chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: UNK
Symptoms: Malaise, Vitamin D decreased
Clinical narrative: Patient reports getting RSV vaccine but unable to provide any other information. Patient reports that he was sick for a month after receiving RSV vaccine, pt was vaccinated all during childhood, received one of the COVID vaccines (no other information provided on manufacter, lot, expiration, etc.), but does not routienly vaccinate as an adult (does not get annual flu shot); however did get an RSV vaccine that made him sick for a month. Patient also reports low vitamin d levels.
Age: 73.0
Sex: F
Vaccine: COVID19, PNC21
Symptoms: Amnesia, Confusional state, Malaise, Neurological symptom, Pyrexia
Clinical narrative: The patient reported being taken the the Emergency Department several hours following her two vaccines.  She was told by her husband and sister that she was exhibiting symptoms of a stroke, including confusion.  She was also running a 104-degree fever and felt "very sick" when she was taken to the hospital.  She has very little recollection of the series of events.  The physician treating her told the patient's sister that she was exhibiting symptoms of COVID-19 exposure, but to her knowledge they did not run a test to confirm this.  The patient was feeling well enough to discuss this with me the following day (4/4/2025) and appeared to be coherent and in good spirits.  She was discharged home and no further treatments were apparent at this time.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Brain fog, Dizziness, Eye disorder, Headache, Malaise
Clinical narrative: Sore entire right  arm that hasn't gone away. Ended into neck area and caused back headaches about 1-2 days after. Lasted until 03/31/25 Greying in right eye lasting 8 hours about 4 weeks after Malaise right away. Lasted until 03/31/25 Dizzyness and Lightheadedness continuously 2 days after receiving the vaccine, Lasted until 03/31/25 Feeling "in a fog" and not all there right away. Lasted until 03/31/25 As of 04/04/2025 only has the sore right arm and choose not to receive treatment
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Sore entire right  arm that hasn't gone away. Ended into neck area and caused back headaches about 1-2 days after. Lasted until 03/31/25 Greying in right eye lasting 8 hours about 4 weeks after Malaise right away. Lasted until 03/31/25 Dizzyness and Lightheadedness continuously 2 days after receiving the vaccine, Lasted until 03/31/25 Feeling "in a fog" and not all there right away. Lasted until 03/31/25 As of 04/04/2025 only has the sore right arm and choose not to receive treatment
Age: 50.0
Sex: F
Vaccine: PNC20
Symptoms: Blood test, Chills, Decreased appetite, Headache, Initial insomnia
Clinical narrative: Patient received Boostrix and Prevnar on 3/29/25.  At around nighttime on  3/30/25, she started experiencing pounding headaches, nausea, chills, loss of appetite and difficulty falling asleep.  Patient took tylenol so far and was prescribed ondansetron ODT on 4/4/25.  Blood work will be drawn on 4/5/25.
Age: 50.0
Sex: F
Vaccine: PNC20
Symptoms: Nausea
Clinical narrative: Patient received Boostrix and Prevnar on 3/29/25.  At around nighttime on  3/30/25, she started experiencing pounding headaches, nausea, chills, loss of appetite and difficulty falling asleep.  Patient took tylenol so far and was prescribed ondansetron ODT on 4/4/25.  Blood work will be drawn on 4/5/25.
Age: 68.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient received dupicate Prevnar20 vaccine first dose was given 12/22/2023
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Contusion, Immediate post-injection reaction, Mobility decreased
Clinical narrative: Symptoms of severe left shoulder pain, weakness, abnormal bruising, and decreased range of motion with onset immediately after vaccine which still persist today (2 weeks after vaccine administration). Diagnosed on 4/3/25 with SIRVA (shoulder injury related to vaccine administration) as a result of an administration error during this vaccination.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: Symptoms of severe left shoulder pain, weakness, abnormal bruising, and decreased range of motion with onset immediately after vaccine which still persist today (2 weeks after vaccine administration). Diagnosed on 4/3/25 with SIRVA (shoulder injury related to vaccine administration) as a result of an administration error during this vaccination.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Computerised tomogram head normal, Memory impairment
Clinical narrative: After my most recent Covid-19 booster 3-24-2025, I noticed a dramatic increase in memory issues. The most recent and disturbing was my loss of ability to remember which road to turn down to drive to the medical center I have been going to for 40 years. It was as if a screen in my mind went blank. I was fully aware of who I am, where I was, but I could not "see' which road I needed to turn down. I had to activate my Maps and look at it to remember the way. Very disturbing and different from the usual "where did I leave my coffee cup" that I have always had. I literally could not pull up my mental GPS.  These types of "going blank" have been slowly increasing since my first booster this year (9-6-2024). In doing some professional medical research reading, I found that memory issues, though rare can be a side-effect of Covid vaccines as well as the disease itself. I wanted to document my experience as the CT scan (listed below) came out "normal."
