chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: YF
Symptoms: Muscular weakness
Clinical narrative: Acute muscular skeletal weakness in left hip, left knee, left thigh, left calf, left ankle. No particular symptoms on right side, or left upper body, nor thoracic bits
Age: 73.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Patient is describing a sore arm/shoulder 6 months after injection.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Blood test abnormal, Computerised tomogram abnormal, Cough, Fatigue
Clinical narrative: After the last injection on 1.10.2022, within 5 months I started feeling symptoms of fatigue, cough, puffy eyes, high blood pressure, heart palpitations and just not feeling right.  I went to my PCP and she recommended an endocrinologist due to symptoms and exam.  Bloodwork was completed and my T3/T4 numbers were HIGH resulting in Graves disease.  Following this outcome within 9 months I developed multiple lumps throughout my body on the surface and inside.  After months of testing, (bloodwork, CT Scan, MRI, US, biopsies, etc) I was diagnosed with Sarcoidosis, an inflammatory disease that effects the entire body.  I am now high risk for lymphoma, along with an auto immune disease, interstitial lung disease, and inflammatory disease, I am seeing my next doctor to determine if Rheumatoid Arthritis is now part of my list of diseases that I will have the rest of my life.  Interesting concept, I was healthy and doing just fine before the COVID vaccine, none of these disease with the exception of Graves disease, runs in my family nor have ever had any complications.  I have  never heard of Sarcoidosis until this happened and upon doing the research, I am not even a close candidate to get it, yet somehow I did.  (Sarcoidosis typically is prominent in other cultures between the ages of 20-40)
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Graves' disease, Hypertension, Laboratory test abnormal, Magnetic resonance imaging head abnormal
Clinical narrative: After the last injection on 1.10.2022, within 5 months I started feeling symptoms of fatigue, cough, puffy eyes, high blood pressure, heart palpitations and just not feeling right.  I went to my PCP and she recommended an endocrinologist due to symptoms and exam.  Bloodwork was completed and my T3/T4 numbers were HIGH resulting in Graves disease.  Following this outcome within 9 months I developed multiple lumps throughout my body on the surface and inside.  After months of testing, (bloodwork, CT Scan, MRI, US, biopsies, etc) I was diagnosed with Sarcoidosis, an inflammatory disease that effects the entire body.  I am now high risk for lymphoma, along with an auto immune disease, interstitial lung disease, and inflammatory disease, I am seeing my next doctor to determine if Rheumatoid Arthritis is now part of my list of diseases that I will have the rest of my life.  Interesting concept, I was healthy and doing just fine before the COVID vaccine, none of these disease with the exception of Graves disease, runs in my family nor have ever had any complications.  I have  never heard of Sarcoidosis until this happened and upon doing the research, I am not even a close candidate to get it, yet somehow I did.  (Sarcoidosis typically is prominent in other cultures between the ages of 20-40)
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mass, Palpitations, Periorbital swelling, Sarcoidosis, Thyroxine increased
Clinical narrative: After the last injection on 1.10.2022, within 5 months I started feeling symptoms of fatigue, cough, puffy eyes, high blood pressure, heart palpitations and just not feeling right.  I went to my PCP and she recommended an endocrinologist due to symptoms and exam.  Bloodwork was completed and my T3/T4 numbers were HIGH resulting in Graves disease.  Following this outcome within 9 months I developed multiple lumps throughout my body on the surface and inside.  After months of testing, (bloodwork, CT Scan, MRI, US, biopsies, etc) I was diagnosed with Sarcoidosis, an inflammatory disease that effects the entire body.  I am now high risk for lymphoma, along with an auto immune disease, interstitial lung disease, and inflammatory disease, I am seeing my next doctor to determine if Rheumatoid Arthritis is now part of my list of diseases that I will have the rest of my life.  Interesting concept, I was healthy and doing just fine before the COVID vaccine, none of these disease with the exception of Graves disease, runs in my family nor have ever had any complications.  I have  never heard of Sarcoidosis until this happened and upon doing the research, I am not even a close candidate to get it, yet somehow I did.  (Sarcoidosis typically is prominent in other cultures between the ages of 20-40)
