chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test positive, Delivery, Exposure during pregnancy, Rash, Urticaria
Clinical narrative: Conceived 12/19/2021 (second pregnancy, carried to term), body welts/hives started 12/29/2021. Initially went to urgent care and later to ER (12/31/2021) because rash was unbearable. Was given multiple high doses of prednisone and then prescribed antihistamines (Zyrtec and Benadryl) for the entirety of my symptoms, which lasted for 15 months, though there are still lingering symptoms. Baby born, 8lbs. Coincidentally (or not), baby was rushed to the ER 4 days after his 2-month vaccines, and has since been diagnosed with congenital nystagmus with no co-occurring disease/disability, though his condition extends to balance and other vestibular functions.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test abnormal, Colonoscopy, Decreased appetite, Diarrhoea
Clinical narrative: 1 hour post vaccination, experienced sour taste in mouth. 6 days post vaccine, spit out small blood clots.  Went to hospital. Within 1 month post vaccine, experienced anorexia, feeling of fullness, nausea, diarrhea, stomach pain, heartburn, acid reflux, extreme fatigue, weight loss of 26 pounds, (1. 5  months post vaccination.)
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Duodenitis, Dysgeusia, Dyspepsia, Endoscopy abnormal, Fatigue
Clinical narrative: 1 hour post vaccination, experienced sour taste in mouth. 6 days post vaccine, spit out small blood clots.  Went to hospital. Within 1 month post vaccine, experienced anorexia, feeling of fullness, nausea, diarrhea, stomach pain, heartburn, acid reflux, extreme fatigue, weight loss of 26 pounds, (1. 5  months post vaccination.)
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Gastrooesophageal reflux disease, Haemoptysis, Metabolic function test, Nausea
Clinical narrative: 1 hour post vaccination, experienced sour taste in mouth. 6 days post vaccine, spit out small blood clots.  Went to hospital. Within 1 month post vaccine, experienced anorexia, feeling of fullness, nausea, diarrhea, stomach pain, heartburn, acid reflux, extreme fatigue, weight loss of 26 pounds, (1. 5  months post vaccination.)
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased, X-ray
Clinical narrative: 1 hour post vaccination, experienced sour taste in mouth. 6 days post vaccine, spit out small blood clots.  Went to hospital. Within 1 month post vaccine, experienced anorexia, feeling of fullness, nausea, diarrhea, stomach pain, heartburn, acid reflux, extreme fatigue, weight loss of 26 pounds, (1. 5  months post vaccination.)
Age: 3.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: Time course
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: patient came in the morning after vaccination with a large bruise, with no pain, on the arm of the injection site.  Patient was advised to go to the Emergency Room to have it checked out.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Arthritis, Injected limb mobility decreased, Magnetic resonance imaging abnormal, Magnetic resonance imaging joint
Clinical narrative: I felt like the vaccine was given higher up in my arm than it should have been. Then I started to have moderate R shoulder pain beginning later the same day that progressively worsened into the next day. I was unable to lift my arm up to take my clothes off, push down, pull up, or reach over my body without being in severe pain. Although somewhat improved, there is still ongoing pain.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Periarthritis, Tendonitis
Clinical narrative: I felt like the vaccine was given higher up in my arm than it should have been. Then I started to have moderate R shoulder pain beginning later the same day that progressively worsened into the next day. I was unable to lift my arm up to take my clothes off, push down, pull up, or reach over my body without being in severe pain. Although somewhat improved, there is still ongoing pain.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient seen on 4/19/25 for shingles rash that started 4/17/25, the same day she received the vaccine. It is unknown if the rash started before or after the vaccine as patient did not mention this at her visit.