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Neovascular age-related macular degeneration, Retinal pigment epithelial tear
Clinical narrative: I have developed wet and in my left eye. It has been treated with eye I sections x 5 with no improvement then I developed PED in .y right eye with no treatment available.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site induration, Injection site mass
Clinical narrative: Next day, patient developed a white, hard, raised lump at the injection site about 3 inches in diameter.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction.  Vaccine was expired by 5 days at administration.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction.  Noting vaccine given 3 days after vaccine expiration.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction.  Noting that the vaccine was given 2 days after expiration date.
Age: 43.0
Sex: M
Vaccine: FLU3, HEPAB, HPV9, MMR, PNC21, FLU3, HEPAB, HPV9, MMR, PNC21
Symptoms: Erythema, Nausea, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Patient experiences redness/swelling/warmth and tenderness in the left arm (for the first few days but this has subsided). He also has had nausea and vomiting for 9 day which is still going on
Age: 43.0
Sex: M
Vaccine: FLU3, HEPAB, HPV9, MMR, PNC21, FLU3, HEPAB, HPV9, MMR, PNC21
Symptoms: Vomiting
Clinical narrative: Patient experiences redness/swelling/warmth and tenderness in the left arm (for the first few days but this has subsided). He also has had nausea and vomiting for 9 day which is still going on
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Hypoaesthesia, Vomiting
Clinical narrative: Arm felt numb, Dizziness and weakness, and felt like he was going to faint and throw-up, sweating,
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness, Posture abnormal
Clinical narrative: Immediately after injection, pt stated they felt faint, their head rolled back, they fainted, then about 30 seconds afterward they had a seizure for about 30 seconds. Pt slowly regained consciousness, followed by vomiting several times and sweating.  After about 30 minutes, pt was able to get up, leave and walk out of the store unaided.  Pt refused emergency services
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Syncope, Vomiting
Clinical narrative: Immediately after injection, pt stated they felt faint, their head rolled back, they fainted, then about 30 seconds afterward they had a seizure for about 30 seconds. Pt slowly regained consciousness, followed by vomiting several times and sweating.  After about 30 minutes, pt was able to get up, leave and walk out of the store unaided.  Pt refused emergency services
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Electric shock sensation
Clinical narrative: CNS effect, "jolts" shortness of breath
Age: 64.0
Sex: F
Vaccine: PNC21
Symptoms: Abdominal distension, Cellulitis, Decreased appetite, Injection site erythema
Clinical narrative: Patient reported redness and swelling in left upper arm, lack of appetite for 2 days, beginning 6 days after administration of vaccine (3/28/25). She went to her PCP on 4/4/25 and was prescribed Augmentin 875 mg twice daily for cellulitis. She reported the adverse reaction on 4/5/25 to the pharmacy when she came to pick up her prescription.