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tri-iodothyronine increased, Ultrasound scan abnormal
Clinical narrative: After the last injection on 1.10.2022, within 5 months I started feeling symptoms of fatigue, cough, puffy eyes, high blood pressure, heart palpitations and just not feeling right.  I went to my PCP and she recommended an endocrinologist due to symptoms and exam.  Bloodwork was completed and my T3/T4 numbers were HIGH resulting in Graves disease.  Following this outcome within 9 months I developed multiple lumps throughout my body on the surface and inside.  After months of testing, (bloodwork, CT Scan, MRI, US, biopsies, etc) I was diagnosed with Sarcoidosis, an inflammatory disease that effects the entire body.  I am now high risk for lymphoma, along with an auto immune disease, interstitial lung disease, and inflammatory disease, I am seeing my next doctor to determine if Rheumatoid Arthritis is now part of my list of diseases that I will have the rest of my life.  Interesting concept, I was healthy and doing just fine before the COVID vaccine, none of these disease with the exception of Graves disease, runs in my family nor have ever had any complications.  I have  never heard of Sarcoidosis until this happened and upon doing the research, I am not even a close candidate to get it, yet somehow I did.  (Sarcoidosis typically is prominent in other cultures between the ages of 20-40)
Age: 22.0
Sex: F
Vaccine: HPV9, MENB, TDAP
Symptoms: Dizziness, Dyskinesia, Syncope
Clinical narrative: After the administration of the three vaccines, the patient had a syncope. He became dizzy and began to have involuntary movements. About a minute later he opened his eyes and looked at us and fainted again. We put alcohol on napkins and put him in to inhale. When he recovered, he began to talk to us and apologize. He said that had never happened to him. At 338 we took the pressure and it came out in 91/73 pulse 74. We stayed with her for a while longer, she called her mom to come and pick her up
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Mobility decreased
Clinical narrative: Inability to raise arm .
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swollen left upper arm, warm to the touch,
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Eye inflammation, Hypersensitivity
Clinical narrative: My eyes have been inflamed. Doctor thinks it?s likely more allergic reaction.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood electrolytes normal, Computerised tomogram normal, Electrocardiogram normal, Electroencephalogram normal, Seizure
Clinical narrative: First time seizure the day of the vaccinations followed by two more seizures  one on 4/25/24 and 4/28/24.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Nausea
Clinical narrative: Donor called center reporting symptoms of nausea and dizziness that started the morning of 04/28/2024. She believed symptoms were due to Tdap vaccine that was administered on 04/27/2024 at 1022. Donor reports symptoms have not progressed or become better.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Pyrexia, Rash erythematous
Clinical narrative: Patient c/o fever x 48 hours and developed a red, warm rash underneath the injection site.  She went to her doctor, who prescribed Cephalexin 500mg bid x 7 days/
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: After about 1 and 1/2 days after receiving the Arexvy, the patient had AFib. His resting heart rate was 100 to 110. The patient has AFib  normally and takes Multaq to help for the AFib. Pt said if he has episodes the md said to take 2 tablets at one time and this usually decreases the AFib. However, the patient tried to take 2 tablets of Multaq on 5 separate occasions over a 5-6 day period and this did not decrease the AFib. He spoke to his cardiologist twice who had said to take the 2 tabs of Multaq also. After 6 days the AFib subsided on its own. The patient was fine after that and is fine now. He did not have to see the cardiologist or go to the hospital.
