chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Full blood count, Metabolic function test, Palpitations, Troponin I
Clinical narrative: Follow up: Symptoms got extra more severe - even worse: the nausea and the dizziness - it was getting very bad. Nausea making it hard to eat. I lost a lot of weight. I weigh 95 lbs now - I think I was at 110 before. I called 9-1-1. The nausea was caused by the more severe symptoms of dizziness. I can feel like a beating in my ear. It happens in both but not at the same time - sometimes the right one and sometimes the left ear. I  have it every day but not all the time. I had an appt today with my regular doctor. Had been given Steroid - Prednisone - last week for five days and it didn't work. The doctor says I need to see a specialist. No new treatment. I am seeing  a cardiologist and have been referred ENT doctor and neurologist doctor. I get an episode of dizziness and nausea  and it goes away and  then I get it back - every day it comes back. When it happens it may go away for a couple of hours or so, but the next day I either wake up with it or I get it later (the severe dizziness). Once I get it, it usually last the whole day - I just don't know what time I'm going to get it. I've had three CT scans in the past and can't do anymore right this time.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dizziness, Headache, Palpitations, Syncope
Clinical narrative: Follow up: Symptoms got extra more severe - even worse: the nausea and the dizziness - it was getting very bad. Nausea making it hard to eat. I lost a lot of weight. I weigh 95 lbs now - I think I was at 110 before. I called 9-1-1. The nausea was caused by the more severe symptoms of dizziness. I can feel like a beating in my ear. It happens in both but not at the same time - sometimes the right one and sometimes the left ear. I  have it every day but not all the time. I had an appt today with my regular doctor. Had been given Steroid - Prednisone - last week for five days and it didn't work. The doctor says I need to see a specialist. No new treatment. I am seeing  a cardiologist and have been referred ENT doctor and neurologist doctor. I get an episode of dizziness and nausea  and it goes away and  then I get it back - every day it comes back. When it happens it may go away for a couple of hours or so, but the next day I either wake up with it or I get it later (the severe dizziness). Once I get it, it usually last the whole day - I just don't know what time I'm going to get it. I've had three CT scans in the past and can't do anymore right this time.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dizziness, Loss of consciousness, Palpitations, Syncope
Clinical narrative: Follow up: Symptoms got extra more severe - even worse: the nausea and the dizziness - it was getting very bad. Nausea making it hard to eat. I lost a lot of weight. I weigh 95 lbs now - I think I was at 110 before. I called 9-1-1. The nausea was caused by the more severe symptoms of dizziness. I can feel like a beating in my ear. It happens in both but not at the same time - sometimes the right one and sometimes the left ear. I  have it every day but not all the time. I had an appt today with my regular doctor. Had been given Steroid - Prednisone - last week for five days and it didn't work. The doctor says I need to see a specialist. No new treatment. I am seeing  a cardiologist and have been referred ENT doctor and neurologist doctor. I get an episode of dizziness and nausea  and it goes away and  then I get it back - every day it comes back. When it happens it may go away for a couple of hours or so, but the next day I either wake up with it or I get it later (the severe dizziness). Once I get it, it usually last the whole day - I just don't know what time I'm going to get it. I've had three CT scans in the past and can't do anymore right this time.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Dizziness, Ear discomfort, Nausea, Weight decreased
Clinical narrative: Follow up: Symptoms got extra more severe - even worse: the nausea and the dizziness - it was getting very bad. Nausea making it hard to eat. I lost a lot of weight. I weigh 95 lbs now - I think I was at 110 before. I called 9-1-1. The nausea was caused by the more severe symptoms of dizziness. I can feel like a beating in my ear. It happens in both but not at the same time - sometimes the right one and sometimes the left ear. I  have it every day but not all the time. I had an appt today with my regular doctor. Had been given Steroid - Prednisone - last week for five days and it didn't work. The doctor says I need to see a specialist. No new treatment. I am seeing  a cardiologist and have been referred ENT doctor and neurologist doctor. I get an episode of dizziness and nausea  and it goes away and  then I get it back - every day it comes back. When it happens it may go away for a couple of hours or so, but the next day I either wake up with it or I get it later (the severe dizziness). Once I get it, it usually last the whole day - I just don't know what time I'm going to get it. I've had three CT scans in the past and can't do anymore right this time.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Dizziness, Dry mouth, Dysarthria, Dyspnoea