Age: 59.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Erythema, Flushing, Inflammation
Clinical narrative: pt experienced symptoms when she was home after receiving 2 vaccines. She said her left arm was sore inflamed and red. her neck was flushed , red and felt like hives. she took benadryl  over a couple days and started feeling better each day from 3/28/25 to 4/2/2025
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Cerebrovascular accident, Paralysis, Transient ischaemic attack
Clinical narrative: TIA, 8 hour stroke, hospitalized.  Paralysis, could not speak or move for 8 hours.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: quarter size bruise at injection site, no redness, tender only upon touch.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: 2 hours after administering, fatigue and arm soreness started. Around 8 pm the injection site started to feel hard and swell. The next morning it was significantly swollen. The symptoms at the injection site have increased exponentially, with a welt around 6 inches long and 3 inches wide. Currently experiencing swollen, Redness, Hot to touch, Peeling, Intense itching at the site, rest of body more sensitive to allergens.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity, Skin exfoliation, Urticaria
Clinical narrative: 2 hours after administering, fatigue and arm soreness started. Around 8 pm the injection site started to feel hard and swell. The next morning it was significantly swollen. The symptoms at the injection site have increased exponentially, with a welt around 6 inches long and 3 inches wide. Currently experiencing swollen, Redness, Hot to touch, Peeling, Intense itching at the site, rest of body more sensitive to allergens.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast mass, Breast swelling, Hamartoma, Intraductal proliferative breast lesion, Mammogram abnormal
Clinical narrative: I received the Pfizer COVID-19 vaccine in my right arm on May 15,2021 and the 2nd vaccine on June 10, 2021. in July of 2021 I developed a mass in my right breast that was later diagnosed as a hamartoma wild type. In February of 2023 DCIs was visible on a mammogram, that was not present six months prior. In September of 2023 I had swelling of my right breast and bloody discharge from nipple. In December 2023 I was diagnosed with ductal carcinoma in situ (DCIS), high-grade, also in my right breast. There is no family history of breast cancer, and I had no known prior breast abnormalities before this timeframe. I am reporting this due to the temporal relationship between the vaccine and the development of two separate breast-related conditions on the same side as the injection site. I understand this does not prove causation, but I believe it should be documented for safety monitoring purposes. I had a single mastectomy in February of 2024 with clean margins' and no lymph node involvement.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nipple exudate bloody, Pathology test, Simple mastectomy
Clinical narrative: I received the Pfizer COVID-19 vaccine in my right arm on May 15,2021 and the 2nd vaccine on June 10, 2021. in July of 2021 I developed a mass in my right breast that was later diagnosed as a hamartoma wild type. In February of 2023 DCIs was visible on a mammogram, that was not present six months prior. In September of 2023 I had swelling of my right breast and bloody discharge from nipple. In December 2023 I was diagnosed with ductal carcinoma in situ (DCIS), high-grade, also in my right breast. There is no family history of breast cancer, and I had no known prior breast abnormalities before this timeframe. I am reporting this due to the temporal relationship between the vaccine and the development of two separate breast-related conditions on the same side as the injection site. I understand this does not prove causation, but I believe it should be documented for safety monitoring purposes. I had a single mastectomy in February of 2024 with clean margins' and no lymph node involvement.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Carpal tunnel syndrome, Condition aggravated
Clinical narrative: The next day when I woke up I was unable to move my arm and my right hand was swollen and I was unable to do daily tasks like eat, write, drive or work and my legs became very swollen down to my feet . I also went to Emergency Dept twice and they referred me to a Neurologist and Orthopedic. I'm in constant pain and still unable to do daily tasks .
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Dysgraphia, Feeding disorder, Impaired driving ability, Impaired work ability
Clinical narrative: The next day when I woke up I was unable to move my arm and my right hand was swollen and I was unable to do daily tasks like eat, write, drive or work and my legs became very swollen down to my feet . I also went to Emergency Dept twice and they referred me to a Neurologist and Orthopedic. I'm in constant pain and still unable to do daily tasks .
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Loss of personal independence in daily activities, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: The next day when I woke up I was unable to move my arm and my right hand was swollen and I was unable to do daily tasks like eat, write, drive or work and my legs became very swollen down to my feet . I also went to Emergency Dept twice and they referred me to a Neurologist and Orthopedic. I'm in constant pain and still unable to do daily tasks .
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Acne conglobata, Cyst
Clinical narrative: Pfizer- following the vaccine I started getting cystic legions all over my head. They are now at a point that I am being reviewed for medical Retirment. Diagnosis (Dissecting Cellulitis of the Scalp).
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: patient started to experience burning, soreness and redness of area and then started blistering and sore like a boil.  She went to her Md and he said to take Claritin and apply ice to reduce redness.  Patient came in to report adverse reaction after speaking with her MD and she presented still with redness and burning of area but improving every day.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Erythema, Skin lesion, Urticaria
Clinical narrative: The hives were described as red raised welts, covering most of his body.  No joint swelling, no swelling of his eyelids, lips, tongue, scrotum, hands or feet were noted.  The hives were described as not painful, but did seem to bother him.  The individual lesions lasted less than 24 hours, and when they resolved, there was no residual bruise or mark that was left over.  He was initially treated with Benadryl, but this was felt to be giving him side effects, so this was switched to Zyrtec 2.5mg daily.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: A few days after my Shingrix shot, I developed a red rash on my lower back. Comparing my rash to images of Shingles online, it looked pretty similar. Red, bumpy. Not itchy, not painful unless I bumped it or rubbed up against it. It was more sensitive than painful. Lasted maybe two weeks and then went away.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Arthropathy, Mobility decreased, X-ray limb normal
Clinical narrative: Post-immunization arthropathy to Left shoulder w/ prolonged pain, limited range of motion.  Treated with NSAIDS initially, then escalated to oral corticosteroids for a burst and now receiving physical therapy.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor, Syncope
Clinical narrative: vasovagal syncope. pt said he has nausea and asked for trash, he thought he may vomit, I runned to the phone and called 911 for few seconds, as I was working alone. pt was getting pale, sweating,  dizzy, ears ringing and felt he will pass out.  pt did not loss conscious. 911 arrive and took over, pt did not go to the hospital. pt said he feels better.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Tinnitus
Clinical narrative: vasovagal syncope. pt said he has nausea and asked for trash, he thought he may vomit, I runned to the phone and called 911 for few seconds, as I was working alone. pt was getting pale, sweating,  dizzy, ears ringing and felt he will pass out.  pt did not loss conscious. 911 arrive and took over, pt did not go to the hospital. pt said he feels better.