Age: 59.0
Sex: F
Vaccine: PNC21
Symptoms: Urticaria
Clinical narrative: broke out in hives all over body.  pt went to urgent care and got treated.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Injection site bruising, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Earlier this morning on Saturday April 19th, patient came to the consultation window to show a bruise mark on her right arm from a Arexvy vaccine that she had received yesterday morning. During our consultation,  I asked if she was taking any blood thinners and she stated yes, but I didn't see anything listed under her medication history. The name of the blood thinner is unknown. Patient has a bruise mark on her right arm probably "2 inches wide by one inch and 1/2 tall." The color is more purplish-blue than red. She stated this vaccine was more painful compared to the other vaccines she has received in the past. I asked patient to describe the level of pain on a pain scale from 1 to 10 (where 1 is the lowest and 10 is the highest), as she rated it a four.    She stated it still felt warm to touch and a little swollen at the injection site. I recommended her to ice the site and monitor for any other signs in the next few days.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Additional dose error only, 2nd influenza vaccine in the 2024-2025 influenza season. Doses given around 6 months apart.  No adverse effects noted after the vaccination.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test normal, Contusion, Hypoaesthesia, Muscle spasms, Neuralgic amyotrophy
Clinical narrative: Three days following the vaccine, I have experienced all of the symptoms described with Parsonage-Turner Syndrome. There were no other possible causes of these symptoms. I was diagnosed on the 4th day after with a muscle spasm by my upper left shoulder blade. I was prescribed a muscle relaxer and steroids for 5 days. There has been no relief. I have had 2 therapeutic massages which has brought temporary relief but not long after the massage. I have experienced pain, numbness and tingling that radiates down my arm to my fingers. They are often numb and tingling. I have an unexplained purple bruise in the top of my hand of the same arm.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Paraesthesia, X-ray normal
Clinical narrative: Three days following the vaccine, I have experienced all of the symptoms described with Parsonage-Turner Syndrome. There were no other possible causes of these symptoms. I was diagnosed on the 4th day after with a muscle spasm by my upper left shoulder blade. I was prescribed a muscle relaxer and steroids for 5 days. There has been no relief. I have had 2 therapeutic massages which has brought temporary relief but not long after the massage. I have experienced pain, numbness and tingling that radiates down my arm to my fingers. They are often numb and tingling. I have an unexplained purple bruise in the top of my hand of the same arm.
Age: 62.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Redness, hardness, itching and pain at injection site- continued pain reported on 4/19/25. injected vaccine on 4/15/25.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Needle issue, Underdose
Clinical narrative: Needle was not screwed onto syringe tight enough and part of dose leaked out when being administered. Called patient and notified him dose should be repeated.
Age: 47.0
Sex: F
Vaccine: COVID19, HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Asthenia, Blood pressure decreased, Cyanosis, Dizziness, Electrocardiogram
Clinical narrative: Patient came into Pharmacy requesting 6 vaccines. She has no history on (state) shots registry as she is new to the country ( < 1 yr). She stated no pregnancy and NKDA. After administering the last vaccine. She stated that she did not feel well. I told her to remain seated. She fainted for about 45 seconds to 1 minute. her lips and skin on face became purple, she was non-responsive and very cold hands. Paramedics were called. her bp was a bit low 80/60. I applied ice packs, and alcohol up to her nose to stimulate a response. she slowly regained consciousness but was still feeling dizzy and weak. Paramedics took her vital and perform EKG. She did not need hospitalization and was ok to go back home with her husband.
Age: 47.0
Sex: F
Vaccine: COVID19, HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Malaise, Peripheral coldness, Syncope, Unresponsive to stimuli
Clinical narrative: Patient came into Pharmacy requesting 6 vaccines. She has no history on (state) shots registry as she is new to the country ( < 1 yr). She stated no pregnancy and NKDA. After administering the last vaccine. She stated that she did not feel well. I told her to remain seated. She fainted for about 45 seconds to 1 minute. her lips and skin on face became purple, she was non-responsive and very cold hands. Paramedics were called. her bp was a bit low 80/60. I applied ice packs, and alcohol up to her nose to stimulate a response. she slowly regained consciousness but was still feeling dizzy and weak. Paramedics took her vital and perform EKG. She did not need hospitalization and was ok to go back home with her husband.