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered on 4/26/24, product expired 4/16/24
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered on 4/26/24,  product expired 4/16/24
Age: 68.0
Sex: F
Vaccine: PNC20, RSV, VARZOS
Symptoms: Erythema
Clinical narrative: erythema, no treatment, no itching, soreness, anyphylaxis or shortness of breath. counseled patient to ice and take benadryl if burdensome and to reach out to PCP if s/sx worsen
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Eye pain, Headache, Hypersomnia, Muscular weakness
Clinical narrative: Nausea and vomiting, weakness in the knees, shaking, crying, eye pain, headache, slept for 15 hours
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tremor, Vomiting
Clinical narrative: Nausea and vomiting, weakness in the knees, shaking, crying, eye pain, headache, slept for 15 hours
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: swelling, redness and bruising at injection sight.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Influenza like illness, Injection site pain, Malaise, Pain
Clinical narrative: Extreme arm soreness at injection site with throbbing pain persistent one week after injection.  Flu like symptoms for 4 days following injection.  General malaise since injection
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptomatic events were reported.; HBP reports that a patient was inadvertently administered a dose of VARIVAX after a Temperature Excursion.; This spontaneous report was received from health business professional (HBP) and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-APR-2024, the patient was inadvertently vaccinated a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, after a temperature excursion, 0.5ml/ series, lot #X012267, expiration date: 30-APR-2025 (conflicting information, expiry date also reported as 10-APR-2024), administered for prophylaxis (strength, dose number and route of administration were not provided)). The vaccine was involved in a TE of 7.3 F, during a time frame of 0 hours 0 minutes 9 seconds (Product storage error). Previous temperature excursion was reported as not applicable. No symptomatic events were reported. No further information provided. Operation of device was reported as health professional. No additional adverse event (AE) and no product quality complaint (PQC) were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; experienced a TE was administered to one patient on 04/22/2024.; This spontaneous report was received from medical assistant referring to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 22-APR-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1957405, expiration date: 11-NOV-2025, administered for prophylaxis (strength, dose and route of administration were not provided). The vaccine was exposed to temperature excursion (Product storage error). No additional adverse event.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: sore and swollen injected arm; sore and swollen injected arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included swelling arm (received a pneumonia shot that the injected arm was sore and swollen for one day) and pain in arm (received a pneumonia shot that the injected arm was sore and swollen for one day). Previously administered products included Influenza vaccine with an associated reaction of pain in extremity (received a flu shot that the injected arm was sore and swollen for one day). Concurrent medical conditions included cancer (cancer survivor) and lymphedema (lymphedema (swelling in legs)).   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 swelling arm (Verbatim: sore and swollen injected arm) and pain in arm (Verbatim: sore and swollen injected arm). The outcome of the swelling arm and pain in arm were resolved (duration 1 day).   The reporter considered the swelling arm and pain in arm to be related to Shingrix.     The company considered the swelling arm and pain in arm to be related to Shingrix.   Linked case(s) involving the same patient:  US2024050055   Additional Information: GSK Receipt Date: 18-APR-2024 The reporter was a patient. The patient had flu shot in past and experienced the injected arm was sore and swollen for one day. The patient received the Shingrix vaccine and experienced the injected arm was sore and swollen for one day. The reporter did not consent to follow-up. The case had been linked with the case US2024050055, reported by same reporter.; Sender's Comments:  US-GSK-US2024050055:Same patient/Dose 2
Sex: U
Vaccine: HEP, HEP, HEP, HEP, HEP, HEP, HEP