Age: 10.0
Sex: M
Vaccine: FLUN3
Symptoms: Cardiac failure, Malaise
Clinical narrative: Sick,hart failure
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Insomnia, Peripheral swelling, Pruritus
Clinical narrative: Symptoms started the day following the vaccine.  She said her arm was swollen, red, and itchy. She also developed a headache and insomnia. She did not treat any symptoms. Today (6 days later) the patient reports her symptoms to be "much better", but she still has a headache and insomnia. The swelling has gone down. Arm is still red and itchy though. I recommended taking Claritin every day (she cannot take Benadryl) and ibuprofen until she can be seen by her physician.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Injected limb mobility decreased, Injection site pain, Laboratory test, Pain in extremity
Clinical narrative: Got the shot on 1/4/25. Starting feeling the sore arm within hours of the shot and as the days went on it got more painful and was not able to use my left are for much of anything  as my range of motion became extremely limited.  I ask my primary and she said if it didn't feel better in a few days she would look into it. I then had other test done because as you know if you say you have any pain in your arm and hands they run all kids of test and she did.  Once she realized I was not having  stroke symptoms she suggested we give it time and that we needed to focus on another issue I was having. Nothing pertaining to the arm of course.  It is now April and I need to get the second shot and at this appt the person asked if I had any issues with the first shot and I said yeas and that I am terrified of getting this second shot needed. I explained that I still have limited range of motion with severe  upper left arm pain and she gave me this information.
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site rash, Peripheral swelling, Skin mass, Skin warm
Clinical narrative: Patient reported a lump under her skin , swollen upper arm, warm, rash below injection site
Age: 0.17
Sex: F
Vaccine: RV1, DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: Cerebrovascular accident, Computerised tomogram, Endotracheal intubation, Haematemesis, Infantile diarrhoea
Clinical narrative: Received the vaccine and 3 days later patient first began throwing up blood and had diarrhea. Went to the hospital then she started having seizures and a stroke. She is now intubated and sedated. Nothing was wrong with her previously and was healthy.
Age: 0.17
Sex: F
Vaccine: RV1, DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: Lumbar puncture, Magnetic resonance imaging, Rotavirus test positive, Seizure
Clinical narrative: Received the vaccine and 3 days later patient first began throwing up blood and had diarrhea. Went to the hospital then she started having seizures and a stroke. She is now intubated and sedated. Nothing was wrong with her previously and was healthy.
Age: 0.17
Sex: F
Vaccine: RV1, DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: CSF test, Cerebrovascular accident, Computerised tomogram head abnormal, Culture, Dehydration
Clinical narrative: Received the vaccine and 3 days later patient first began throwing up blood and had diarrhea. Went to the hospital then she started having seizures and a stroke. She is now intubated and sedated. Nothing was wrong with her previously and was healthy.
Age: 0.17
Sex: F
Vaccine: RV1, DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: Endotracheal intubation, Epstein-Barr virus test positive, Haematemesis, Haematochezia, Infant irritability
Clinical narrative: Received the vaccine and 3 days later patient first began throwing up blood and had diarrhea. Went to the hospital then she started having seizures and a stroke. She is now intubated and sedated. Nothing was wrong with her previously and was healthy.
Age: 0.17
Sex: F
Vaccine: RV1, DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: Intensive care, Rotavirus test positive, Seizure, Staring, Streptococcus test positive
Clinical narrative: Received the vaccine and 3 days later patient first began throwing up blood and had diarrhea. Went to the hospital then she started having seizures and a stroke. She is now intubated and sedated. Nothing was wrong with her previously and was healthy.
