccine, inactivated (VAQTA) injection (0.5 ml, lot#: W036135, expiration date: 13-MAY-2024; strength, route of administration, anatomical location were not reported) for prophylaxis. The patient was less than the recommended age (product administered to patient of inappropriate age). No additional adverse event details were reported (no adverse event).
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; RECOMBIVAX HB was administered after the expiry date; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 04-JAN-2023, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) pre-filled syringe, lot #U019135, expiration date: 22-NOV-2022 (strength, dose, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis (expired product administered). No adverse event was reported.
Age: 36.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: was intended to receive Gardasil however the HCP accidentally gave trumenba; no side effects at this time; This spontaneous report was received from a other health professional via other company Pfizer and refers to a 36-year-old female. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was intended to receive quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection ( dose, anatomical location, lot #, expiry date, and route of administration were not provided) for prophylaxis, however the healthcare professional (HCP) accidentally gave her meningococcal vaccine b rfhbpa/fhbpb (TRUMENBA), (dose, anatomical location, formulation, lot #, expiry date, and route of administration were not provided) (Wrong product administered). The HCP reported no side effects at this time from the patient (No adverse event).
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; HBP reported that VARIVAX was administered to a patient on 01/05/2023 after a temperature excursion; This spontaneous report has been received from  an office manager concerning to a 6-year-old patient of an unknown gender. The patient's medical history, previous drug reactions or allergies, concurrent conditions, and concomitant therapies were not provided.   On 05-JAN-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, vaccination scheme frequency, route of administration and anatomical location were not provided; lot number W017551 that was verified to be valid, expiration date reported and established as 01-JUN-2024) for prophylaxis (product storage error).  The administered vaccine underwent a temperature excursion of 6 degrees Fahrenheit (F) up to 14 degrees Fahrenheit (F) with a time frame reported as 0 hours and 0 seconds; and 14 degrees Fahrenheit (F) up to 46  degrees Fahrenheit (F) (34.3 F) with a time frame reported as 0 hours 40 minutes and 0 seconds.There was a previous temperature excursion reported.  No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; Caller reported that PNEUMOVAX 23(syringe) that underwent a temperature excursion was administered.    ?; This spontaneous report has been received from another reporter, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 05-JAN-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (valid lot number U027357 [expiration date 25-MAR-2023]) (dose, vaccination scheme, route of administration, and frequency were not provided) for prophylaxis, after a temperature excursion and timeframe below 2 degrees Celsius (C) (-40.0C) for 22 hours (h) 0 minutes (min) and 0 seconds (sec). No previous temperature excursion was reported.  No additional adverse events (AE) were reported.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Vaccination failure
Clinical narrative: Negative, Non-Immune (Hep B Surface Antibody Titer); Negative, Non-Immune (Hep B Surface Antibody Titer); Initial Report Received on 27-Dec-2022, 28-Dec-2022 and 29-Dec-2022 (confirmed immunological failure)  This is a spontaneous report received from an Advanced Nurse Practitioner (ANP) who reported that a 53-year-old male who received HEPLISAV-B for Hepatitis B immunization had a "negative, non-immune" titer after having received 2 doses of HEPLISAV-B.  There were no medications or additional medical history provided.   On 27-Sep-2022, dose 1 of HEPLISAV-B (Lot # 938793, expiration date 07-Oct-2023, NDC not provided), was administered intramuscularly in the left deltoid by work.  On 31-Oct-2022, dose 2 of HEPLISAV-B (Lot # 938794, expiration date 09-Oct-2023, NDC not provided), was administered intramuscularly in the left deltoid by work.  On 20-Dec-2022, 85 days after dose 1 and 51 days after dose 2 of HEPLISAV-B, a Hepatitis B surface antibody titer was drawn and the results were reported as "non-reactive."   No additional information was provided.   Company Comment: The company assessed the event as non-serious and confirmed immunological  failure based on the dosing interval, time to serological marker testing and antibody titer.; Sender's Comments: The company assessed the event as non-serious and confirmed immunological  failure based on the dosing interval, time to serological marker testing and antibody titer.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/Got vaccination but still got them; Still got them, it was mild probably; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be probably related to Shingles vaccine.     Additional Information: GSK receipt date: 8-Jan-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the vaccination but still got them (shingles).  It was mild probably because of the vaccination. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Temperature; Muscle aches; This case was reported by a consumer via call center representative and described the occurrence of fever 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, unknown after receiving Shingrix, the patient experienced fever and muscle pain. On an unknown date, the outcome of the fever and muscle pain were unknown.   It was unknown if the reporter considered the fever and muscle pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-JAN-2023 Reporter's Comment: The patient self-reported this case. The patient reported temperature and muscle aches with first dose of Shingrix. The patient stated that she was on her way to work and could not stay on the phone. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Scheme not completed on time; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 15th June 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-JAN-2023 Reporter's Comments: A medical assistant called to inform that a varicella vaccine was administered to a patient by accident instead of the Shingrix vaccine, also informed that due to this event the scheme of Shingrix was not completed on time. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Details were reported for non-gsk product.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2019, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 11th March 2019, received 1st dose with batch number 43Y5R, expiry date: 08th February 2024.). Concurrent medical conditions included bone marrow transplant (In April 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt date: 04-Jan-2023. Reporter's Comment: The patient got first dose of Shingrix in 2019 and had not had a second dose administered. The reporter did not consent to follow-up. Additional Supportive Information: Patient did not receive 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient was just give the adjuvant of the Menveo vaccine versus it being mixed with the antigen; patient was just give the adjuvant of the Menveo vaccine versus it being mixed with the antigen; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK Receipt Date: 04-JAN-2023 Reporter's Comments: The GSK representative reported an adverse event with limited information. The reporter stated that a healthcare professional (HCP) at one of her accounts reported that, a patient was just given the adjuvant of the Menveo vaccine versus it being mixed with the antigen.  The reporter had no further information concerning the event, patient or vaccine. The reporter consented to follow up. Additional Supportive Information: The patient received Menveo vaccine without antigen part, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: patient today inadvertently received an expired dose of Twinrix; This 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 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 4th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 04-JAN-2023 Reporter's Comments: The pharmacist reported that a patient today (on the day of reporting) inadvertently received an expired dose of Twinrix. No additional information was known.  The reporter did not consent to follow-up.   Additional Supportive Information: The patient received Twinrix beyond the expiration date, which led to expired vaccine used.
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received HAB (Twinrix) (batch number unknown, expiry date 2nd January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 4th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 5-Jan-2023 Reporter's comment: The healthcare professional stated that the Twinrix was administered to an employee 2 days after the expiration date. The reporter declined to provide the patient's date of birth and did not had the lot number. The reporter provided an expiration date but was not certain that it was correct. The reporter consented to follow-up via mail. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Age: 24.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 24-year-old female patient who received HAB (Twinrix) (batch number 4s3yy, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th January 2023, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 5th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 5-Jan-2023 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received a dose of Twinrix, which led to expired vaccine used.
Age: 63.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 63-year-old female patient who received HAV (Havrix) (batch number 2B8BA99, expiry date 16th December 2022) for prophylaxis.   On 4th January 2023, the patient received Havrix. On 4th January 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK receipt date: 05-JAN-2023 Reporters comment: The Nurse reported that Havrix expired dose administered on 4th January 2023 which expired 16th December 2022. The reporter consented to follow up. Batch number HCP provided did not come up upon searching given number.  The HCP declined to provide patient initials.  The HCP consents to safety team follow up. Additional supportive information: The Nurse reported that the patient received expired dose of Havrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antibody test negative, Therapy non-responder
Clinical narrative: Shingrix series completed, no antibodies; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 67-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 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   Additional Information: GSK receipt date: 05-JAN-2022 Reporters comment: The pharmacist reported that patient completed the shingrix series over the summer of 2022 had lab work done and it showed she did not had any Shingrix antibodies so the doctor wants to repeat the series. No further information was shared on the call and specialist did not note potential adverse event during the conversation, so permission to follow up was not requested. Specialist attempted to clarify what lab work was done, but the pharmacist said she did not have any additional information, only that the patient shared she had been told she did not have antibodies after completion of the Shingrix series Additional Supportive information: The patient completed the shingrix series, had lab work done and it showed she did not had any Shingrix antibodies which led to therapy non responder Note-As per narrative patient gender captured as female
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix-B administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number unknown, expiry date 25th December 2022) for prophylaxis.   On 5th January 2023, the patient received Engerix B. On 5th January 2023, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comment: The reporter did not want to provide any detail, so vaccine lot was not provided. The reporter did not consent to follow up. Additional Supportive Information: The patient was administered an expired dose of Engerix-B, which led to expired vaccine used.
