chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Infection, Pyrexia
Clinical narrative: Fever, chills, fatigue, serious infection
Age: 1.67
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy, Blood test, Fatigue, Fear, Gait inability
Clinical narrative: Mowed the yard on Friday had been tired all week Saturday Ankles  knees buckling tried to walk can't sliding down bed can't get to bathroom. Scared hyper ventilating  Still cannot walk
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperventilation, Imaging procedure, Immunoglobulin therapy, Lumbar puncture, Mobility decreased
Clinical narrative: Mowed the yard on Friday had been tired all week Saturday Ankles  knees buckling tried to walk can't sliding down bed can't get to bathroom. Scared hyper ventilating  Still cannot walk
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Mowed the yard on Friday had been tired all week Saturday Ankles  knees buckling tried to walk can't sliding down bed can't get to bathroom. Scared hyper ventilating  Still cannot walk
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Bell's palsy, Blood pressure decreased, Blood test normal, Choking
Clinical narrative: Within 15-20 minutes left side of face begin to tingle, go numb, and loose ability to move. This spread to my tongue and throat. This has improves somewhat, but only after 6-7 months. It still lacks mobility, tingles and has numbness. Bell's palsy type symptoms. Tongue swollen. Can't talk, eat or drink properly. I get choked easily. I have to eat extremely small bites and slowly,  Face is swollen, Eyes swollen and sight diminished.  Facial pain Paresthesia Slurred Speech Headaches - sharp and sudden. Tinnitus.   BP dropped at pharmacy, but has since stabilized.  Dizziness and disoriented Extreme mental fog -dementia  Tremors in extremities Extreme fatigue Abnormal Walking Gait that effect everyday activities such as walking. Insomnia Memory issues Mobility Issues Small motor sill issues Excessive overheating and sweating. Muscle cramps I was sent home from pharmacy with Benadryl and told to go to the Emergency department if symptoms worsened or wast better by morning.  I went to Emergency Department, the following morning. They first suspected stroke, CT showed no stoke. Diagnosed with Bell's palsy type symptoms, paresthesia. I was given prednisone and told to follow up with PCP. Was told I had had a reaction form covid vaccine. Followed up with PCP, was given more prednisone, had bloodwork drawn. I was called and told to give it time and it would get better.  February 2022, I began seeing Dr. Much bloodwork and test. IV vitamins and supplements,. Doxycycline,  Armour Thyroid,  Other supplements to help rid inflammation Covid vaccine has left in my body. It has begun to help, somewhat, but still have most all of these symptoms.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head normal, Dementia, Disorientation, Dizziness, Dysarthria
Clinical narrative: Within 15-20 minutes left side of face begin to tingle, go numb, and loose ability to move. This spread to my tongue and throat. This has improves somewhat, but only after 6-7 months. It still lacks mobility, tingles and has numbness. Bell's palsy type symptoms. Tongue swollen. Can't talk, eat or drink properly. I get choked easily. I have to eat extremely small bites and slowly,  Face is swollen, Eyes swollen and sight diminished.  Facial pain Paresthesia Slurred Speech Headaches - sharp and sudden. Tinnitus.   BP dropped at pharmacy, but has since stabilized.  Dizziness and disoriented Extreme mental fog -dementia  Tremors in extremities Extreme fatigue Abnormal Walking Gait that effect everyday activities such as walking. Insomnia Memory issues Mobility Issues Small motor sill issues Excessive overheating and sweating. Muscle cramps I was sent home from pharmacy with Benadryl and told to go to the Emergency department if symptoms worsened or wast better by morning.  I went to Emergency Department, the following morning. They first suspected stroke, CT showed no stoke. Diagnosed with Bell's palsy type symptoms, paresthesia. I was given prednisone and told to follow up with PCP. Was told I had had a reaction form covid vaccine. Followed up with PCP, was given more prednisone, had bloodwork drawn. I was called and told to give it time and it would get better.  February 2022, I began seeing Dr. Much bloodwork and test. IV vitamins and supplements,. Doxycycline,  Armour Thyroid,  Other supplements to help rid inflammation Covid vaccine has left in my body. It has begun to help, somewhat, but still have most all of these symptoms.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Eye swelling, Facial pain, Fatigue, Feeling abnormal