Age: 65.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: red, hot painful arm
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: pt's husband reports fever and body aches for first two days.  now pt is having a full body rash
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood follicle stimulating hormone increased, Premature menopause, Ultrasound scan
Clinical narrative: Early menopause
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Rash, Skin fissures, Swelling face
Clinical narrative: Per patient, she developed a rash within 24 hours of receiving the vaccine. Vaccine was administered on 4/16/25 and reaction began 4/17/25. On 4/18/25, she developed facial swelling and noticed skin drying and cracking. Patient called at 5pm on 4/19/25 to report adverse event to pharmacy and was instructed to seek medical attention as soon as possible. Rash and some swelling is ongoing, but patient reported some relief when taking Benadryl.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Mild fever, rash primarily on torso and limbs, some rash on face
Age: 31.0
Sex: F
Vaccine: VARZOS
Symptoms: Brain fog, Chills, Dizziness, Fatigue, Injection site erythema
Clinical narrative: Dizziness, body aches, sudden jolts of pain in jaw, fatigue, brain fog, chills, fever, local swelling/redness/inching at injx site. Started 2 hours after injx, still ongoing though improving as of 4/19
Age: 31.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Pain, Pain in jaw, Pyrexia
Clinical narrative: Dizziness, body aches, sudden jolts of pain in jaw, fatigue, brain fog, chills, fever, local swelling/redness/inching at injx site. Started 2 hours after injx, still ongoing though improving as of 4/19
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Lethargy
Clinical narrative: All day headache and lethargy
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site haemorrhage
Clinical narrative: MD OFFICE CALLED PHARMACY TO INFORM PHARMCY THAT PATIENT'S SISTER CALLED MD OFFICE ON 4/16/25 AND STATED PATIENT RECEIVED VACCINE ON 4/10/25 AND THE SITE WAS BLEEDING AND BRUISED.  4/16/25 MD STATED UNCERTAIN HOW LONG OR HOW MUCH BLED BUT BLEEDING HAS ALREADY STOPPED ON 4/16/25
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Computerised tomogram head, Computerised tomogram neck, Disorientation
Clinical narrative: 103 fever followed by middle of the night awakening with prolonged disorientation and a stiff gait.  At 3am, he believed it was morning (despite it still being dark outside) and got dressed to go run errands.  Wife called 911 and he was taken to Hospital Center and admitted for stroke protocol.  After CT scan and MRI confirmed no evidence of stroke, he was discharged and told the disorientation and gait issues were the likely result of an inflammatory response to the Moderna vaccine received the day prior.  Prior COVID vaccines resulted in fever and body aches but no similar disorientation and gait issues.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Gait disturbance, Inflammation, Magnetic resonance imaging, Middle insomnia
Clinical narrative: 103 fever followed by middle of the night awakening with prolonged disorientation and a stiff gait.  At 3am, he believed it was morning (despite it still being dark outside) and got dressed to go run errands.  Wife called 911 and he was taken to Hospital Center and admitted for stroke protocol.  After CT scan and MRI confirmed no evidence of stroke, he was discharged and told the disorientation and gait issues were the likely result of an inflammatory response to the Moderna vaccine received the day prior.  Prior COVID vaccines resulted in fever and body aches but no similar disorientation and gait issues.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Urine analysis
Clinical narrative: 103 fever followed by middle of the night awakening with prolonged disorientation and a stiff gait.  At 3am, he believed it was morning (despite it still being dark outside) and got dressed to go run errands.  Wife called 911 and he was taken to Hospital Center and admitted for stroke protocol.  After CT scan and MRI confirmed no evidence of stroke, he was discharged and told the disorientation and gait issues were the likely result of an inflammatory response to the Moderna vaccine received the day prior.  Prior COVID vaccines resulted in fever and body aches but no similar disorientation and gait issues.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC15, RV5, DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: Cardiac arrest, Resuscitation
Clinical narrative: Cardiac arrest at home while sleeping. Ultimately achieved return of circulation in the ED after 30+ minutes of CPR. Concern for myocarditis as a potential cause of cardiac arrest.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC15, RV5, DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: Cardiac arrest, Death, Resuscitation
Clinical narrative: Cardiac arrest at home while sleeping. Ultimately achieved return of circulation in the ED after 30+ minutes of CPR. Concern for myocarditis as a potential cause of cardiac arrest.