Clinical narrative: After receiving the vaccine,  I was brought to an area for 30 min observation, Immediately, I was told I was complaining of numbness to my legs and I remember feeling very exhausted and my head felt very heavy.  Someone was talking to me and I couldn't understand them. I put my head on my aunts shoulder and was told I passed out.  I was brought to a secluded area which I do not recall.  I was told I was in and out of consciousness and kept saying I couldn't process what anyone was saying to me and I was having difficulty responding, I was having an issue with comprehension as well.  I was also told I had tremors and was asked if I had a history of Guillain Barre (which I don't) , Both my BP and HR was elevated. I was having difficulty catching my breath and the site called ED.  My mouth was very dry and I started vomiting.  I am unaware of the time from when the symptoms began until EMS arrived. In the ambulance I my lip started itching and I began to have hives on my arms, chest and face.  I was taken to  Hospital
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral, Lethargy, Nausea
Clinical narrative: After receiving the vaccine,  I was brought to an area for 30 min observation, Immediately, I was told I was complaining of numbness to my legs and I remember feeling very exhausted and my head felt very heavy.  Someone was talking to me and I couldn't understand them. I put my head on my aunts shoulder and was told I passed out.  I was brought to a secluded area which I do not recall.  I was told I was in and out of consciousness and kept saying I couldn't process what anyone was saying to me and I was having difficulty responding, I was having an issue with comprehension as well.  I was also told I had tremors and was asked if I had a history of Guillain Barre (which I don't) , Both my BP and HR was elevated. I was having difficulty catching my breath and the site called ED.  My mouth was very dry and I started vomiting.  I am unaware of the time from when the symptoms began until EMS arrived. In the ambulance I my lip started itching and I began to have hives on my arms, chest and face.  I was taken to  Hospital
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Tachycardia, Vomiting
Clinical narrative: After receiving the vaccine,  I was brought to an area for 30 min observation, Immediately, I was told I was complaining of numbness to my legs and I remember feeling very exhausted and my head felt very heavy.  Someone was talking to me and I couldn't understand them. I put my head on my aunts shoulder and was told I passed out.  I was brought to a secluded area which I do not recall.  I was told I was in and out of consciousness and kept saying I couldn't process what anyone was saying to me and I was having difficulty responding, I was having an issue with comprehension as well.  I was also told I had tremors and was asked if I had a history of Guillain Barre (which I don't) , Both my BP and HR was elevated. I was having difficulty catching my breath and the site called ED.  My mouth was very dry and I started vomiting.  I am unaware of the time from when the symptoms began until EMS arrived. In the ambulance I my lip started itching and I began to have hives on my arms, chest and face.  I was taken to  Hospital
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Blood pressure increased, Consciousness fluctuating, Dry mouth, Dyspnoea
Clinical narrative: After receiving the vaccine,  I was brought to an area for 30 min observation, Immediately, I was told I was complaining of numbness to my legs and I remember feeling very exhausted and my head felt very heavy.  Someone was talking to me and I couldn't understand them. I put my head on my aunts shoulder and was told I passed out.  I was brought to a secluded area which I do not recall.  I was told I was in and out of consciousness and kept saying I couldn't process what anyone was saying to me and I was having difficulty responding, I was having an issue with comprehension as well.  I was also told I had tremors and was asked if I had a history of Guillain Barre (which I don't) , Both my BP and HR was elevated. I was having difficulty catching my breath and the site called ED.  My mouth was very dry and I started vomiting.  I am unaware of the time from when the symptoms began until EMS arrived. In the ambulance I my lip started itching and I began to have hives on my arms, chest and face.  I was taken to  Hospital
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Head discomfort, Heart rate increased, Hypoaesthesia, Language disorder
Clinical narrative: After receiving the vaccine,  I was brought to an area for 30 min observation, Immediately, I was told I was complaining of numbness to my legs and I remember feeling very exhausted and my head felt very heavy.  Someone was talking to me and I couldn't understand them. I put my head on my aunts shoulder and was told I passed out.  I was brought to a secluded area which I do not recall.  I was told I was in and out of consciousness and kept saying I couldn't process what anyone was saying to me and I was having difficulty responding, I was having an issue with comprehension as well.  I was also told I had tremors and was asked if I had a history of Guillain Barre (which I don't) , Both my BP and HR was elevated. I was having difficulty catching my breath and the site called ED.  My mouth was very dry and I started vomiting.  I am unaware of the time from when the symptoms began until EMS arrived. In the ambulance I my lip started itching and I began to have hives on my arms, chest and face.  I was taken to  Hospital