Age: 44.0
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Fourth dose not received; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 22nd February 2013), Twinrix (2nd dose received on 1st March 2013) and Twinrix (3rd dose received on 27th March 2013).   On an unknown date, the patient did not receive the 4th dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 05-JAN-2023 Reporter's Comment: The nurse reported that a patient started Twinrix accelerated dosing in 2013 and did not receive the fourth dose.   The doses were given at a different facility and the reporter did not had the lot numbers or expiration dates. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 4th dose of Twinrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: A drop fall from the syringe, reconstitution technique; Volume administered 0.48ml; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate reconstitution technique in a 49-year-old female patient who received Herpes zoster (Shingrix) (batch number 943GS, expiry date 9th February 2024) for prophylaxis.   Concurrent medical conditions included immunosuppression.   On 5th January 2023, the patient received the 1st dose of Shingrix .48 ml. On 5th January 2023, unknown after receiving Shingrix, the patient experienced inappropriate reconstitution technique and incomplete dose administered. On an unknown date, the outcome of the inappropriate reconstitution technique and incomplete dose administered were unknown.   Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comment: The reporter stated that neither skin contact or product quality complaint (PQC) were reported by health care professional (HCP), HCP was referring to reconstitution technique for the drop fall. The reporter consented to follow up via email. Additional Supportive Information: The reporter reported a drop fall from the syringe of Shingrix and the total volume administered was 0.48ml, which led to inappropriate reconstitution technique and incomplete dose administered. Due to limited information, the events were captured conservatively (as reported).
Age: 38.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of Twinrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 38-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 6th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 06-JAN-2023 Reporter's Comments: The pharmacist reported that today (on the day of reporting), a patient received an expired dose of Twinrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email. Additional Supportive Information: The patient received Twinrix beyond the expiration date, which led to expired vaccine used.
Age: 46.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 46-year-old female patient who received HAB (Twinrix adult) (batch number 4f3yy, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th January 2023, the patient received Twinrix adult and Twinrix Pre-Filled Syringe Device. On 5th January 2023, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 06-JAN-2023 Reporter's Comments: The reporter consented to follow up. Additional Supportive Information:  The patient was accidentally administered an expired dose of Twinrix, which led to expired vaccine used.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-year-old male patient who received HAV (Havrix 720) (batch number 2JD3Y, expiry date 4th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th January 2023, the patient received Havrix 720 and Havrix Pre-Filled Syringe Device. On 5th January 2023, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 6-Jan-2023 Reporter's comment: The licensed practical nurse called to inquire any information if administered after expiration or the expiration date changed. The reporter did not consent to follow-up. Additional supportive information: The pediatric patient was inadvertently administered an expired Harvix dose one day before the reporting date, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 07Jan2020, 2nd never; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 7th January 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 6-Jan-2023 Reporter's comment: The patient never received the second dose. At the time of reporting, the reporter did not have the lot number/ expiration date information of the first dose available.  The reporter gave permission for follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The details were reported for the first dose.
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 72-year-old female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th January 2023, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 6th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 06-JAN-2023 Reporter's Comments: The patient received the first dose of Twinrix on 6th January 2023, yet the dose expired on 1st January 2023. The reporter consented to follow up. Additional Supportive Information: The patient received expired dose of Twinrix, which led to expired vaccine used.
Sex: U
Vaccine: FLUX
Symptoms: Bell's palsy, Facial paralysis, Illness
Clinical narrative: Bell's palsy, half face paralyzed; Got really sick; This case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant) and sickness. On an unknown date, the outcome of the bell's palsy and sickness were unknown.   The reporter considered the bell's palsy and sickness to be possibly related to Flu vaccine.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comment: The case was received from the patient's parent via interactive digital media. The patient got the flu shot one year and got really sick while half the face went paralyzed (Bell's palsy). The patient reported this as side effect from the flu shot.  The patient stated that it was funny though, so he/she never got another flu though. Additional Supportive Information: The follow-up could not be possible as no contact details were available.