Age: 0.17
Sex: F
Vaccine: RV1, DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: Vomiting
Clinical narrative: Received the vaccine and 3 days later patient first began throwing up blood and had diarrhea. Went to the hospital then she started having seizures and a stroke. She is now intubated and sedated. Nothing was wrong with her previously and was healthy.
Age: 56.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Headache, Hypersomnia, Influenza, Pyrexia
Clinical narrative: Got shot at 0900, diarrhea at 1300, fever and full blown flu symptoms at 1800, fever gone by 2300. Next day flu symptoms all day, slept whole day.  Felt better by third day around 1500.  Headache and some minor symptoms lingering for a week.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antiphospholipid syndrome, Beta-2 glycoprotein antibody, Cardiolipin antibody, Coeliac disease, Condition aggravated
Clinical narrative: I have celiacs and I was noticing in 2022 and 2023 I was starting to react more and having for fatigue and flare ups. My PCP sent me to an allergist who drew many labs and noted some high levels. He sent me to another provider to draw more labs which were abnormal. These tests were to be repeated after 12 weeks, and after 2 times with my numbers gettinh higher they sent me to an oncologist/hemotologist where she drew more labs multiple times. Due to the rarity of this new disease I have it has been dificult to have a plan. I developed APS (antiphospholipid syndrome) which typicaly will show some sort of blood clotting incident along with the labs. I have not had an "clotting" issue yet and for how high my numbers are tells me it was the vaccine that pushed it along.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Laboratory test abnormal
Clinical narrative: I have celiacs and I was noticing in 2022 and 2023 I was starting to react more and having for fatigue and flare ups. My PCP sent me to an allergist who drew many labs and noted some high levels. He sent me to another provider to draw more labs which were abnormal. These tests were to be repeated after 12 weeks, and after 2 times with my numbers gettinh higher they sent me to an oncologist/hemotologist where she drew more labs multiple times. Due to the rarity of this new disease I have it has been dificult to have a plan. I developed APS (antiphospholipid syndrome) which typicaly will show some sort of blood clotting incident along with the labs. I have not had an "clotting" issue yet and for how high my numbers are tells me it was the vaccine that pushed it along.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient signed up for RSV online and shot was never processed through the system. When patient arrived she mentioned she was receiving two vaccines prevnar and RSV. Pharmacist administered the shots right then the prevnar that was ready and the RSV and told patient she would give her the receipt after. Once she the vaccine was processed through the insurance is when it was noticed it was dose number 2.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash macular
Clinical narrative: Blotchy red, irritated at injection site
Age: 59.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: rejection site reaction. redness and pain at injection site. treatment prophylactic antibiotics and corticosteroid dose pack
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: I developed shingles after after my Modern Booster
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Gait disturbance, Granuloma annulare, Migraine, Neuropathy peripheral
Clinical narrative: Achalasia, Granuloma Annulare, Chronic Pneumonia, Migraine Headaches, Weakness, Inability to walk distances, neuropathy
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oesophageal achalasia, Pneumonia
Clinical narrative: Achalasia, Granuloma Annulare, Chronic Pneumonia, Migraine Headaches, Weakness, Inability to walk distances, neuropathy
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Fatigue, Lymph node pain, Lymphadenopathy, Rash
Clinical narrative: Supraclavicular lymphadenopathy - lymph nodes on bilateral clavicles swollen and tender to touch, brain fog, fatigue, itchy pink rash on thoracic region of back
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Supraclavicular lymphadenopathy - lymph nodes on bilateral clavicles swollen and tender to touch, brain fog, fatigue, itchy pink rash on thoracic region of back
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Pain/weakness/tingling in arm
Age: 0.17
Sex: F
Vaccine: RV1, DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: Cerebrovascular accident, Computerised tomogram, Endotracheal intubation, Haematemesis, Infantile diarrhoea
Clinical narrative: Patient was given routine vaccinations at her 2 month well check-up on 03/31/25. Mom states she was a bit fussy the next 24 hrs, which had been anticipated. On 04/03/25 she was being cared fro by a Grandparent when she started to have dark coffee-ground like emesis. Mom quickly took  patient to the local emergency department. She continued to have recurrent emesis and bloody stools. Was treated for dehydration and transferred to Hospital for admission.  Full cultures, CSF collected. Positive to date for Rotavirus, EBV (suspected from mom ) and Strep viridans (suspected contaminent). Subsequent reapet collections positive for Rotavirus. On Saturday 03/05/25 mom states patient started to appear to be doing better when she began to have staring episodes followed by seizures.  CT revealed multiple small strokes.  Due to continued seizures and respiratory concerns she was intubated and sedated. Sezuires being controlled with Keprra.  She remains in ICU as of 04/07/25.