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip pruritus, Loss of consciousness, Tremor, Urticaria, Vomiting
Clinical narrative: After receiving the vaccine,  I was brought to an area for 30 min observation, Immediately, I was told I was complaining of numbness to my legs and I remember feeling very exhausted and my head felt very heavy.  Someone was talking to me and I couldn't understand them. I put my head on my aunts shoulder and was told I passed out.  I was brought to a secluded area which I do not recall.  I was told I was in and out of consciousness and kept saying I couldn't process what anyone was saying to me and I was having difficulty responding, I was having an issue with comprehension as well.  I was also told I had tremors and was asked if I had a history of Guillain Barre (which I don't) , Both my BP and HR was elevated. I was having difficulty catching my breath and the site called ED.  My mouth was very dry and I started vomiting.  I am unaware of the time from when the symptoms began until EMS arrived. In the ambulance I my lip started itching and I began to have hives on my arms, chest and face.  I was taken to  Hospital
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: Fully vaccinated with breakthrough infection 10/10/21.   Inpatient admit, medical unit
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Cardioversion, Chest X-ray, Electrocardiogram
Clinical narrative: 86 Years  Female with history of multiple medical problems including cardiomyopathy chronic obstructive pulmonary disease chronic kidney disease depression heart failure non-Hodgkin's lymphoma and peripheral vascular disease developed severe tachycardia.  Patient reported G-tube change.  Patient was cardioverted in the emergency room.  Patient is also suspected to have sepsis.  Patient was hypotensive in the emergency room.  Patient was given fluid boluses.  Patient is admitted for further evaluation treatment.  Patient was also altered at the time of arrival.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Bundle branch block left, Cardiomegaly, Cardioversion, Chest X-ray abnormal
Clinical narrative: 86 Years  Female with history of multiple medical problems including cardiomyopathy chronic obstructive pulmonary disease chronic kidney disease depression heart failure non-Hodgkin's lymphoma and peripheral vascular disease developed severe tachycardia.  Patient reported G-tube change.  Patient was cardioverted in the emergency room.  Patient is also suspected to have sepsis.  Patient was hypotensive in the emergency room.  Patient was given fluid boluses.  Patient is admitted for further evaluation treatment.  Patient was also altered at the time of arrival.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Electrocardiogram ST segment abnormal, Electrocardiogram abnormal, Gastrostomy, Hypotension, Lung hypoinflation
Clinical narrative: 86 Years  Female with history of multiple medical problems including cardiomyopathy chronic obstructive pulmonary disease chronic kidney disease depression heart failure non-Hodgkin's lymphoma and peripheral vascular disease developed severe tachycardia.  Patient reported G-tube change.  Patient was cardioverted in the emergency room.  Patient is also suspected to have sepsis.  Patient was hypotensive in the emergency room.  Patient was given fluid boluses.  Patient is admitted for further evaluation treatment.  Patient was also altered at the time of arrival.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Mental status changes, Pleural effusion, Sepsis, Tachycardia
Clinical narrative: 86 Years  Female with history of multiple medical problems including cardiomyopathy chronic obstructive pulmonary disease chronic kidney disease depression heart failure non-Hodgkin's lymphoma and peripheral vascular disease developed severe tachycardia.  Patient reported G-tube change.  Patient was cardioverted in the emergency room.  Patient is also suspected to have sepsis.  Patient was hypotensive in the emergency room.  Patient was given fluid boluses.  Patient is admitted for further evaluation treatment.  Patient was also altered at the time of arrival.
Age: 71.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Arthralgia, Blood test, Dysstasia, Pain in extremity, Scan brain
Clinical narrative: 71 year old patient and her husband came and got their moderna booster on 10/22/21. Patient woke up next morning and had severe pain in her knees. Patient was hospitalized on 10/24/21 and stayed for 6 days in the hospital. She was then moved to rehabilitation on 10/29/21 and is still there but now feeling much better and her pain is almost gone today 11/1/21. Doctor wants to keep her in rehab for some more time to monitor her but she is progressing well.