Age: 61.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: left arm, warm, swollen, red and itchy
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Electric shock sensation, Electrocardiogram, Fatigue
Clinical narrative: Woke up from my sleep with around 2:30am with  what felt like fireworks going off in my head.  Felt like  I was about to die and told my wife to call 911 then I went Sepsis.  This happened around 12 hours after my injection.  911 showed up I back to and to and just wanted to go back to bed.  When I woke up in the morning I still felt ver seriously wrong I couldn't get out of bed.  Had my my call 911 again.  they rushed me to the hospital and when i arrived i went Sepsis again.   The stayed in the hospital over night while they ran tests.  They were not able to find anything wrong but I still felt extremely weak and sick and could barley move.  I had to take a leave from work and ended up having to leave my job because i was too sick to work.  I returned to the hospital many times after this event because I was not getting better.  The hospitals had no idea what to do so after years of no help I relied on my own research to help.  Through supplementation and hard work I have over come many of my symptoms in the last 4 years. However still to this day suffer from adverse effects from the vaccine which  I never had prior which include insomnia, fatigue, brain zaps.  and other issues
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Impaired work ability, Insomnia, Laboratory test, Malaise
Clinical narrative: Woke up from my sleep with around 2:30am with  what felt like fireworks going off in my head.  Felt like  I was about to die and told my wife to call 911 then I went Sepsis.  This happened around 12 hours after my injection.  911 showed up I back to and to and just wanted to go back to bed.  When I woke up in the morning I still felt ver seriously wrong I couldn't get out of bed.  Had my my call 911 again.  they rushed me to the hospital and when i arrived i went Sepsis again.   The stayed in the hospital over night while they ran tests.  They were not able to find anything wrong but I still felt extremely weak and sick and could barley move.  I had to take a leave from work and ended up having to leave my job because i was too sick to work.  I returned to the hospital many times after this event because I was not getting better.  The hospitals had no idea what to do so after years of no help I relied on my own research to help.  Through supplementation and hard work I have over come many of my symptoms in the last 4 years. However still to this day suffer from adverse effects from the vaccine which  I never had prior which include insomnia, fatigue, brain zaps.  and other issues
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Scan brain, Sepsis, Sleep disorder
Clinical narrative: Woke up from my sleep with around 2:30am with  what felt like fireworks going off in my head.  Felt like  I was about to die and told my wife to call 911 then I went Sepsis.  This happened around 12 hours after my injection.  911 showed up I back to and to and just wanted to go back to bed.  When I woke up in the morning I still felt ver seriously wrong I couldn't get out of bed.  Had my my call 911 again.  they rushed me to the hospital and when i arrived i went Sepsis again.   The stayed in the hospital over night while they ran tests.  They were not able to find anything wrong but I still felt extremely weak and sick and could barley move.  I had to take a leave from work and ended up having to leave my job because i was too sick to work.  I returned to the hospital many times after this event because I was not getting better.  The hospitals had no idea what to do so after years of no help I relied on my own research to help.  Through supplementation and hard work I have over come many of my symptoms in the last 4 years. However still to this day suffer from adverse effects from the vaccine which  I never had prior which include insomnia, fatigue, brain zaps.  and other issues
Age: 61.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: pt mentioned arm was right arm (where she received capvaxive) was quite sore and she couldn't lift arm very well. the area of shot was sensitive as well.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient was inadvertently given 3rd dose of shingles vaccine.