Age: 0.17
Sex: F
Vaccine: RV1, DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: Lumbar puncture, Magnetic resonance imaging, Rotavirus test positive, Seizure
Clinical narrative: Patient was given routine vaccinations at her 2 month well check-up on 03/31/25. Mom states she was a bit fussy the next 24 hrs, which had been anticipated. On 04/03/25 she was being cared fro by a Grandparent when she started to have dark coffee-ground like emesis. Mom quickly took  patient to the local emergency department. She continued to have recurrent emesis and bloody stools. Was treated for dehydration and transferred to Hospital for admission.  Full cultures, CSF collected. Positive to date for Rotavirus, EBV (suspected from mom ) and Strep viridans (suspected contaminent). Subsequent reapet collections positive for Rotavirus. On Saturday 03/05/25 mom states patient started to appear to be doing better when she began to have staring episodes followed by seizures.  CT revealed multiple small strokes.  Due to continued seizures and respiratory concerns she was intubated and sedated. Sezuires being controlled with Keprra.  She remains in ICU as of 04/07/25.
Age: 0.17
Sex: F
Vaccine: RV1, DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: CSF test, Cerebrovascular accident, Computerised tomogram head abnormal, Culture, Dehydration
Clinical narrative: Patient was given routine vaccinations at her 2 month well check-up on 03/31/25. Mom states she was a bit fussy the next 24 hrs, which had been anticipated. On 04/03/25 she was being cared fro by a Grandparent when she started to have dark coffee-ground like emesis. Mom quickly took  patient to the local emergency department. She continued to have recurrent emesis and bloody stools. Was treated for dehydration and transferred to Hospital for admission.  Full cultures, CSF collected. Positive to date for Rotavirus, EBV (suspected from mom ) and Strep viridans (suspected contaminent). Subsequent reapet collections positive for Rotavirus. On Saturday 03/05/25 mom states patient started to appear to be doing better when she began to have staring episodes followed by seizures.  CT revealed multiple small strokes.  Due to continued seizures and respiratory concerns she was intubated and sedated. Sezuires being controlled with Keprra.  She remains in ICU as of 04/07/25.
Age: 0.17
Sex: F
Vaccine: RV1, DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: Endotracheal intubation, Epstein-Barr virus test positive, Haematemesis, Haematochezia, Infant irritability
Clinical narrative: Patient was given routine vaccinations at her 2 month well check-up on 03/31/25. Mom states she was a bit fussy the next 24 hrs, which had been anticipated. On 04/03/25 she was being cared fro by a Grandparent when she started to have dark coffee-ground like emesis. Mom quickly took  patient to the local emergency department. She continued to have recurrent emesis and bloody stools. Was treated for dehydration and transferred to Hospital for admission.  Full cultures, CSF collected. Positive to date for Rotavirus, EBV (suspected from mom ) and Strep viridans (suspected contaminent). Subsequent reapet collections positive for Rotavirus. On Saturday 03/05/25 mom states patient started to appear to be doing better when she began to have staring episodes followed by seizures.  CT revealed multiple small strokes.  Due to continued seizures and respiratory concerns she was intubated and sedated. Sezuires being controlled with Keprra.  She remains in ICU as of 04/07/25.
Age: 0.17
Sex: F
Vaccine: RV1, DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: Intensive care, Rotavirus test positive, Seizure, Staring, Streptococcus test positive
Clinical narrative: Patient was given routine vaccinations at her 2 month well check-up on 03/31/25. Mom states she was a bit fussy the next 24 hrs, which had been anticipated. On 04/03/25 she was being cared fro by a Grandparent when she started to have dark coffee-ground like emesis. Mom quickly took  patient to the local emergency department. She continued to have recurrent emesis and bloody stools. Was treated for dehydration and transferred to Hospital for admission.  Full cultures, CSF collected. Positive to date for Rotavirus, EBV (suspected from mom ) and Strep viridans (suspected contaminent). Subsequent reapet collections positive for Rotavirus. On Saturday 03/05/25 mom states patient started to appear to be doing better when she began to have staring episodes followed by seizures.  CT revealed multiple small strokes.  Due to continued seizures and respiratory concerns she was intubated and sedated. Sezuires being controlled with Keprra.  She remains in ICU as of 04/07/25.