Clinical narrative: Within 15-20 minutes left side of face begin to tingle, go numb, and loose ability to move. This spread to my tongue and throat. This has improves somewhat, but only after 6-7 months. It still lacks mobility, tingles and has numbness. Bell's palsy type symptoms. Tongue swollen. Can't talk, eat or drink properly. I get choked easily. I have to eat extremely small bites and slowly,  Face is swollen, Eyes swollen and sight diminished.  Facial pain Paresthesia Slurred Speech Headaches - sharp and sudden. Tinnitus.   BP dropped at pharmacy, but has since stabilized.  Dizziness and disoriented Extreme mental fog -dementia  Tremors in extremities Extreme fatigue Abnormal Walking Gait that effect everyday activities such as walking. Insomnia Memory issues Mobility Issues Small motor sill issues Excessive overheating and sweating. Muscle cramps I was sent home from pharmacy with Benadryl and told to go to the Emergency department if symptoms worsened or wast better by morning.  I went to Emergency Department, the following morning. They first suspected stroke, CT showed no stoke. Diagnosed with Bell's palsy type symptoms, paresthesia. I was given prednisone and told to follow up with PCP. Was told I had had a reaction form covid vaccine. Followed up with PCP, was given more prednisone, had bloodwork drawn. I was called and told to give it time and it would get better.  February 2022, I began seeing Dr. Much bloodwork and test. IV vitamins and supplements,. Doxycycline,  Armour Thyroid,  Other supplements to help rid inflammation Covid vaccine has left in my body. It has begun to help, somewhat, but still have most all of these symptoms.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Hyperhidrosis, Hypoaesthesia, Insomnia
Clinical narrative: Within 15-20 minutes left side of face begin to tingle, go numb, and loose ability to move. This spread to my tongue and throat. This has improves somewhat, but only after 6-7 months. It still lacks mobility, tingles and has numbness. Bell's palsy type symptoms. Tongue swollen. Can't talk, eat or drink properly. I get choked easily. I have to eat extremely small bites and slowly,  Face is swollen, Eyes swollen and sight diminished.  Facial pain Paresthesia Slurred Speech Headaches - sharp and sudden. Tinnitus.   BP dropped at pharmacy, but has since stabilized.  Dizziness and disoriented Extreme mental fog -dementia  Tremors in extremities Extreme fatigue Abnormal Walking Gait that effect everyday activities such as walking. Insomnia Memory issues Mobility Issues Small motor sill issues Excessive overheating and sweating. Muscle cramps I was sent home from pharmacy with Benadryl and told to go to the Emergency department if symptoms worsened or wast better by morning.  I went to Emergency Department, the following morning. They first suspected stroke, CT showed no stoke. Diagnosed with Bell's palsy type symptoms, paresthesia. I was given prednisone and told to follow up with PCP. Was told I had had a reaction form covid vaccine. Followed up with PCP, was given more prednisone, had bloodwork drawn. I was called and told to give it time and it would get better.  February 2022, I began seeing Dr. Much bloodwork and test. IV vitamins and supplements,. Doxycycline,  Armour Thyroid,  Other supplements to help rid inflammation Covid vaccine has left in my body. It has begun to help, somewhat, but still have most all of these symptoms.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Loss of personal independence in daily activities, Memory impairment, Mobility decreased, Motor dysfunction
Clinical narrative: Within 15-20 minutes left side of face begin to tingle, go numb, and loose ability to move. This spread to my tongue and throat. This has improves somewhat, but only after 6-7 months. It still lacks mobility, tingles and has numbness. Bell's palsy type symptoms. Tongue swollen. Can't talk, eat or drink properly. I get choked easily. I have to eat extremely small bites and slowly,  Face is swollen, Eyes swollen and sight diminished.  Facial pain Paresthesia Slurred Speech Headaches - sharp and sudden. Tinnitus.   BP dropped at pharmacy, but has since stabilized.  Dizziness and disoriented Extreme mental fog -dementia  Tremors in extremities Extreme fatigue Abnormal Walking Gait that effect everyday activities such as walking. Insomnia Memory issues Mobility Issues Small motor sill issues Excessive overheating and sweating. Muscle cramps I was sent home from pharmacy with Benadryl and told to go to the Emergency department if symptoms worsened or wast better by morning.  