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Mild Localized Reaction - Erythema and swelling at the injection site noted on left upper arm. Treatment: symptomatic care and OTC meds recommended. Apply cold compress to the injection site for 20 minutes and repeat every 2-4 hours as needed. Consider OTC analgesic (pain reliever) unless contraindicated. Wear lightweight clothing over the injection site. Patient in no acute distress, strict UC/ER precautions provided. Recommended to monitor symptoms and  follow up if symptoms worsen or do not improve as discussed.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Blood test, Chromaturia, Diagnostic procedure, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: hemolytic anemia (symptoms included jaundice, dark urine, undetectable haptoglobin, low hematocrit and low hemoglobin), treated with Prednisone (60 mg/day for 3 wks, then 40 mg/day for 2 wks, then 30 mg/day for 2 wks, then 20 mg/day for 2 wks, then 15 mg/day for 2 wks, then 10 mg/day for 2 wks, then 5 mg/day for 3 wks, then 5 mg/on alternate days for 4 wks), resulting in restoration within 1 month and subsequent maintenance of normal hemoglobin levels - no recurrence over past 10 years
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Haemolytic anaemia, Haptoglobin decreased, Jaundice
Clinical narrative: hemolytic anemia (symptoms included jaundice, dark urine, undetectable haptoglobin, low hematocrit and low hemoglobin), treated with Prednisone (60 mg/day for 3 wks, then 40 mg/day for 2 wks, then 30 mg/day for 2 wks, then 20 mg/day for 2 wks, then 15 mg/day for 2 wks, then 10 mg/day for 2 wks, then 5 mg/day for 3 wks, then 5 mg/on alternate days for 4 wks), resulting in restoration within 1 month and subsequent maintenance of normal hemoglobin levels - no recurrence over past 10 years
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Kaleidoscope vision, Visual field defect
Clinical narrative: Approximately 34 hours after the vaccine, I developed a visual field deficit, which appeared like an arc of kaleidoscope or prism-like objects in my visual field. This madenit difficult to read sub-titles on the tv or even watch tv.  The visual disturbance persisted after turning the tv off.  It lasted 5 minutes and then resolved.  I worried this was a TIA or stroke symptom, but did not go to the hospital since it quickly resolved.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives, urticaria,
Age: 66.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Dizziness, Fatigue, Injection site rash, Pyrexia
Clinical narrative: Beginning the night after vaccinations, patient experienced severe dizziness, fatigue, and fever. Also rash around injection site. Treated with Tylenol and benadryl.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Back pain, Balance disorder, Chills, Diplopia, Fatigue
Clinical narrative: having a mild COVID-19 infection after a previous dose/had a very brief episode of mild COVID after the third Pfizer vaccine; having a mild COVID-19 infection after a previous dose/had a very brief episode of mild COVID after the third Pfizer vaccine; This is a spontaneous report received from a Physician from medical information team.  A male patient in his 70's received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "having a mild COVID-19 infection after a previous dose/had a very brief episode of mild COVID after the third Pfizer vaccine".  Clinical course: He recalled having a mild COVID-19 infection after the third Pfizer vaccine, with 3 to 4 rough days that included a bad headache, loss of smell and taste, but otherwise mild symptoms, almost like seasonal allergies. He believed the vaccine had helped protect him from more severe illness in that instance.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded.  ,Linked Report(s) : US-PFIZER INC-202500080996 same patient, different event, different dose of vaccine;US-PFIZER INC-202500081839 same patient, different event, different dose of vaccine;
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Neurological symptom, Pain in extremity, Poor quality sleep
Clinical narrative: having a mild COVID-19 infection after a previous dose/had a very brief episode of mild COVID after the third Pfizer vaccine; having a mild COVID-19 infection after a previous dose/had a very brief episode of mild COVID after the third Pfizer vaccine; This is a spontaneous report received from a Physician from medical information team.  A male patient in his 70's received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "having a mild COVID-19 infection after a previous dose/had a very brief episode of mild COVID after the third Pfizer vaccine".  Clinical course: He recalled having a mild COVID-19 infection after the third Pfizer vaccine, with 3 to 4 rough days that included a bad headache, loss of smell and taste, but otherwise mild symptoms, almost like seasonal allergies. He believed the vaccine had helped protect him from more severe illness in that instance.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded.  ,Linked Report(s) : US-PFIZER INC-202500080996 same patient, different event, different dose of vaccine;US-PFIZER INC-202500081839 same patient, different event, different dose of vaccine;