Symptoms: Extra dose administered, Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: has been deemed a nonresponder after several doses of ENGERIX-B; never came back for 3rd dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis, HBV (Engerix B) for prophylaxis, HBV (Engerix B) for prophylaxis, HBV (Engerix B) for prophylaxis, HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (On an unknown date in 2023, received first dose.) and Engerix B (On an unknown date in 2023, received second dose.).   On an unknown date, the patient received the 3rd dose of Engerix B, the 2nd dose of Engerix B, the 1st dose of Engerix B, the 3rd dose of Engerix B, the 2nd dose of Engerix B, the 1st dose of Engerix B and did not receive the 3rd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, Engerix B, Engerix B, Engerix B, Engerix B and Engerix B and not applicable after receiving Engerix B, the patient experienced therapy non-responder (Verbatim: has been deemed a nonresponder after several doses of ENGERIX-B) and incomplete course of vaccination (Verbatim: never came back for 3rd dose). The outcome of the therapy non-responder and incomplete course of vaccination were unknown.   Additional Information: GSK Receipt Date: 15-APR-2024 Nurse practitioner stated that the patient had been deemed a non-responder after several doses of Engerix-B. Patient received the first series in 1995 when they were 28- to 29-year-old. There was no titer information in records. Another round of 3 doses of Engerix B was administered in 2012 and patient got titers a year later and they came back negative, which led to therapy non-responder. Reporter reported that in 2023, patient received 2 more doses of Engerix B, never came back for 3rd  dose and did not get titers. The reporter consented to follow-up. Till the time of reporting patient did not received the 3rd dose of Engerix-B in 2023, which led to incomplete course of vaccination.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis.   Previously administered products included Tdap (received the Tdap shots on an Unknown date).   On an unknown date, the patient received dTpa vaccine. On an unknown date, an unknown time after receiving dTpa vaccine, the patient experienced vaccine exposure during pregnancy (Verbatim: Vaccine exposure during pregnancy). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Gestation time at first exposure (dTpa vaccine): 38 Weeks Pregnancy Exposure (dTpa vaccine): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   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: 16-APR-2024 The pharmacist reported that she herself was the patient. She was currently 38 weeks pregnant and got an a tetanus shot from her obstetrician-gynecologist. She was not sure if it was brand name Boostrix but she was assuming that she got Boostrix not Adacel since Boostrix had FDA approval for use during the third trimester. This case has been linked to the case US2024048905 reported by the same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2024048905:Same reporter diffrent patient
Age: 66.0
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Menveo was inadvertently administered to an adult patient older than the approved age; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 66-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number L7373, expiry date 30-NOV-2024) for prophylaxis.   On 13-APR-2024, the patient received Menveo. On 13-APR-2024, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Menveo was inadvertently administered to an adult patient older than the approved age). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 16-APR-2024 The pharmacist reported that the Menveo was inadvertently administered to an adult patient older than the approved age, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had a Shingles outbreak around 6 months ago; received first dose of Shingrix around 2020 and second dose on January 2024; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In JAN-2024, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. In JAN-2024, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received first dose of Shingrix around 2020 and second dose on January 2024). On an unknown date, the patient experienced shingles (Verbatim: had a Shingles outbreak around 6 months ago). The outcome of the shingles and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-APR-2024 The patient self-reported this case. The patient had a Shingles outbreak around 6 months ago. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow-up.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: 5 year old kid received a kinrix vaccine that expired 3 days ago; 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 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   In APR-2024, the patient received Kinrix. In APR-2024, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: 5 year old kid received a kinrix vaccine that expired 3 days ago). 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: 17-APR-2024 The reporter wanted to know the information on a patient who received a kinrix vaccine that expired 3 days ago, which led to expired vaccine used.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This non-serious case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a 21-year-old male patient who received Men B NVS (Bexsero) (batch number G7KX2, expiry date 31-MAR-2024) for prophylaxis.   On 03-APR-2024, the patient received Bexsero. On 03-APR-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: expired dose administered). 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: 18-APR-2024 Licensed practical nurse (LPN) looking for potential side effects of administering expired Bexsero. The patient received a Bexsero vaccine which was already expired, which led to expired vaccine used. The reporter consented to follow up.