I went to Emergency Department, the following morning. They first suspected stroke, CT showed no stoke. Diagnosed with Bell's palsy type symptoms, paresthesia. I was given prednisone and told to follow up with PCP. Was told I had had a reaction form covid vaccine. Followed up with PCP, was given more prednisone, had bloodwork drawn. I was called and told to give it time and it would get better.  February 2022, I began seeing Dr. Much bloodwork and test. IV vitamins and supplements,. Doxycycline,  Armour Thyroid,  Other supplements to help rid inflammation Covid vaccine has left in my body. It has begun to help, somewhat, but still have most all of these symptoms.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Neurological symptom, Paraesthesia, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: Within 15-20 minutes left side of face begin to tingle, go numb, and loose ability to move. This spread to my tongue and throat. This has improves somewhat, but only after 6-7 months. It still lacks mobility, tingles and has numbness. Bell's palsy type symptoms. Tongue swollen. Can't talk, eat or drink properly. I get choked easily. I have to eat extremely small bites and slowly,  Face is swollen, Eyes swollen and sight diminished.  Facial pain Paresthesia Slurred Speech Headaches - sharp and sudden. Tinnitus.   BP dropped at pharmacy, but has since stabilized.  Dizziness and disoriented Extreme mental fog -dementia  Tremors in extremities Extreme fatigue Abnormal Walking Gait that effect everyday activities such as walking. Insomnia Memory issues Mobility Issues Small motor sill issues Excessive overheating and sweating. Muscle cramps I was sent home from pharmacy with Benadryl and told to go to the Emergency department if symptoms worsened or wast better by morning.  I went to Emergency Department, the following morning. They first suspected stroke, CT showed no stoke. Diagnosed with Bell's palsy type symptoms, paresthesia. I was given prednisone and told to follow up with PCP. Was told I had had a reaction form covid vaccine. Followed up with PCP, was given more prednisone, had bloodwork drawn. I was called and told to give it time and it would get better.  February 2022, I began seeing Dr. Much bloodwork and test. IV vitamins and supplements,. Doxycycline,  Armour Thyroid,  Other supplements to help rid inflammation Covid vaccine has left in my body. It has begun to help, somewhat, but still have most all of these symptoms.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue, Tinnitus, Tremor, Visual impairment
Clinical narrative: Within 15-20 minutes left side of face begin to tingle, go numb, and loose ability to move. This spread to my tongue and throat. This has improves somewhat, but only after 6-7 months. It still lacks mobility, tingles and has numbness. Bell's palsy type symptoms. Tongue swollen. Can't talk, eat or drink properly. I get choked easily. I have to eat extremely small bites and slowly,  Face is swollen, Eyes swollen and sight diminished.  Facial pain Paresthesia Slurred Speech Headaches - sharp and sudden. Tinnitus.   BP dropped at pharmacy, but has since stabilized.  Dizziness and disoriented Extreme mental fog -dementia  Tremors in extremities Extreme fatigue Abnormal Walking Gait that effect everyday activities such as walking. Insomnia Memory issues Mobility Issues Small motor sill issues Excessive overheating and sweating. Muscle cramps I was sent home from pharmacy with Benadryl and told to go to the Emergency department if symptoms worsened or wast better by morning.  I went to Emergency Department, the following morning. They first suspected stroke, CT showed no stoke. Diagnosed with Bell's palsy type symptoms, paresthesia. I was given prednisone and told to follow up with PCP. Was told I had had a reaction form covid vaccine. Followed up with PCP, was given more prednisone, had bloodwork drawn. I was called and told to give it time and it would get better.  February 2022, I began seeing Dr. Much bloodwork and test. IV vitamins and supplements,. Doxycycline,  Armour Thyroid,  Other supplements to help rid inflammation Covid vaccine has left in my body. It has begun to help, somewhat, but still have most all of these symptoms.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Dizziness, Electronystagmogram, Gait disturbance
Clinical narrative: I woke up with vertigo.  Unable to leave my bed for many days. I went to one ENT for treatments for about 2 months. I was prescribed Valium so I could function. I then went to another ENT and had many tests done. I then went to a Sensory  Occupational Therapist. This started April 2021 through July 2022. I could open my eyes, I was dizzy, nauseous, walked into furniture and walls. Could not drive my car. Could not take a walk because I felt as if I was going to fall off the sidewalk. All physical activities stopped. Debilitating! Never had headaches or dizziness until this vaccine entered my system.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hemiparesis, Impaired driving ability, Laboratory test abnormal, Loss of personal independence in daily activities