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: having a mild COVID-19 infection after a previous dose/had a very brief episode of mild COVID after the third Pfizer vaccine; having a mild COVID-19 infection after a previous dose/had a very brief episode of mild COVID after the third Pfizer vaccine; This is a spontaneous report received from a Physician from medical information team.  A male patient in his 70's received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "having a mild COVID-19 infection after a previous dose/had a very brief episode of mild COVID after the third Pfizer vaccine".  Clinical course: He recalled having a mild COVID-19 infection after the third Pfizer vaccine, with 3 to 4 rough days that included a bad headache, loss of smell and taste, but otherwise mild symptoms, almost like seasonal allergies. He believed the vaccine had helped protect him from more severe illness in that instance.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded.  ,Linked Report(s) : US-PFIZER INC-202500080996 same patient, different event, different dose of vaccine;US-PFIZER INC-202500081839 same patient, different event, different dose of vaccine;
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Cerebrovascular accident, Chest pain, Colitis, Dysphagia
Clinical narrative: having a mild COVID-19 infection after a previous dose/had a very brief episode of mild COVID after the third Pfizer vaccine; having a mild COVID-19 infection after a previous dose/had a very brief episode of mild COVID after the third Pfizer vaccine; This is a spontaneous report received from a Physician from medical information team.  A male patient in his 70's received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "having a mild COVID-19 infection after a previous dose/had a very brief episode of mild COVID after the third Pfizer vaccine".  Clinical course: He recalled having a mild COVID-19 infection after the third Pfizer vaccine, with 3 to 4 rough days that included a bad headache, loss of smell and taste, but otherwise mild symptoms, almost like seasonal allergies. He believed the vaccine had helped protect him from more severe illness in that instance.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded.  ,Linked Report(s) : US-PFIZER INC-202500080996 same patient, different event, different dose of vaccine;US-PFIZER INC-202500081839 same patient, different event, different dose of vaccine;
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Illness, Myalgia, Myocardial infarction, Myocarditis
Clinical narrative: having a mild COVID-19 infection after a previous dose/had a very brief episode of mild COVID after the third Pfizer vaccine; having a mild COVID-19 infection after a previous dose/had a very brief episode of mild COVID after the third Pfizer vaccine; This is a spontaneous report received from a Physician from medical information team.  A male patient in his 70's received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "having a mild COVID-19 infection after a previous dose/had a very brief episode of mild COVID after the third Pfizer vaccine".  Clinical course: He recalled having a mild COVID-19 infection after the third Pfizer vaccine, with 3 to 4 rough days that included a bad headache, loss of smell and taste, but otherwise mild symptoms, almost like seasonal allergies. He believed the vaccine had helped protect him from more severe illness in that instance.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded.  ,Linked Report(s) : US-PFIZER INC-202500080996 same patient, different event, different dose of vaccine;US-PFIZER INC-202500081839 same patient, different event, different dose of vaccine;
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pneumonia, Post-acute COVID-19 syndrome, Productive cough, Respiratory disorder, SARS-CoV-2 test
Clinical narrative: having a mild COVID-19 infection after a previous dose/had a very brief episode of mild COVID after the third Pfizer vaccine; having a mild COVID-19 infection after a previous dose/had a very brief episode of mild COVID after the third Pfizer vaccine; This is a spontaneous report received from a Physician from medical information team.  A male patient in his 70's received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "having a mild COVID-19 infection after a previous dose/had a very brief episode of mild COVID after the third Pfizer vaccine".  Clinical course: He recalled having a mild COVID-19 infection after the third Pfizer vaccine, with 3 to 4 rough days that included a bad headache, loss of smell and taste, but otherwise mild symptoms, almost like seasonal allergies. He believed the vaccine had helped protect him from more severe illness in that instance.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded.  ,Linked Report(s) : US-PFIZER INC-202500080996 same patient, different event, different dose of vaccine;US-PFIZER INC-202500081839 same patient, different event, different dose of vaccine;