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: a patient was administered an expired dose of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received HBV (Engerix B) (batch number SM93R, expiry date 05-APR-2024) for prophylaxis.   On 17-APR-2024, the patient received the 3rd dose of Engerix B. On 17-APR-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: a patient was administered an expired dose of Engerix-B). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-APR-2024 Medical assistant reported that a patient was administered an expired dose of Engerix B, which led to expired vaccine used. This was her 3rd dose in the series. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Product storage error
Clinical narrative: vaccine fridge was set on coldest setting and the temperature was reading at -4C; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number ZF5C7, expiry date 13-OCT-2025) for prophylaxis.   On 15-APR-2024, the patient received Arexvy. On 15-APR-2024, an unknown time after receiving Arexvy, the patient experienced incorrect storage of drug (Verbatim: vaccine fridge was set on coldest setting and the temperature was reading at -4C). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 18-APR-2024 Clinical Operations Director stated she went to one of their clinical sites on 16th April 2024 and discovered that vaccine fridge was set on coldest setting and the temperature was reading at -4degree Celsius  She stated that the Medical Assistant at that facility had not documented a temperature recording since 05th April 2024, so she was unsure how long the temperature was out of range.  The Vaccine Administration Facility was the same as Primary Reporter There was a dose administered to patient, which led to incorrect storage of drug. At the time of reporting, the dose had not been repeated. The reporter consented to follow up. The case was 1 out of 3 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024050070:SAME REPORTER / DIFFERENT PATIENT US-GSK-US2024050063:SAME REPORTER / DIFFERENT PATIENT
Sex: F
Vaccine: MENB
Symptoms: Expired product administered, Stem cell transplant
Clinical narrative: she had a stem cell transplant; patient was administered Bexsero that was expired 3/31/2024; This serious case was reported by a nurse via call center representative and described the occurrence of stem cell transplant in a 72-year-old female patient who received Men B NVS (Bexsero) (batch number G7KX2, expiry date 31-MAR-2024) for prophylaxis.   In APR-2024, the patient received Bexsero. In APR-2024, an unknown time after receiving Bexsero, the patient experienced stem cell transplant (Verbatim: she had a stem cell transplant) (serious criteria clinically significant/intervention required) and expired vaccine used (Verbatim: patient was administered Bexsero that was expired 3/31/2024). The outcome of the stem cell transplant and expired vaccine used were unknown.   It was unknown if the reporter considered the stem cell transplant to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the stem cell transplant to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 18-APR-2024 Registered nurse called and wondering if there was information on patient who administered Bexsero that was expired, which led to expired vaccine used. Patient had stem cell transplant after and was advised a 2 month window for the replacement dose by her doctors. Reporter wanted to known if patient needs to repeat the expired dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 820 days ago prior to the reporting).   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: Inappropriate schedule of vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-Apr-2024 The reporter was a pharmacist calling from and reporting on a patient who received her first Shingrix vaccine 820 days ago at the pharmacy. The reporter attempted to warm transfer to GSK , but they were closed for lunch.  The reporter provided phone number and times of GSK.  The reporter will call for further guidance on the second dose of Shingrix.  No product information provided to caller. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Disturbance in attention, Ear pain, Headache, Tinnitus
Clinical narrative: CONSTANT RINGING FROM THE END OF LAST YEAR. PAIN AROUND THE BOTH EARS. HEADACHE. CAN'T FOCUS ON WORKING.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reporting temperature excursion. Dose administered to patient was considered "not supported" after temperature excursion evaluation.; This spontaneous report has been received from an office manager and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications was not provided.  On 15-MAY-2023, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, at a dose of 0.5 milliliter, as prophylaxis (route of administration and anatomical location were not provided) (lot number W018824 has been verified to be valid, expiration date 14-JUN-2024); which was considered "not supported" after temperature excursion evaluation. The timeframes were reported as follows: from -14 degree Celsius (C) to -10 C for 240 hours; and from -10 C up to 8 C (-6 C) for 48 hours (product storage error).   There was no previous temperature excursion reported. No additional adverse events.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination 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: Suspected vaccination 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 reported.   