Age: 0.17
Sex: F
Vaccine: RV1, DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: Vomiting
Clinical narrative: Patient was given routine vaccinations at her 2 month well check-up on 03/31/25. Mom states she was a bit fussy the next 24 hrs, which had been anticipated. On 04/03/25 she was being cared fro by a Grandparent when she started to have dark coffee-ground like emesis. Mom quickly took  patient to the local emergency department. She continued to have recurrent emesis and bloody stools. Was treated for dehydration and transferred to Hospital for admission.  Full cultures, CSF collected. Positive to date for Rotavirus, EBV (suspected from mom ) and Strep viridans (suspected contaminent). Subsequent reapet collections positive for Rotavirus. On Saturday 03/05/25 mom states patient started to appear to be doing better when she began to have staring episodes followed by seizures.  CT revealed multiple small strokes.  Due to continued seizures and respiratory concerns she was intubated and sedated. Sezuires being controlled with Keprra.  She remains in ICU as of 04/07/25.
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillian-Barre was a likely result of the immunization; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Guillian-Barre was a likely result of the immunization) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was resolving.   The reporter considered the guillain barre syndrome to be probably related to Shingrix.     The company considered the guillain barre syndrome to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 22-MAR-2025 This case was reported by a consumer via interactive digital media. The reporter reported he/she two years into recovering from a Shingrix dose.  Because symptoms took a month to develop neither the physician nor himself/herself understood that Guillian Barre was a likely result of the immunization.  Therefore, did not get to hospital for as close to a diagnosis as could get.  A cautionary tale to encourage people to research this syndrome and be informed enough to seek help. It could had been worse, but it was, and was, a nightmare.; Sender's Comments: Guillain-Barre syndrome is a listed event which, due to the following criteria (insufficient information on medical history, concurrent conditions, concomitant medications, completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Drug ineffective, Herpes zoster, Incomplete course of vaccination
Clinical narrative: Lack of drug effect/shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Lack of drug effect/shingles). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date:19-MAR-2025 The reporter was a friend of the consumer.   The consumer informed the reporter that he had one dose of Shingrix administered and then he got shingles (lack of effect). The reporter stated that the consumer only had one dose administered (missed dose). The reporter declined to provide any demographic information for himself or information regarding the consumer.   No other information provided/obtained including patient initials, DOB, HCP information/consent, lot number, date vaccinated, date diagnosed with shingles, outcome, dose, or route of administration.
Age: 12.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: administer an Engerix-B vaccine and it was expired, it expired 09-Mar-2025; received Engerix B on 29th July 2024 and 23 OCT 2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-year-old female patient who received HBV (Engerix B) (expiry date 09-MAR-2025) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b).   On 18-MAR-2025, the patient received the 3rd dose of Engerix B. On 23-OCT-2024, the patient received the 2nd dose of Engerix B. On 23-OCT-2024, not applicable after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: received Engerix B on 29th July 2024 and 23 OCT 2024). On 18-MAR-2025, the patient experienced expired vaccine used (Verbatim: administer an Engerix-B vaccine and it was expired, it expired 09-Mar-2025). The outcome of the expired vaccine used and drug dose administration interval too long were not applicable.   Additional Information: GSK Receipt Date: 19-MAR-2025 The patient received 2nd dose of Engerix B later than the recommended schedule, which led to lengthening of vaccination schedule. The patient received expired dose of Engerix B, which led to expired vaccine used.
Age: 16.0
Sex: F
Vaccine: MEN, MENB
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: cellulitis; This non-serious case was reported by a physician via other manufacturer and described the occurrence of cellulitis in a 16-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis.   On an unknown date, the patient received Bexsero (left arm) and Menquadfi (left arm). On an unknown date, less than a day after receiving Bexsero, the patient experienced cellulitis (Verbatim: cellulitis). The patient was treated with ibuprofen (Advil), paracetamol (Tylenol) and cephalexin. The outcome of the cellulitis was not resolved.   It was unknown if the reporter considered the cellulitis to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the cellulitis to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-MAR-2025 The patient received Bexsero and Menquadi administered and after injection site was wiped with alcohol swab.  The patient experienced significant pain started in left arm less than 5 hours after shot, advil provided around 8pm due to pain. Pain continued 16-March-2025, advil administered around 6am, alieve around 11am, and tylenol around 3pm. Touching/bumping arm caused significantly more pain. Rash, that was swollen, pink, and hot to the touch noted on arm around 8pm approximately 2cm below the injection site.  On 15-March-2025, 8 am pain persisted, rash was red, hot to the touch, very tender, and slightly outside circle drawn the night before.  On 15-March-2025 at 11am, diagnosed with cellulitis. Rash measured approximately 8 cm by 6cm. Oral cephalexin prescribed. It was unknown if the reporter considered the cellulitis to be related to Menquadfi.