Clinical narrative: I woke up with vertigo.  Unable to leave my bed for many days. I went to one ENT for treatments for about 2 months. I was prescribed Valium so I could function. I then went to another ENT and had many tests done. I then went to a Sensory  Occupational Therapist. This started April 2021 through July 2022. I could open my eyes, I was dizzy, nauseous, walked into furniture and walls. Could not drive my car. Could not take a walk because I felt as if I was going to fall off the sidewalk. All physical activities stopped. Debilitating! Never had headaches or dizziness until this vaccine entered my system.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Nausea, Nervous system disorder, Vertigo
Clinical narrative: I woke up with vertigo.  Unable to leave my bed for many days. I went to one ENT for treatments for about 2 months. I was prescribed Valium so I could function. I then went to another ENT and had many tests done. I then went to a Sensory  Occupational Therapist. This started April 2021 through July 2022. I could open my eyes, I was dizzy, nauseous, walked into furniture and walls. Could not drive my car. Could not take a walk because I felt as if I was going to fall off the sidewalk. All physical activities stopped. Debilitating! Never had headaches or dizziness until this vaccine entered my system.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after three vaccines Moderna 3/7/21 Lot# 023M20A;  Moderna 4/8/21 Lot# 018B21A;  Moderna 7/18/22 Lot# 037A22B
Age: 17.0
Sex: F
Vaccine: COVID19, MNQ, COVID19, MNQ
Symptoms: Confusional state, Loss of consciousness, Pallor, Retching, Urinary incontinence
Clinical narrative: Pt came to Facility to receive  menactra and first dose of covid 19 vaccine.  Pt was given injection  was t alking  with nurse and parent when she became pale  started gag like motion like she was going to vomit.  Pt  seated in chair  then passes out loses incontinence of urine.  Vitals are taken, at parent request 911 activated  pt is out approx 5- mintues.  Pt regains  consciousness  pt states she is confused.  Pt vitals  monitored  pt is alert to name place DOB .  EMS arrives pt walks to cot and is transferred to hospital per parent request.     Vitals 14:15 Resp 12  unlabored BP 97/72            14:20 Resp 14 unlabored  BP 102/78
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Rhinorrhoea
Clinical narrative: tested positive for covid 8/28/22
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid 8/28/22
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Rhinorrhoea
Clinical narrative: developed cough, tested positive for covid 8/28/2022
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, SARS-CoV-2 test positive
Clinical narrative: developed cough, tested positive for covid 8/28/2022
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Pain
Clinical narrative: had pain after the first vaccine and then felt better/ experiencing more pain; pulse was high after the first vaccine; This spontaneous case was reported by a patient and describes the occurrence of PAIN (had pain after the first vaccine and then felt better/ experiencing more pain) and HEART RATE INCREASED (pulse was high after the first vaccine) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Walking disability.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (had pain after the first vaccine and then felt better/ experiencing more pain) and HEART RATE INCREASED (pulse was high after the first vaccine). At the time of the report, PAIN (had pain after the first vaccine and then felt better/ experiencing more pain) had not resolved and HEART RATE INCREASED (pulse was high after the first vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: pulse was high after the first vaccine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was on blood pressure pills for many years. Had no other heart conditions.  The patient had not taken any medication for the pain. Took a warm shower and used cool towel.   This case was linked to MOD-2022-633791 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Condition aggravated, Gait inability, Headache, Heart rate