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: 22-APR-2024  The case was received from the patient via interactive digital media. The patient reported that it was horrible and he/she had a mild case after he/she got the shingles shot. 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.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received a third dose of Shingrix on 2//5/2024 by error; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 7th May 2018) and Shingrix (received 2nd dose on 4th August 2018).   On 05-FEB-2024, the patient received the 3rd dose of Shingrix. On 05-FEB-2024, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Patient received a third dose of Shingrix on 2//5/2024 by error). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 16-APR-2024 The reporter reported that a patient received a third dose of Shingrix by error, which led to extra dose administered. The reporter did not consent to follow-up. This case is linked with US2024048877, reported by the same reporter.; Sender's Comments:  US-GSK-US2024048877:SAME REPORTER
Age: 8.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no symptomatic adverse events were reported from administration of the PROQUAD; Inbound call from nurse calling to report TE for PROQUAD.  Caller states that they found a temperature excursion on their data logger that occurred on 26-JAN-2024.  Nurse states that one dose was administered to a patient on 25-MAR-2024.; This spontaneous report was received from a licensed practical nurse referring to an 8-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  The reporter stated that they found a temperature excursion for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin [rHA]) (PROQUAD) on their data logger that occurred on 26-JAN-2024. The temperature was 5.58F and time frame was 66 hours 30 minutes. No previous temperature excursion. On 25-MAR-2024, one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (0.5 ml / once [product quantity: 1], lot #X000792, expiration date: 07-JUL-2024, administered for prophylaxis [strength, and route of administration were not provided]) was administered to the patient (Product storage error). It was confirmed no symptomatic adverse events were reported from administration of the measles, mumps, rubella and varicella (oka-merck) avirus vaccine live (rHA) (PROQUAD) (No adverse event).
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; PROQUAD was administered after experiencing a temperature excursion; This spontaneous report has been received from a medical assistant and refers to a 1-year-old patient of unknown gender. Information about the patient's pertinent medical history, current conditions and previous drug reactions or allergies was not provided. Concomitant medications included sterile diluent.  On 17-APR-2024, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection, at a dose of 0.5 milliliter, as prophylaxis (lot number X023316 has been verified to be valid, expiration date 19-MAR-2025) (route of administration and anatomical location were not provided); which was administered after experiencing a temperature excursion at -14.4 degree Celsius (C) for 15 minutes (product storage error).  There was no previous temperature excursion. No additional adverse events.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reporting PEDVAX HIB was administered during supported TE; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-APR-2024, the patient was vaccinated during supported temperature excursion with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, single dose, valid lot # X017447 expiration date: 11-MAR-2026, administered for prophylaxis (strength, and route of administration were not provided) (product storage error). It was reported that temperature: 54.7 Fahrenheit (F), with time frame: 8 hours 0 minutes with no previous temperature excursion. No additional adverse event (AE) reported.
Age: 0.17
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient's family has not reported any adverse events since administration; dose of VAQTA was accidentally administered to a 2 month old male patient; This spontaneous report has been received from a medical assistant, referring to a 2-month-old male patient. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not reported.  On 22-APR-2024, the patient was accidentally vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) pre-filled syringe at a dose of 0.5 mL, administered intramuscularly in right thigh, lot# X025163, expiry date 12-MAY-2025, for prophylaxis (product administered to patient of inappropriate age). The patient's family had not reported any adverse events since administration (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Pharmacist reported a patient was administered a dose of VARIVAX on 4/3/2024 that had been involved in a temperature excursion.; This spontaneous report was received from Pharmacist and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-APR-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, valid lot #W032507, expiration date: 11-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided) that had been involved in a temperature excursion (product storage error).  Administered dose of vaccine was exposed to the temperature excursion of -8 degrees Celsius for 105 hours. Cumulative excursion time provided. Caller stated that the products were involved in multiple excursions starting sometime in March 2024, but her data logger did not break down the excursions any further (Product storage error). Caller stated that no patient symptoms have been reported, no additional adverse event reported (no adverse event).