Age: 16.0
Sex: F
Vaccine: MEN, MENB
Symptoms: Pain in extremity
Clinical narrative: cellulitis; This non-serious case was reported by a physician via other manufacturer and described the occurrence of cellulitis in a 16-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis.   On an unknown date, the patient received Bexsero (left arm) and Menquadfi (left arm). On an unknown date, less than a day after receiving Bexsero, the patient experienced cellulitis (Verbatim: cellulitis). The patient was treated with ibuprofen (Advil), paracetamol (Tylenol) and cephalexin. The outcome of the cellulitis was not resolved.   It was unknown if the reporter considered the cellulitis to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the cellulitis to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-MAR-2025 The patient received Bexsero and Menquadi administered and after injection site was wiped with alcohol swab.  The patient experienced significant pain started in left arm less than 5 hours after shot, advil provided around 8pm due to pain. Pain continued 16-March-2025, advil administered around 6am, alieve around 11am, and tylenol around 3pm. Touching/bumping arm caused significantly more pain. Rash, that was swollen, pink, and hot to the touch noted on arm around 8pm approximately 2cm below the injection site.  On 15-March-2025, 8 am pain persisted, rash was red, hot to the touch, very tender, and slightly outside circle drawn the night before.  On 15-March-2025 at 11am, diagnosed with cellulitis. Rash measured approximately 8 cm by 6cm. Oral cephalexin prescribed. It was unknown if the reporter considered the cellulitis to be related to Menquadfi.
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: feverish; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: feverish). The outcome of the fever was not reported.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.     It was unknown if the company considered the fever to be related to Shingles vaccine.   Additional Information: GSK Receipt Date:21-MAR-2025 This case was reported by a consumer via interactive digital media. The reporter stated that go ahead and get the new shots. The patient was feverish and schlepped around after the second one but didn't fret because he/she knew it was just his/her immune system revving up like a car in a passing lane.
Vaccine: VARZOS
Symptoms: Allergy to vaccine
Clinical narrative: I'm allergic to the vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergy to vaccine in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced allergy to vaccine (Verbatim: I'm allergic to the vaccine). The outcome of the allergy to vaccine was not reported.   It was unknown if the reporter considered the allergy to vaccine to be related to Shingles vaccine.     It was unknown if the company considered the allergy to vaccine to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-MAR-2025 This case was reported by a patient via interactive digital media. The patient got Shingles vaccine and was allergic to the vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced rash (Verbatim: Rash). The outcome of the rash was not reported.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     It was unknown if the company considered the rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date:19-MAR-2025 This case was reported by a patient's wife via interactive digital media. The patient had it and got the shot.  He didn't have pain and just had a little rash.  The reporter advised to get the shots.
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: very ill; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of unwell in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced unwell (Verbatim: very ill). The outcome of the unwell was not reported.   The reporter considered the unwell to be related to Shingles vaccine.     The company considered the unwell to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2025 The reporter reported everyone that he/she knows that's gotten the shingles shot, has been very ill from it. This case was linked with case US2025AMR034450 reported by the same reporter, for different patient.; Sender's Comments:  US-GSK-US2025AMR034450:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure, Visual impairment
Clinical narrative: Suspected Vaccination failure; almost lost his eyesight; got the shingles so bad on his face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 9 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), loss of vision (Verbatim: almost lost his eyesight) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: got the shingles so bad on his face). The outcome of the vaccination failure, loss of vision and facial herpes zoster were not reported.   It was unknown if the reporter considered the vaccination failure, loss of vision and facial herpes zoster to be related to Shingles vaccine.     The company considered the vaccination failure, loss of vision and facial herpes zoster to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-MAR-2025 This case was reported by a patient's brother via interactive digital media. The patient got the Shingles shot and then 9 months to a year later got the shingles so bad on his face and he almost lost his eyesight.  The reporter stated that don't get any jabs and said god did not create us that way, traditional medicine did. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine Herpes zoster and Blindness  are unlisted events which are considered unrelated to GSK Shingles vaccine."