Age: 71.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: X-ray
Clinical narrative: 71 year old patient and her husband came and got their moderna booster on 10/22/21. Patient woke up next morning and had severe pain in her knees. Patient was hospitalized on 10/24/21 and stayed for 6 days in the hospital. She was then moved to rehabilitation on 10/29/21 and is still there but now feeling much better and her pain is almost gone today 11/1/21. Doctor wants to keep her in rehab for some more time to monitor her but she is progressing well.
Age: 71.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Arthralgia
Clinical narrative: 71 year old patient and her husband came and got their moderna booster on 10/22/21. Patient woke up next morning and had severe pain in her knees. Patient was hospitalized on 10/24/21 and stayed for 6 days in the hospital. She was then moved to rehabilitation on 10/29/21 and is still there but now feeling much better and her pain is almost gone today 11/1/21. Doctor wants to keep her in rehab for some more time to monitor her but she is progressing well.
Age: 60.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Chills, Dyspnoea, Injection site reaction, Livedo reticularis, Oedema
Clinical narrative: Chills, shortness of breath, kidney failure, diarrhea
Age: 60.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Pyrexia
Clinical narrative: Chills, shortness of breath, kidney failure, diarrhea
Age: 60.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Chills, Diarrhoea, Dyspnoea, Renal failure
Clinical narrative: Chills, shortness of breath, kidney failure, diarrhea
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Extra dose administered, Peripheral swelling, Pruritus
Clinical narrative: Arm very swollen, red, hardness, very itchy especially at night.  Kept ice compresses on at night. Took Tylenol one time at night. Feel fatigued from morning to night. Have never had a reaction to shot of any kind before ( including first two Maderna vaccinations prior to this last Maderna booster shot.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Fatigue, Induration, Peripheral swelling, Pruritus
Clinical narrative: Arm very swollen, red, hardness, very itchy especially at night.  Kept ice compresses on at night. Took Tylenol one time at night. Feel fatigued from morning to night. Have never had a reaction to shot of any kind before ( including first two Maderna vaccinations prior to this last Maderna booster shot.
Age: 53.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional adverse events reported; VARIVAX had been administered today,21OCT2021, to a patient via the intramuscular route versus the recommended subcutaneous route of administration; This spontaneous report was received from a pharmacist referring to a 53-year-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 21-OCT-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number T024283, expiration date 15-JUL-2022, intramuscular (instead of subcutaneous) for prophylaxis (incorrect route of product administration). No adverse event was reported.
Age: 8.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE details or PQC; Inadvertent administration to 8 year old; This spontaneous report as received from a licensed practical nurse concerning an 8-year-old patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On 25-OCT-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  inadvertently, dose: 0.5 milliliter, lot # T026167, expiration date: 04-DEC-2022 for prophylaxis (dose number,  and route of administration was not reported)(Product administered to patient of inappropriate age). No additional adverse events or product quality complaint were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Bronchial disorder, Condition aggravated, Herpes zoster
Clinical narrative: bronchiactasis flared up.; flare up; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of bronchial disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included bronchial disorder (had bronchiactasis).   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced bronchial disorder, condition aggravated and shingles. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the bronchial disorder, condition aggravated and shingles were unknown.   It was unknown if the reporter considered the bronchial disorder, condition aggravated and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingles vaccine and few days later bronchiactasis flared up. The patient after suffering through 3 weeks of bronchiactasis nowhad full blown shingles. The patient received steroids for the breathing issues which caused a reaction to the shingles shot.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles rash; rash; This case was reported by a physician via sales rep and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced shingles rash three days after administration. The reporter was not sure if it was 1st or 2nd dose for patient. No further information reported. The reporter consented to follow up. This case has been linked with case US2021094202, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021094202:same reporter
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 35-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix b (1st dose received on 22nd December 2020, batch number bg92z, expiry date 4th July 2022).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had received the first dose of the Engeri B and had not yet received the second dose of the schedule, which led to incomplete course of vaccination. No further events were reported. The reporter agreed to contacted for follow-up. Did not consent to follow-up.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-year-old male patient who received HAV (Havrix) (batch number 94j24, expiry date 26th September 2021) for prophylaxis.   On 29th September 2021, the patient received Havrix. On 29th September 2021, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: The patient received dose of Havrix that was already got expired on 26th September 2021, which led to expired vaccine used. The reporter consented to follow up. This case has been linked with US2021221638, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021221638:Same reporter. Patient 1 of 2.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: menveo reconstituted with sterile water instead of the CYW-135 liquid conjugate.; menveo reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 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 wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The pharmacy technician called on behalf of another clinic. The patient administered with Menveo vaccine that was reconstituted with sterile water instead of the CYW-135 liquid conjugate, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not have any patient details, date of administration, or vaccine lot number and expiration date. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: had difficulty mixing; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number P7N2H, expiry date 30th January 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate preparation of medication was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, her partner pharmacist had difficulty mixing a Shingrix vaccine, which led to inappropriate preparation of medication. The reporter stated they no longer had the adjuvant vial due to this difficulty. The reporter was not sure of the details of what occurred. The reporter was unable to provide answers to questions to rule in or rule out PQC (product quality complaint). The reporter requested replacement product, but unable to provide until PQC ruled in. The reporter stated, the pharmacist directly involved with incident would call back. The patient details and PQC question answers unavailable as the reporter was not the pharmacist directly involved with incident. The reporter did not consent to follow-up. No additional details provided by the caller.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered Boostrix, but it had expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 66-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43E4T, expiry date 1st October 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th October 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 26th October 2021, unknown after receiving Boostrix and Boostrix 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 details were provided as follows: The patient received expired dose of Menveo, which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: administered the recalled lot (CP23D); administered the recalled lot (CP23D); This case was reported by a nurse via call center representative and described the occurrence of recalled drug administered in an unspecified number of patients who received HBV (Engerix B) (batch number CP23D, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The multiple patients were administered the recalled lot, which led to recalled drug administered and drug dispensing error. The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: administered Engerix-B inadvertently; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 62-year-old male patient who received HBV (Engerix B) (batch number 90746, expiry date 7th September 2023) for prophylaxis.   On 1st September 2021, the patient received Engerix B. On 1st September 2021, unknown after receiving Engerix B, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.  Additional details were provided as follows: The patient was administered Engerix-B inadvertently, which led to wrong vaccine administered. The reporter consented to follow up. This case has been linked to US2021222750, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021222750:Same reporter
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: administered Engerix-B inadvertently; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 62-year-old female patient who received HBV (Engerix B) (batch number 90746, expiry date 7th September 2023) for prophylaxis.   On 1st September 2021, the patient received the 1st dose of Engerix B. On 1st September 2021, unknown after receiving Engerix B, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.  Additional details were provided as follows: The patient was administered the Engerix-B vaccine inadvertently, which led to wrong vaccine administered. The reporter consented to follow up. This case has been linked to US2021222751, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021222751:Same reporter
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Underdose
Clinical narrative: able to withdraw 0.47-0.48ml, patient received; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect dose administered in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number KZ455, expiry date 4th February 2023) for prophylaxis.   On 25th October 2021, the patient received Shingrix. On 25th October 2021, unknown after receiving Shingrix, the patient experienced incorrect dose administered. On an unknown date, the outcome of the incorrect dose administered was unknown.  Additional details were provided as follows: The patient received 0.47 to 0.48ml of Shingrix vaccine , which led to incorrect dose administered. The pharmacist called to report that after reconstitution, he was unable to withdraw 0.5ml of the vaccine into the syringe. The pharmacist reported that this occurred with two Shingrix vaccine after reconstitution. The reporter stated that, this was the first time this has happened, and no cracks or leaks were observed in the vial. The patient did not experience any adverse event. The reprter did not consent to follow up.
Sex: U
Vaccine: HEP
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: lot number involved in a RECALL was administered; lot number involved in a RECALL was administered; This case was reported by a nurse via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 31st December 2023) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The patient received the recalled lot of Engerix B, which led to recalled drug administered and drug dispensing error. The reporter consented to follow up. The reporter would like to knowdid need to inform patients and revaccinate them and need to report this situation. The reporter consented to follow up. This was 1 of 10 linked cases reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR223917:same reporter US-GLAXOSMITHKLINE-US2021AMR223918:same reporter US-GLAXOSMITHKLINE-US2021AMR223919:same reporter US-GLAXOSMITHKLINE-US2021AMR223916:same reporter US-GLAXOSMITHKLINE-US2021AMR223915:same reporter US-GLAXOSMITHKLINE-US2021AMR223914:same reporter US-GLAXOSMITHKLINE-US2021AMR223920:same reporter US-GLAXOSMITHKLINE-US2021AMR223912:same reporter US-GLAXOSMITHKLINE-US2021AMR223913:same reporter
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: doses 26 days apart; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number HM2YH, expiry date 25th March 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 20th October 2021, the patient received the 2nd dose of Shingrix. On 20th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were reported as follows: The pharmacist reported a patient received their 2nd dose of Shingrix 26 days apart and not the minimum two months apart from 1st dose which led to shortening of vaccination schedule. The reporter consented to follow up.