Sex: F
Vaccine: HPV4
Symptoms: Seizure, Syncope
Clinical narrative: Vasovagal syncope; non epileptic seizures; This spontaneous report was received from Lawyer via a plaintiff fact sheet from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (MARRS 2403USA007440) and referred to an unknown age female patient. 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 received the dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).   On unknown dates, following the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the patient experienced Vasovagal syncope and non epileptic seizures. At the time of reporting, the outcome of the event Vasovagal syncope and non epileptic seizures was not known.   The causal relationship between Vasovagal syncope and non epileptic seizures and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown. Upon internal review, the events Vasovagal syncope and non epileptic seizures were determined to be medically significant.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2403USA007440:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no side effects or symptoms reported; a patient was administered VARIVAX today, 4/24/2024, that expired on 4/6/2024; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 24-APR-2024 (reported as "today"), the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (0.5mL/once, lot#: w011621, expiration date: 06-APR-2024; strength and route of administration were not reported) for prophylaxis together with sterile diluent (lot#: 1950647, expiration date: 06-JAN-2026) (expired product administered). No side effects or symptoms were reported (no adverse event).
Age: 65.0
Sex: U
Vaccine: PNC15
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects/symptoms reported; expired VAXNEUVANCE was administered inadvertently yesterday, 4/23/2024.; This spontaneous report has been received from a medical assistant, referring to a 65-year-old patient of unknown gender. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not reported.  On 23-APR-2024, the patient was inadvertently vaccinated with expired pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) (dose, route of administration, anatomical location, lot# and expiry date were not reported) for prophylaxis (expired product administered). No side effects/symptoms reported (no adverse event).  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination 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: Suspected vaccination 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: 15-APR-2024 The case was received from the patient via interactive digital media. The patient was reporter. The patient reported that vaccine has not worked. The reported that Patient suffered with shingles now. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination 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, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patient's who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   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: 22-APR-2024 This case was reported by a patient via interactive digital media. The reporter reported that he/she had the Shingles on his/her chest, back and back side of his/her arm, it lasted for 3 weeks and with an antibiotic it went away completely and there was no vaccine received by him or her. The patient stated that it hurt like heck just like Covid and no shot for that either. The reporter know multiple patients who got all the shot Covid shots forced on them and Shingle shot and still got it. So did not say these vaccines were work. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination 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, Vaccination failure
Clinical narrative: Suspected vaccination faliure; Shingles; This serious case was reported by a consumer and described the occurrence of vaccination failure in a specified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination faliure) (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 reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-APR-2024 The reporter stated that it's amazing how GlaxoSmithKline made a vaccination that did not cured anything.  Three of the reporter's friends (patients) all got shingles after taking Shingirx. Soon nobody would use GlaxoSmithKline vaccine. Shame on GlaxoSmithKline. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: patient developed shingles 4 weeks after receiving 1st dose of Shingrix; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAR-2024, the patient received the 1st dose of Shingrix. On 15-APR-2024, 4 weeks after receiving Shingrix, the patient experienced shingles (Verbatim: patient developed shingles 4 weeks after receiving 1st dose of Shingrix). The outcome of the shingles was not resolved.   The reporter considered the shingles to be related to Shingrix.     The company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-APR-2024 The patient developed shingles 4 weeks after receiving 1st dose of Shingrix. The reporter did not consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: Large hot red welt; This non-serious case was reported by a consumer and described the occurrence of welts in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-APR-2024, the patient received Shingrix. On 22-APR-2024, 2 days after receiving Shingrix, the patient experienced welts (Verbatim: Large hot red welt). The outcome of the welts was unknown.   It was unknown if the reporter considered the welts to be related to Shingrix.     It was unknown if the company considered the welts to be related to Shingrix.   Additional Information: GSK receipt date: 23-APR-2024 The patient experienced welts large hot red welt after receiving Shingrix vaccine.