Clinical narrative: had pain after the first vaccine and then felt better/ experiencing more pain; pulse was high after the first vaccine; This spontaneous case was reported by a patient and describes the occurrence of PAIN (had pain after the first vaccine and then felt better/ experiencing more pain) and HEART RATE INCREASED (pulse was high after the first vaccine) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Walking disability.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (had pain after the first vaccine and then felt better/ experiencing more pain) and HEART RATE INCREASED (pulse was high after the first vaccine). At the time of the report, PAIN (had pain after the first vaccine and then felt better/ experiencing more pain) had not resolved and HEART RATE INCREASED (pulse was high after the first vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: pulse was high after the first vaccine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was on blood pressure pills for many years. Had no other heart conditions.  The patient had not taken any medication for the pain. Took a warm shower and used cool towel.   This case was linked to MOD-2022-633791 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Pain
Clinical narrative: had pain after the first vaccine and then felt better/ experiencing more pain; pulse was high after the first vaccine; This spontaneous case was reported by a patient and describes the occurrence of PAIN (had pain after the first vaccine and then felt better/ experiencing more pain) and HEART RATE INCREASED (pulse was high after the first vaccine) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Walking disability.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (had pain after the first vaccine and then felt better/ experiencing more pain) and HEART RATE INCREASED (pulse was high after the first vaccine). At the time of the report, PAIN (had pain after the first vaccine and then felt better/ experiencing more pain) had not resolved and HEART RATE INCREASED (pulse was high after the first vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: pulse was high after the first vaccine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was on blood pressure pills for many years. Had no other heart conditions.  The patient had not taken any medication for the pain. Took a warm shower and used cool towel.   This case was linked to MOD-2022-633791 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Gotten sick for about a day and a half starting about 5 hours after the dose) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. Patient had never tested positive for Covid.  Concurrent medical conditions included Depression. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Antidepressant therapy. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (Gotten sick for about a day and a half starting about 5 hours after the dose). In February 2021, ILLNESS (Gotten sick for about a day and a half starting about 5 hours after the dose) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. It was reported that patient had never been in a psyche ward. No treatment information was reported. This case was linked to MOD-2022-633800, MOD-2022-633801 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgic amyotrophy
Clinical narrative: left brachial plexitis
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 01st August 2022, 2nd dose 19th August 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number KJ937, expiry date 11th June 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 19th August 2022, the patient received the 2nd dose of Shingrix. On 19th August 2022, 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 Information: GSK Receipt Date: 19-Aug-2022 Reporter's Comments: The pharmacy manager reports administered the Shingrix 1st dose to a patient on 1st August 2022 and a 2nd dose on the reporting day. Additional Supportive Information: The patient received 2nd dose early than the recommended time interval, which led to shortening of vaccination schedule. The reporter did not consent to follow up.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient got Kinrix instead of Pediarix; 3 year old pt received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number 2kl4k, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (had two doses of Pediarix ).   On 15th August 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 15th August 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-AUG-2022 Reporter's Comment: The patient was administrated with Kinrix instead of Pediarix.  No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: The patient was administrated with kinrix instead of Pediarix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 16.0
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired Menveo administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA418A, expiry date 31st October 2021) for prophylaxis.   On 21st February 2022, the patient received Menveo. On 21st February 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's Comment: The reporter stated that Menveo expired dose was administered to the patient. The reporter gave consent to follow up.