Age: 14.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: pediarix was administered to a 14 yr old; This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 14-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number j953n, expiry date 11th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th October 2021, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 27th October 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: The pediarix dose was administered to a 14 years old patient, which led to inappropriate age at vaccine administration. No vaccination history was available for the patient. The reporter consented to follow up. This case has been linked to US2021223565, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223565:same reporter
Age: 7.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: pediarix was administered to a 7 yr; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number j953n, expiry date 11th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th October 2021, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 27th October 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: Adose of pediarix was administered to a 7 yr patient, which led to inappropriate age at vaccine administration. No vaccination history available for the patient. The reporter consented to follow up. This case has been linked to US2021223563, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223563:same reporter
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: 1st dose given subcutaneously; This case was reported by a consumer via call center representative and described the occurrence of intramuscular formulation administered by other route in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd October 2021, the patient received the 1st dose of Shingrix (subcutaneous). On 22nd October 2021, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The patient received his first dose of Shingrix and it was given subcutaneously, which led to intramuscular formulation administered by other route. The reporter did not consent to follow-up.
Age: 7.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pediarix to 7 year old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number J9593N, expiry date 11th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th October 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 27th October 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: A dose of Pediarix was administered to 7 year old patient, which led to inappropriate age at vaccine administration. The reporter consented to follow up. This case has been linked to US2021223568, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223568:same reporter
Age: 14.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pediarix to child over the age of 7; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number J9593N, expiry date 11th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th October 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 27th October 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: A dose of Pediarix was administered to the patient at 14 years of age, which led to inappropriate age at vaccine administration. The reporter consented to follow up. This case has been linked to US2021223564, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223564:same reporter
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: expired dose of kinrix was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number pp9l5, expiry date 16th October 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th October 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 19th October 2021, unknown after receiving Kinrix and Kinrix 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 details were reported as follows: Health care professional reported dose of kinrix was administered to a patient which was already expired on 16th October 2021. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Computerised tomogram, Fall, Foot fracture, Guillain-Barre syndrome
Clinical narrative: BRAIN BLEED; RECURRENT GUILLAIN BARRE SYNDROME; BROKEN HER FOOT; DISLOCATED HER FOOT; SMACKED HER HEAD; FALL; This spontaneous report received from a consumer concerned an 8 decade old female. The patient's weight was 191 pounds, and height was 66 inches. The patient's concurrent conditions included: penicillin allergy. The patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 23-AUG-2021) dose was not reported, Frequency 1 total administered on 23-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  It was reported that few weeks after vaccination the patient started developing arm weakness and went to see her HCP who "misdiagnosed it as rotator cuff injury". After waiting to let that try and heal, the event progressively worsened, to the point that she could not perform her activities of daily living because of the weakness. On an unspecified date in Sep-2021, the patient became weaker, she fell at home and had broken/dislocated her foot during that fall, and smacked her head and had a brain bleed on holiday weekend. The patient was sent to the Emergency Room and subsequently hospitalized. There she was diagnosed with Guillain barre syndrome (GBS), after having an MRI (Magnetic resonance imaging), CT (Computerized tomogram) scan, and lumbar puncture was done, and the patient was started with 5-day treatment of antibodies. The patient was in hospital for about 2 weeks, and she improved greatly and was then sent for strengthening to a rehabilitation facility. At around 10 days into rehabilitation, the Guillain barre syndrome (GBS) symptoms started again. She was sent back to hospital again from the rehabilitation, and had another round of 5-day antibody treatment, was discharged back to the rehab this time with weakness still in her legs and not at 100%. The patient was in rehab at the time of reporting, and she is reporting that two days ago the same GBS symptoms started again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from recurrent guillain barre syndrome, and the outcome of fall, broken her foot, brain bleed, smacked her head and dislocated her foot was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211058478- COVID-19 VACCINE AD26.COV2.S- Fall, broken her foot, dislocated her foot, smacked her head and brain bleed. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20211058478 -COVID-19 VACCINE AD26.COV2.S -Guillain Barre Syndrome. This event is labeled per RSI and is therefore considered potentially related.