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: having a mild COVID-19 infection after a previous dose/had a very brief episode of mild COVID after the third Pfizer vaccine; having a mild COVID-19 infection after a previous dose/had a very brief episode of mild COVID after the third Pfizer vaccine; This is a spontaneous report received from a Physician from medical information team.  A male patient in his 70's received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "having a mild COVID-19 infection after a previous dose/had a very brief episode of mild COVID after the third Pfizer vaccine".  Clinical course: He recalled having a mild COVID-19 infection after the third Pfizer vaccine, with 3 to 4 rough days that included a bad headache, loss of smell and taste, but otherwise mild symptoms, almost like seasonal allergies. He believed the vaccine had helped protect him from more severe illness in that instance.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded.  ,Linked Report(s) : US-PFIZER INC-202500080996 same patient, different event, different dose of vaccine;US-PFIZER INC-202500081839 same patient, different event, different dose of vaccine;
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: having a mild COVID-19 infection after a previous dose/had a very brief episode of mild COVID after the third Pfizer vaccine; having a mild COVID-19 infection after a previous dose/had a very brief episode of mild COVID after the third Pfizer vaccine; This is a spontaneous report received from a Physician from medical information team.  A male patient in his 70's received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "having a mild COVID-19 infection after a previous dose/had a very brief episode of mild COVID after the third Pfizer vaccine".  Clinical course: He recalled having a mild COVID-19 infection after the third Pfizer vaccine, with 3 to 4 rough days that included a bad headache, loss of smell and taste, but otherwise mild symptoms, almost like seasonal allergies. He believed the vaccine had helped protect him from more severe illness in that instance.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 in this patient cannot be completely excluded.  ,Linked Report(s) : US-PFIZER INC-202500080996 same patient, different event, different dose of vaccine;US-PFIZER INC-202500081839 same patient, different event, different dose of vaccine;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective
Clinical narrative: and left side of heart is enlarged a little bit; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 26May2022 as dose 4 (booster), single (Lot number: FN19992) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, lot: EN6205), administration date: 25Feb2021, for Covid-19 immunization, reaction(s): "Covid-19"; bnt162b2 (DOSE 2, SINGLE, lot: EP7534), administration date: 18Mar2021, for Covid-19 immunization, reaction(s): "Covid-19"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, lot: 30155BA), administration date: 15Oct2021, for Covid-19 immunization, reaction(s): "Covid-19". The following information was reported: CARDIOMEGALY (non-serious), outcome "unknown", described as "and left side of heart is enlarged a little bit".  Additional information: Reporter clarified and confirmed that she did have Covid every time, clarified caller had Covid after every Pfizer COVID vaccine, had Covid four times after getting the first Pfizer COVID vaccine, after each dose. Decided to stop taking, was too bad on heart, thinks did something to heart. Every time got sick, felt it doing something to heart. Goes to heart specialist, so tired all of the time, went in there this last 6 months, and left side of heart is enlarged a little bit.  No follow-up attempts are possible.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiomegaly
Clinical narrative: and left side of heart is enlarged a little bit; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 26May2022 as dose 4 (booster), single (Lot number: FN19992) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, lot: EN6205), administration date: 25Feb2021, for Covid-19 immunization, reaction(s): "Covid-19"; bnt162b2 (DOSE 2, SINGLE, lot: EP7534), administration date: 18Mar2021, for Covid-19 immunization, reaction(s): "Covid-19"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, lot: 30155BA), administration date: 15Oct2021, for Covid-19 immunization, reaction(s): "Covid-19". The following information was reported: CARDIOMEGALY (non-serious), outcome "unknown", described as "and left side of heart is enlarged a little bit".  Additional information: Reporter clarified and confirmed that she did have Covid every time, clarified caller had Covid after every Pfizer COVID vaccine, had Covid four times after getting the first Pfizer COVID vaccine, after each dose. Decided to stop taking, was too bad on heart, thinks did something to heart. Every time got sick, felt it doing something to heart. Goes to heart specialist, so tired all of the time, went in there this last 6 months, and left side of heart is enlarged a little bit.  No follow-up attempts are possible.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint injury
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: called patient and have not been able to make contact. on 4/13/2025 got a voicemail left that they would be unavailable and at a concert
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: called patient and have not been able to make contact. on 4/13/2025 got a voicemail left that they would be unavailable and at a concert
Age: 71.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Hypoaesthesia, Influenza like illness, Injection site pain, Nausea
Clinical narrative: 9:00 pm.  Chills, headache, nausea for 24 hours.  Injection sight red and swollen.