Age: 19.0
Sex: F
Vaccine: HEP, HEP, HEP, HEP, HEP
Symptoms: Hepatitis B antibody, Product administered to patient of inappropriate age, Therapeutic response decreased, Underdose
Clinical narrative: Insufficient titers for hepatitis B; 5th dose of hepatitis B administered/pediatric Engerix-B received.; 19 year old female patient was given dose of pediatric Engerix-B; This case was reported by a nurse via sales rep and described the occurrence of therapeutic response decreased in a 19-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 5th dose of Engerix B pediatric, the 4th dose of Hepatitis B vaccine, the 3rd dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 1st dose of Hepatitis B vaccine. On an unknown date, not applicable after receiving Engerix B pediatric and unknown after receiving Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapeutic response decreased, underdose and adult use of a child product. On an unknown date, the outcome of the therapeutic response decreased, underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 23-AUG-2022 Reporter's Comment: The reporter was a nurse. The patient received pediatric Engerix-B vaccine. And it was patients 5th dose of hepatitis B due to insufficient titers. The reporter consented to follow up.  Additional supportive information: The patients received four doses of Hepatitis-B vaccine series and had insufficient titers of Hepatitis-B, which led to therapeutic response decreased. The adult patient was administered a pediatric dose of Engerix-B which led to, adult use of a child product and underdose.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administered an expired Bexsero; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB38AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 23rd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-AUG-2022 Reporter's Comments: The physician reported that they administered an expired Bexsero dose to a patient.  The reporter called to enquire what to do. The reporter consented to follow-up.  Additional Supportive Information:On the day of reporting, the patient received an expired dose of Bexsero, which led to expired vaccine used.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Somnolence
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PAIN (aches) and SOMNOLENCE (she felt sleepy for about 3 or 4 days.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Bee sting hypersensitivity (Allergic to Bumblebees). In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN (aches) and SOMNOLENCE (she felt sleepy for about 3 or 4 days.). In 2021, PAIN (aches) and SOMNOLENCE (she felt sleepy for about 3 or 4 days.) had resolved. Patient's date of birth was reported as Jul 1941. Patient was under a lot of concomitant and regular medications, but there were a lot of them and she could not provide names. After first dose in 2021 and second dose in Apr 2021 patient experienced a few aches, and felt sleepy for about 3 or 4 days. Patient had no medical history related to mentioned AE and both acute and chronic illnesses at the time of vaccination. The Adverse event did not cause patient to seek medical care. The patient did not experience a similar event in the past. No treatment had been given for her symptoms. This case was linked to MOD-2022-635784, MOD-2022-635787 (Patient Link).
Age: 41.0
Sex: F
Vaccine: IPV
Symptoms: Fatigue, Muscle fatigue
Clinical narrative: rapid muscle tiring and total body exhaustion lasting for more than a week
Sex: U
Vaccine: VARZOS
Symptoms: Feeling hot, Pain, Swelling
Clinical narrative: My first dose swelled; sore; was hot; This case was reported by a consumer via interactive digital media and described the occurrence of swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced swelling, pain and feeling hot. On an unknown date, the outcome of the swelling, pain and feeling hot were recovered/resolved.   It was unknown if the reporter considered the swelling, pain and feeling hot to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient reported that his/her first dose swelled and was hot and sore. The second dose nothing. It was fine. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: The site of the shot is swollen; The site of the shot hurts; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21st August 2022, the patient received the 1st dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received his/her Shingles vaccine on Sunday at 11:00 am.  The patient stated that, the site of the shot, left upper arm, was swollen and hurting.  The reporter wanted to know anything he/she could do.  The reporter asked that he/she should be worried. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: HCP gave menveo to a patient but only gave the diluent instead of properly mixing the vaccine; HCP gave menveo to a patient but only gave the diluent instead of properly mixing the vaccine; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.      Additional Information: GSK receipt date:19-AUG-2022 Reporters comment: The health care professional (HCP) gave menveo diluent only instead of properly mixing the vaccine. Additional Supportive information:The patient received diluent instead of properly mixing the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
Age: 0.92
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-month-old male patient who received HAV (Havrix pediatric) (batch number Zj3g3, expiry date 12th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd August 2022, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 22nd August 2022, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-Aug-2022:  Reporter's comments: Medical assistant reported that the patient was administered with an expired dose Havrix.  The reporter did not consented to follow up. Additional Supportive Information: The patient was administered an expired dose of Havrix pediatric, which led to expired vaccine used.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: Arm soreness; Headache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm and headache. On an unknown date, the outcome of the pain in arm and headache were recovered/resolved.   It was unknown if the reporter considered the pain in arm and headache to be related to Shingrix.  Linked case(s) involving the same patient:US2022AMR122951   Additional Information: GSK Receipt Date: 23-AUG-2022 Reporter's Comment: The reporter called at the time of reporting and stated that, she had her Shingrix about two months ago and experienced arm soreness and headache that resolved. The reporter consented to follow up. Additional Supportive Information: For tolerance of 2nd dose ,refer case US2022AMR122951.; Sender's Comments:  US-GSK-US2022AMR122951:Same reporter
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a nursing assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 patient expired Moderna dose/2 patients expired Moderna dose) and NO ADVERSE EVENT (No adverse event) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 prophylaxis. No Medical History information was reported. On 25-Jan-2022 at 2:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 25-Jan-2022 at 2:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 patient expired Moderna dose/2 patients expired Moderna dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 patient expired Moderna dose/2 patients expired Moderna dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (1 patient expired Moderna dose/2 patients expired Moderna dose) to have an unknown relationship. It was unknown whether patient took over the counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event. It was unknown whether the patient ever been diagnosed with tested/positive for Covid-19. It was unknown whether the patient had acute illnesses at the time of vaccination and up to one month before. It was unknown whether the patient had chronic or long standing health conditions. The event did not cause the patient to seek medical care. It was unknown whether the patient had any other potential cause. It was unknown whether the patient experienced a similar event in the past. No treatment medication was provided. This case was linked to US-MODERNATX, INC.-MOD-2022-635425, US-MODERNATX, INC.-MOD-2022-635428 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2022: Significant follow-up received included updated report type, reporter details added, patient details added, dosage information updated, event onset date added, narrative updated. Sender's Comments: US-MODERNATX, INC.-MOD-2022-635425:88 year old male. US-MODERNATX, INC.-MOD-2022-635428.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial initially stored in refrigerator on 20-Jul-2022 and administered on 20-Aug-2022, after 30 days use by date; No adverse event; Patient received dose after 30 days use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose after 30 days use by date), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 20-Jul-2022 and administered on 20-Aug-2022, after 30 days use by date) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 055A22A) for COVID-19 vaccination.     It was unknown if the patient was ever been diagnosed with or tested positive for covid-19.Also it was unknown if the patient had any acute illness at the time of vaccination and up to one month before. It was unknown if the patient had any chronic or long standing health conditions. It was unknown if the patient had prescriptions, over the counter medications, dietary supplements or herbal remedies taken at the time of vaccination or at the time of the adverse event.     On 20-Aug-2022 at 10:46 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-Aug-2022 at 10:46 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose after 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 20-Jul-2022 and administered on 20-Aug-2022, after 30 days use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose after 30 days use by date), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 20-Jul-2022 and administered on 20-Aug-2022, after 30 days use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received dose after 30 days use by date) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 20-Jul-2022 and administered on 20-Aug-2022, after 30 days use by date).    No concomitant medications were reported.  On 20-Jul-2022, the pharmacy received the vials and stored them in refrigerator. It was stored in the refrigerator for 31 days after which it was administered to the patient. The pharmacist did not realize it was only good for 30 days in the fridge. The vial had no temperature excursion. No adverse reaction was reported. And it was enquired by the pharmacist if the patient's needs to be re-dozed.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-632107 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-632107:Master case
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received expired Moderna dose; This spontaneous case was reported by a nursing assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna dose) and NO ADVERSE EVENT (No adverse event) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     It was unknown if patient ever been diagnosed with/tested positive for covid-19.  It was unknown if patient had acute illness at the time of vaccination and up to one month before.  Unknown about chronic or long-standing health condition.     On 01-Dec-2021 at 2:45 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Dec-2021 at 2:45 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna dose) to have an unknown relationship.    Prescriptions, over the counter medications, dietary supplements or herbal medicines being taken at the time of vaccination and or at the time of adverse event was unknown. Dose administered after manufacturer expiry date was reported with lot number 048C21A and date 09-Nov-2021. Date the vial was stored in the refrigerator was unknown. The vial had not underwent any temperature excursion issues. It was unknown if the patient had experienced a similar event in the past.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-630555, US-MODERNATX, INC.-MOD-2022-635428 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-630555:88 year old male US-MODERNATX, INC.-MOD-2022-635428:58 year old female
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after manufacture expiry date; This spontaneous case was reported by a nursing assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacture expiry date) and NO ADVERSE EVENT (No adverse event) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Apr-2022 at 10:50 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacture expiry date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacture expiry date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacture expiry date) to have an unknown relationship.    Vaccine did not undergo and temperature excursion issue.  No concomitant product reported by reporter.  Event did not caused patient to seek medical care.  No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-635425, US-MODERNATX, INC.-MOD-2022-630555 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-635425:76 year old female US-MODERNATX, INC.-MOD-2022-630555:88 year old male