Age: 71.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: 9:00 pm.  Chills, headache, nausea for 24 hours.  Injection sight red and swollen.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Full body rash; This non-serious case was reported by a physician via sales rep and described the occurrence of generalized rash in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number Fj9a7, expiry date 16-JUL-2025) for prophylaxis.   On 21-JAN-2025, the patient received the 1st dose of Shingrix. On 24-JAN-2025, 3 days after receiving Shingrix, the patient experienced generalized rash (Verbatim: Full body rash). The outcome of the generalized rash was not resolved.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.     It was unknown if the company considered the generalized rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-APR-2025 The patient experienced full body rash.
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation issue
Clinical narrative: vaccine was not reconstitied with the adjuvant was just administered; vaccine was not reconstitied with the adjuvant was just administered; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number PC5Y3, expiry date 30-JAN-2027) for prophylaxis.   In APR-2025, the patient received Shingrix (unknown deltoid). In APR-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: vaccine was not reconstitied with the adjuvant was just administered) and inappropriate dose of vaccine administered (Verbatim: vaccine was not reconstitied with the adjuvant was just administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 14-APR-2025 There were no symptoms had been reported. Only adjuvant was administered to the patient without having it mixed with the Vaccine Inappropriate dose of vaccine administered and Inappropriate preparation of medication. The health care professional was unaware to whom they administered it too. It was when they were checking on their product quantity, they found out that the vaccine was not reconstituted with the adjuvant and the adjuvant was just administered. Unsure about primary disease because they do not know the patient and usually patient take it as a preventive measures. No further information.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Possible adminstration of Diluent only to the pateint; Possible adminstration of Diluent only to the pateint; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 3G5T3, expiry date 20-JUL-2026) for prophylaxis.   On 02-FEB-2025, the patient received the 2nd dose of Shingrix (right deltoid). On 02-FEB-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Possible adminstration of Diluent only to the pateint) and inappropriate dose of vaccine administered (Verbatim: Possible adminstration of Diluent only to the pateint). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 14-APR-2025 The nurse reported possible administration of diluent only to the patient which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case was linked with US2024158602, reported by same reporter.; Sender's Comments:  US-VIIV HEALTHCARE-US2024158602:same reporter
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: injection site was becoming red; the injection site was swollen; the injection site was hot; fever; Fatigue; Nausea; headach; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-APR-2025, the patient received the 1st dose of Shingrix. In APR-2025, less than a week after receiving Shingrix, the patient experienced injection site erythema (Verbatim: injection site was becoming red), injection site swelling (Verbatim: the injection site was swollen), injection site warmth (Verbatim: the injection site was hot), fever (Verbatim: fever), fatigue (Verbatim: Fatigue), nausea (Verbatim: Nausea) and headache (Verbatim: headach). The outcome of the injection site erythema, injection site swelling, injection site warmth, fever, fatigue, nausea and headache were not reported.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, fever, fatigue, nausea and headache to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site swelling, injection site warmth, fever, fatigue, nausea and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-APR-2025 The patient had Shingrix vaccine on 09 Apr 2025 and the injection site was becoming red and hot and swollen. Also running 100.4 fever, fatigue, nausea and headache. They questions was this ok and how likely would patient have such severe symptoms at second shot.
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: injection site was becoming red; the injection site was swollen; the injection site was hot; fever; Fatigue; Nausea; headach; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-APR-2025, the patient received the 1st dose of Shingrix. In APR-2025, less than a week after receiving Shingrix, the patient experienced injection site erythema (Verbatim: injection site was becoming red), injection site swelling (Verbatim: the injection site was swollen), injection site warmth (Verbatim: the injection site was hot), fever (Verbatim: fever), fatigue (Verbatim: Fatigue), nausea (Verbatim: Nausea) and headache (Verbatim: headach). The outcome of the injection site erythema, injection site swelling, injection site warmth, fever, fatigue, nausea and headache were not reported.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, fever, fatigue, nausea and headache to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site swelling, injection site warmth, fever, fatigue, nausea and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-APR-2025 The patient had Shingrix vaccine on 09 Apr 2025 and the injection site was becoming red and hot and swollen. Also running 100.4 fever, fatigue, nausea and headache. They questions was this ok and how likely would patient have such severe symptoms at second shot.